Trial Outcomes & Findings for Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer (NCT NCT01506609)

Last Updated: 2021-10-25

Results Overview

PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

294 participants

Primary outcome timeframe

Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.

Results posted on

2021-10-25

Participant Flow

Under the original protocol, approximately 4 participants were randomized in a 1:1:1 ratio (Group 1) to 1 of the 3 treatment arms (1 participant in veliparib 40 mg twice daily (BID)+temozolomide (TMZ) arm and a total of 3 participants in either the veliparib 80 mg BID+carboplatin+paclitaxel or the placebo BID+carboplatin+paclitaxel arms) at approximately 3 research sites. Participants randomized under the original protocol were in Group 1, and were not included in the primary efficacy analyses.

Following approval of Amendment 1, the veliparib dose in combination with carboplatin and paclitaxel was increased to 120 mg BID. Participants were randomized 1:1:1 ratio (Group 2) to 1 of the 3 treatment arms (veliparib 40 mg BID+TMZ, veliparib 120 mg BID+carboplatin+paclitaxel, placebo BID+carboplatin+paclitaxel) at approximately 120 research sites. Participants randomized following approval of Amendment 1 were in Group 2 and were included in the primary efficacy analyses.

Participant milestones

Participant milestones
Measure	Group 1 Placebo + Carboplatin/Paclitaxel Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + Carboplatin/Paclitaxel Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + TMZ Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.	Group 2 Placebo + Carboplatin/Paclitaxel Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.
Overall Study STARTED	2	1	1	99	97	94
Overall Study COMPLETED	0	0	0	0	1	0
Overall Study NOT COMPLETED	2	1	1	99	96	94

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Placebo + Carboplatin/Paclitaxel Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + Carboplatin/Paclitaxel Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + TMZ Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.	Group 2 Placebo + Carboplatin/Paclitaxel Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.
Overall Study Adverse Event Related to Progression	0	0	0	3	7	3
Overall Study Adverse Event Not Related to Progression	0	1	0	6	10	5
Overall Study Withdrawal by Subject	0	0	0	9	7	7
Overall Study Lost to Follow-up	0	0	0	1	2	0
Overall Study Sponsor Discontinued Study	0	0	0	2	2	0
Overall Study Progressive Disease per Protocol	1	0	0	64	57	74
Overall Study Other, Not Specified	0	0	0	10	7	3
Overall Study Missing / Unknown Reason	1	0	1	4	4	2

Baseline Characteristics

Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Placebo + Carboplatin/Paclitaxel n=2 Participants Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + Carboplatin/Paclitaxel n=1 Participants Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + TMZ n=1 Participants Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.	Group 2 Placebo + Carboplatin/Paclitaxel n=99 Participants Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel n=97 Participants Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ n=94 Participants Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.	Total n=294 Participants Total of all reporting groups
Age, Customized < 45 years	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	47 Participants n=4 Participants	49 Participants n=21 Participants	41 Participants n=8 Participants	140 Participants n=8 Participants
Age, Customized 45 to 64 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	49 Participants n=4 Participants	47 Participants n=21 Participants	46 Participants n=8 Participants	143 Participants n=8 Participants
Age, Customized >= 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=8 Participants	11 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	97 Participants n=4 Participants	95 Participants n=21 Participants	92 Participants n=8 Participants	288 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	5 Participants n=8 Participants	18 Participants n=8 Participants
Race/Ethnicity, Customized No Ethnicity	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	93 Participants n=4 Participants	90 Participants n=21 Participants	89 Participants n=8 Participants	276 Participants n=8 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	93 Participants n=4 Participants	92 Participants n=21 Participants	83 Participants n=8 Participants	272 Participants n=8 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=8 Participants	17 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Other, Not Specified	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.

Population: Group 2: All randomized participants with suspected deleterious or deleterious breast cancer gene (BRCA)1 or BRCA2 mutation determined by sponsor core lab.

Outcome measures

Outcome measures
Measure	Group 2 Placebo + Carboplatin/Paclitaxel n=98 Participants Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel n=95 Participants Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ n=91 Participants Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.
Progression-Free Survival (PFS)	12.3 months Interval 9.3 to 14.5	14.1 months Interval 11.5 to 16.2	7.4 months Interval 5.9 to 8.5

SECONDARY outcome

Timeframe: From Cycle 1 Day 1 until participant's death or 3 years post discontinuation (data cutoff date: 04 March 2016); maximum duration of follow up for OS was 72 months.

Population: Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab.

Time to death for a given participant was defined as the number of months from the day the participant is randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurs while the participant was still taking study drug, or after the participant discontinued study drug. If a participant had not died, then the data will be censored at the date when the participant was last known to be alive.

Outcome measures

Outcome measures
Measure	Group 2 Placebo + Carboplatin/Paclitaxel n=98 Participants Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel n=95 Participants Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ n=91 Participants Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.
Overall Survival (OS)	25.4 months Interval 18.3 to 32.1	28.3 months Interval 24.9 to 33.4	19.1 months Interval 14.3 to 21.3

SECONDARY outcome

Timeframe: Week 18

Population: Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab.

CBR: percentage of participants who were progression-free at 18 weeks, defined as complete response (CR), partial response (PR), stable disease (SD) or non-CR/non-disease progression (PD) per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 0 mm. PR: \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters (SOD). PD: \>= 20% increase in the SOD of target lesions, taking as reference the smallest SOD recorded since the treatment started (baseline or after) or the appearance of \>=1 new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after).

Outcome measures

Outcome measures
Measure	Group 2 Placebo + Carboplatin/Paclitaxel n=98 Participants Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel n=95 Participants Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ n=91 Participants Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.
Clinical Benefit Rate (CBR) at Week 18	87.0 percentage of participants Interval 78.3 to 92.4	90.7 percentage of participants Interval 82.2 to 95.2	73.0 percentage of participants Interval 62.2 to 81.2

SECONDARY outcome

Timeframe: Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for ORR was 34 months.

Population: Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab. Participants with at least 1 measurable lesion at baseline.

The objective response rate, defined as percentage of participants with a confirmed CR or PR based on RECIST 1.1 criteria. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 0 mm. PR: \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline SODs.

Outcome measures

Outcome measures
Measure	Group 2 Placebo + Carboplatin/Paclitaxel n=80 Participants Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel n=72 Participants Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ n=70 Participants Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.
Objective Response Rate (ORR)	61.3 percentage of participants Interval 49.7 to 71.9	77.8 percentage of participants Interval 66.4 to 86.7	28.6 percentage of participants Interval 18.4 to 40.6

SECONDARY outcome

Timeframe: Baseline, Week 18

Population: Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab. Participants with a baseline and post baseline value. Per protocol, this outcome measure was not planned for the Veliparib + TMZ arm.

EORTC QLQ-CIPN20 sensory subscale score was calculated following the standard scoring algorithm, transformed to a 0 (low quality of life) to 100 (best quality of life) scale. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Group 2 Placebo + Carboplatin/Paclitaxel n=62 Participants Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel n=69 Participants Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.
Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score	13.94 score on a scale Standard Deviation 14.123	11.24 score on a scale Standard Deviation 13.954	—

Adverse Events

Group 1 Placebo + Carboplatin/Paclitaxel

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Group 1 Veliparib + Carboplatin/Paclitaxel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Group 1 Veliparib + TMZ

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Group 2 Placebo + Carboplatin/Paclitaxel

Serious events: 26 serious events

Other events: 93 other events

Deaths: 65 deaths

Group 2 Veliparib + Carboplatin/Paclitaxel

Serious events: 32 serious events

Other events: 93 other events

Deaths: 59 deaths

Group 2 Veliparib + TMZ

Serious events: 16 serious events

Other events: 91 other events

Deaths: 76 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 Placebo + Carboplatin/Paclitaxel n=2 participants at risk Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + Carboplatin/Paclitaxel n=1 participants at risk Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + TMZ n=1 participants at risk Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.	Group 2 Placebo + Carboplatin/Paclitaxel n=96 participants at risk Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel n=93 participants at risk Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ n=93 participants at risk Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.
Infections and infestations DIVERTICULITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations EMPYEMA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations GASTROENTERITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations HERPES ZOSTER	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations MASTITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations OTITIS MEDIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations PNEUMONIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations PYELONEPHRITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations SEPSIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Injury, poisoning and procedural complications PROCEDURAL HYPOTENSION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Injury, poisoning and procedural complications RECALL PHENOMENON	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations BLOOD CREATININE INCREASED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations EJECTION FRACTION DECREASED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations OXYGEN SATURATION DECREASED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders PATHOLOGICAL FRACTURE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER METASTATIC	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders CENTRAL NERVOUS SYSTEM LESION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders HEADACHE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders SEIZURE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders SYNCOPE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders VOCAL CORD PARALYSIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Psychiatric disorders ANXIETY	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Renal and urinary disorders URINARY RETENTION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Vascular disorders THROMBOPHLEBITIS SUPERFICIAL	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Cardiac disorders CARDIAC TAMPONADE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Cardiac disorders TACHYCARDIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders DIARRHOEA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders NAUSEA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders VOMITING	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders ASTHENIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders DISEASE PROGRESSION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders FATIGUE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders PYREXIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders SUDDEN DEATH	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Hepatobiliary disorders BILE DUCT OBSTRUCTION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Hepatobiliary disorders HEPATOTOXICITY	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Immune system disorders DRUG HYPERSENSITIVITY	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations BACTERAEMIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations BETA HAEMOLYTIC STREPTOCOCCAL INFECTION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations BREAST CELLULITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations DEVICE RELATED INFECTION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.

Other adverse events

Other adverse events
Measure	Group 1 Placebo + Carboplatin/Paclitaxel n=2 participants at risk Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + Carboplatin/Paclitaxel n=1 participants at risk Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 1 Veliparib + TMZ n=1 participants at risk Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.	Group 2 Placebo + Carboplatin/Paclitaxel n=96 participants at risk Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + Carboplatin/Paclitaxel n=93 participants at risk Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.	Group 2 Veliparib + TMZ n=93 participants at risk Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.
Blood and lymphatic system disorders ANAEMIA	100.0% 2/2 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	51.0% 49/96 • Number of events 113 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	57.0% 53/93 • Number of events 139 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	28.0% 26/93 • Number of events 52 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders LEUKOPENIA	50.0% 1/2 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	28.1% 27/96 • Number of events 88 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	30.1% 28/93 • Number of events 112 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	17.2% 16/93 • Number of events 55 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders LYMPHOPENIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.2% 4/96 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	8.6% 8/93 • Number of events 30 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders NEUTROPENIA	100.0% 2/2 • Number of events 13 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	72.9% 70/96 • Number of events 373 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	73.1% 68/93 • Number of events 402 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	49.5% 46/93 • Number of events 211 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Blood and lymphatic system disorders THROMBOCYTOPENIA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	67.7% 65/96 • Number of events 239 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	71.0% 66/93 • Number of events 312 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	77.4% 72/93 • Number of events 187 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Cardiac disorders TACHYCARDIA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.2% 5/96 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Ear and labyrinth disorders EAR PAIN	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.1% 3/96 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Ear and labyrinth disorders VERTIGO	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.2% 5/96 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Eye disorders DRY EYE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.2% 5/96 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Eye disorders LACRIMATION INCREASED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.2% 5/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Eye disorders VISION BLURRED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.3% 7/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	12.9% 12/93 • Number of events 15 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	16.7% 16/96 • Number of events 19 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	21.5% 20/93 • Number of events 23 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	16.1% 15/93 • Number of events 24 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.3% 7/96 • Number of events 14 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	11.8% 11/93 • Number of events 15 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 14 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders CONSTIPATION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	29.2% 28/96 • Number of events 49 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	40.9% 38/93 • Number of events 57 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	40.9% 38/93 • Number of events 57 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders DIARRHOEA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	26.0% 25/96 • Number of events 44 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	39.8% 37/93 • Number of events 63 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	20.4% 19/93 • Number of events 27 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders DRY MOUTH	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.2% 4/96 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.5% 6/93 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	8.6% 8/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders DYSPEPSIA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.6% 15/96 • Number of events 23 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	9.7% 9/93 • Number of events 17 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.5% 6/93 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders GASTRITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.2% 4/96 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	9.7% 9/93 • Number of events 14 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders MELAENA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders NAUSEA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	58.3% 56/96 • Number of events 133 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	71.0% 66/93 • Number of events 152 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	74.2% 69/93 • Number of events 166 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders STOMATITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	11.5% 11/96 • Number of events 20 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	11.8% 11/93 • Number of events 15 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders TOOTHACHE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Gastrointestinal disorders VOMITING	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	22.9% 22/96 • Number of events 36 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	28.0% 26/93 • Number of events 41 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	43.0% 40/93 • Number of events 81 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders ASTHENIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.6% 15/96 • Number of events 29 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	24.7% 23/93 • Number of events 61 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	18.3% 17/93 • Number of events 59 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders CHILLS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.1% 3/96 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders FATIGUE	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	59.4% 57/96 • Number of events 141 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	50.5% 47/93 • Number of events 93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	47.3% 44/93 • Number of events 76 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.2% 4/96 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders MALAISE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders MUCOSAL INFLAMMATION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.3% 7/96 • Number of events 10 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	9.7% 9/93 • Number of events 10 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.2% 6/96 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.5% 6/93 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders OEDEMA PERIPHERAL	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	14.6% 14/96 • Number of events 18 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	14.0% 13/93 • Number of events 18 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.2% 4/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.1% 14/93 • Number of events 20 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
General disorders PYREXIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	18.8% 18/96 • Number of events 23 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	16.1% 15/93 • Number of events 16 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	9.7% 9/93 • Number of events 12 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Immune system disorders DRUG HYPERSENSITIVITY	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	16.7% 16/96 • Number of events 26 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	19.4% 18/93 • Number of events 24 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations EAR INFECTION	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations GASTROENTERITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations INFLUENZA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.1% 3/96 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations NASOPHARYNGITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	12.5% 12/96 • Number of events 13 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	12.9% 12/93 • Number of events 18 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations SINUSITIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.3% 7/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	10.4% 10/96 • Number of events 11 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	21.5% 20/93 • Number of events 28 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.1% 14/93 • Number of events 17 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	9.4% 9/96 • Number of events 14 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	12.9% 12/93 • Number of events 13 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	14.0% 13/93 • Number of events 13 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.2% 4/96 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.2% 5/96 • Number of events 10 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 10 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	10.4% 10/96 • Number of events 17 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	14.0% 13/93 • Number of events 20 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.5% 6/93 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	10.4% 10/96 • Number of events 12 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	10.8% 10/93 • Number of events 16 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	10.8% 10/93 • Number of events 12 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 11 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations PLATELET COUNT DECREASED	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.0% 1/96 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 12 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations WEIGHT DECREASED	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.2% 6/96 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Investigations WEIGHT INCREASED	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.2% 4/96 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	20.8% 20/96 • Number of events 27 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	23.7% 22/93 • Number of events 30 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	22.6% 21/93 • Number of events 29 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.2% 5/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.2% 6/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	9.7% 9/93 • Number of events 12 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	11.5% 11/96 • Number of events 18 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	18.3% 17/93 • Number of events 21 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders ARTHRALGIA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	32.3% 31/96 • Number of events 45 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	36.6% 34/93 • Number of events 62 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.1% 14/93 • Number of events 18 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	24.0% 23/96 • Number of events 40 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	30.1% 28/93 • Number of events 43 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	25.8% 24/93 • Number of events 32 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	12.5% 12/96 • Number of events 16 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	22.6% 21/93 • Number of events 37 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.5% 6/93 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	9.4% 9/96 • Number of events 9 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	10.8% 10/93 • Number of events 14 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.5% 6/93 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.3% 7/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.3% 7/96 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.1% 14/93 • Number of events 16 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	8.6% 8/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders MYALGIA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	20.8% 20/96 • Number of events 38 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	34.4% 32/93 • Number of events 56 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	8.6% 8/93 • Number of events 9 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.1% 3/96 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	24.0% 23/96 • Number of events 39 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	18.3% 17/93 • Number of events 55 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	14.0% 13/93 • Number of events 15 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders DISTURBANCE IN ATTENTION	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders DIZZINESS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	18.8% 18/96 • Number of events 28 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	24.7% 23/93 • Number of events 31 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders DYSGEUSIA	100.0% 2/2 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	12.5% 12/96 • Number of events 34 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	19.4% 18/93 • Number of events 19 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	12.9% 12/93 • Number of events 12 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders HEADACHE	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	32.3% 31/96 • Number of events 41 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	36.6% 34/93 • Number of events 61 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	29.0% 27/93 • Number of events 50 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders HYPOAESTHESIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.2% 6/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders LETHARGY	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/96 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	35.4% 34/96 • Number of events 64 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	45.2% 42/93 • Number of events 60 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders PARAESTHESIA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	17.7% 17/96 • Number of events 32 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	18.3% 17/93 • Number of events 24 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	22.9% 22/96 • Number of events 47 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	33.3% 31/93 • Number of events 64 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Psychiatric disorders ANXIETY	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.3% 7/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	10.8% 10/93 • Number of events 13 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 9 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Psychiatric disorders DEPRESSION	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.2% 6/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.3% 4/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Psychiatric disorders INSOMNIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	24.0% 23/96 • Number of events 26 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.1% 14/93 • Number of events 16 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	21.5% 20/93 • Number of events 21 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Renal and urinary disorders DYSURIA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.2% 4/96 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Reproductive system and breast disorders BREAST PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.2% 6/96 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.6% 15/96 • Number of events 23 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	22.6% 21/93 • Number of events 27 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	14.0% 13/93 • Number of events 23 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	22.9% 22/96 • Number of events 28 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.1% 14/93 • Number of events 16 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	8.6% 8/93 • Number of events 11 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.2% 6/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 8 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.1% 3/96 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	8.6% 8/93 • Number of events 10 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Skin and subcutaneous tissue disorders ALOPECIA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	57.3% 55/96 • Number of events 69 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	65.6% 61/93 • Number of events 79 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	10.8% 10/93 • Number of events 13 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 3 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.2% 6/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.5% 6/93 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.2% 6/96 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	12.9% 12/93 • Number of events 16 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	9.7% 9/93 • Number of events 9 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Skin and subcutaneous tissue disorders RASH	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	17.7% 17/96 • Number of events 23 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	7.5% 7/93 • Number of events 10 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Skin and subcutaneous tissue disorders URTICARIA	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.1% 2/96 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/93 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	1.1% 1/93 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Vascular disorders HAEMATOMA	0.00% 0/2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.2% 5/96 • Number of events 5 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	3.2% 3/93 • Number of events 4 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	6.5% 6/93 • Number of events 10 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Vascular disorders HOT FLUSH	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	100.0% 1/1 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	8.3% 8/96 • Number of events 12 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	15.1% 14/93 • Number of events 22 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	11.8% 11/93 • Number of events 13 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.
Vascular disorders HYPERTENSION	50.0% 1/2 • Number of events 1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	0.00% 0/1 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	4.2% 4/96 • Number of events 6 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	2.2% 2/93 • Number of events 2 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.	5.4% 5/93 • Number of events 7 • All cause mortality: from enrollment through data cutoff date (04 March 2016); maximum duration of follow up was 72 months. Adverse events (AEs) and serious AEs (SAEs): from first dose of study drug up to 30 days after the last dose of study drug. The median duration of treatment with study drug for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively. All-Cause Mortality: All randomized participants. AEs/SAEs: As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.

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