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    Clinical Trial Results:
    Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC)

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2011-003427-36
    Trial protocol
    		 DE   CZ   HU   SK  
    Global end of trial date
    30 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jul 2016
    First version publication date
    24 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M10-898
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01560104
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abbvie Deutschland GmbH & Co.KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Information, AbbVie, 011 800-633-9110,
    Scientific contact
    Vincent Giranda, MD, AbbVie , Vincent.Giranda@Abbvie.com
    Paediatric regulatory details
    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
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess if the addition of oral veliparib to carboplatin and paclitaxel compared to carboplatin and paclitaxel alone in subjects with metastatic or advanced non-small cell lung cancer (NSCLC) will improve progression-free survival (PFS).
    Protection of trial subjects
    All subjects entering the study had to sign an informed consent that was explained to them and questions encouraged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Czech Republic: 10
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Russian Federation: 56
    Country: Number of subjects enrolled
    United States: 37
    Worldwide total number of subjects
    160
    EEA total number of subjects
    56
    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)
    92
    From 65 to 84 years
    68
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult subjects ≥ 18 years of age, with life expectancy > 12 weeks (per investigator's clinical assessment), with confirmed metastatic or advanced NSCLC not amenable to surgical resection or radiation with curative intent, and who had not received prior anticancer therapy for their metastatic NSCLC were eligible to enroll.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Placebo
    Arm description
    		 Participants enrolled under the original protocol received placebo capsules twice a day (BID) on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered intravenously (IV) on Day 3 of each 21-day cycle for up to 6 cycles.
    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
    Placebo capsules administered orally twice a day

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered IV over approximately 15 to 30 minutes at (AUC 6 mg/mL/min)

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered IV over 3 hours at a dose of 200 mg/m^2.

    Arm title
    		 Group 1: Veliparib 80 mg
    Arm description
    		 Participants enrolled under the original protocol received 80 mg veliparib capsules BID on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles.
    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
    Veliparib capsules administered orally twice a day

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered IV over approximately 15 to 30 minutes at (AUC 6 mg/mL/min)

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered IV over 3 hours at a dose of 200 mg/m^2.

    Arm title
    		 Group 2: Placebo
    Arm description
    		 Participants enrolled under protocol amendment 2 received placebo capsules twice a day (BID) on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles.
    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
    Placebo capsules administered orally twice a day

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered IV over approximately 15 to 30 minutes at (AUC 6 mg/mL/min)

    Arm title
    		 Group 2: Veliparib 120 mg
    Arm description
    		 Participants enrolled under protocol amendment 2 received 120 mg veliparib capsules BID on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles
    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
    Veliparib capsules administered orally twice a day

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered IV over approximately 15 to 30 minutes at (AUC 6 mg/mL/min)

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered IV over 3 hours at a dose of 200 mg/m^2.

    Number of subjects in period 1
    		Group 1: Placebo Group 1: Veliparib 80 mg Group 2: Placebo Group 2: Veliparib 120 mg
    Started
    1
    1
    53
    105
    Received Treatment
    1
    1
    52
    105
    Completed
    1
    1
    39
    75
    Not completed
    0
    0
    14
    30
         Consent withdrawn by subject
    -
    -
    4
    10
         Other
    -
    -
    2
    4
         Adverse event
    -
    -
    8
    14
         Sponsor discontinued study
    -
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Placebo
    Reporting group description
    		 Participants enrolled under the original protocol received placebo capsules twice a day (BID) on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered intravenously (IV) on Day 3 of each 21-day cycle for up to 6 cycles.

    Reporting group title
    Group 1: Veliparib 80 mg
    Reporting group description
    		 Participants enrolled under the original protocol received 80 mg veliparib capsules BID on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles.

    Reporting group title
    Group 2: Placebo
    Reporting group description
    		 Participants enrolled under protocol amendment 2 received placebo capsules twice a day (BID) on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles.

    Reporting group title
    Group 2: Veliparib 120 mg
    Reporting group description
    		 Participants enrolled under protocol amendment 2 received 120 mg veliparib capsules BID on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles

    Reporting group values
    		 Group 1: Placebo Group 1: Veliparib 80 mg Group 2: Placebo Group 2: Veliparib 120 mg Total
    Number of subjects
    		 1 1 53 105 160
    Age categorical
    Units: Subjects
        < 65 years
    		 0 0 30 62 92
        ≥ 65 years
    		 1 1 23 43 68
    Gender categorical
    Units: Subjects
        Female
    		 0 1 21 30 52
        Male
    		 1 0 32 75 108
    Stratification Factor: Histology
    Units: Subjects
        Squamous cell
    		 1 0 25 51 77
        Non-squamous cell
    		 0 1 28 54 83

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Placebo
    Reporting group description
    		 Participants enrolled under the original protocol received placebo capsules twice a day (BID) on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered intravenously (IV) on Day 3 of each 21-day cycle for up to 6 cycles.

    Reporting group title
    Group 1: Veliparib 80 mg
    Reporting group description
    		 Participants enrolled under the original protocol received 80 mg veliparib capsules BID on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles.

    Reporting group title
    Group 2: Placebo
    Reporting group description
    		 Participants enrolled under protocol amendment 2 received placebo capsules twice a day (BID) on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles.

    Reporting group title
    Group 2: Veliparib 120 mg
    Reporting group description
    		 Participants enrolled under protocol amendment 2 received 120 mg veliparib capsules BID on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles

    Primary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS) [1]
    End point description
    Progression-free survival was defined as the time from the date that the subject was randomized to the date the subject experienced an event of disease progression (as determined by the central imaging center) or to the date of death (all causes of mortality) if disease progression was not reached. All events of disease progression occurring on or before the date of the 78th PFS event were included, regardless of whether the event occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject did not have disease progression nor had the subject died, the subject's data were censored at the date of the last disease assessment. if a disease progression event occurred after a subject missed 2 or more consecutive disease progression assessments, this subject was censored at the last disease progression assessment prior to the missing assessments. Efficacy analyses were performed for Group 2 subjects only.
    End point type
    Primary
    End point timeframe
    From randomization to the data cutoff at the 78th PFS event (18 July 2013)
    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: Efficacy analyses were performed for Group 2 subjects only.
    End point values
    		 Group 2: Placebo Group 2: Veliparib 120 mg
    Number of subjects analysed
    53
    105
    Units: days
        median (confidence interval 95%)
    129 (93 to 171)
    176 (130 to 198)
    Statistical analysis title
    		 Analysis of progression-free Survival
    Statistical analysis description
    Statistical significance was determined by a two-sided P value ≤ 0.05.
    Comparison groups
    Group 2: Placebo v Group 2: Veliparib 120 mg
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.167 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.722
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.453
         upper limit
    		 1.149
    Notes
    [2] - Log-rank test stratified by histology (squamous cell versus non-squamous cell).

    Secondary: Overall Survival

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    End point title
    		 Overall Survival [3]
    End point description
    Time to death for a given subject was defined as the number of days from the date that the subject was randomized to the date of the subject's death. All events of death were included, regardless of whether the event occurred while the subject was still taking study drug or after the subject discontinued study drug. If a subject had not died, the data were censored at the date when the subject was last known to be alive.
    End point type
    Secondary
    End point timeframe
    From randomization until end of study
    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: Efficacy analyses were performed for Group 2 subjects only.
    End point values
    		 Group 2: Placebo Group 2: Veliparib 120 mg
    Number of subjects analysed
    53
    105
    Units: days
        median (confidence interval 95%)
    277 (165 to 374)
    357 (268 to 416)
    Statistical analysis title
    		 Analysis of Overall Survival
    Comparison groups
    Group 2: Placebo v Group 2: Veliparib 120 mg
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.266 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.802
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.544
         upper limit
    		 1.183
    Notes
    [4] - Log rank test stratified by histology (squamous cell versus non-squamous cell)

    Secondary: Objective Response Rate

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    End point title
    		 Objective Response Rate [5]
    End point description
    Objective response rate was defined as the proportion of subjects with complete or partial response, as determined by the central imaging center per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Confirmation was not required to determine objective response.
    End point type
    Secondary
    End point timeframe
    From randomization until the cut-off at the 78th PFS event (18 July 2013)
    Notes
    [5] - 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: Efficacy analyses were performed for Group 2 subjects only.
    End point values
    		 Group 2: Placebo Group 2: Veliparib 120 mg
    Number of subjects analysed
    53
    105
    Units: percentage of participants
        number (confidence interval 95%)
    32.1 (19.9 to 46.3)
    32.4 (23.6 to 42.2)
    Statistical analysis title
    		 Analysis of Objective Response Rate
    Comparison groups
    Group 2: Placebo v Group 2: Veliparib 120 mg
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.992 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [6] - P value is from Cochran-Mantel-Haenszel test stratified by histology (squamous cell versus non-squamous cell).

    Secondary: Duration of Overall Response

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    End point title
    		 Duration of Overall Response [7]
    End point description
    The duration of overall response for a given subject was defined as the number of days from the day the criteria were met for complete response or partial response (whichever was recorded first) to the date that progressive disease was objectively documented (by the central imaging center). If a subject was still responding, the subject's data were censored at the date of the last available disease progression assessment. "99999" indicates data that could not be estimated.
    End point type
    Secondary
    End point timeframe
    From randomization until the cut-off date of the 78th PFS event (18 July 2013)
    Notes
    [7] - 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: Efficacy analyses were performed for Group 2 subjects only.
    End point values
    		 Group 2: Placebo Group 2: Veliparib 120 mg
    Number of subjects analysed
    17
    34
    Units: days
        median (confidence interval 95%)
    130 (84 to 99999)
    211 (137 to 212)
    Statistical analysis title
    		 Analysis of Duration of Response
    Comparison groups
    Group 2: Placebo v Group 2: Veliparib 120 mg
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.182 [8]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.474
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.158
         upper limit
    		 1.424
    Notes
    [8] - Log-rank P value stratified by histology (squamous cell versus non-squamous cell).

    Secondary: Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20)

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    End point title
    		 Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) [9]
    End point description
    The impact of chemotherapy-induced neuropathy (CIPN) on quality of life was assessed with the EORTC QLQ CIPN20, a 20-item questionnaire module developed to evaluate various aspects of CIPN. Each item is measured on a Likert scale ranging from 1 (not at all) to 4 (very much). The overall score was linearly transformed to a 0 to 100 scale, with higher scores representing more complaints. The mean change from baseline was calculated using an analysis of covariance (ANCOVA) model with treatment group as the factor and the corresponding baseline value as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline and every 3 weeks until end of study
    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: Efficacy analyses were performed for Group 2 subjects only.
    End point values
    		 Group 2: Placebo Group 2: Veliparib 120 mg
    Number of subjects analysed
    48
    94
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Cycle 2 Day 1 (N = 48, 94)
    4.009 (1.2408 to 6.777)
    4.413 (2.4348 to 6.3904)
        Cycle 3 Day 1 (N = 44, 85)
    4.916 (1.5535 to 8.278)
    6.555 (4.1365 to 8.973)
        Cycle 4 Day 1 (N = 39. 77)
    8.414 (4.4077 to 12.4198)
    6.767 (3.9161 to 9.6176)
        Cycle 5 Day 1 (N = 35, 67)
    8.509 (4.5908 to 12.4274)
    8.629 (5.7978 to 11.4611)
        Cycle 6 Day 1 (N = 29, 60)
    10.942 (5.6451 to 16.2396)
    12.321 (8.6382 to 16.0036)
        Cycle 7 Day 1 (N = 25, 52)
    13.576 (7.4149 to 19.7367)
    15.597 (11.325 to 19.8684)
        Cycle 8 Day 1 (N = 16, 41)
    9.505 (1.2527 to 17.7569)
    14.034 (8.9009 to 19.1678)
        Cycle 9 Day 1 (N = 16, 34)
    5.452 (-2.1343 to 13.0386)
    15.426 (10.2566 to 20.5955)
        Cycle 10 Day 1 (N = 9, 27)
    9.854 (-0.966 to 20.6744)
    15.19 (8.9632 to 21.4174)
        Cycle 11 day 1 (N = 9, 21)
    3.72 (-3.7312 to 11.1718)
    9.602 (4.7245 to 14.4801)
        Cycle 12 Day 1 (N = 8, 18)
    11.223 (2.0688 to 20.377)
    8.344 (2.255 to 14.4336)
        Cycle 13 Day 1 (N = 7, 12 )
    3.487 (-5.4678 to 12.4409)
    8.652 (1.8145 to 15.4905)
    No statistical analyses for this end point

    Secondary: Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Events of Peripheral Neuropathy

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    End point title
    		 Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Events of Peripheral Neuropathy [10]
    End point description
    Chemotherapy-induced peripheral neuropathy was assessed by the investigator utilizing the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading for neuropathy. Grade 3 or 4 treatment-emergent adverse events of peripheral neuropathy were identified based on a standardized Medical Dictionary for Regulatory Activities (SMQ) (broach search).
    End point type
    Secondary
    End point timeframe
    Day 1 of each cycle and at the final visit
    Notes
    [10] - 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: Efficacy analyses were performed for Group 2 subjects only.
    End point values
    		 Group 2: Placebo Group 2: Veliparib 120 mg
    Number of subjects analysed
    52
    105
    Units: participants
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose until 30 days after last dose. Median treatment duration was 42 days for Group 1 participants, 40.5 days for Group 2 placebo participants and 36 days for Group 2 veliparib participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Group 1: Placebo
    Reporting group description
    		 Participants enrolled under the original protocol received placebo capsules twice a day (BID) on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered intravenously (IV) on Day 3 of each 21-day cycle for up to 6 cycles.

    Reporting group title
    Group 1: Veliparib 80 mg
    Reporting group description
    		 Participants enrolled under the original protocol received 80 mg veliparib capsules BID on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles.

    Reporting group title
    Group 2: Placebo
    Reporting group description
    		 Participants enrolled under protocol amendment 2 received placebo capsules twice a day (BID) on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles.

    Reporting group title
    Group 2: Veliparib 120 mg
    Reporting group description
    		 Participants enrolled under protocol amendment 2 received 120 mg veliparib capsules BID on Days 1 through 7 plus carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m^2 administered IV on Day 3 of each 21-day cycle for up to 6 cycles

    Serious adverse events
    		 Group 1: Placebo Group 1: Veliparib 80 mg Group 2: Placebo Group 2: Veliparib 120 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    12 / 52 (23.08%)
    28 / 105 (26.67%)
         number of deaths (all causes)
    1
    0
    39
    74
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant Neoplasm Progression
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    Malignant Pleural Effusion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Non-Small Cell Lung Cancer
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Vascular disorders
    Embolism
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superior Vena Cava Occlusion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Vena Cava Thrombosis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pulmonary Haemorrhage
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    Respiratory Distress
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Weight Decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic Stroke
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Nausea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    2 / 105 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Abscess
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal Abscess
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: Placebo Group 1: Veliparib 80 mg Group 2: Placebo Group 2: Veliparib 120 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    41 / 52 (78.85%)
    92 / 105 (87.62%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    2 / 52 (3.85%)
    9 / 105 (8.57%)
         occurrences all number
    1
    0
    3
    13
    Fatigue
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    13 / 52 (25.00%)
    23 / 105 (21.90%)
         occurrences all number
    1
    1
    15
    39
    Mucosal Inflammation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    1 / 105 (0.95%)
         occurrences all number
    0
    0
    4
    3
    Oedema Peripheral
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    5 / 52 (9.62%)
    6 / 105 (5.71%)
         occurrences all number
    1
    0
    5
    10
    Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    2 / 105 (1.90%)
         occurrences all number
    0
    0
    3
    3
    Pyrexia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 52 (7.69%)
    5 / 105 (4.76%)
         occurrences all number
    0
    0
    5
    6
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 52 (3.85%)
    8 / 105 (7.62%)
         occurrences all number
    0
    0
    3
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    8 / 52 (15.38%)
    8 / 105 (7.62%)
         occurrences all number
    1
    0
    8
    9
    Dyspnoea
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    5 / 52 (9.62%)
    15 / 105 (14.29%)
         occurrences all number
    1
    0
    6
    17
    Haemoptysis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    6 / 105 (5.71%)
         occurrences all number
    0
    0
    1
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    5 / 52 (9.62%)
    10 / 105 (9.52%)
         occurrences all number
    0
    0
    5
    13
    Investigations
    Platelet Count Decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    4 / 105 (3.81%)
         occurrences all number
    0
    0
    9
    5
    Weight Decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 52 (3.85%)
    7 / 105 (6.67%)
         occurrences all number
    0
    0
    2
    8
    Cardiac disorders
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    0 / 105 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    7 / 105 (6.67%)
         occurrences all number
    0
    0
    3
    9
    Dysgeusia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 52 (3.85%)
    6 / 105 (5.71%)
         occurrences all number
    0
    0
    2
    7
    Headache
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    8 / 105 (7.62%)
         occurrences all number
    0
    0
    3
    10
    Neuropathy Peripheral
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    13 / 52 (25.00%)
    25 / 105 (23.81%)
         occurrences all number
    1
    0
    19
    38
    Paraesthesia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    4 / 105 (3.81%)
         occurrences all number
    0
    0
    3
    6
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    4 / 52 (7.69%)
    8 / 105 (7.62%)
         occurrences all number
    1
    0
    7
    13
    Polyneuropathy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 52 (7.69%)
    3 / 105 (2.86%)
         occurrences all number
    0
    0
    5
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    21 / 52 (40.38%)
    30 / 105 (28.57%)
         occurrences all number
    1
    0
    36
    44
    Leukopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    10 / 105 (9.52%)
         occurrences all number
    0
    0
    0
    13
    Neutropenia
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    15 / 52 (28.85%)
    37 / 105 (35.24%)
         occurrences all number
    1
    1
    28
    55
    Thrombocytopenia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    8 / 52 (15.38%)
    11 / 105 (10.48%)
         occurrences all number
    0
    1
    16
    20
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    7 / 52 (13.46%)
    9 / 105 (8.57%)
         occurrences all number
    0
    1
    8
    12
    Diarrhoea
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    8 / 52 (15.38%)
    13 / 105 (12.38%)
         occurrences all number
    1
    0
    9
    16
    Nausea
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    13 / 52 (25.00%)
    26 / 105 (24.76%)
         occurrences all number
    0
    1
    18
    42
    Stomatitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    3 / 105 (2.86%)
         occurrences all number
    0
    0
    3
    3
    Vomiting
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    5 / 52 (9.62%)
    5 / 105 (4.76%)
         occurrences all number
    0
    0
    5
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    22 / 52 (42.31%)
    41 / 105 (39.05%)
         occurrences all number
    0
    1
    26
    50
    Pruritus
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    1 / 105 (0.95%)
         occurrences all number
    1
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    2 / 52 (3.85%)
    1 / 105 (0.95%)
         occurrences all number
    0
    1
    2
    1
    Rash Pruritic
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    1 / 52 (1.92%)
    0 / 105 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 52 (0.00%)
    0 / 105 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    7 / 52 (13.46%)
    20 / 105 (19.05%)
         occurrences all number
    0
    1
    7
    31
    Back Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    3 / 52 (5.77%)
    8 / 105 (7.62%)
         occurrences all number
    0
    1
    4
    8
    Bone Pain
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    2 / 52 (3.85%)
    5 / 105 (4.76%)
         occurrences all number
    1
    0
    2
    9
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 52 (0.00%)
    2 / 105 (1.90%)
         occurrences all number
    0
    1
    0
    3
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    4 / 105 (3.81%)
         occurrences all number
    0
    0
    4
    5
    Myalgia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 52 (7.69%)
    13 / 105 (12.38%)
         occurrences all number
    0
    0
    7
    29
    Pain In Extremity
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    6 / 52 (11.54%)
    12 / 105 (11.43%)
         occurrences all number
    0
    0
    9
    14
    Infections and infestations
    Lobar Pneumonia
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    1 / 52 (1.92%)
    0 / 105 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 52 (0.00%)
    4 / 105 (3.81%)
         occurrences all number
    0
    1
    0
    4
    Urinary Tract Infection
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    2 / 105 (1.90%)
         occurrences all number
    0
    0
    3
    2
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    9 / 52 (17.31%)
    14 / 105 (13.33%)
         occurrences all number
    0
    0
    12
    19
    Hyperglycaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 52 (3.85%)
    6 / 105 (5.71%)
         occurrences all number
    0
    0
    3
    8
    Hyperkalaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 52 (5.77%)
    5 / 105 (4.76%)
         occurrences all number
    0
    0
    3
    7
    Hypokalaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 52 (7.69%)
    6 / 105 (5.71%)
         occurrences all number
    0
    0
    5
    6
    Hypomagnesaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 52 (7.69%)
    10 / 105 (9.52%)
         occurrences all number
    0
    0
    8
    12
    Hyponatraemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 52 (7.69%)
    5 / 105 (4.76%)
         occurrences all number
    0
    0
    6
    7

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Feb 2012
    The primary purpose of this amendment was to update the recommended Phase 2 dose to 120 mg BID veliparib after reviewing recent data from Studies GOG 9923 and CTEP 7967. The 120 mg BID dose of veliparib was determined to be the recommended Phase 2 dose based on data from Study GOG 9923 (Phase 1 dose-escalation study in subjects with advanced or metastatic ovarian cancer). Changes included the following: ● Updated veliparib/placebo dose to 120 mg BID throughout the protocol. Subjects enrolled under the original protocol received a starting dose of 80 mg BID veliparib/placebo and subjects enrolled under Amendment No. 1 were to receive a starting dose of 120 mg BID veliparib/placebo. ● Clarified Section 3.5, Study Rationale, and Section 5.6.4, Selection of Doses in the Study, to substantiate the rationale for selecting the 120 mg BID veliparib/placebo dose. ● Revised details of the IDMC safety review. ● Veliparib/placebo dose reduction guidelines were added in Section 5.7 for subjects starting at 120 mg BID veliparib/placebo. ● Revised the approximate number of subjects enrolled to 135 across approximately 50 sites. ● Added further detail to Section 5.2.3.2, Concomitant Therapy. ● Clarified several study activities in Table 2 (Study Activities). ● Added a complete blood count draw on C1D17. ● Corrected timing of serum pregnancy test to 14 days prior to C1D1 to clarify previous inconsistency within the protocol. ● Added clarification to the smoking status definitions for stratification.
    29 Apr 2013
    The primary purpose of this amendment was to increase enrollment to approximately 150 subjects. Due to the number of progression events reported by investigators in the study thus far, the target sample size was increased to maintain timing of the efficacy and safety evaluation that was to commence once 78 PFS events had been observed. Additional changes included: ● Updated AbbVie medical monitor contact. ● Updated Section 3.4.3, Toxicology to reflect the most current data. ● Revised visit schedule for subjects who stopped treatment or completed maximum number of treatment cycles prior to reaching an event of disease progression from every 3 weeks to every 6 weeks. ● Added request for an unscheduled tumor assessment to be performed if the investigator anticipated subject discontinuation for a reason other than radiographic progression (unless a scan had been performed within the last 2 weeks). ● Added footnote to Table 3 regarding the archived tissue sample collection time to reflect corresponding lab manual. ● Updated Section 5.2.3.2, Concomitant Therapy to clarify excluded radiation therapy. ● Revised Section 5.3.1.3, Blood Samples for Pharmacodynamic Analyses to allow for cytology sample collection in certain cases where there was no archived tissue sample available. ● Clarification that subsequent IDMC meetings could have been requested by AbbVie (as indicated in the IDMC charter). ● Added guidance to Section 5.7.1 for subjects who commenced a cycle but could not receive chemotherapy on Day 3 due to an adverse event. ● Added clarifications throughout Section 8.0, Statistical Methods and Determination of Sample Size. ● Changed all instances of Abbott or Abbott Laboratories found within the protocol to AbbVie except if outside documents were referenced (e.g., Investigator's Brochure, references). ● Changed the manufacturer of drug supply in Section 5.5.2, Table 6, Identity of Investigational Product from Abbott to AbbVie/Abbott.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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