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Clinical Trial Results:
A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

Summary
EudraCT number	2011-002913-12
Trial protocol	CZ HU DK SK FI SE BE NL ES
Global end of trial date	02 Sep 2020

Results information
Results version number	v1(current)
This version publication date	27 Aug 2021
First version publication date	27 Aug 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

M12-895

ISRCTN number

-

US NCT number

NCT01506609

WHO universal trial number (UTN)

-

Sponsor organisation name

AbbVie

Sponsor organisation address

AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United States, SL6 4UB

Public contact

Global Medical Services, AbbVie, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com

Scientific contact

Global Medical Services, AbbVie, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

02 Sep 2020

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

02 Sep 2020

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with Breast Cancer Gene (BRCA)1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

Protection of trial subjects

Subject and/or legal guardian read and understood the information provided about the study and gave written permission.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

23 Jan 2012

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 6

Country: Number of subjects enrolled

Australia: 14

Country: Number of subjects enrolled

Belgium: 12

Country: Number of subjects enrolled

Brazil: 4

Country: Number of subjects enrolled

Canada: 17

Country: Number of subjects enrolled

Czechia: 12

Country: Number of subjects enrolled

Denmark: 9

Country: Number of subjects enrolled

Finland: 2

Country: Number of subjects enrolled

France: 36

Country: Number of subjects enrolled

Hungary: 7

Country: Number of subjects enrolled

Israel: 9

Country: Number of subjects enrolled

Netherlands: 8

Country: Number of subjects enrolled

Norway: 1

Country: Number of subjects enrolled

Poland: 7

Country: Number of subjects enrolled

Romania: 1

Country: Number of subjects enrolled

Russian Federation: 5

Country: Number of subjects enrolled

Spain: 9

Country: Number of subjects enrolled

Sweden: 5

Country: Number of subjects enrolled

Ukraine: 20

Country: Number of subjects enrolled

United States: 110

Worldwide total number of subjects

294

EEA total number of subjects

109

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

283

From 65 to 84 years

11

85 years and over

0

Subject disposition

Top of page

Recruitment details

Under the original protocol, approximately 4 participants were randomized in a 1:1:1 ratio (Group 1) to 1 of the 3 treatment arms at approximately 3 research sites. Participants randomized under the original protocol were in Group 1, and were not included in the primary efficacy analyses.

Screening details

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

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject

Blinding implementation details

This is a partially blinded study. AbbVie, the investigator, the study site personnel, and the subject remained blinded to each subject's treatment with veliparib or placebo in the carboplatin + paclitaxel arms throughout the course of the study. All subjects randomized to the veliparib + TMZ treatment arm were treated in an open-label fashion.

Are arms mutually exclusive

Yes

Group 1 Placebo + Carboplatin/ Paclitaxel

Arm description

Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects self-administer the morning dose of placebo and the evening dose placebo approximately 12 hours after the morning dose with or without food in the same calendar day for Days 1 through 7 of the 21-day cycle.

Investigational medicinal product name

Carboplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Carboplatin will be administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

Investigational medicinal product name

Paclitaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Paclitaxel will be administered intravenously over approximately 3 hours at a dose of 175 mg/m^2.

Group 1 Veliparib + Carboplatin/ Paclitaxel

Arm description

Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

Veliparib

Investigational medicinal product code

ABT-888

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects will self-administer the morning dose of veliparib and the evening dose of veliparib approximately 12 hours after the morning dose with or without food in the same calendar day for Days 1 through 7 of the 21-day cycle.

Investigational medicinal product name

Carboplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Carboplatin will be administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

Investigational medicinal product name

Paclitaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Paclitaxel will be administered intravenously over approximately 3 hours at a dose of 175 mg/m^2.

Group 1 Veliparib + TMZ

Arm description

Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.

Arm type

Experimental

Investigational medicinal product name

Temozolomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects will self-administer the morning dose of veliparib and TMZ at the same time under fasting conditions (to reduce the chance of nausea and vomiting per the TMZ label recommendation) and the evening doses of veliparib approximately 12 hours after the morning dose with or without food in the same calendar day.

Investigational medicinal product name

Veliparib

Investigational medicinal product code

ABT-888

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects will self-administer the morning dose of veliparib and TMZ at the same time under fasting conditions (to reduce the chance of nausea and vomiting per the TMZ label recommendation) and the evening doses of veliparib approximately 12 hours after the morning dose with or without food in the same calendar day.

Group 2 Placebo + Carboplatin/ Paclitaxel

Arm description

Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects self-administer the morning dose of placebo and the evening dose placebo approximately 12 hours after the morning dose with or without food in the same calendar day for Days 1 through 7 of the 21-day cycle.

Investigational medicinal product name

Carboplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Carboplatin will be administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

Investigational medicinal product name

Paclitaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Paclitaxel will be administered intravenously over approximately 3 hours at a dose of 175 mg/m^2.

Group 2 Veliparib + Carboplatin/ Paclitaxel

Arm description

Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

Veliparib

Investigational medicinal product code

ABT-888

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects will self-administer the morning dose of veliparib and the evening dose of veliparib approximately 12 hours after the morning dose with or without food in the same calendar day for Days 1 through 7 of the 21-day cycle.

Investigational medicinal product name

Carboplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Carboplatin will be administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

Investigational medicinal product name

Paclitaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Paclitaxel will be administered intravenously over approximately 3 hours at a dose of 175 mg/m^2.

Group 2 Veliparib + TMZ

Arm description

Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.

Arm type

Experimental

Investigational medicinal product name

Temozolomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects will self-administer the morning dose of veliparib and TMZ at the same time under fasting conditions (to reduce the chance of nausea and vomiting per the TMZ label recommendation) and the evening doses of veliparib approximately 12 hours after the morning dose with or without food in the same calendar day.

Investigational medicinal product name

Veliparib

Investigational medicinal product code

ABT-888

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects will self-administer the morning dose of veliparib and TMZ at the same time under fasting conditions (to reduce the chance of nausea and vomiting per the TMZ label recommendation) and the evening doses of veliparib approximately 12 hours after the morning dose with or without food in the same calendar day.

Number of subjects in period 1	Group 1 Placebo + Carboplatin/ Paclitaxel	Group 1 Veliparib + Carboplatin/ Paclitaxel	Group 1 Veliparib + TMZ	Group 2 Placebo + Carboplatin/ Paclitaxel	Group 2 Veliparib + Carboplatin/ Paclitaxel	Group 2 Veliparib + TMZ
Started	2	1	1	99	97	94
Completed	0	0	0	0	1	0
Not completed	2	1	1	99	96	94
Adverse Event Related to Progression	-	-	-	3	7	3
Consent withdrawn by subject	-	-	-	9	7	7
Missing / Unknown Reason	1	-	1	4	4	2
Progressive Disease per Protocol	1	-	-	64	57	74
Sponsor Discontinued Study	-	-	-	2	2	-
Adverse Event Not Related to Progression	-	1	-	6	10	5
Lost to follow-up	-	-	-	1	2	-
Other, Not Specified	-	-	-	10	7	3

Baseline characteristics

Top of page

Reporting group title

Group 1 Placebo + Carboplatin/ Paclitaxel

Reporting group description

Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 1 Veliparib + Carboplatin/ Paclitaxel

Reporting group description

Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 1 Veliparib + TMZ

Reporting group description

Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.

Reporting group title

Group 2 Placebo + Carboplatin/ Paclitaxel

Reporting group description

Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 2 Veliparib + Carboplatin/ Paclitaxel

Reporting group description

Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 2 Veliparib + TMZ

Reporting group description

Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.

Reporting group values	Group 1 Placebo + Carboplatin/ Paclitaxel	Group 1 Veliparib + Carboplatin/ Paclitaxel	Group 1 Veliparib + TMZ	Group 2 Placebo + Carboplatin/ Paclitaxel	Group 2 Veliparib + Carboplatin/ Paclitaxel	Group 2 Veliparib + TMZ	Total
Number of subjects	2	1	1	99	97	94	294
Age categorical
Units: Subjects
< 45 years	2	1	0	47	49	41	140
45 to 64 years	0	0	1	49	47	46	143
>= 65 years	0	0	0	3	1	7	11
Gender categorical
Units: Subjects
Female	2	1	1	97	95	92	288
Male	0	0	0	2	2	2	6
Ethnicity
Units: Subjects
Hispanic or Latino	0	0	0	6	7	5	18
No Ethnicity	2	1	1	93	90	89	276
Race
Units: Subjects
White	2	1	1	93	92	83	272
Black	0	0	0	4	3	10	17
Asian	0	0	0	0	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	1	0	1
Other, Not Specified	0	0	0	2	0	0	2

End points

Top of page

Reporting group title

Group 1 Placebo + Carboplatin/ Paclitaxel

Reporting group description

Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 1 Veliparib + Carboplatin/ Paclitaxel

Reporting group description

Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 1 Veliparib + TMZ

Reporting group description

Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.

Reporting group title

Group 2 Placebo + Carboplatin/ Paclitaxel

Reporting group description

Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 2 Veliparib + Carboplatin/ Paclitaxel

Reporting group description

Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 2 Veliparib + TMZ

Reporting group description

Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.

Primary: Progression-Free Survival (PFS)

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End point title

Progression-Free Survival (PFS) ^[1]

End point description

PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached. Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab.

End point type

Primary

End point timeframe

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

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Group 2 was used for all efficacy analyses per protocol.

End point values	Group 2 Placebo + Carboplatin/ Paclitaxel	Group 2 Veliparib + Carboplatin/ Paclitaxel	Group 2 Veliparib + TMZ
Number of subjects analysed	98	95	91
Units: months
median (confidence interval 95%)	12.3 (9.3 to 14.5)	14.1 (11.5 to 16.2)	7.4 (5.9 to 8.5)

Statistical Analysis 1

Comparison groups

Group 2 Placebo + Carboplatin/ Paclitaxel v Group 2 Veliparib + Carboplatin/ Paclitaxel

Number of subjects included in analysis

193

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.227

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.789

Confidence interval

level

95%

sides

2-sided

lower limit

0.536

upper limit

1.162

Statistical Analysis 2

Comparison groups

Group 2 Placebo + Carboplatin/ Paclitaxel v Group 2 Veliparib + TMZ

Number of subjects included in analysis

189

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

1.858

Confidence interval

level

95%

sides

2-sided

lower limit

1.278

upper limit

2.702

Secondary: Overall Survival (OS)

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End point title

Overall Survival (OS) ^[2]

End point description

Time to death for a given participant was defined as the number of months from the day the participant is randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurs while the participant was still taking study drug, or after the participant discontinued study drug. If a participant had not died, then the data will be censored at the date when the participant was last known to be alive. Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab.

End point type

Secondary

End point timeframe

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

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Group 2 was used for all efficacy analyses per protocol.

End point values	Group 2 Placebo + Carboplatin/ Paclitaxel	Group 2 Veliparib + Carboplatin/ Paclitaxel	Group 2 Veliparib + TMZ
Number of subjects analysed	98	95	91
Units: months
median (confidence interval 95%)	25.4 (18.3 to 32.1)	28.3 (24.9 to 33.4)	19.1 (14.3 to 21.3)

Statistical Analysis 1

Comparison groups

Group 2 Placebo + Carboplatin/ Paclitaxel v Group 2 Veliparib + Carboplatin/ Paclitaxel

Number of subjects included in analysis

193

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.368

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.848

Confidence interval

level

95%

sides

2-sided

lower limit

0.59

upper limit

1.218

Statistical Analysis 2

Comparison groups

Group 2 Placebo + Carboplatin/ Paclitaxel v Group 2 Veliparib + TMZ

Number of subjects included in analysis

189

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.017

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

1.512

Confidence interval

level

95%

sides

2-sided

lower limit

1.074

upper limit

2.127

Secondary: Clinical Benefit Rate (CBR) at Week 18

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End point title

Clinical Benefit Rate (CBR) at Week 18 ^[3]

End point description

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

End point type

Secondary

End point timeframe

Week 18

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Group 2 was used for all efficacy analyses per protocol.

End point values	Group 2 Placebo + Carboplatin/ Paclitaxel	Group 2 Veliparib + Carboplatin/ Paclitaxel	Group 2 Veliparib + TMZ
Number of subjects analysed	98	95	91
Units: percentage of participants
number (confidence interval 95%)	87.0 (78.3 to 92.4)	90.7 (82.2 to 95.2)	73.0 (62.2 to 81.2)

Statistical Analysis 1

Comparison groups

Group 2 Placebo + Carboplatin/ Paclitaxel v Group 2 Veliparib + Carboplatin/ Paclitaxel

Number of subjects included in analysis

193

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.434 ^[4]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[4] - P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.

Statistical Analysis 2

Comparison groups

Group 2 Placebo + Carboplatin/ Paclitaxel v Group 2 Veliparib + TMZ

Number of subjects included in analysis

189

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019 ^[5]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[5] - P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.

Secondary: Objective Response Rate (ORR)

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End point title

Objective Response Rate (ORR) ^[6]

End point description

The objective response rate, defined as percentage of participants with a confirmed CR or PR based on RECIST 1.1 criteria. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 0 mm. PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline SODs. Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab. Participants with at least 1 measurable lesion at baseline.

End point type

Secondary

End point timeframe

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

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Group 2 was used for all efficacy analyses per protocol.

End point values	Group 2 Placebo + Carboplatin/ Paclitaxel	Group 2 Veliparib + Carboplatin/ Paclitaxel	Group 2 Veliparib + TMZ
Number of subjects analysed	80	72	70
Units: percentage of participants
number (confidence interval 95%)	61.3 (49.7 to 71.9)	77.8 (66.4 to 86.7)	28.6 (18.4 to 40.6)

Statistical Analysis 1

Comparison groups

Group 2 Placebo + Carboplatin/ Paclitaxel v Group 2 Veliparib + Carboplatin/ Paclitaxel

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.027 ^[7]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[7] - P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.

Statistical Analysis 2

Comparison groups

Group 2 Placebo + Carboplatin/ Paclitaxel v Group 2 Veliparib + TMZ

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[8]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[8] - P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.

Secondary: Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score

Top of page

End point title

Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score ^[9]

End point description

EORTC QLQ-CIPN20 sensory subscale score was calculated following the standard scoring algorithm, transformed to a 0 (low quality of life) to 100 (best quality of life) scale. A positive change from baseline indicates improvement. Group 2: All randomized participants with suspected deleterious or deleterious BRCA1 or BRCA2 mutation determined by sponsor core lab. Participants with a baseline and post baseline value. Per protocol, this outcome measure was not planned for the Veliparib + TMZ arm.

End point type

Secondary

End point timeframe

Baseline, Week 18

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Group 2 was used for all efficacy analyses per protocol. No analysis was planned for the Velparib + TMZ arm for this endpoint per protocol.

End point values	Group 2 Placebo + Carboplatin/ Paclitaxel	Group 2 Veliparib + Carboplatin/ Paclitaxel
Number of subjects analysed	62	69
Units: score on a scale
arithmetic mean (standard deviation)	13.94 ( 14.123 )	11.24 ( 13.954 )

Statistical Analysis 1

Comparison groups

Group 2 Veliparib + Carboplatin/ Paclitaxel v Group 2 Placebo + Carboplatin/ Paclitaxel

Number of subjects included in analysis

131

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.354 ^[10]

Method

ANCOVA

Parameter type

Least Squares (LS) Mean of Difference

Point estimate

-2.302

Confidence interval

level

95%

sides

2-sided

lower limit

-7.2

upper limit

2.6

Variability estimate

Standard error of the mean

Dispersion value

2.476

Notes
[10] - ANCOVA with treatment arm and baseline value as covariate.

Adverse events

Top of page

Timeframe for reporting adverse events

From first dose of study drug up to 30 days after last dose of study drug. Median duration of treatment for Placebo + Carboplatin/Paclitaxel, Veliparib + Carboplatin/Paclitaxel, and Veliparib + TMZ arms were 70 days, 84 days, and 42 days, respectively.

Adverse event reporting additional description

As Treated population: all randomized participants who took at least 1 dose of study drug (veliparib/placebo), analyzed by the actual treatment that participant received.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.1

Reporting group title

Group 1 Placebo + Carboplatin/ Paclitaxel

Reporting group description

Placebo BID Days 1 through 7 plus carboplatin carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 1 Veliparib + Carboplatin/Paclitaxel

Reporting group description

Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 1 Veliparib + TMZ

Reporting group description

Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.

Reporting group title

Group 2 Placebo + Carboplatin/Paclitaxel

Reporting group description

Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 2 Veliparib + Carboplatin/Paclitaxel

Reporting group description

Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.

Reporting group title

Group 2 Veliparib + TMZ

Reporting group description

Veliparib 40 mg BID Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.

Serious adverse events	Group 1 Placebo + Carboplatin/ Paclitaxel	Group 1 Veliparib + Carboplatin/Paclitaxel	Group 1 Veliparib + TMZ	Group 2 Placebo + Carboplatin/Paclitaxel	Group 2 Veliparib + Carboplatin/Paclitaxel	Group 2 Veliparib + TMZ
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	26 / 96 (27.08%)	32 / 93 (34.41%)	16 / 93 (17.20%)
number of deaths (all causes)	2	1	1	64	58	76
number of deaths resulting from adverse events	0	0	0	2	3	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
CANCER PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MALIGNANT NEOPLASM PROGRESSION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	5 / 93 (5.38%)	4 / 93 (4.30%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1
Vascular disorders
THROMBOPHLEBITIS SUPERFICIAL
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
ASTHENIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DISEASE PROGRESSION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
FATIGUE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PYREXIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	4 / 93 (4.30%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SUDDEN DEATH
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Immune system disorders
DRUG HYPERSENSITIVITY
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
EPISTAXIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PLEURAL EFFUSION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMOTHORAX
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PULMONARY EMBOLISM
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
ANXIETY
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MENTAL STATUS CHANGES
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
BLOOD CREATININE INCREASED
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
EJECTION FRACTION DECREASED
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
OXYGEN SATURATION DECREASED
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
FEMUR FRACTURE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PROCEDURAL HYPOTENSION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
RECALL PHENOMENON
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
THORACIC VERTEBRAL FRACTURE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
ATRIAL FIBRILLATION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CARDIAC TAMPONADE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PERICARDIAL EFFUSION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
TACHYCARDIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
CENTRAL NERVOUS SYSTEM LESION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HAEMORRHAGE INTRACRANIAL
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HEADACHE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SEIZURE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SYNCOPE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
VOCAL CORD PARALYSIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	2 / 93 (2.15%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
FEBRILE NEUTROPENIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	7 / 93 (7.53%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 2	5 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LYMPHADENOPATHY
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
NEUTROPENIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PANCYTOPENIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
THROMBOCYTOPENIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	2 / 93 (2.15%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	2 / 2	2 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
ABDOMINAL PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	3 / 93 (3.23%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	3 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DIARRHOEA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 2	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
NAUSEA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
VOMITING
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	1 / 93 (1.08%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	3 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
BILE DUCT OBSTRUCTION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HEPATOTOXICITY
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
URINARY RETENTION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
BONE PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
NECK PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
PATHOLOGICAL FRACTURE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
BACTERAEMIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BREAST CELLULITIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	2 / 93 (2.15%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DEVICE RELATED INFECTION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DIVERTICULITIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
EMPYEMA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
GASTROENTERITIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HERPES ZOSTER
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MASTITIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
OTITIS MEDIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PYELONEPHRITIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SEPSIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
URINARY TRACT INFECTION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
VIRAL UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
DEHYDRATION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HYPOCALCAEMIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Group 1 Placebo + Carboplatin/ Paclitaxel	Group 1 Veliparib + Carboplatin/Paclitaxel	Group 1 Veliparib + TMZ	Group 2 Placebo + Carboplatin/Paclitaxel	Group 2 Veliparib + Carboplatin/Paclitaxel	Group 2 Veliparib + TMZ
Total subjects affected by non serious adverse events
subjects affected / exposed	2 / 2 (100.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	93 / 96 (96.88%)	93 / 93 (100.00%)	91 / 93 (97.85%)
Vascular disorders
HAEMATOMA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	5 / 96 (5.21%)	3 / 93 (3.23%)	6 / 93 (6.45%)
occurrences all number	0	0	0	5	4	10
HOT FLUSH
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	8 / 96 (8.33%)	14 / 93 (15.05%)	11 / 93 (11.83%)
occurrences all number	1	0	1	12	22	13
HYPERTENSION
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	4 / 96 (4.17%)	2 / 93 (2.15%)	5 / 93 (5.38%)
occurrences all number	1	0	0	6	2	7
General disorders and administration site conditions
ASTHENIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	15 / 96 (15.63%)	23 / 93 (24.73%)	17 / 93 (18.28%)
occurrences all number	0	0	0	29	61	59
CHILLS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	3 / 96 (3.13%)	7 / 93 (7.53%)	2 / 93 (2.15%)
occurrences all number	0	0	0	3	8	3
FATIGUE
subjects affected / exposed	1 / 2 (50.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	57 / 96 (59.38%)	47 / 93 (50.54%)	44 / 93 (47.31%)
occurrences all number	1	1	0	141	93	76
INFLUENZA LIKE ILLNESS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	4 / 96 (4.17%)	5 / 93 (5.38%)	3 / 93 (3.23%)
occurrences all number	0	0	0	5	8	4
MALAISE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	3 / 93 (3.23%)	5 / 93 (5.38%)
occurrences all number	0	0	0	2	4	5
MUCOSAL INFLAMMATION
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	7 / 96 (7.29%)	9 / 93 (9.68%)	3 / 93 (3.23%)
occurrences all number	0	2	0	10	10	3
NON-CARDIAC CHEST PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	6 / 96 (6.25%)	6 / 93 (6.45%)	1 / 93 (1.08%)
occurrences all number	0	0	0	6	6	1
OEDEMA PERIPHERAL
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	14 / 96 (14.58%)	13 / 93 (13.98%)	3 / 93 (3.23%)
occurrences all number	0	0	0	18	18	5
PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	4 / 96 (4.17%)	14 / 93 (15.05%)	5 / 93 (5.38%)
occurrences all number	0	0	0	7	20	5
PYREXIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	18 / 96 (18.75%)	15 / 93 (16.13%)	9 / 93 (9.68%)
occurrences all number	0	0	0	23	16	12
Immune system disorders
DRUG HYPERSENSITIVITY
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	16 / 96 (16.67%)	18 / 93 (19.35%)	0 / 93 (0.00%)
occurrences all number	0	0	0	26	24	0
Reproductive system and breast disorders
BREAST PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	6 / 96 (6.25%)	1 / 93 (1.08%)	1 / 93 (1.08%)
occurrences all number	0	0	0	6	1	1
Respiratory, thoracic and mediastinal disorders
COUGH
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	15 / 96 (15.63%)	21 / 93 (22.58%)	13 / 93 (13.98%)
occurrences all number	0	0	0	23	27	23
DYSPNOEA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	22 / 96 (22.92%)	14 / 93 (15.05%)	8 / 93 (8.60%)
occurrences all number	0	0	0	28	16	11
EPISTAXIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	6 / 96 (6.25%)	7 / 93 (7.53%)	3 / 93 (3.23%)
occurrences all number	0	0	0	7	8	8
OROPHARYNGEAL PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	7 / 93 (7.53%)	2 / 93 (2.15%)
occurrences all number	0	0	0	2	8	2
RHINORRHOEA
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	3 / 96 (3.13%)	8 / 93 (8.60%)	3 / 93 (3.23%)
occurrences all number	0	1	0	4	10	3
Psychiatric disorders
ANXIETY
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	7 / 96 (7.29%)	10 / 93 (10.75%)	5 / 93 (5.38%)
occurrences all number	0	0	0	7	13	9
DEPRESSION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	6 / 96 (6.25%)	7 / 93 (7.53%)	4 / 93 (4.30%)
occurrences all number	0	0	0	7	8	4
INSOMNIA
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	23 / 96 (23.96%)	14 / 93 (15.05%)	20 / 93 (21.51%)
occurrences all number	0	1	0	26	16	21
Investigations
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	10 / 96 (10.42%)	13 / 93 (13.98%)	6 / 93 (6.45%)
occurrences all number	0	0	0	17	20	6
ASPARTATE AMINOTRANSFERASE INCREASED
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	10 / 96 (10.42%)	10 / 93 (10.75%)	10 / 93 (10.75%)
occurrences all number	0	0	0	12	16	12
BLOOD ALKALINE PHOSPHATASE INCREASED
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	5 / 93 (5.38%)	5 / 93 (5.38%)
occurrences all number	0	0	0	1	11	5
BLOOD BILIRUBIN INCREASED
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences all number	0	1	0	0	1	0
PLATELET COUNT DECREASED
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	5 / 93 (5.38%)	1 / 93 (1.08%)
occurrences all number	0	0	0	1	12	2
WEIGHT DECREASED
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	6 / 96 (6.25%)	4 / 93 (4.30%)	3 / 93 (3.23%)
occurrences all number	1	0	0	8	5	3
WEIGHT INCREASED
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	4 / 96 (4.17%)	2 / 93 (2.15%)	1 / 93 (1.08%)
occurrences all number	1	0	0	5	5	1
Injury, poisoning and procedural complications
CONTUSION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	4 / 96 (4.17%)	2 / 93 (2.15%)	5 / 93 (5.38%)
occurrences all number	0	0	0	4	2	5
INFUSION RELATED REACTION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	5 / 96 (5.21%)	5 / 93 (5.38%)	0 / 93 (0.00%)
occurrences all number	0	0	0	10	10	0
Cardiac disorders
TACHYCARDIA
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	5 / 96 (5.21%)	2 / 93 (2.15%)	0 / 93 (0.00%)
occurrences all number	1	0	0	6	2	0
Nervous system disorders
DISTURBANCE IN ATTENTION
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences all number	1	0	0	0	0	0
DIZZINESS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	18 / 96 (18.75%)	23 / 93 (24.73%)	7 / 93 (7.53%)
occurrences all number	0	0	1	28	31	8
DYSGEUSIA
subjects affected / exposed	2 / 2 (100.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	12 / 96 (12.50%)	18 / 93 (19.35%)	12 / 93 (12.90%)
occurrences all number	2	0	0	34	19	12
HEADACHE
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	31 / 96 (32.29%)	34 / 93 (36.56%)	27 / 93 (29.03%)
occurrences all number	1	0	1	41	61	50
HYPOAESTHESIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	6 / 96 (6.25%)	4 / 93 (4.30%)	2 / 93 (2.15%)
occurrences all number	0	0	0	7	4	2
LETHARGY
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	0 / 93 (0.00%)
occurrences all number	0	0	1	0	1	0
NEUROPATHY PERIPHERAL
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	34 / 96 (35.42%)	42 / 93 (45.16%)	7 / 93 (7.53%)
occurrences all number	0	0	0	64	60	7
PARAESTHESIA
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	17 / 96 (17.71%)	17 / 93 (18.28%)	4 / 93 (4.30%)
occurrences all number	1	0	0	32	24	4
PERIPHERAL SENSORY NEUROPATHY
subjects affected / exposed	1 / 2 (50.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	22 / 96 (22.92%)	31 / 93 (33.33%)	4 / 93 (4.30%)
occurrences all number	1	1	0	47	64	5
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	2 / 2 (100.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	49 / 96 (51.04%)	53 / 93 (56.99%)	26 / 93 (27.96%)
occurrences all number	3	5	0	113	139	52
LEUKOPENIA
subjects affected / exposed	1 / 2 (50.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	27 / 96 (28.13%)	28 / 93 (30.11%)	16 / 93 (17.20%)
occurrences all number	2	3	0	88	112	55
LYMPHOPENIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	4 / 96 (4.17%)	8 / 93 (8.60%)	7 / 93 (7.53%)
occurrences all number	0	0	0	4	30	8
NEUTROPENIA
subjects affected / exposed	2 / 2 (100.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	70 / 96 (72.92%)	68 / 93 (73.12%)	46 / 93 (49.46%)
occurrences all number	13	3	0	373	402	211
THROMBOCYTOPENIA
subjects affected / exposed	1 / 2 (50.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	65 / 96 (67.71%)	66 / 93 (70.97%)	72 / 93 (77.42%)
occurrences all number	1	5	2	239	312	187
Ear and labyrinth disorders
EAR PAIN
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	3 / 96 (3.13%)	4 / 93 (4.30%)	3 / 93 (3.23%)
occurrences all number	1	0	0	8	4	3
VERTIGO
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	5 / 96 (5.21%)	2 / 93 (2.15%)	2 / 93 (2.15%)
occurrences all number	0	0	0	6	3	2
Eye disorders
DRY EYE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	5 / 96 (5.21%)	4 / 93 (4.30%)	4 / 93 (4.30%)
occurrences all number	0	0	0	6	4	6
LACRIMATION INCREASED
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	5 / 96 (5.21%)	4 / 93 (4.30%)	2 / 93 (2.15%)
occurrences all number	0	0	0	7	6	2
VISION BLURRED
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	7 / 96 (7.29%)	12 / 93 (12.90%)	1 / 93 (1.08%)
occurrences all number	0	0	0	7	15	1
Gastrointestinal disorders
ABDOMINAL PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	16 / 96 (16.67%)	20 / 93 (21.51%)	15 / 93 (16.13%)
occurrences all number	0	0	0	19	23	24
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	7 / 96 (7.29%)	11 / 93 (11.83%)	7 / 93 (7.53%)
occurrences all number	0	0	0	14	15	14
CONSTIPATION
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	28 / 96 (29.17%)	38 / 93 (40.86%)	38 / 93 (40.86%)
occurrences all number	0	2	0	49	57	57
DIARRHOEA
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	25 / 96 (26.04%)	37 / 93 (39.78%)	19 / 93 (20.43%)
occurrences all number	0	1	2	44	63	27
DRY MOUTH
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	4 / 96 (4.17%)	6 / 93 (6.45%)	8 / 93 (8.60%)
occurrences all number	0	0	0	4	6	8
DYSPEPSIA
subjects affected / exposed	1 / 2 (50.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	15 / 96 (15.63%)	9 / 93 (9.68%)	5 / 93 (5.38%)
occurrences all number	1	2	0	23	17	5
DYSPHAGIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	2 / 93 (2.15%)	6 / 93 (6.45%)
occurrences all number	0	0	0	1	2	7
GASTRITIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	5 / 93 (5.38%)	0 / 93 (0.00%)
occurrences all number	0	0	0	0	5	0
GASTROOESOPHAGEAL REFLUX DISEASE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	4 / 96 (4.17%)	9 / 93 (9.68%)	4 / 93 (4.30%)
occurrences all number	0	0	0	4	14	4
MELAENA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 96 (0.00%)	1 / 93 (1.08%)	1 / 93 (1.08%)
occurrences all number	0	0	1	0	1	1
NAUSEA
subjects affected / exposed	1 / 2 (50.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	56 / 96 (58.33%)	66 / 93 (70.97%)	69 / 93 (74.19%)
occurrences all number	1	2	3	133	152	166
STOMATITIS
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	11 / 96 (11.46%)	11 / 93 (11.83%)	5 / 93 (5.38%)
occurrences all number	0	1	0	20	15	6
TOOTHACHE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	5 / 93 (5.38%)	3 / 93 (3.23%)
occurrences all number	0	0	0	5	5	3
VOMITING
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	22 / 96 (22.92%)	26 / 93 (27.96%)	40 / 93 (43.01%)
occurrences all number	0	1	0	36	41	81
Skin and subcutaneous tissue disorders
ALOPECIA
subjects affected / exposed	1 / 2 (50.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	55 / 96 (57.29%)	61 / 93 (65.59%)	10 / 93 (10.75%)
occurrences all number	1	1	0	69	79	13
DERMATITIS ACNEIFORM
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	3 / 93 (3.23%)	0 / 93 (0.00%)
occurrences all number	1	0	0	2	3	0
ERYTHEMA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	6 / 96 (6.25%)	6 / 93 (6.45%)	1 / 93 (1.08%)
occurrences all number	0	0	0	7	7	1
PRURITUS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	6 / 96 (6.25%)	12 / 93 (12.90%)	9 / 93 (9.68%)
occurrences all number	0	0	0	7	16	9
RASH
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	17 / 96 (17.71%)	7 / 93 (7.53%)	5 / 93 (5.38%)
occurrences all number	0	1	0	23	10	7
URTICARIA
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	0 / 93 (0.00%)	1 / 93 (1.08%)
occurrences all number	1	0	0	2	0	1
Renal and urinary disorders
DYSURIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	4 / 96 (4.17%)	5 / 93 (5.38%)	1 / 93 (1.08%)
occurrences all number	0	0	0	4	5	2
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	31 / 96 (32.29%)	34 / 93 (36.56%)	14 / 93 (15.05%)
occurrences all number	1	0	0	45	62	18
BACK PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	23 / 96 (23.96%)	28 / 93 (30.11%)	24 / 93 (25.81%)
occurrences all number	0	0	0	40	43	32
BONE PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	12 / 96 (12.50%)	21 / 93 (22.58%)	6 / 93 (6.45%)
occurrences all number	0	0	0	16	37	6
MUSCLE SPASMS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	9 / 96 (9.38%)	10 / 93 (10.75%)	6 / 93 (6.45%)
occurrences all number	0	0	0	9	14	6
MUSCULAR WEAKNESS
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	2 / 96 (2.08%)	3 / 93 (3.23%)	1 / 93 (1.08%)
occurrences all number	0	1	0	3	3	1
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	7 / 96 (7.29%)	4 / 93 (4.30%)	7 / 93 (7.53%)
occurrences all number	0	0	0	7	5	8
MUSCULOSKELETAL PAIN
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	7 / 96 (7.29%)	14 / 93 (15.05%)	8 / 93 (8.60%)
occurrences all number	0	0	0	8	16	8
MYALGIA
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	20 / 96 (20.83%)	32 / 93 (34.41%)	8 / 93 (8.60%)
occurrences all number	1	0	0	38	56	9
NECK PAIN
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	3 / 96 (3.13%)	4 / 93 (4.30%)	2 / 93 (2.15%)
occurrences all number	0	1	0	4	4	3
PAIN IN EXTREMITY
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	23 / 96 (23.96%)	17 / 93 (18.28%)	13 / 93 (13.98%)
occurrences all number	0	0	0	39	55	15
Infections and infestations
EAR INFECTION
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 96 (1.04%)	0 / 93 (0.00%)	0 / 93 (0.00%)
occurrences all number	1	0	0	1	0	0
GASTROENTERITIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	1 / 96 (1.04%)	4 / 93 (4.30%)	2 / 93 (2.15%)
occurrences all number	0	0	1	1	4	2
INFLUENZA
subjects affected / exposed	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	3 / 96 (3.13%)	3 / 93 (3.23%)	4 / 93 (4.30%)
occurrences all number	1	0	0	5	4	4
NASOPHARYNGITIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	12 / 96 (12.50%)	12 / 93 (12.90%)	5 / 93 (5.38%)
occurrences all number	0	0	0	13	18	5
SINUSITIS
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	7 / 96 (7.29%)	5 / 93 (5.38%)	1 / 93 (1.08%)
occurrences all number	0	0	0	7	6	1
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	10 / 96 (10.42%)	20 / 93 (21.51%)	14 / 93 (15.05%)
occurrences all number	0	0	0	11	28	17
URINARY TRACT INFECTION
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	9 / 96 (9.38%)	12 / 93 (12.90%)	13 / 93 (13.98%)
occurrences all number	0	0	0	14	13	13
Metabolism and nutrition disorders
DECREASED APPETITE
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	20 / 96 (20.83%)	22 / 93 (23.66%)	21 / 93 (22.58%)
occurrences all number	0	0	0	27	30	29
DEHYDRATION
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 96 (0.00%)	3 / 93 (3.23%)	0 / 93 (0.00%)
occurrences all number	0	1	0	0	3	0
HYPERGLYCAEMIA
subjects affected / exposed	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	5 / 96 (5.21%)	3 / 93 (3.23%)	1 / 93 (1.08%)
occurrences all number	0	0	0	7	4	1
HYPOKALAEMIA
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	6 / 96 (6.25%)	9 / 93 (9.68%)	1 / 93 (1.08%)
occurrences all number	0	3	0	7	12	1
HYPOMAGNESAEMIA
subjects affected / exposed	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	11 / 96 (11.46%)	17 / 93 (18.28%)	2 / 93 (2.15%)
occurrences all number	0	2	0	18	21	2

More information

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Were there any global substantial amendments to the protocol? Yes

16 Mar 2012

Modified the dose of veliparib/placebo to 120 mg BID for subjects randomized to the C/P treatment arms as the recommended Phase 2 dose based on the currently available data from the Cancer Treatment Evaluation Program 7967 and GOG 9923 studies.

28 Jan 2013

Allowed for broader eligibility while maintaining patient characteristics consistent with the trial intent and modified secondary efficacy endpoints and clarified definition of CBR to include all intent-to-treat (ITT) subjects and ORR to include only subjects with at least 1 measurable lesion at baseline.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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