Trial Outcomes & Findings for Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT02470585)

NCT ID: NCT02470585

Last Updated: 2024-10-26

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1140 participants
• Primary outcome timeframe: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
• Results posted on: 2024-10-26

Participant Flow

This trial was conducted at 188 sites in 10 countries (Australia, Brazil, Denmark, Israel, Japan, Poland, Republic of Korea, Spain, United Kingdom, and United States).

Participants were randomized in a 1:1:1 ratio to one of three treatment groups. Randomization was stratified according to the timing of surgery and residual disease after primary surgery or interval surgery, the paclitaxel schedule, stage of disease, geographic region, and germline breast cancer susceptibility gene (BRCA) mutation status.

Participant milestones

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Overall Study STARTED	375	383	382
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	375	383	382

Reasons for withdrawal

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Overall Study Death	224	227	199
Overall Study Withdrew consent	21	22	31
Overall Study Lost to Follow-up	8	15	13
Overall Study Sponsor discontinued study	117	110	122
Overall Study Other, not specified	5	7	14
Overall Study Missing due to site non-compliance	0	2	3

Baseline Characteristics

Participants who underwent primary surgery

Baseline characteristics by cohort

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=375 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=383 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=382 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.	Total n=1140 Participants Total of all reporting groups
Age, Customized < 65 years	233 Participants n=375 Participants	226 Participants n=383 Participants	228 Participants n=382 Participants	687 Participants n=1140 Participants
Age, Customized ≥ 65 years	142 Participants n=375 Participants	157 Participants n=383 Participants	154 Participants n=382 Participants	453 Participants n=1140 Participants
Sex: Female, Male Female	375 Participants n=375 Participants	383 Participants n=383 Participants	382 Participants n=382 Participants	1140 Participants n=1140 Participants
Sex: Female, Male Male	0 Participants n=375 Participants	0 Participants n=383 Participants	0 Participants n=382 Participants	0 Participants n=1140 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=375 Participants	27 Participants n=383 Participants	26 Participants n=382 Participants	81 Participants n=1140 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	347 Participants n=375 Participants	356 Participants n=383 Participants	356 Participants n=382 Participants	1059 Participants n=1140 Participants
Age, Continuous	62.0 years n=375 Participants	62.0 years n=383 Participants	62.0 years n=382 Participants	62.0 years n=1140 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=375 Participants	0 Participants n=383 Participants	0 Participants n=382 Participants	0 Participants n=1140 Participants
Race/Ethnicity, Customized White	299 Participants n=375 Participants	297 Participants n=383 Participants	300 Participants n=382 Participants	896 Participants n=1140 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=375 Participants	13 Participants n=383 Participants	20 Participants n=382 Participants	43 Participants n=1140 Participants
Race/Ethnicity, Customized Asian	59 Participants n=375 Participants	69 Participants n=383 Participants	56 Participants n=382 Participants	184 Participants n=1140 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=375 Participants	1 Participants n=383 Participants	1 Participants n=382 Participants	3 Participants n=1140 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=375 Participants	0 Participants n=383 Participants	2 Participants n=382 Participants	3 Participants n=1140 Participants
Race/Ethnicity, Customized Multi-race	3 Participants n=375 Participants	0 Participants n=383 Participants	0 Participants n=382 Participants	3 Participants n=1140 Participants
Race/Ethnicity, Customized Missing	2 Participants n=375 Participants	3 Participants n=383 Participants	3 Participants n=382 Participants	8 Participants n=1140 Participants
Geographic Region North America	266 Participants n=375 Participants	261 Participants n=383 Participants	267 Participants n=382 Participants	794 Participants n=1140 Participants
Geographic Region Japan	23 Participants n=375 Participants	30 Participants n=383 Participants	25 Participants n=382 Participants	78 Participants n=1140 Participants
Geographic Region Rest of World	86 Participants n=375 Participants	92 Participants n=383 Participants	90 Participants n=382 Participants	268 Participants n=1140 Participants
BRCA-Deficient Status Germline or tissue BRCA1/2 mutation	92 Participants n=375 Participants	98 Participants n=383 Participants	108 Participants n=382 Participants	298 Participants n=1140 Participants
BRCA-Deficient Status Germline or tissue BRCA1/2 wildtype	254 Participants n=375 Participants	243 Participants n=383 Participants	245 Participants n=382 Participants	742 Participants n=1140 Participants
BRCA-Deficient Status Missing	29 Participants n=375 Participants	42 Participants n=383 Participants	29 Participants n=382 Participants	100 Participants n=1140 Participants
Homologous Recombination Deficiency (HRD) Status HRD	207 Participants n=375 Participants	206 Participants n=383 Participants	214 Participants n=382 Participants	627 Participants n=1140 Participants
Homologous Recombination Deficiency (HRD) Status Non-HRD	124 Participants n=375 Participants	123 Participants n=383 Participants	125 Participants n=382 Participants	372 Participants n=1140 Participants
Homologous Recombination Deficiency (HRD) Status Missing	44 Participants n=375 Participants	54 Participants n=383 Participants	43 Participants n=382 Participants	141 Participants n=1140 Participants
Stage of Disease Stage III	292 Participants n=375 Participants	288 Participants n=383 Participants	295 Participants n=382 Participants	875 Participants n=1140 Participants
Stage of Disease Stage IV	82 Participants n=375 Participants	94 Participants n=383 Participants	87 Participants n=382 Participants	263 Participants n=1140 Participants
Stage of Disease Missing	1 Participants n=375 Participants	1 Participants n=383 Participants	0 Participants n=382 Participants	2 Participants n=1140 Participants
Type of Surgery Received Primary	250 Participants n=375 Participants	253 Participants n=383 Participants	261 Participants n=382 Participants	764 Participants n=1140 Participants
Type of Surgery Received Interval	107 Participants n=375 Participants	114 Participants n=383 Participants	99 Participants n=382 Participants	320 Participants n=1140 Participants
Type of Surgery Received No surgery received	18 Participants n=375 Participants	16 Participants n=383 Participants	22 Participants n=382 Participants	56 Participants n=1140 Participants
Residual Disease After Primary Surgery No residual disease	116 Participants n=250 Participants • Participants who underwent primary surgery	118 Participants n=253 Participants • Participants who underwent primary surgery	124 Participants n=261 Participants • Participants who underwent primary surgery	358 Participants n=764 Participants • Participants who underwent primary surgery
Residual Disease After Primary Surgery Microscopic residual disease only	58 Participants n=250 Participants • Participants who underwent primary surgery	46 Participants n=253 Participants • Participants who underwent primary surgery	54 Participants n=261 Participants • Participants who underwent primary surgery	158 Participants n=764 Participants • Participants who underwent primary surgery
Residual Disease After Primary Surgery Any macroscopic residual disease	76 Participants n=250 Participants • Participants who underwent primary surgery	89 Participants n=253 Participants • Participants who underwent primary surgery	83 Participants n=261 Participants • Participants who underwent primary surgery	248 Participants n=764 Participants • Participants who underwent primary surgery
Residual Disease After Interval Surgery No residual disease	50 Participants n=107 Participants • Participants who underwent interval surgery	46 Participants n=114 Participants • Participants who underwent interval surgery	45 Participants n=99 Participants • Participants who underwent interval surgery	141 Participants n=320 Participants • Participants who underwent interval surgery
Residual Disease After Interval Surgery Microscopic residual disease only	22 Participants n=107 Participants • Participants who underwent interval surgery	30 Participants n=114 Participants • Participants who underwent interval surgery	24 Participants n=99 Participants • Participants who underwent interval surgery	76 Participants n=320 Participants • Participants who underwent interval surgery
Residual Disease After Interval Surgery Any macroscopic residual disease	31 Participants n=107 Participants • Participants who underwent interval surgery	34 Participants n=114 Participants • Participants who underwent interval surgery	27 Participants n=99 Participants • Participants who underwent interval surgery	92 Participants n=320 Participants • Participants who underwent interval surgery
Residual Disease After Interval Surgery Missing	4 Participants n=107 Participants • Participants who underwent interval surgery	4 Participants n=114 Participants • Participants who underwent interval surgery	3 Participants n=99 Participants • Participants who underwent interval surgery	11 Participants n=320 Participants • Participants who underwent interval surgery
Paclitaxel Dosing Regimen Weekly	193 Participants n=375 Participants	203 Participants n=383 Participants	190 Participants n=382 Participants	586 Participants n=1140 Participants
Paclitaxel Dosing Regimen Every 3 weeks	179 Participants n=375 Participants	178 Participants n=383 Participants	189 Participants n=382 Participants	546 Participants n=1140 Participants
Paclitaxel Dosing Regimen Missing	3 Participants n=375 Participants	2 Participants n=383 Participants	3 Participants n=382 Participants	8 Participants n=1140 Participants
Germline BRCA Status Germline BRCA1/2 mutation	63 Participants n=375 Participants	71 Participants n=383 Participants	80 Participants n=382 Participants	214 Participants n=1140 Participants
Germline BRCA Status Germline BRCA1/2 wildtype	305 Participants n=375 Participants	305 Participants n=383 Participants	298 Participants n=382 Participants	908 Participants n=1140 Participants
Germline BRCA Status Missing	7 Participants n=375 Participants	7 Participants n=383 Participants	4 Participants n=382 Participants	18 Participants n=1140 Participants

PRIMARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

Population: Analyses were performed in 3 sequentially inclusive populations. The first analysis was conducted using the BRCA-mutation cohort which included participants with either a gBRCA and/or tBRCA deleterious or suspected deleterious mutation in BRCA1 or BRCA2.

PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached.

Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=92 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=98 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=108 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)	22.0 months Interval 17.8 to 29.1	21.1 months Interval 17.0 to 25.5	34.7 months Interval 31.8 to Could not be estimated due to the low number of events

PRIMARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

Population: Analyses were performed in 3 sequentially inclusive populations. The second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors.

PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations.

Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.

.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=207 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=206 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=214 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)	20.5 months Interval 17.8 to 22.8	18.1 months Interval 16.4 to 22.7	31.9 months Interval 25.8 to 38.0

PRIMARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

Population: Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants).

PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method.

Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.

The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=375 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=383 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=382 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)	17.3 months Interval 15.1 to 19.1	15.2 months Interval 14.1 to 17.3	23.5 months Interval 19.3 to 26.3

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

Population: Analyses were performed in 3 sequentially inclusive populations. The first analysis was conducted using the BRCA-mutation cohort which included participants with either a gBRCA and/or tBRCA deleterious or suspected deleterious mutation in BRCA1 or BRCA2.

PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached.

Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=92 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=98 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=108 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)	22.0 months Interval 17.8 to 29.1	21.1 months Interval 17.0 to 25.5	34.7 months Interval 31.8 to Could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

Population: Analyses were performed in 3 sequentially inclusive populations. The second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors.

PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations.

Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.

.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=207 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=206 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=214 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1)	20.5 months Interval 17.8 to 22.8	18.1 months Interval 16.4 to 22.7	31.9 months Interval 25.8 to 38.0

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

Population: Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants).

PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method.

Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.

The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=375 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=383 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=382 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1)	17.3 months Interval 15.1 to 19.1	15.2 months Interval 14.1 to 17.3	23.5 months Interval 19.3 to 26.3

SECONDARY outcome

Timeframe: From the time of randomization to the end of the study, up to 98 months

Population: BRCA-Deficient population: All randomized participants with germline and/or tissue deleterious/suspected deleterious BRCA1/2 mutation

OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=92 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=98 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=108 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Overall Survival (OS) in the BRCA-deficient Population	89.5 months Interval 83.3 to Could not be estimated due to the low number of events	NA months Interval 69.3 to Could not be estimated due to the low number of events	NA months Could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: From the time of randomization to the end of the study, up to 98 months

Population: All randomized participants considered BRCA-Deficient and those determined to have HRD tumors based on HRD score

OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=207 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=206 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=214 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Overall Survival (OS) in the Homologous Recombination Deficiency Population	71.5 months Interval 59.6 to 87.6	74.4 months Interval 65.4 to Could not be estimated due to the low number of events	NA months Interval 73.8 to Could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: From the time of randomization to the end of the study, up to 98 months

Population: All randomized participants

OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=375 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=383 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=382 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Overall Survival (OS) in the Whole Population	57.8 months Interval 52.3 to 63.8	58.0 months Interval 50.6 to 64.1	59.2 months Interval 52.1 to 68.2

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

Population: BRCA-mutation population, participants with available data at each time point.

The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement.

Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate.

DRS was not included in the fixed-sequence testing procedure.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=92 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=98 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=108 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 3	1.8 score on a scale Standard Error 0.52	0.5 score on a scale Standard Error 0.53	0.9 score on a scale Standard Error 0.51
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 5	1.7 score on a scale Standard Error 0.57	0.7 score on a scale Standard Error 0.58	0.3 score on a scale Standard Error 0.56
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 7	2.6 score on a scale Standard Error 0.55	1.8 score on a scale Standard Error 0.54	1.8 score on a scale Standard Error 0.54
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 9	3.3 score on a scale Standard Error 0.60	3.3 score on a scale Standard Error 0.60	2.4 score on a scale Standard Error 0.59
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 11	3.2 score on a scale Standard Error 0.56	3.6 score on a scale Standard Error 0.55	2.9 score on a scale Standard Error 0.54
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 13	3.6 score on a scale Standard Error 0.57	3.8 score on a scale Standard Error 0.57	3.0 score on a scale Standard Error 0.57
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 15	4.3 score on a scale Standard Error 0.53	4.0 score on a scale Standard Error 0.54	3.4 score on a scale Standard Error 0.52
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 17	3.8 score on a scale Standard Error 0.56	4.0 score on a scale Standard Error 0.57	3.2 score on a scale Standard Error 0.55
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 19	4.0 score on a scale Standard Error 0.62	4.0 score on a scale Standard Error 0.63	2.7 score on a scale Standard Error 0.59
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 21	4.6 score on a scale Standard Error 0.59	3.9 score on a scale Standard Error 0.59	3.2 score on a scale Standard Error 0.55
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 23	4.2 score on a scale Standard Error 0.55	4.0 score on a scale Standard Error 0.56	2.8 score on a scale Standard Error 0.52
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 25	4.0 score on a scale Standard Error 0.58	5.0 score on a scale Standard Error 0.60	3.5 score on a scale Standard Error 0.55
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 27	4.5 score on a scale Standard Error 0.56	4.8 score on a scale Standard Error 0.56	3.0 score on a scale Standard Error 0.52
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 29	4.0 score on a scale Standard Error 0.66	5.3 score on a scale Standard Error 0.66	2.9 score on a scale Standard Error 0.59
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 31	4.8 score on a scale Standard Error 0.57	4.8 score on a scale Standard Error 0.58	2.9 score on a scale Standard Error 0.52
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 33	3.9 score on a scale Standard Error 0.66	5.1 score on a scale Standard Error 0.67	3.9 score on a scale Standard Error 0.59
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population Cycle 35	4.5 score on a scale Standard Error 0.61	5.0 score on a scale Standard Error 0.62	3.2 score on a scale Standard Error 0.56

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

Population: HRD population, participants with available data at each time point.

The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement.

Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate.

DRS was not included in the fixed-sequence testing procedure.

Outcome measures

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=207 Participants Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=206 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=214 Participants Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 3	1.5 score on a scale Standard Error 0.35	0.5 score on a scale Standard Error 0.36	0.9 score on a scale Standard Error 0.35
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 5	1.7 score on a scale Standard Error 0.37	1.1 score on a scale Standard Error 0.37	0.8 score on a scale Standard Error 0.37
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 7	2.4 score on a scale Standard Error 0.35	1.8 score on a scale Standard Error 0.36	2.2 score on a scale Standard Error 0.35
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 9	3.3 score on a scale Standard Error 0.37	3.6 score on a scale Standard Error 0.38	2.3 score on a scale Standard Error 0.38
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 11	3.5 score on a scale Standard Error 0.36	3.5 score on a scale Standard Error 0.36	2.7 score on a scale Standard Error 0.36
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 13	3.6 score on a scale Standard Error 0.37	3.8 score on a scale Standard Error 0.38	2.7 score on a scale Standard Error 0.39
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 15	4.2 score on a scale Standard Error 0.35	3.9 score on a scale Standard Error 0.36	3.3 score on a scale Standard Error 0.37
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 17	3.9 score on a scale Standard Error 0.39	3.4 score on a scale Standard Error 0.40	3.0 score on a scale Standard Error 0.40
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 19	4.2 score on a scale Standard Error 0.40	3.7 score on a scale Standard Error 0.42	2.7 score on a scale Standard Error 0.41
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 21	4.6 score on a scale Standard Error 0.40	3.6 score on a scale Standard Error 0.41	3.0 score on a scale Standard Error 0.40
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 23	4.1 score on a scale Standard Error 0.38	3.6 score on a scale Standard Error 0.39	3.1 score on a scale Standard Error 0.38
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 25	4.1 score on a scale Standard Error 0.40	4.4 score on a scale Standard Error 0.41	3.5 score on a scale Standard Error 0.40
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 27	4.4 score on a scale Standard Error 0.39	4.4 score on a scale Standard Error 0.40	3.0 score on a scale Standard Error 0.38
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 29	4.2 score on a scale Standard Error 0.43	4.7 score on a scale Standard Error 0.44	3.2 score on a scale Standard Error 0.41
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 31	3.9 score on a scale Standard Error 0.41	4.3 score on a scale Standard Error 0.42	3.3 score on a scale Standard Error 0.40
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 33	4.2 score on a scale Standard Error 0.45	4.7 score on a scale Standard Error 0.45	3.9 score on a scale Standard Error 0.42
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population Cycle 35	4.1 score on a scale Standard Error 0.44	4.6 score on a scale Standard Error 0.45	3.4 score on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

Population: All randomized participants with available data at each time point

The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement.

Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease, stage of disease, choice of paclitaxel dosing regimen and BRCA-deficient status, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate.

DRS was not included in the fixed-sequence testing procedure.

Outcome measures

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

Adverse Events

Placebo + Carboplatin + Paclitaxel -> Placebo

Serious events: 143 serious events

Other events: 369 other events

Deaths: 228 deaths

Veliparib + Carboplatin + Paclitaxel -> Placebo

Serious events: 130 serious events

Other events: 375 other events

Deaths: 234 deaths

Veliparib + Carboplatin + Paclitaxel -> Veliparib

Serious events: 146 serious events

Other events: 376 other events

Deaths: 209 deaths

Serious adverse events

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=375 participants at risk Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=383 participants at risk Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=382 participants at risk Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent\\ veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Blood and lymphatic system disorders ANAEMIA	1.1% 4/375 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.4% 13/383 • Number of events 14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.7% 14/382 • Number of events 18 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders APLASTIC ANAEMIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders BONE MARROW FAILURE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	2.4% 9/375 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.0% 19/383 • Number of events 20 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.9% 15/382 • Number of events 17 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders NEUTROPENIA	1.6% 6/375 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.2% 16/383 • Number of events 22 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.1% 12/382 • Number of events 16 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.80% 3/375 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.3% 9/383 • Number of events 12 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.6% 10/382 • Number of events 20 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Cardiac disorders ACUTE CORONARY SYNDROME	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Cardiac disorders ATRIAL FIBRILLATION	0.80% 3/375 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Cardiac disorders MYOCARDIAL INFARCTION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Cardiac disorders PALPITATIONS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Cardiac disorders STRESS CARDIOMYOPATHY	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Cardiac disorders TACHYCARDIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Endocrine disorders ADRENAL INSUFFICIENCY	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Endocrine disorders HYPERTHYROIDISM	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Eye disorders VISION BLURRED	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ABDOMINAL ADHESIONS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ABDOMINAL HERNIA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ABDOMINAL INCARCERATED HERNIA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ABDOMINAL PAIN	1.3% 5/375 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.3% 9/383 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.4% 9/382 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ASCITES	1.9% 7/375 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.78% 3/383 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders COLITIS	0.27% 1/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.78% 3/383 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders COLITIS ULCERATIVE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders CONSTIPATION	0.80% 3/375 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.3% 5/383 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders DIARRHOEA	0.80% 3/375 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.0% 4/383 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders DIVERTICULAR PERFORATION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ENTEROCOLITIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders EPIPLOIC APPENDAGITIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders GASTRIC VOLVULUS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders HAEMOPERITONEUM	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders HIATUS HERNIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ILEAL PERFORATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ILEUS	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.8% 7/383 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.79% 3/382 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.53% 2/375 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.6% 6/382 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders INTESTINAL PERFORATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders INTESTINAL PSEUDO-OBSTRUCTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders INTRA-ABDOMINAL FLUID COLLECTION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders LARGE INTESTINAL OBSTRUCTION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders LARGE INTESTINE PERFORATION	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders MECHANICAL ILEUS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders NAUSEA	1.1% 4/375 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.9% 11/383 • Number of events 11 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.4% 13/382 • Number of events 16 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders OESOPHAGITIS ULCERATIVE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders PANCREATITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders PNEUMOPERITONEUM	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.80% 3/375 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	5.1% 19/375 • Number of events 22 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.4% 13/383 • Number of events 17 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.9% 11/382 • Number of events 14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders SMALL INTESTINAL PERFORATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders SPIGELIAN HERNIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders VOMITING	1.3% 5/375 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.6% 10/383 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.1% 12/382 • Number of events 16 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders ASTHENIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders CHEST DISCOMFORT	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders CHEST PAIN	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders CHILLS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders DISEASE PROGRESSION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders FATIGUE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders HERNIA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders IMPLANT SITE EXTRAVASATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders INCARCERATED HERNIA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders NON-CARDIAC CHEST PAIN	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.0% 4/382 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders PAIN	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders PELVIC MASS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders PYREXIA	1.6% 6/375 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.78% 3/383 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.4% 9/382 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Hepatobiliary disorders BILE DUCT STONE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Hepatobiliary disorders CHOLECYSTITIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Immune system disorders ANAPHYLACTIC REACTION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Immune system disorders DRUG HYPERSENSITIVITY	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations ABDOMINAL ABSCESS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.78% 3/383 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations ATYPICAL MYCOBACTERIAL INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations BACTERAEMIA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations BACTEROIDES BACTERAEMIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations BRONCHITIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations CATHETER SITE INFECTION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations CELLULITIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.80% 3/375 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations COLONIC ABSCESS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations CYSTITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations DEVICE RELATED INFECTION	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations DIVERTICULITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations EMPYEMA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations ENDOCARDITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations ENTEROBACTER INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations ENTEROCOCCAL BACTERAEMIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations ENTEROCOLITIS INFECTIOUS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations ERYSIPELAS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations ESCHERICHIA INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations GASTROENTERITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations GROIN ABSCESS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations HERPES ZOSTER	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations IMPLANT SITE INFECTION	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations INFECTED LYMPHOCELE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations INFLUENZA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.78% 3/383 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.79% 3/382 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations INTERVERTEBRAL DISCITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations KIDNEY INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations LARGE INTESTINE INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations LYMPHANGITIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations MENINGITIS CRYPTOCOCCAL	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations NAIL INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations NASOPHARYNGITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations NEUTROPENIC SEPSIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations OPHTHALMIC HERPES ZOSTER	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations OSTEOMYELITIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations OTITIS MEDIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PELVIC ABSCESS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PELVIC INFECTION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PERIORBITAL CELLULITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PERITONEAL ABSCESS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PERITONITIS	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PHARYNGITIS STREPTOCOCCAL	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PHLEBITIS INFECTIVE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PNEUMONIA	1.6% 6/375 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.3% 5/383 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.0% 4/382 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PNEUMONIA ASPIRATION	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations POST PROCEDURAL INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations POSTOPERATIVE ABSCESS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations PYELONEPHRITIS ACUTE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations SEPSIS	1.9% 7/375 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.78% 3/383 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.3% 5/382 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations SEPTIC EMBOLUS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations SEPTIC SHOCK	1.3% 5/375 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.78% 3/383 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.0% 4/382 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations SPONTANEOUS BACTERIAL PERITONITIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations SUBCUTANEOUS ABSCESS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations SUBDIAPHRAGMATIC ABSCESS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations SYSTEMIC CANDIDA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations URINARY TRACT INFECTION	1.1% 4/375 • Number of events 5 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.6% 6/383 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.8% 7/382 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations UROSEPSIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations VIRAL INFECTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations WOUND INFECTION	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.78% 3/383 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications ACETABULUM FRACTURE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications ANASTOMOTIC LEAK	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications CONCUSSION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications FALL	1.9% 7/375 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications FRACTURED SACRUM	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications GASTROINTESTINAL STOMA COMPLICATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications HEAT ILLNESS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications INTESTINAL ANASTOMOSIS COMPLICATION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications MULTIPLE INJURIES	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications PELVIC FRACTURE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications PROCEDURAL COMPLICATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications RIB FRACTURE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications SKELETAL INJURY	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications SPINAL FRACTURE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications VAGINAL CUFF DEHISCENCE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications WOUND COMPLICATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications WOUND DECOMPOSITION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Investigations SOLUBLE FIBRIN MONOMER COMPLEX INCREASED	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders DEHYDRATION	1.6% 6/375 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.6% 6/382 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPERKALAEMIA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.79% 3/382 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPONATRAEMIA	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.6% 6/382 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 3 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	3.7% 14/375 • Number of events 14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.9% 11/383 • Number of events 13 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.3% 5/382 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PLEURAL EFFUSION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO CENTRAL NERVOUS SYSTEM	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN CANCER	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders CEREBELLAR INFARCTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders CEREBRAL ARTERY EMBOLISM	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders CEREBRAL VENOUS SINUS THROMBOSIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders HEADACHE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders HYPERSOMNIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders MIGRAINE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders MIGRAINE WITH AURA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders NEURALGIA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders SYNCOPE	1.6% 6/375 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.6% 6/382 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Product Issues DEVICE BREAKAGE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Product Issues DEVICE DISLOCATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Psychiatric disorders ANXIETY	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Psychiatric disorders CONFUSIONAL STATE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Psychiatric disorders DEPRESSION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Psychiatric disorders SUICIDE ATTEMPT	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Renal and urinary disorders HAEMATURIA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Renal and urinary disorders HYDRONEPHROSIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Renal and urinary disorders RENAL INFARCT	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Renal and urinary disorders RENAL VEIN THROMBOSIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Renal and urinary disorders URETEROLITHIASIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Renal and urinary disorders URINARY RETENTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Reproductive system and breast disorders FEMALE GENITAL TRACT FISTULA	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders DYSPNOEA AT REST	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	1.1% 4/375 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.8% 7/383 • Number of events 7 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS ASPIRATION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX SPONTANEOUS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	2.7% 10/375 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.6% 10/383 • Number of events 11 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.1% 12/382 • Number of events 13 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders PULMONARY THROMBOSIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT CONGESTION	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders DEEP VEIN THROMBOSIS	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.0% 4/382 • Number of events 4 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders EMBOLISM	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders HYPERTENSION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders HYPOTENSION	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/383 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders JUGULAR VEIN THROMBOSIS	0.53% 2/375 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.52% 2/382 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders LYMPHOCELE	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders PHLEBITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders SUBCLAVIAN VEIN THROMBOSIS	0.27% 1/375 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders THROMBOPHLEBITIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/383 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/382 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders VENOUS THROMBOSIS	0.00% 0/375 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.00% 0/383 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	0.26% 1/382 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.

Other adverse events

Measure	Placebo + Carboplatin + Paclitaxel -> Placebo n=375 participants at risk Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Placebo n=383 participants at risk Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.	Veliparib + Carboplatin + Paclitaxel -> Veliparib n=382 participants at risk Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent\\ veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
Blood and lymphatic system disorders ANAEMIA	50.9% 191/375 • Number of events 514 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	60.6% 232/383 • Number of events 603 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	59.2% 226/382 • Number of events 672 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders LEUKOPENIA	23.7% 89/375 • Number of events 223 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	22.7% 87/383 • Number of events 261 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	29.8% 114/382 • Number of events 333 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders LYMPHOPENIA	4.0% 15/375 • Number of events 28 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.9% 15/383 • Number of events 20 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.8% 26/382 • Number of events 57 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders NEUTROPENIA	65.9% 247/375 • Number of events 673 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	69.5% 266/383 • Number of events 881 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	71.5% 273/382 • Number of events 848 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Blood and lymphatic system disorders THROMBOCYTOPENIA	31.7% 119/375 • Number of events 266 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	56.4% 216/383 • Number of events 630 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	54.7% 209/382 • Number of events 735 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Eye disorders VISION BLURRED	8.5% 32/375 • Number of events 33 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.0% 19/383 • Number of events 22 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	7.1% 27/382 • Number of events 27 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ABDOMINAL DISTENSION	12.0% 45/375 • Number of events 55 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	12.5% 48/383 • Number of events 54 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.9% 34/382 • Number of events 39 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ABDOMINAL PAIN	30.4% 114/375 • Number of events 163 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	27.4% 105/383 • Number of events 143 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	30.9% 118/382 • Number of events 162 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	7.7% 29/375 • Number of events 38 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.7% 18/383 • Number of events 24 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	7.6% 29/382 • Number of events 37 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders CONSTIPATION	41.9% 157/375 • Number of events 203 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	46.2% 177/383 • Number of events 241 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	43.2% 165/382 • Number of events 228 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders DIARRHOEA	39.7% 149/375 • Number of events 248 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	35.8% 137/383 • Number of events 228 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	42.9% 164/382 • Number of events 255 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders DRY MOUTH	5.1% 19/375 • Number of events 20 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.6% 10/383 • Number of events 12 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.8% 22/382 • Number of events 23 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders DYSPEPSIA	10.9% 41/375 • Number of events 53 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	11.7% 45/383 • Number of events 55 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	9.4% 36/382 • Number of events 42 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	5.9% 22/375 • Number of events 23 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	7.3% 28/383 • Number of events 30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.9% 34/382 • Number of events 46 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders NAUSEA	65.6% 246/375 • Number of events 425 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	67.6% 259/383 • Number of events 433 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	75.7% 289/382 • Number of events 578 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders STOMATITIS	13.9% 52/375 • Number of events 67 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	12.3% 47/383 • Number of events 52 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	15.4% 59/382 • Number of events 67 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Gastrointestinal disorders VOMITING	34.1% 128/375 • Number of events 211 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	32.1% 123/383 • Number of events 170 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	45.5% 174/382 • Number of events 309 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders ASTHENIA	7.5% 28/375 • Number of events 58 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	9.4% 36/383 • Number of events 56 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	10.7% 41/382 • Number of events 64 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders FATIGUE	58.9% 221/375 • Number of events 353 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	61.4% 235/383 • Number of events 407 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	67.3% 257/382 • Number of events 456 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders MALAISE	5.6% 21/375 • Number of events 34 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.7% 22/383 • Number of events 31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.1% 31/382 • Number of events 37 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders MUCOSAL INFLAMMATION	5.1% 19/375 • Number of events 21 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.2% 16/383 • Number of events 18 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.7% 18/382 • Number of events 21 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders OEDEMA PERIPHERAL	19.5% 73/375 • Number of events 84 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	15.1% 58/383 • Number of events 62 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	14.7% 56/382 • Number of events 77 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders PAIN	5.9% 22/375 • Number of events 25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.7% 22/383 • Number of events 31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.5% 21/382 • Number of events 23 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
General disorders PYREXIA	6.7% 25/375 • Number of events 28 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.6% 33/383 • Number of events 38 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.0% 23/382 • Number of events 30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Immune system disorders DRUG HYPERSENSITIVITY	16.8% 63/375 • Number of events 84 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	12.5% 48/383 • Number of events 63 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	13.4% 51/382 • Number of events 56 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations NASOPHARYNGITIS	5.6% 21/375 • Number of events 26 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.0% 19/383 • Number of events 22 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.8% 26/382 • Number of events 32 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations SINUSITIS	4.8% 18/375 • Number of events 27 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.7% 18/383 • Number of events 20 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.5% 21/382 • Number of events 22 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	11.5% 43/375 • Number of events 52 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	7.3% 28/383 • Number of events 36 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.9% 34/382 • Number of events 44 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Infections and infestations URINARY TRACT INFECTION	17.9% 67/375 • Number of events 104 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	16.7% 64/383 • Number of events 91 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	18.3% 70/382 • Number of events 91 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications CONTUSION	3.5% 13/375 • Number of events 13 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.4% 17/383 • Number of events 21 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.2% 20/382 • Number of events 28 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications FALL	5.1% 19/375 • Number of events 20 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.9% 15/383 • Number of events 16 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.7% 18/382 • Number of events 23 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Injury, poisoning and procedural complications PROCEDURAL PAIN	9.9% 37/375 • Number of events 46 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.7% 18/383 • Number of events 19 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.5% 25/382 • Number of events 25 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Investigations ALANINE AMINOTRANSFERASE INCREASED	10.9% 41/375 • Number of events 64 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.1% 31/383 • Number of events 55 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	10.5% 40/382 • Number of events 52 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	8.3% 31/375 • Number of events 46 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.7% 22/383 • Number of events 41 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.1% 31/382 • Number of events 35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	5.1% 19/375 • Number of events 26 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.6% 10/383 • Number of events 13 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.2% 16/382 • Number of events 21 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Investigations WEIGHT DECREASED	8.5% 32/375 • Number of events 45 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	10.7% 41/383 • Number of events 52 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	14.1% 54/382 • Number of events 71 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Investigations WEIGHT INCREASED	9.3% 35/375 • Number of events 49 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.8% 26/383 • Number of events 34 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	9.4% 36/382 • Number of events 52 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders DECREASED APPETITE	22.7% 85/375 • Number of events 101 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	21.4% 82/383 • Number of events 106 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	28.8% 110/382 • Number of events 143 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders DEHYDRATION	5.3% 20/375 • Number of events 21 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.4% 32/383 • Number of events 48 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	7.9% 30/382 • Number of events 37 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPERGLYCAEMIA	4.8% 18/375 • Number of events 35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.7% 18/383 • Number of events 26 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	7.1% 27/382 • Number of events 50 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	5.1% 19/375 • Number of events 31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.1% 12/383 • Number of events 17 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.2% 16/382 • Number of events 31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPOKALAEMIA	18.4% 69/375 • Number of events 107 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	17.8% 68/383 • Number of events 113 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	15.4% 59/382 • Number of events 94 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	26.1% 98/375 • Number of events 199 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	25.1% 96/383 • Number of events 142 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	22.3% 85/382 • Number of events 143 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPONATRAEMIA	6.7% 25/375 • Number of events 33 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.5% 21/383 • Number of events 24 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.5% 25/382 • Number of events 35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	5.6% 21/375 • Number of events 31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	3.7% 14/383 • Number of events 18 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.9% 11/382 • Number of events 14 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders ARTHRALGIA	36.3% 136/375 • Number of events 217 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	29.2% 112/383 • Number of events 152 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	29.8% 114/382 • Number of events 166 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders BACK PAIN	17.6% 66/375 • Number of events 87 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	17.2% 66/383 • Number of events 75 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	17.5% 67/382 • Number of events 88 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders BONE PAIN	7.2% 27/375 • Number of events 46 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.5% 25/383 • Number of events 36 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.6% 33/382 • Number of events 37 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	6.1% 23/375 • Number of events 28 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.3% 24/383 • Number of events 34 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.0% 23/382 • Number of events 33 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders MYALGIA	20.0% 75/375 • Number of events 106 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	15.4% 59/383 • Number of events 80 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	18.6% 71/382 • Number of events 96 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	14.7% 55/375 • Number of events 70 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	12.0% 46/383 • Number of events 56 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	13.4% 51/382 • Number of events 64 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders DIZZINESS	24.0% 90/375 • Number of events 121 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	21.7% 83/383 • Number of events 105 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	26.2% 100/382 • Number of events 126 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders DYSGEUSIA	15.2% 57/375 • Number of events 70 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	12.3% 47/383 • Number of events 54 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	19.1% 73/382 • Number of events 80 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders HEADACHE	25.9% 97/375 • Number of events 136 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	23.5% 90/383 • Number of events 124 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	25.7% 98/382 • Number of events 143 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	68.3% 256/375 • Number of events 415 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	61.4% 235/383 • Number of events 346 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	63.4% 242/382 • Number of events 373 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Nervous system disorders TREMOR	2.4% 9/375 • Number of events 11 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.6% 6/383 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.0% 23/382 • Number of events 26 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Psychiatric disorders ANXIETY	15.5% 58/375 • Number of events 72 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	15.9% 61/383 • Number of events 74 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	15.4% 59/382 • Number of events 70 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Psychiatric disorders DEPRESSION	10.4% 39/375 • Number of events 46 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	12.0% 46/383 • Number of events 58 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.9% 34/382 • Number of events 43 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Psychiatric disorders INSOMNIA	23.7% 89/375 • Number of events 105 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	31.3% 120/383 • Number of events 141 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	28.5% 109/382 • Number of events 134 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Renal and urinary disorders DYSURIA	5.9% 22/375 • Number of events 24 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.4% 17/383 • Number of events 18 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.2% 16/382 • Number of events 17 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders COUGH	15.5% 58/375 • Number of events 70 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	14.9% 57/383 • Number of events 63 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	15.4% 59/382 • Number of events 70 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	20.3% 76/375 • Number of events 106 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	23.8% 91/383 • Number of events 112 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	22.0% 84/382 • Number of events 111 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	15.7% 59/375 • Number of events 70 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	15.9% 61/383 • Number of events 66 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	14.7% 56/382 • Number of events 61 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	6.9% 26/375 • Number of events 29 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	1.6% 6/383 • Number of events 6 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	4.7% 18/382 • Number of events 22 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	10.4% 39/375 • Number of events 46 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	6.3% 24/383 • Number of events 27 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	7.1% 27/382 • Number of events 33 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Skin and subcutaneous tissue disorders ALOPECIA	57.1% 214/375 • Number of events 271 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	56.4% 216/383 • Number of events 271 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	51.6% 197/382 • Number of events 256 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Skin and subcutaneous tissue disorders NAIL DISCOLOURATION	5.6% 21/375 • Number of events 21 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.6% 10/383 • Number of events 10 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.4% 9/382 • Number of events 9 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Skin and subcutaneous tissue disorders PRURITUS	10.7% 40/375 • Number of events 49 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	9.1% 35/383 • Number of events 41 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	7.3% 28/382 • Number of events 33 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Skin and subcutaneous tissue disorders RASH	14.9% 56/375 • Number of events 68 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	14.1% 54/383 • Number of events 64 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	12.6% 48/382 • Number of events 53 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	8.0% 30/375 • Number of events 35 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	2.9% 11/383 • Number of events 15 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	5.8% 22/382 • Number of events 31 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders HOT FLUSH	13.1% 49/375 • Number of events 53 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	11.5% 44/383 • Number of events 48 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	11.3% 43/382 • Number of events 50 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Vascular disorders HYPERTENSION	10.1% 38/375 • Number of events 66 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	9.9% 38/383 • Number of events 60 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.	8.4% 32/382 • Number of events 60 • All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.

Additional Information

Global Medical Services

AbbVie

Phone: 1-800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

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

Restriction type: OTHER