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    Clinical Trial Results:
    A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

    Summary
    EudraCT number
    		 2014-000345-70
    Trial protocol
    		 FI   AT   SE   GB   DK   PT   DE   BE   CZ   NO   HU   IT   NL   LV   ES   FR   LT   EE   PL  
    Global end of trial date
    25 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2025
    First version publication date
    01 Feb 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M12-914
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02163694
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB, Berkshire, United Kingdom,
    Public contact
    Global Medical Services, AbbVie, Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@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
    25 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P.
    Protection of trial subjects
    The investigator or his/her representative will explain the nature of the study to the subject, the benefits and risks anticipated from participation in the study, and answer all questions regarding this study. Prior to any study-related screening procedures being performed on the subject or any medications being discontinued by the subject in order to participate in this study, the informed consent statement will be reviewed, signed, and dated by the subject, the person who administered the informed consent, and any other signatories according to local requirements. A copy of the signed informed consent will be given to the subject and the original will be placed in the subject's medical record. An entry must also be made in the subject's dated source documents to confirm that informed consent was obtained prior to any study-related procedures and that the subject received a signed copy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Apr 2014
    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
    Argentina: 2
    Country: Number of subjects enrolled
    Australia: 20
    Country: Number of subjects enrolled
    Austria: 9
    Country: Number of subjects enrolled
    Belarus: 9
    Country: Number of subjects enrolled
    Belgium: 23
    Country: Number of subjects enrolled
    Canada: 10
    Country: Number of subjects enrolled
    Chile: 15
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    Czechia: 21
    Country: Number of subjects enrolled
    Denmark: 14
    Country: Number of subjects enrolled
    Estonia: 2
    Country: Number of subjects enrolled
    Finland: 2
    Country: Number of subjects enrolled
    France: 41
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Israel: 23
    Country: Number of subjects enrolled
    Italy: 19
    Country: Number of subjects enrolled
    Korea, Republic of: 25
    Country: Number of subjects enrolled
    Latvia: 1
    Country: Number of subjects enrolled
    Lithuania: 5
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Portugal: 16
    Country: Number of subjects enrolled
    Romania: 11
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Singapore: 3
    Country: Number of subjects enrolled
    South Africa: 13
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Sweden: 11
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Türkiye: 10
    Country: Number of subjects enrolled
    Ukraine: 33
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    United States: 74
    Worldwide total number of subjects
    513
    EEA total number of subjects
    241
    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)
    478
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 513 subjects enrolled in the study (N=174 to the placebo + C/P arm, and N=339 to the veliparib + C/P arm). Two subjects form each arm (N= 4) were determined not to have a suspected deleterious or deleterious mutation in BRCA1/2 and were excluded from the ITT population

    Pre-assignment
    Screening details
    		 Subjects randomized to Pbo were eligible to crossover to unblinded veliparib monotherapy. Post Protocol Amend 5, investigators and subjects were unblinded,subjects randomized to Pbo discontinued from the study, subjects discontinuing therapy prior to progression no longer remained on study, and no new subjects initiated crossover unblinded therapy.

    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
    		 Placebo + C/P
    Arm description
    		 Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Veliparib Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously over approximately 15 to 30 minutes at an area under the curve (AUC) of 6 mg/mL/min immediately following paclitaxel infusion on Day 1 of every cycle. The duration of carboplatin infusion may be lengthened according to institutional guidelines.

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered by intravenous infusion over approximately 1 hour at a dose of 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel is to be infused prior to carboplatin on Day 1. Dosing of veliparib/placebo is to be completed before the carboplatin or paclitaxel infusions.

    Arm title
    		 Veliparib + C/P
    Arm description
    		 Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/ min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Veliparib
    Investigational medicinal product code
    Other name
    ABT-888
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Supplied as 40 mg, 50 mg, or 100 mg capsules for oral administration twice daily (BID) on Days -2 through 5 of a 21-day cycle.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously over approximately 15 to 30 minutes at an area under the curve (AUC) of 6 mg/mL/min immediately following paclitaxel infusion on Day 1 of every cycle. The duration of carboplatin infusion may be lengthened according to institutional guidelines.

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered by intravenous infusion over approximately 1 hour at a dose of 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel is to be infused prior to carboplatin on Day 1. Dosing of veliparib/placebo is to be completed before the carboplatin or paclitaxel infusions.

    Number of subjects in period 1 [1]
    		Placebo + C/P Veliparib + C/P
    Started
    172
    337
    Completed
    0
    0
    Not completed
    172
    337
         Adverse event- related to progression
    4
    10
         Consent withdrawn by subject
    13
    28
         Progressive disease per protocol
    125
    224
         Adverse event- not related to progression
    7
    22
         Other, not specified
    17
    22
         Lost to follow-up
    2
    2
         Sponsor discontinued study
    3
    29
         Randomized but Not Treated
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 513 subjects were enrolled; 2 subjects were determined not to have a suspected deleterious or deleterious mutation in BRCA1/2 and were excluded from the ITT population. One (1) subject Age information missing; this subject has been categorized in the 18-64 or 65-84 Age Category.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + C/P
    Reporting group description
    		 Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.

    Reporting group title
    Veliparib + C/P
    Reporting group description
    		 Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/ min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.

    Reporting group values
    		 Placebo + C/P Veliparib + C/P Total
    Number of subjects
    		 172 337 509
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.8 ( 10.81 ) 46.8 ( 10.73 ) -
    Gender categorical
    Units: Subjects
        Female
    		 169 333 502
        Male
    		 3 4 7

    End points

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    End points reporting groups
    Reporting group title
    Placebo + C/P
    Reporting group description
    		 Placebo capsules for veliparib (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.

    Reporting group title
    Veliparib + C/P
    Reporting group description
    		 Veliparib capsules (120 mg) administered by mouth twice daily (BID) on Days -2 through 5 of a 21-day cycle. Carboplatin administered intravenously over approximately 15 to 30 minutes at AUC 6 mg/ml/ min immediately following paclitaxel infusion on Day 1 of every cycle. Paclitaxel administered intravenously over approximately 1 hour at a dose of 80 mg/m² on Days 1, 8, and 15 of every cycle.

    Primary: Progression free survival (PFS)

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    End point title
    		 Progression free survival (PFS)
    End point description
    Number of days from the date the subject is randomized to the date the subject experiences a confirmed event of disease progression or to the date of death if disease progression is not reached
    End point type
    Primary
    End point timeframe
    Measured up to 3 years after the last subject has enrolled in the study.
    End point values
    		 Placebo + C/P Veliparib + C/P
    Number of subjects analysed
    172
    337
    Units: month
        median (confidence interval 95%)
    12.6 (10.6 to 14.4)
    14.6 (12.5 to 17.7)
    Statistical analysis title
    		 Placebo + C/P, Veliparib + C/P
    Comparison groups
    Placebo + C/P v Veliparib + C/P
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Placebo + C/P, Veliparib + C/P
    Comparison groups
    Placebo + C/P v Veliparib + C/P
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Stratified Cox proportional hazards
    Parameter type
    		 Stratified Cox proportional hazards
    Point estimate
    0.728
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.9

    Secondary: Progression-free survival 2 (PFS2)

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    End point title
    		 Progression-free survival 2 (PFS2)
    End point description
    Days from randomization to the second objective radiographic progression or death of any cause after the first objective radiographic progression, whichever occurs first
    End point type
    Secondary
    End point timeframe
    Measured up to 5 years after the last subject has enrolled in the study.
    End point values
    		 Placebo + C/P Veliparib + C/P
    Number of subjects analysed
    172
    337
    Units: month
        median (confidence interval 95%)
    17.4 (16.0 to 20.7)
    21.5 (19.9 to 25.3)
    Statistical analysis title
    		 Placebo + C/P, Veliparib + C/P
    Comparison groups
    Placebo + C/P v Veliparib + C/P
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Stratified Cox proportional hazards
    Parameter type
    		 Stratified Cox proportional hazards
    Point estimate
    0.737
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.597
         upper limit
    		 0.908

    Secondary: Objective response rate (ORR)

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    End point title
    		 Objective response rate (ORR)
    End point description
    Proportion of subjects with a complete or partial objective response
    End point type
    Secondary
    End point timeframe
    Measured up to 2 years after the last subject has enrolled in the study.
    End point values
    		 Placebo + C/P Veliparib + C/P
    Number of subjects analysed
    172
    337
    Units: percentage of participants
        number (confidence interval 95%)
    93.2 (89.5 to 95.7)
    90.7 (87.9 to 92.9)
    Statistical analysis title
    		 Placebo + C/P, Veliparib + C/P
    Comparison groups
    Placebo + C/P v Veliparib + C/P
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.202 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Number of days from the day the subject is randomized to the date of the subject's death
    End point type
    Secondary
    End point timeframe
    Measured up to 5 years after the last subject has enrolled in the study.
    End point values
    		 Placebo + C/P Veliparib + C/P
    Number of subjects analysed
    172
    337
    Units: month
        median (confidence interval 95%)
    28.2 (24.7 to 32.8)
    32.4 (27.4 to 38.1)
    Statistical analysis title
    		 Placebo + C/P, Veliparib + C/P
    Comparison groups
    Veliparib + C/P v Placebo + C/P
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Stratified Cox proportional hazards
    Parameter type
    		 Stratified Cox proportional hazards
    Point estimate
    0.914
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.737
         upper limit
    		 1.333

    Secondary: Clinical benefit rate (CBR)

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    End point title
    		 Clinical benefit rate (CBR)
    End point description
    Progression-free rate at 24 weeks from the Kaplan-Meier curve for time to progression
    End point type
    Secondary
    End point timeframe
    Measured up to 5 years after the last subject has enrolled in the study.
    End point values
    		 Placebo + C/P Veliparib + C/P
    Number of subjects analysed
    172
    337
    Units: percentage of participants
        number (confidence interval 95%)
    93.2 (89.5 to 95.7)
    90.7 (87.9 to 92.9)
    Statistical analysis title
    		 Placebo + C/P, Veliparib + C/P
    Comparison groups
    Placebo + C/P v Veliparib + C/P
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.202 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality were reported from enrollment to the end of study, median time on follow up was 84.5 and 81.8 months for Placebo + C/P and Veliparib + C/P, respectively.
    Adverse event reporting additional description
    Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 115.0 and 117.5 days for Placebo + C/P and Veliparib + C/P, respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Veliparib_120_mg_BID_plus_Carboplatin_Paclitaxel
    Reporting group description
    		 -

    Reporting group title
    Placebo_120_mg_BID_plus_Carboplatin_Paclitaxel
    Reporting group description
    		 -

    Serious adverse events
    		 Veliparib_120_mg_BID_plus_Carboplatin_Paclitaxel Placebo_120_mg_BID_plus_Carboplatin_Paclitaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    135 / 339 (39.82%)
    68 / 174 (39.08%)
         number of deaths (all causes)
    244
    129
         number of deaths resulting from adverse events
    14
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ACUTE MYELOID LEUKAEMIA
         subjects affected / exposed
    4 / 339 (1.18%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    5 / 6
    0 / 0
         deaths causally related to treatment / all
    3 / 3
    0 / 0
    BASAL CELL CARCINOMA
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT NEOPLASM PROGRESSION
         subjects affected / exposed
    19 / 339 (5.60%)
    11 / 174 (6.32%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 12
         deaths causally related to treatment / all
    0 / 7
    0 / 3
    GASTRIC NEOPLASM
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLON CANCER
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CANCER PAIN
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT PLEURAL EFFUSION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METASTASES TO BONE
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METASTASES TO BONE MARROW
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METASTASES TO CENTRAL NERVOUS SYSTEM
         subjects affected / exposed
    1 / 339 (0.29%)
    4 / 174 (2.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METASTASES TO LYMPH NODES
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METASTASES TO MENINGES
         subjects affected / exposed
    3 / 339 (0.88%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYELODYSPLASTIC SYNDROME
         subjects affected / exposed
    5 / 339 (1.47%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    7 / 7
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    SECOND PRIMARY MALIGNANCY
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TUMOUR PAIN
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    ILIAC ARTERY OCCLUSION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POOR VENOUS ACCESS
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    1 / 339 (0.29%)
    3 / 174 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AORTIC STENOSIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    ABORTION INDUCED
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    HYPERTHERMIA
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FATIGUE
         subjects affected / exposed
    2 / 339 (0.59%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DISEASE PROGRESSION
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHEST PAIN
         subjects affected / exposed
    3 / 339 (0.88%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALAISE
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 339 (0.29%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    9 / 339 (2.65%)
    4 / 174 (2.30%)
         occurrences causally related to treatment / all
    3 / 12
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAIN
         subjects affected / exposed
    1 / 339 (0.29%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    ANAPHYLACTIC REACTION
         subjects affected / exposed
    2 / 339 (0.59%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONTRAST MEDIA ALLERGY
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERSENSITIVITY
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    1 / 339 (0.29%)
    3 / 174 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    PELVIC PAIN
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ATELECTASIS
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARYNGEAL OEDEMA
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPISTAXIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    2 / 339 (0.59%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMOMEDIASTINUM
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURITIC PAIN
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    1 / 339 (0.29%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY ARTERY THROMBOSIS
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PULMONARY EMBOLISM
         subjects affected / exposed
    5 / 339 (1.47%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PNEUMOTHORAX
         subjects affected / exposed
    2 / 339 (0.59%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    MANIA
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANXIETY
         subjects affected / exposed
    1 / 339 (0.29%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PSYCHOTIC DISORDER
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    DEVICE BREAKAGE
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUMBAR VERTEBRAL FRACTURE
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCEDURAL PAIN
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    PERICARDITIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIOPULMONARY FAILURE
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIO-RESPIRATORY ARREST
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    APHASIA
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CERVICAL CORD COMPRESSION
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL INFARCTION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRAIN OEDEMA
         subjects affected / exposed
    2 / 339 (0.59%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    LETHARGY
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSARTHRIA
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDROCEPHALUS
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEADACHE
         subjects affected / exposed
    0 / 339 (0.00%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIZZINESS
         subjects affected / exposed
    2 / 339 (0.59%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTRACRANIAL PRESSURE INCREASED
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENINGEAL DISORDER
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    VASCULAR ENCEPHALOPATHY
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYNCOPE
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEIZURE
         subjects affected / exposed
    4 / 339 (1.18%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    2 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCIATICA
         subjects affected / exposed
    1 / 339 (0.29%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PRESYNCOPE
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARTIAL SEIZURES
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    HAEMORRHAGIC DISORDER
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LEUKOPENIA
         subjects affected / exposed
    2 / 339 (0.59%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAEMIA
         subjects affected / exposed
    16 / 339 (4.72%)
    5 / 174 (2.87%)
         occurrences causally related to treatment / all
    21 / 21
    8 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    11 / 339 (3.24%)
    3 / 174 (1.72%)
         occurrences causally related to treatment / all
    11 / 11
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIA
         subjects affected / exposed
    8 / 339 (2.36%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    11 / 11
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
         subjects affected / exposed
    14 / 339 (4.13%)
    5 / 174 (2.87%)
         occurrences causally related to treatment / all
    20 / 21
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    DIPLOPIA
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETINAL ARTERY OCCLUSION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    COLITIS MICROSCOPIC
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN LOWER
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN
         subjects affected / exposed
    1 / 339 (0.29%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL HERNIA
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEUS
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRITIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FAECALOMA
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    2 / 339 (0.59%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONSTIPATION
         subjects affected / exposed
    2 / 339 (0.59%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS ACUTE
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NONINFECTIVE SIALOADENITIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NAUSEA
         subjects affected / exposed
    6 / 339 (1.77%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    6 / 9
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOOTHACHE
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    6 / 339 (1.77%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    6 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    2 / 339 (0.59%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLECYSTITIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    ANGIOEDEMA
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    HAEMATURIA
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC KIDNEY DISEASE
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    4 / 339 (1.18%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULAR WEAKNESS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JOINT LOCK
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL STENOSIS
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OSTEONECROSIS OF JAW
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OSTEOARTHRITIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NECK PAIN
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    BREAST CELLULITIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APPENDICITIS
         subjects affected / exposed
    2 / 339 (0.59%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABSCESS JAW
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTED DERMAL CYST
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ERYSIPELAS
         subjects affected / exposed
    2 / 339 (0.59%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    4 / 339 (1.18%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS MORAXELLA
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTED LYMPHOCELE
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLUENZA
         subjects affected / exposed
    3 / 339 (0.88%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENINGITIS
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION
         subjects affected / exposed
    0 / 339 (0.00%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYELITIS
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OPHTHALMIC HERPES ZOSTER
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIC SEPSIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIC INFECTION
         subjects affected / exposed
    2 / 339 (0.59%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAROTID ABSCESS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    7 / 339 (2.06%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    4 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMOCYSTIS JIROVECII PNEUMONIA
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    4 / 339 (1.18%)
    4 / 174 (2.30%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    STAPHYLOCOCCAL SKIN INFECTION
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUSITIS
         subjects affected / exposed
    3 / 339 (0.88%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPTIC SHOCK
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 339 (0.59%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL INFECTION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UROSEPSIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE RELATED INFECTION
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE RELATED SEPSIS
         subjects affected / exposed
    1 / 339 (0.29%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR DEVICE INFECTION
         subjects affected / exposed
    5 / 339 (1.47%)
    2 / 174 (1.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DIABETES MELLITUS
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEHYDRATION
         subjects affected / exposed
    2 / 339 (0.59%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ELECTROLYTE IMBALANCE
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GOUT
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 174 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOKALAEMIA
         subjects affected / exposed
    2 / 339 (0.59%)
    0 / 174 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Veliparib_120_mg_BID_plus_Carboplatin_Paclitaxel Placebo_120_mg_BID_plus_Carboplatin_Paclitaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    332 / 339 (97.94%)
    169 / 174 (97.13%)
    Vascular disorders
    HOT FLUSH
         subjects affected / exposed
    41 / 339 (12.09%)
    13 / 174 (7.47%)
         occurrences all number
    52
    16
    HYPERTENSION
         subjects affected / exposed
    25 / 339 (7.37%)
    12 / 174 (6.90%)
         occurrences all number
    40
    14
    LYMPHOEDEMA
         subjects affected / exposed
    20 / 339 (5.90%)
    11 / 174 (6.32%)
         occurrences all number
    20
    15
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    19 / 339 (5.60%)
    14 / 174 (8.05%)
         occurrences all number
    29
    15
    ASTHENIA
         subjects affected / exposed
    85 / 339 (25.07%)
    45 / 174 (25.86%)
         occurrences all number
    346
    141
    FATIGUE
         subjects affected / exposed
    168 / 339 (49.56%)
    90 / 174 (51.72%)
         occurrences all number
    383
    218
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    27 / 339 (7.96%)
    15 / 174 (8.62%)
         occurrences all number
    50
    26
    MUCOSAL INFLAMMATION
         subjects affected / exposed
    30 / 339 (8.85%)
    7 / 174 (4.02%)
         occurrences all number
    37
    7
    PYREXIA
         subjects affected / exposed
    59 / 339 (17.40%)
    35 / 174 (20.11%)
         occurrences all number
    83
    45
    PERIPHERAL SWELLING
         subjects affected / exposed
    18 / 339 (5.31%)
    9 / 174 (5.17%)
         occurrences all number
    21
    10
    PAIN
         subjects affected / exposed
    20 / 339 (5.90%)
    11 / 174 (6.32%)
         occurrences all number
    22
    11
    OEDEMA PERIPHERAL
         subjects affected / exposed
    69 / 339 (20.35%)
    20 / 174 (11.49%)
         occurrences all number
    96
    25
    Immune system disorders
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    58 / 339 (17.11%)
    32 / 174 (18.39%)
         occurrences all number
    91
    66
    Reproductive system and breast disorders
    BREAST PAIN
         subjects affected / exposed
    19 / 339 (5.60%)
    10 / 174 (5.75%)
         occurrences all number
    25
    13
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    77 / 339 (22.71%)
    34 / 174 (19.54%)
         occurrences all number
    126
    48
    DYSPNOEA
         subjects affected / exposed
    71 / 339 (20.94%)
    34 / 174 (19.54%)
         occurrences all number
    105
    43
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    24 / 339 (7.08%)
    7 / 174 (4.02%)
         occurrences all number
    32
    18
    EPISTAXIS
         subjects affected / exposed
    62 / 339 (18.29%)
    29 / 174 (16.67%)
         occurrences all number
    87
    37
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    31 / 339 (9.14%)
    14 / 174 (8.05%)
         occurrences all number
    44
    16
    PRODUCTIVE COUGH
         subjects affected / exposed
    18 / 339 (5.31%)
    9 / 174 (5.17%)
         occurrences all number
    23
    14
    RHINORRHOEA
         subjects affected / exposed
    21 / 339 (6.19%)
    4 / 174 (2.30%)
         occurrences all number
    29
    5
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    63 / 339 (18.58%)
    33 / 174 (18.97%)
         occurrences all number
    84
    47
    DEPRESSION
         subjects affected / exposed
    30 / 339 (8.85%)
    10 / 174 (5.75%)
         occurrences all number
    36
    12
    ANXIETY
         subjects affected / exposed
    40 / 339 (11.80%)
    13 / 174 (7.47%)
         occurrences all number
    48
    17
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    59 / 339 (17.40%)
    25 / 174 (14.37%)
         occurrences all number
    151
    61
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    50 / 339 (14.75%)
    23 / 174 (13.22%)
         occurrences all number
    115
    62
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    26 / 339 (7.67%)
    9 / 174 (5.17%)
         occurrences all number
    48
    18
    WEIGHT INCREASED
         subjects affected / exposed
    19 / 339 (5.60%)
    5 / 174 (2.87%)
         occurrences all number
    40
    13
    Cardiac disorders
    PALPITATIONS
         subjects affected / exposed
    20 / 339 (5.90%)
    4 / 174 (2.30%)
         occurrences all number
    28
    4
    TACHYCARDIA
         subjects affected / exposed
    14 / 339 (4.13%)
    11 / 174 (6.32%)
         occurrences all number
    20
    16
    Nervous system disorders
    PERIPHERAL SENSORY NEUROPATHY
         subjects affected / exposed
    158 / 339 (46.61%)
    89 / 174 (51.15%)
         occurrences all number
    347
    185
    PARAESTHESIA
         subjects affected / exposed
    33 / 339 (9.73%)
    16 / 174 (9.20%)
         occurrences all number
    40
    30
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    22 / 339 (6.49%)
    15 / 174 (8.62%)
         occurrences all number
    27
    19
    HEADACHE
         subjects affected / exposed
    124 / 339 (36.58%)
    67 / 174 (38.51%)
         occurrences all number
    217
    113
    DYSGEUSIA
         subjects affected / exposed
    48 / 339 (14.16%)
    19 / 174 (10.92%)
         occurrences all number
    61
    27
    DIZZINESS
         subjects affected / exposed
    68 / 339 (20.06%)
    34 / 174 (19.54%)
         occurrences all number
    114
    53
    TASTE DISORDER
         subjects affected / exposed
    19 / 339 (5.60%)
    13 / 174 (7.47%)
         occurrences all number
    39
    19
    Blood and lymphatic system disorders
    LEUKOPENIA
         subjects affected / exposed
    133 / 339 (39.23%)
    65 / 174 (37.36%)
         occurrences all number
    700
    319
    ANAEMIA
         subjects affected / exposed
    256 / 339 (75.52%)
    117 / 174 (67.24%)
         occurrences all number
    1147
    501
    LYMPHOPENIA
         subjects affected / exposed
    43 / 339 (12.68%)
    14 / 174 (8.05%)
         occurrences all number
    139
    33
    NEUTROPENIA
         subjects affected / exposed
    292 / 339 (86.14%)
    156 / 174 (89.66%)
         occurrences all number
    2450
    1286
    THROMBOCYTOPENIA
         subjects affected / exposed
    257 / 339 (75.81%)
    118 / 174 (67.82%)
         occurrences all number
    1659
    581
    Ear and labyrinth disorders
    TINNITUS
         subjects affected / exposed
    21 / 339 (6.19%)
    8 / 174 (4.60%)
         occurrences all number
    43
    8
    VERTIGO
         subjects affected / exposed
    24 / 339 (7.08%)
    14 / 174 (8.05%)
         occurrences all number
    38
    20
    Eye disorders
    DRY EYE
         subjects affected / exposed
    24 / 339 (7.08%)
    10 / 174 (5.75%)
         occurrences all number
    26
    11
    VISION BLURRED
         subjects affected / exposed
    10 / 339 (2.95%)
    9 / 174 (5.17%)
         occurrences all number
    13
    10
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    52 / 339 (15.34%)
    24 / 174 (13.79%)
         occurrences all number
    81
    30
    ABDOMINAL DISTENSION
         subjects affected / exposed
    18 / 339 (5.31%)
    7 / 174 (4.02%)
         occurrences all number
    19
    10
    DYSPEPSIA
         subjects affected / exposed
    61 / 339 (17.99%)
    20 / 174 (11.49%)
         occurrences all number
    88
    24
    DRY MOUTH
         subjects affected / exposed
    34 / 339 (10.03%)
    17 / 174 (9.77%)
         occurrences all number
    42
    17
    DIARRHOEA
         subjects affected / exposed
    151 / 339 (44.54%)
    69 / 174 (39.66%)
         occurrences all number
    337
    141
    CONSTIPATION
         subjects affected / exposed
    117 / 339 (34.51%)
    59 / 174 (33.91%)
         occurrences all number
    183
    87
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    56 / 339 (16.52%)
    23 / 174 (13.22%)
         occurrences all number
    90
    33
    GASTRITIS
         subjects affected / exposed
    4 / 339 (1.18%)
    10 / 174 (5.75%)
         occurrences all number
    5
    10
    VOMITING
         subjects affected / exposed
    118 / 339 (34.81%)
    72 / 174 (41.38%)
         occurrences all number
    280
    160
    TOOTHACHE
         subjects affected / exposed
    26 / 339 (7.67%)
    11 / 174 (6.32%)
         occurrences all number
    30
    12
    STOMATITIS
         subjects affected / exposed
    46 / 339 (13.57%)
    24 / 174 (13.79%)
         occurrences all number
    74
    32
    NAUSEA
         subjects affected / exposed
    240 / 339 (70.80%)
    118 / 174 (67.82%)
         occurrences all number
    772
    328
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    18 / 339 (5.31%)
    8 / 174 (4.60%)
         occurrences all number
    20
    8
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    43 / 339 (12.68%)
    22 / 174 (12.64%)
         occurrences all number
    58
    28
    PRURITUS
         subjects affected / exposed
    32 / 339 (9.44%)
    8 / 174 (4.60%)
         occurrences all number
    45
    12
    ALOPECIA
         subjects affected / exposed
    182 / 339 (53.69%)
    87 / 174 (50.00%)
         occurrences all number
    254
    113
    DRY SKIN
         subjects affected / exposed
    27 / 339 (7.96%)
    6 / 174 (3.45%)
         occurrences all number
    29
    7
    ERYTHEMA
         subjects affected / exposed
    18 / 339 (5.31%)
    9 / 174 (5.17%)
         occurrences all number
    20
    18
    Musculoskeletal and connective tissue disorders
    BONE PAIN
         subjects affected / exposed
    41 / 339 (12.09%)
    23 / 174 (13.22%)
         occurrences all number
    54
    39
    BACK PAIN
         subjects affected / exposed
    66 / 339 (19.47%)
    42 / 174 (24.14%)
         occurrences all number
    105
    62
    ARTHRALGIA
         subjects affected / exposed
    77 / 339 (22.71%)
    58 / 174 (33.33%)
         occurrences all number
    133
    98
    MYALGIA
         subjects affected / exposed
    60 / 339 (17.70%)
    26 / 174 (14.94%)
         occurrences all number
    88
    39
    MUSCLE SPASMS
         subjects affected / exposed
    20 / 339 (5.90%)
    9 / 174 (5.17%)
         occurrences all number
    25
    13
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    25 / 339 (7.37%)
    9 / 174 (5.17%)
         occurrences all number
    29
    9
    PAIN IN EXTREMITY
         subjects affected / exposed
    71 / 339 (20.94%)
    40 / 174 (22.99%)
         occurrences all number
    119
    53
    NECK PAIN
         subjects affected / exposed
    17 / 339 (5.01%)
    8 / 174 (4.60%)
         occurrences all number
    23
    11
    Infections and infestations
    INFLUENZA
         subjects affected / exposed
    19 / 339 (5.60%)
    7 / 174 (4.02%)
         occurrences all number
    26
    7
    BRONCHITIS
         subjects affected / exposed
    21 / 339 (6.19%)
    5 / 174 (2.87%)
         occurrences all number
    27
    6
    NASOPHARYNGITIS
         subjects affected / exposed
    60 / 339 (17.70%)
    27 / 174 (15.52%)
         occurrences all number
    89
    42
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    17 / 339 (5.01%)
    4 / 174 (2.30%)
         occurrences all number
    26
    5
    RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    15 / 339 (4.42%)
    10 / 174 (5.75%)
         occurrences all number
    33
    16
    RHINITIS
         subjects affected / exposed
    20 / 339 (5.90%)
    4 / 174 (2.30%)
         occurrences all number
    24
    5
    SINUSITIS
         subjects affected / exposed
    29 / 339 (8.55%)
    9 / 174 (5.17%)
         occurrences all number
    34
    12
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    52 / 339 (15.34%)
    19 / 174 (10.92%)
         occurrences all number
    86
    27
    URINARY TRACT INFECTION
         subjects affected / exposed
    41 / 339 (12.09%)
    17 / 174 (9.77%)
         occurrences all number
    77
    43
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    17 / 339 (5.01%)
    4 / 174 (2.30%)
         occurrences all number
    23
    4
    HYPERGLYCAEMIA
         subjects affected / exposed
    22 / 339 (6.49%)
    9 / 174 (5.17%)
         occurrences all number
    65
    19
    DECREASED APPETITE
         subjects affected / exposed
    81 / 339 (23.89%)
    56 / 174 (32.18%)
         occurrences all number
    106
    71
    HYPOPHOSPHATAEMIA
         subjects affected / exposed
    26 / 339 (7.67%)
    9 / 174 (5.17%)
         occurrences all number
    51
    28
    HYPONATRAEMIA
         subjects affected / exposed
    18 / 339 (5.31%)
    5 / 174 (2.87%)
         occurrences all number
    24
    5
    HYPOKALAEMIA
         subjects affected / exposed
    44 / 339 (12.98%)
    19 / 174 (10.92%)
         occurrences all number
    95
    47
    HYPOCALCAEMIA
         subjects affected / exposed
    29 / 339 (8.55%)
    14 / 174 (8.05%)
         occurrences all number
    55
    21
    HYPOMAGNESAEMIA
         subjects affected / exposed
    83 / 339 (24.48%)
    39 / 174 (22.41%)
         occurrences all number
    196
    108

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2014
    Amendment 1 – Updated to require contraception use for 6 months following completion of therapy in male and female subjects and to clarify that abstinence is an approved method of birth control; updated exclusion criteria to include hypersensitivity to Tartrazine, Orange Yellow-S or other constituents; updated to clarify definition of uncontrolled hypertension.
    11 Feb 2015
    Amendment 2 – Updated to change the primary efficacy endpoint of PFS as determined by a BICR to PFS as determined by the investigator, with BICR as supportive of the investigator's assessment; to clarify that bone-only disease and/or hormone receptor-positive disease are eligible for the study; that post-baseline CNS imaging is not required in subjects without evidence of CNS metastases at Screening; updated dose modification language; added unblinded team to manage subjects who enter crossover therapy upon confirmed disease progression (no subjects entered crossover prior to Amendment 2).
    17 Jun 2016
    Amendment 3 – Updated to increase the number of subjects based upon data from Phase 2 Study M12-895, including revising protocol assumptions and adjusting the sample size based on pre-planned adaptation; to clarify clinical data to be collected and submitted for central review to support progression; to clarify blinding information; to clarify veliparib/placebo administration after discontinuation of chemotherapy; to clarify screening and randomization pregnancy testing and prior anticancer requirements; to add a post-treatment phase schedule of assessments; included updated NCCN criteria for BRCA testing.
    23 Jul 2020
    Amendment 4 – Updated to add benefits and risks evaluation information and updated study procedures in the context of the COVID-19 pandemic, introduced the option of off-site phone visits every other cycle for subjects who have been receiving single-agent veliparib/placebo at a stable dose without adjustment for multiple cycles without uncontrolled adverse events, and to add table of assessments for these visits, removed references to Blinded/Unblinded TA MD and study teams throughout protocol, included language to indicate that AbbVie may remove the requirements for sites to send clinical laboratory samples to the central laboratory and radiology scans to the central reviewer, or discontinue the requirements for central review at any time during the course of the study, updated tumor assessment schedule from every 9 weeks to allow every 12 weeks (or at longer intervals not to exceed 24 weeks per the investigator's discretion) from the prior scan, update IDMC review language, update the guidelines on when chemotherapy can begin based on hematologic blood counts, added language on the reporting of myelodysplastic syndrome, acute myeloid leukemia, or any secondary primary malignancy, modify the Table of Study Procedures for Post Treatment Phase and for patients that are considered on study, off drug, clarify the timing/conduct of additional OS analyses before the final OS analysis, if needed, changed DOR from secondary to tertiary endpoint, include updates from Administrative Changes 3 and 4 throughout the protocol, updated contacts for safety reporting related questions or concerns and protocol deviations, and corrected grammatical errors and inconsistencies throughout the protocol.
    06 Aug 2022
    Amendment 5 – Updated on the protocol-specified PFS and OS analyses, added actions to be taken with subjects on treatment after final OS analysis, indicated unblinding to treatment assignments, specified no new starts of crossover open-label monotherapy after progression for subjects randomized to placebo, indicated subjects receiving placebo must be discontinued from the study, modified study procedures for subjects continuing on study treatment, increased interval between required on-site visits for subjects on veliparib monotherapy, removed use of central laboratory for clinical laboratory tests, central review of tumor assessment scans, included details on how to perform specific activities/procedures that may be impacted by changes in global/local regulations due to the pandemic and/or the geopolitical conflict in Ukraine and surrounding impacted regions.

    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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