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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

    Summary
    EudraCT number
    		 2015-000952-11
    Trial protocol
    		 FI   DK   BE   SE   IE   DE   FR   GB   HU   CZ   PL   IT  
    Global end of trial date

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Jun 2020
    First version publication date
    20 May 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    213359
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    Interim
    Date of interim/final analysis
    30 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 May 2019
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of niraparib versus placebo as maintenance treatment, as measured by progression-free survival (PFS), in participants with Stage III or IV ovarian cancer (including fallopian and peritoneal cancers) with a complete response (CR) or partial response (PR) following front-line platinumbased chemotherapy treatment.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2016
    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
    Canada: 87
    Country: Number of subjects enrolled
    United States: 246
    Country: Number of subjects enrolled
    Czech Republic: 12
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Russian Federation: 30
    Country: Number of subjects enrolled
    Ukraine: 29
    Country: Number of subjects enrolled
    Belgium: 40
    Country: Number of subjects enrolled
    Switzerland: 8
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    Denmark: 24
    Country: Number of subjects enrolled
    Spain: 95
    Country: Number of subjects enrolled
    Finland: 11
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    Ireland: 3
    Country: Number of subjects enrolled
    Israel: 17
    Country: Number of subjects enrolled
    Italy: 35
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Sweden: 2
    Worldwide total number of subjects
    733
    EEA total number of subjects
    316
    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)
    444
    From 65 to 84 years
    287
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 In this double-blind, randomized, placebo-controlled study, participants with stage III or IV ovarian cancer were randomized to receive either niraparib or placebo in 2:1 ratio. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion.

    Pre-assignment
    Screening details
    		 A total of 989 participants were screened, of which 256 participants did not meet eligibility criteria. A total of 733 participants were enrolled and randomized in the study, of which 728 participants received study treatment (4 participants were screen failures after randomization and 1 participant withdrew consent before first dose).

    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, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram (kg) and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

    Arm title
    		 Niraparib
    Arm description
    		 Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Niraparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

    Number of subjects in period 1
    		Placebo Niraparib
    Started
    246
    487
    Received study treatment
    244
    484
    Completed
    191
    397
    Not completed
    55
    90
         Adverse event, serious fatal
    30
    48
         Consent withdrawn by subject
    18
    36
         Disease progression
    6
    4
         Site closed
    -
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

    Reporting group title
    Niraparib
    Reporting group description
    		 Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

    Reporting group values
    		 Placebo Niraparib Total
    Number of subjects
    		 246 487 733
    Age categorical
    Units: Subjects
        Total participants
    		 246 487 733
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 61.3 ( 10.39 ) 61.1 ( 10.79 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 246 487 733
        Male
    		 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 219 436 655
        Black
    		 2 10 12
        Asian
    		 11 14 25
        American Indian or Alaska Native
    		 0 1 1
        Native Hawaiian or other Pacific Islander
    		 0 1 1
        Unknown
    		 14 25 39

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

    Reporting group title
    Niraparib
    Reporting group description
    		 Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight <77 kg or Baseline platelet count <150,000 per μL).

    Primary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented. Intent-to-Treat (ITT) population comprised of all participants who were randomized into the study.
    End point type
    Primary
    End point timeframe
    Up to 34 months
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    246 [1]
    487 [2]
    Units: Months
        median (confidence interval 95%)
    8.2 (7.3 to 8.5)
    13.8 (11.5 to 14.9)
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    If hazard ratio was found to be <1 then niraparib can be considered as superior to placebo.
    Comparison groups
    Placebo v Niraparib
    Number of subjects included in analysis
    733
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.502
         upper limit
    		 0.755
    Notes
    [3] - p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and homologous recombination deficiency (HRD) status.

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis. 99999 indicates, median and 95% CI (upper limit) could not be derived, as <50% of participants experienced the event within the treatment arm. 88888 indicates, 95% CI (upper limit) could not be derived, as <75% of participants experienced the event within the treatment arm.
    End point type
    Secondary
    End point timeframe
    Up to 34 months
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    246 [4]
    487 [5]
    Units: Months
        median (confidence interval 95%)
    99999 (25.0 to 99999)
    30.3 (30.3 to 88888)
    Notes
    [4] - ITT Population
    [5] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    If hazard ratio was found to be <1 then niraparib can be considered as superior to placebo.
    Comparison groups
    Placebo v Niraparib
    Number of subjects included in analysis
    733
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1238 [6]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.442
         upper limit
    		 1.106
    Notes
    [6] - p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.

    Secondary: Time to first subsequent therapy (TFST)

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    End point title
    		 Time to first subsequent therapy (TFST)
    End point description
    Time to first subsequent therapy was defined as the time from the date of randomization to the date of the first subsequent anti-cancer therapy or death, whichever occurs first. Median and 95% CI are presented.
    End point type
    Secondary
    End point timeframe
    Up to 34 months
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    246 [7]
    487 [8]
    Units: Months
        median (confidence interval 95%)
    12.0 (10.3 to 13.9)
    18.6 (15.8 to 24.7)
    Notes
    [7] - ITT Population
    [8] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    If hazard ratio was found to be <1 then niraparib can be considered as superior to placebo.
    Comparison groups
    Placebo v Niraparib
    Number of subjects included in analysis
    733
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001 [9]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.521
         upper limit
    		 0.802
    Notes
    [9] - p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.

    Secondary: Progression-Free Survival-2 (PFS2)

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    End point title
    		 Progression-Free Survival-2 (PFS2)
    End point description
    PFS2 was defined as the time from the date of randomization to the date of progression on the next anti-cancer therapy following study treatment or death by any cause, whichever occurs first. Median and 95% CI are presented. 99999 indicates, median and 95% CI could not be derived, as <25% of participants experienced the event within the treatment arm. 88888 indicates, 95% CI (upper limit) could not be derived, as <75% of participants experienced the event within the treatment arm.
    End point type
    Secondary
    End point timeframe
    Up to 34 months
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    246 [10]
    487 [11]
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    27.2 (25.3 to 88888)
    Notes
    [10] - ITT Population
    [11] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    If hazard ratio was found to be <1 then niraparib can be considered as superior to placebo.
    Comparison groups
    Placebo v Niraparib
    Number of subjects included in analysis
    733
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2242 [12]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.577
         upper limit
    		 1.139
    Notes
    [12] - p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.

    Secondary: Change from Baseline in participant reported outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)

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    End point title
    		 Change from Baseline in participant reported outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)
    End point description
    FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants responded to their symptom experience over the past 7 days using a 5-point Likert scale scored from “not at all” (0) to “very much” (4). FOSI score was calculated as (sum of item scores)*8 divided by (number of items answered). The FOSI score ranged from 0 (severely symptomatic) to 32 (asymptomatic). A higher score indicated a better quality of life (QoL). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Only those participants with data available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, Pre-dose) and Up to Week 24
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    240 [13]
    479 [14]
    Units: Scores on a scale
        least squares mean (standard error)
    -0.3 ( 0.22 )
    -0.4 ( 0.15 )
    Notes
    [13] - ITT Population
    [14] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in PRO: European quality of life scale, 5-dimensions, 5-levels of severity (EQ-5D-5L) utility score

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    End point title
    		 Change from Baseline in PRO: European quality of life scale, 5-dimensions, 5-levels of severity (EQ-5D-5L) utility score
    End point description
    The EQ-5D-5L is a health-related QoL instrument. The 5-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems & 5=extreme problems. The health state is combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1). Only those participants with data available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, Pre-dose) and Up to Week 24
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    243 [15]
    477 [16]
    Units: Scores on a scale
        least squares mean (standard error)
    0.005 ( 0.0066 )
    0.016 ( 0.0046 )
    Notes
    [15] - ITT Population
    [16] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in functional scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)

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    End point title
    		 Change from Baseline in functional scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
    End point description
    EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social) assessing additional symptoms commonly reported by participants with cancer. 5 functional scales had total 15 items (physical-5, role-2, cognitive-4, emotional-2, and social-2). Each functional scales score was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher (“better”) level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, Pre-dose) and Up to Week 24
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    244 [17]
    479 [18]
    Units: Scores on a scale
    least squares mean (standard error)
        Physical Functioning, n=244,479
    2.119 ( 0.8131 )
    2.013 ( 0.5735 )
        Role Functioning, n=244,479
    2.341 ( 1.2427 )
    1.590 ( 0.8810 )
        Emotional Functioning, n=243,478
    -0.011 ( 1.1218 )
    -0.870 ( 0.7685 )
        Cognitive Functioning, n=243,478
    -0.020 ( 1.2105 )
    -0.842 ( 0.7952 )
        Social Functioning, n=243,478
    5.557 ( 1.2449 )
    4.445 ( 0.8633 )
    Notes
    [17] - ITT Population
    [18] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in global health status/QoL of EORTC-QLQ-C30

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    End point title
    		 Change from Baseline in global health status/QoL of EORTC-QLQ-C30
    End point description
    EORTC-QLQ-C30 incorporates a global health status/QoL scale (global health status, QoL) assessing additional symptoms commonly reported by participants with cancer. A global health status/QoL scale had total 2 items. Each global health status/QoL scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 6*100). The global health status/QoL scales range in score from 0 to 100. Higher score represents a higher (“better”) level of health status/QoL. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Only those participants with data available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, Pre-dose) and Up to Week 24
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    243 [19]
    478 [20]
    Units: Scores on a scale
        least squares mean (standard error)
    1.177 ( 1.0005 )
    1.009 ( 0.6898 )
    Notes
    [19] - ITT Population
    [20] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in symptoms scales and symptoms items (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulty) of EORTC-QLQ-C30

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    End point title
    		 Change from Baseline in symptoms scales and symptoms items (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulty) of EORTC-QLQ-C30
    End point description
    EORTC-QLQ-C30 incorporates 3 symptom scales (fatigue, pain, and nausea/vomiting), and 6 single items assessing additional symptoms commonly reported by participants with cancer. Symptom scale had total 7 items (fatigue-3, pain-2, nausea/vomiting-2). Each symptoms scales and 6 single additional symptoms items score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales and 6 single additional symptoms scales range in score from 0 to 100. Higher score represents a higher (“worse”) level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). 99999 indicates data is not estimable due to insufficient model fit.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, Pre-dose) and Up to Week 24
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    244 [21]
    480 [22]
    Units: Scores on a scale
    least squares mean (standard error)
        Fatigue, n=243,479
    -0.082 ( 1.2394 )
    0.085 ( 0.8363 )
        Nausea/Vomiting, n=244,479
    1.673 ( 0.7595 )
    3.115 ( 0.4828 )
        Pain, n=244,480
    -0.195 ( 1.2274 )
    0.765 ( 1.0166 )
        Dyspnea, n=244,479
    0.644 ( 1.3592 )
    1.347 ( 0.8518 )
        Insomnia, n=244,479
    2.195 ( 1.9882 )
    3.478 ( 1.2791 )
        Appetite Loss, n=8,30
    -0.827 ( 4.3987 )
    -0.395 ( 2.3195 )
        Constipation, n=244,478
    -1.147 ( 1.5793 )
    6.356 ( 1.0446 )
        Diarrhea, n=8,30
    9.335 ( 3.8667 )
    -3.340 ( 2.0136 )
        Financial Difficulties, n=243,475
    -5.058 ( 1.2978 )
    -3.356 ( 0.9276 )
    Notes
    [21] - ITT Population
    [22] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in functional scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)

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    End point title
    		 Change from Baseline in functional scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)
    End point description
    EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher (“better”) level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, Pre-dose) and Up to 34 months
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    244 [23]
    475 [24]
    Units: Scores on a scale
    least squares mean (standard error)
        Body Image, n=244,475
    10.069 ( 1.4820 )
    8.488 ( 1.0138 )
        Sexuality, n=240,471
    3.257 ( 1.1886 )
    3.625 ( 0.8004 )
        Attitude to disease/Treatment, n=244,475
    12.216 ( 1.3257 )
    13.660 ( 0.9309 )
    Notes
    [23] - ITT Population
    [24] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in symptoms scale of EORTC-QLQ-OV28

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    End point title
    		 Change from Baseline in symptoms scale of EORTC-QLQ-OV28
    End point description
    EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/GI symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Symptoms scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales range in score from 0 to 100. Higher score represents a higher (“worse”) level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1, Pre-dose) and Up to 34 months
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    244 [25]
    481 [26]
    Units: Scores on a scale
    least squares mean (standard error)
        Abdominal/GI, n=244,481
    0.832 ( 0.8110 )
    2.185 ( 0.5703 )
        Peripheral Neuropathy, n=244,480
    -9.629 ( 1.3219 )
    -8.217 ( 0.9295 )
        Hormonal/Menopausal Symptoms, n=244,480
    -2.521 ( 1.3074 )
    1.501 ( 0.8803 )
        Other Chemotherapy Side Effects, n=244,480
    -3.023 ( 0.8358 )
    -2.219 ( 0.5581 )
        Hair Loss, n=242,477
    -20.743 ( 1.3690 )
    -23.363 ( 0.9821 )
    Notes
    [25] - ITT Population
    [26] - ITT Population
    No statistical analyses for this end point

    Other pre-specified: Number of participants with any non-serious adverse event (non-SAE) or any SAE

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    End point title
    		 Number of participants with any non-serious adverse event (non-SAE) or any SAE
    End point description
    An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Safety Population comprised of all participants who received at least 1 dose of study drug. 5 participants (2 participants from Placebo group and 3 participants from Niraparib group) out of 733 participants did not receive any study treatment and thus, were excluded from the Safety Population.
    End point type
    Other pre-specified
    End point timeframe
    Up to 34 months
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    244 [27]
    484 [28]
    Units: Participants
        Any non-SAE
    223
    478
        Any SAE
    32
    156
    Notes
    [27] - Safety Population
    [28] - Safety Population
    No statistical analyses for this end point

    Other pre-specified: Area Under the Curve (AUC) from 0 to the last quantifiable concentration (AUC[0-last])

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    End point title
    		 Area Under the Curve (AUC) from 0 to the last quantifiable concentration (AUC[0-last]) [29]
    End point description
    Blood samples were planned to be collected for assessment of AUC(0-last). This was an other pre-specified outcome measure. Data will not be analyzed and reported.
    End point type
    Other pre-specified
    End point timeframe
    Up to 34 months
    Notes
    [29] - 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: This endpoint is only reporting on a subset of the arms that are contained in the baseline period
    End point values
    		 Niraparib
    Number of subjects analysed
    0 [30]
    Units: Hours*nanogram per milliliter
        geometric mean (geometric coefficient of variation)
    ( )
    Notes
    [30] - ITT Population
    No statistical analyses for this end point

    Other pre-specified: Peak plasma concentration (Cmax)

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    End point title
    		 Peak plasma concentration (Cmax) [31]
    End point description
    Blood samples were planned to be collected for assessment of Cmax. This was an other pre-specified outcome measure. Data will not be analyzed and reported.
    End point type
    Other pre-specified
    End point timeframe
    Up to 34 months
    Notes
    [31] - 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: This endpoint is only reporting on a subset of the arms that are contained in the baseline period
    End point values
    		 Niraparib
    Number of subjects analysed
    0 [32]
    Units: Nanograms per milliliter
        geometric mean (geometric coefficient of variation)
    ( )
    Notes
    [32] - ITT Population
    No statistical analyses for this end point

    Other pre-specified: Number of participants with positive HRD test

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    End point title
    		 Number of participants with positive HRD test
    End point description
    Number of participants with positive HRD test was planned to be assessed. This was an other pre-specified outcome measure. Data will not be analyzed and reported.
    End point type
    Other pre-specified
    End point timeframe
    Up to 34 months
    End point values
    		 Placebo Niraparib
    Number of subjects analysed
    0 [33]
    0 [34]
    Units: Participants
    Notes
    [33] - ITT Population
    [34] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis)
    Adverse event reporting additional description
    Non-SAEs and SAEs were presented for Safety Population.5 participants out of 733 participants did not receive any study treatment and thus,were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kilogram [kg] and Baseline platelet count >=150,000 per microliter [μL]) or 200 mg (2×100 mg capsules for participants with a baseline body weight <77 kg or baseline platelet count <150,000 per μL).

    Reporting group title
    Niraparib
    Reporting group description
    		 Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant’s Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight >=77 kg and Baseline platelet count >=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a baseline body weight <77 kg or baseline platelet count <150,000 per μL).

    Serious adverse events
    		 Placebo Niraparib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 244 (13.11%)
    156 / 484 (32.23%)
         number of deaths (all causes)
    31
    48
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to breast
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         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 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Fasting
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (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
    Dyspnoea
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonitis
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    20 / 484 (4.13%)
         occurrences causally related to treatment / all
    0 / 0
    25 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Overdose
         subjects affected / exposed
    3 / 244 (1.23%)
    8 / 484 (1.65%)
         occurrences causally related to treatment / all
    4 / 4
    4 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative hernia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transfusion reaction
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    27 / 484 (5.58%)
         occurrences causally related to treatment / all
    0 / 0
    27 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 244 (0.00%)
    6 / 484 (1.24%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 244 (0.00%)
    59 / 484 (12.19%)
         occurrences causally related to treatment / all
    0 / 0
    65 / 65
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal fat apron
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (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
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 244 (0.41%)
    5 / 484 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Large intestinal obstruction
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    5 / 244 (2.05%)
    14 / 484 (2.89%)
         occurrences causally related to treatment / all
    1 / 5
    2 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureteric stenosis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         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
    Arthralgia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Niraparib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    223 / 244 (91.39%)
    478 / 484 (98.76%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acrochordon
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Benign breast neoplasm
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Benign neoplasm of skin
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Cancer pain
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Lipoma
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    3
    2
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Skin papilloma
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vaginal neoplasm
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Blood pressure fluctuation
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Embolism
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Flushing
         subjects affected / exposed
    2 / 244 (0.82%)
    3 / 484 (0.62%)
         occurrences all number
    3
    3
    Haematoma
         subjects affected / exposed
    0 / 244 (0.00%)
    7 / 484 (1.45%)
         occurrences all number
    0
    7
    Hot flush
         subjects affected / exposed
    20 / 244 (8.20%)
    54 / 484 (11.16%)
         occurrences all number
    20
    64
    Hyperaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Hypertension
         subjects affected / exposed
    17 / 244 (6.97%)
    81 / 484 (16.74%)
         occurrences all number
    28
    142
    Hypotension
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Lymphocele
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Lymphoedema
         subjects affected / exposed
    3 / 244 (1.23%)
    1 / 484 (0.21%)
         occurrences all number
    3
    1
    Orthostatic hypotension
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Pallor
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Peripheral ischaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Phlebitis
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Thrombosis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Varicose vein
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    3
    Surgical and medical procedures
    Astringent therapy
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Tooth extraction
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Adhesion
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    31 / 244 (12.70%)
    78 / 484 (16.12%)
         occurrences all number
    47
    138
    Axillary pain
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Catheter site bruise
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Catheter site haematoma
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Catheter site pain
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    3
    Catheter site rash
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Catheter site vesicles
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Chest discomfort
         subjects affected / exposed
    3 / 244 (1.23%)
    5 / 484 (1.03%)
         occurrences all number
    3
    5
    Chest pain
         subjects affected / exposed
    4 / 244 (1.64%)
    3 / 484 (0.62%)
         occurrences all number
    4
    4
    Chills
         subjects affected / exposed
    3 / 244 (1.23%)
    6 / 484 (1.24%)
         occurrences all number
    3
    7
    Cyst
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Discomfort
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    4
    Early satiety
         subjects affected / exposed
    2 / 244 (0.82%)
    4 / 484 (0.83%)
         occurrences all number
    2
    4
    Facial pain
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    72 / 244 (29.51%)
    168 / 484 (34.71%)
         occurrences all number
    101
    242
    Feeling abnormal
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Feeling hot
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Gait disturbance
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    General physical health deterioration
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Generalised oedema
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Hernia
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    3
    Hernia pain
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Induration
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    11 / 244 (4.51%)
    15 / 484 (3.10%)
         occurrences all number
    12
    22
    Injection site reaction
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Local swelling
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    0 / 244 (0.00%)
    7 / 484 (1.45%)
         occurrences all number
    0
    7
    Mass
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Mucosal dryness
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    6 / 244 (2.46%)
    23 / 484 (4.75%)
         occurrences all number
    10
    29
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 244 (0.82%)
    13 / 484 (2.69%)
         occurrences all number
    2
    15
    Oedema peripheral
         subjects affected / exposed
    11 / 244 (4.51%)
    30 / 484 (6.20%)
         occurrences all number
    19
    35
    Pain
         subjects affected / exposed
    6 / 244 (2.46%)
    16 / 484 (3.31%)
         occurrences all number
    6
    17
    Peripheral swelling
         subjects affected / exposed
    4 / 244 (1.64%)
    6 / 484 (1.24%)
         occurrences all number
    4
    6
    Pyrexia
         subjects affected / exposed
    15 / 244 (6.15%)
    41 / 484 (8.47%)
         occurrences all number
    17
    47
    Secretion discharge
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Sensation of foreign body
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Suprapubic pain
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Swelling
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Ulcer
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Unevaluable event
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vessel puncture site haematoma
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Contrast media reaction
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Seasonal allergy
         subjects affected / exposed
    5 / 244 (2.05%)
    3 / 484 (0.62%)
         occurrences all number
    5
    3
    Reproductive system and breast disorders
    Atrophic vulvovaginitis
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Breast calcifications
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Breast discharge
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Breast pain
         subjects affected / exposed
    3 / 244 (1.23%)
    1 / 484 (0.21%)
         occurrences all number
    3
    1
    Breast tenderness
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    4
    Coital bleeding
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Dyspareunia
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    3
    Female genital tract fistula
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Genital paraesthesia
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Genital swelling
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Menopausal symptoms
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Metrorrhagia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Pelvic pain
         subjects affected / exposed
    6 / 244 (2.46%)
    8 / 484 (1.65%)
         occurrences all number
    7
    8
    Perineal pain
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Uterine polyp
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vaginal discharge
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    2
    6
    Vaginal haemorrhage
         subjects affected / exposed
    3 / 244 (1.23%)
    3 / 484 (0.62%)
         occurrences all number
    3
    3
    Vaginal mucosal blistering
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vaginal prolapse
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vulvovaginal burning sensation
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Vulvovaginal dryness
         subjects affected / exposed
    6 / 244 (2.46%)
    7 / 484 (1.45%)
         occurrences all number
    6
    12
    Vulvovaginal pain
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    4
    Vulvovaginal pruritus
         subjects affected / exposed
    4 / 244 (1.64%)
    1 / 484 (0.21%)
         occurrences all number
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Atelectasis
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    35 / 244 (14.34%)
    74 / 484 (15.29%)
         occurrences all number
    45
    92
    Dry throat
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Dysphonia
         subjects affected / exposed
    2 / 244 (0.82%)
    4 / 484 (0.83%)
         occurrences all number
    2
    4
    Dyspnoea
         subjects affected / exposed
    30 / 244 (12.30%)
    88 / 484 (18.18%)
         occurrences all number
    33
    129
    Dyspnoea at rest
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    1 / 244 (0.41%)
    17 / 484 (3.51%)
         occurrences all number
    1
    18
    Epistaxis
         subjects affected / exposed
    3 / 244 (1.23%)
    23 / 484 (4.75%)
         occurrences all number
    6
    24
    Hiccups
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Hydrothorax
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Interstitial lung disease
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    9 / 244 (3.69%)
    21 / 484 (4.34%)
         occurrences all number
    12
    28
    Nasal discomfort
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Nasal dryness
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Nasal pruritus
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal discomfort
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    18 / 244 (7.38%)
    22 / 484 (4.55%)
         occurrences all number
    19
    24
    Painful respiration
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Paranasal sinus discomfort
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Pleural effusion
         subjects affected / exposed
    2 / 244 (0.82%)
    2 / 484 (0.41%)
         occurrences all number
    2
    3
    Pleuritic pain
         subjects affected / exposed
    2 / 244 (0.82%)
    2 / 484 (0.41%)
         occurrences all number
    2
    4
    Pneumonia aspiration
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    3 / 244 (1.23%)
    14 / 484 (2.89%)
         occurrences all number
    3
    16
    Pulmonary embolism
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Respiratory disorder
         subjects affected / exposed
    2 / 244 (0.82%)
    3 / 484 (0.62%)
         occurrences all number
    3
    3
    Respiratory tract congestion
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    2 / 244 (0.82%)
    6 / 484 (1.24%)
         occurrences all number
    2
    7
    Rhinorrhoea
         subjects affected / exposed
    3 / 244 (1.23%)
    9 / 484 (1.86%)
         occurrences all number
    3
    9
    Rhonchi
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    3 / 244 (1.23%)
    2 / 484 (0.41%)
         occurrences all number
    4
    3
    Sinus pain
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Tonsillar disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    3
    Wheezing
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 244 (0.41%)
    8 / 484 (1.65%)
         occurrences all number
    1
    11
    Anxiety
         subjects affected / exposed
    19 / 244 (7.79%)
    43 / 484 (8.88%)
         occurrences all number
    24
    53
    Confusional state
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Depressed mood
         subjects affected / exposed
    2 / 244 (0.82%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Depression
         subjects affected / exposed
    10 / 244 (4.10%)
    26 / 484 (5.37%)
         occurrences all number
    14
    28
    Dysphoria
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Emotional disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Genito-pelvic pain/penetration disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hallucination
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Hallucination, olfactory
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Initial insomnia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    35 / 244 (14.34%)
    119 / 484 (24.59%)
         occurrences all number
    37
    162
    Irritability
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Libido decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Libido increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Mania
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Mood swings
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Nervousness
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Nightmare
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Panic attack
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Psychotic disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Sleep disorder
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    4
    Stress
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Suicidal ideation
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Investigations
    Alanine aminotransferase
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    15 / 244 (6.15%)
    42 / 484 (8.68%)
         occurrences all number
    21
    67
    Amylase increased
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    4
    Aspartate aminotransferase
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    10 / 244 (4.10%)
    43 / 484 (8.88%)
         occurrences all number
    16
    78
    Bilirubin conjugated increased
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Blood alkaline phosphatase
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    6 / 244 (2.46%)
    42 / 484 (8.68%)
         occurrences all number
    8
    66
    Blood bilirubin increased
         subjects affected / exposed
    0 / 244 (0.00%)
    7 / 484 (1.45%)
         occurrences all number
    0
    13
    Blood calcium increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Blood chloride increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    1
    4
    Blood creatine increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    10 / 244 (4.10%)
    55 / 484 (11.36%)
         occurrences all number
    12
    96
    Blood glucose decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    1
    6
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    3
    Blood magnesium decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    4
    Blood potassium increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 244 (0.00%)
    5 / 484 (1.03%)
         occurrences all number
    0
    5
    Blood sodium decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Blood urea increased
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    3
    4
    Bone density decreased
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Carbohydrate antigen 125 increased
         subjects affected / exposed
    10 / 244 (4.10%)
    7 / 484 (1.45%)
         occurrences all number
    11
    7
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Eosinophil count decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 244 (0.82%)
    11 / 484 (2.27%)
         occurrences all number
    2
    21
    Haematocrit decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Haemoglobin decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    5 / 484 (1.03%)
         occurrences all number
    0
    7
    Heart rate increased
         subjects affected / exposed
    0 / 244 (0.00%)
    9 / 484 (1.86%)
         occurrences all number
    0
    10
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Intraocular pressure increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Lipase increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 244 (1.23%)
    25 / 484 (5.17%)
         occurrences all number
    4
    43
    Mean cell volume increased
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    4
    Monocyte count decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Monocyte count increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    5 / 244 (2.05%)
    82 / 484 (16.94%)
         occurrences all number
    10
    207
    Neutrophil count increased
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Platelet count decreased
         subjects affected / exposed
    3 / 244 (1.23%)
    129 / 484 (26.65%)
         occurrences all number
    4
    338
    Platelet count increased
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Protein total decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Red blood cell count decreased
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4
    Sputum abnormal
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vitamin D decreased
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    4 / 244 (1.64%)
    20 / 484 (4.13%)
         occurrences all number
    6
    27
    Weight increased
         subjects affected / exposed
    19 / 244 (7.79%)
    17 / 484 (3.51%)
         occurrences all number
    30
    24
    White blood cell count decreased
         subjects affected / exposed
    8 / 244 (3.28%)
    74 / 484 (15.29%)
         occurrences all number
    16
    205
    White blood cell count increased
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Allergic transfusion reaction
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Animal bite
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Arthropod bite
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4
    Bone contusion
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Chest injury
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Compression fracture
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    3 / 244 (1.23%)
    22 / 484 (4.55%)
         occurrences all number
    5
    29
    Fall
         subjects affected / exposed
    2 / 244 (0.82%)
    12 / 484 (2.48%)
         occurrences all number
    2
    14
    Foot fracture
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    3
    1
    Head injury
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Humerus fracture
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Incision site pain
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Incision site swelling
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Incisional hernia
         subjects affected / exposed
    3 / 244 (1.23%)
    0 / 484 (0.00%)
         occurrences all number
    3
    0
    Joint dislocation
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Laceration
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Ligament sprain
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Mallet finger
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Meniscus injury
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Muscle injury
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Muscle rupture
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Post-traumatic pain
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Postoperative hernia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Postoperative ileus
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Procedural pain
         subjects affected / exposed
    3 / 244 (1.23%)
    6 / 484 (1.24%)
         occurrences all number
    4
    6
    Procedural site reaction
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Radius fracture
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Rib fracture
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Scar
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Skin abrasion
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Spinal compression fracture
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Stoma complication
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Stoma site discharge
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Stoma site inflammation
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Sunburn
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Tooth fracture
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    3
    Upper limb fracture
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Vaccination complication
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vascular access malfunction
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Wound
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Wound complication
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Wound evisceration
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Wrist fracture
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    4
    Atrial fibrillation
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Cardiac failure
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Conduction disorder
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Coronary artery disease
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Metabolic cardiomyopathy
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    5 / 244 (2.05%)
    39 / 484 (8.06%)
         occurrences all number
    6
    45
    Sinus tachycardia
         subjects affected / exposed
    3 / 244 (1.23%)
    12 / 484 (2.48%)
         occurrences all number
    5
    17
    Tachyarrhythmia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    6 / 244 (2.46%)
    25 / 484 (5.17%)
         occurrences all number
    6
    28
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Aphasia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Aphonia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Aura
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Balance disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    6 / 484 (1.24%)
         occurrences all number
    0
    6
    Burning sensation
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    3 / 244 (1.23%)
    3 / 484 (0.62%)
         occurrences all number
    5
    3
    Cognitive disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Disturbance in attention
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    1
    4
    Dizziness
         subjects affected / exposed
    26 / 244 (10.66%)
    71 / 484 (14.67%)
         occurrences all number
    30
    96
    Dizziness postural
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Dysaesthesia
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    2
    Dysgeusia
         subjects affected / exposed
    10 / 244 (4.10%)
    25 / 484 (5.17%)
         occurrences all number
    13
    34
    Dyskinesia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Facial nerve disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    36 / 244 (14.75%)
    126 / 484 (26.03%)
         occurrences all number
    46
    190
    Hemiparesis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Hypoaesthesia
         subjects affected / exposed
    6 / 244 (2.46%)
    8 / 484 (1.65%)
         occurrences all number
    6
    12
    Loss of consciousness
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Memory impairment
         subjects affected / exposed
    5 / 244 (2.05%)
    7 / 484 (1.45%)
         occurrences all number
    5
    7
    Mental impairment
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    3 / 244 (1.23%)
    4 / 484 (0.83%)
         occurrences all number
    4
    5
    Motor dysfunction
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Neuralgia
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    3
    Neuropathy peripheral
         subjects affected / exposed
    15 / 244 (6.15%)
    31 / 484 (6.40%)
         occurrences all number
    18
    38
    Neurotoxicity
         subjects affected / exposed
    3 / 244 (1.23%)
    1 / 484 (0.21%)
         occurrences all number
    3
    1
    Paraesthesia
         subjects affected / exposed
    8 / 244 (3.28%)
    11 / 484 (2.27%)
         occurrences all number
    9
    20
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Peripheral sensory neuropathy
         subjects affected / exposed
    8 / 244 (3.28%)
    18 / 484 (3.72%)
         occurrences all number
    10
    21
    Polyneuropathy
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    3
    Presyncope
         subjects affected / exposed
    3 / 244 (1.23%)
    2 / 484 (0.41%)
         occurrences all number
    3
    3
    Radiculopathy
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    1
    4
    Sciatica
         subjects affected / exposed
    3 / 244 (1.23%)
    9 / 484 (1.86%)
         occurrences all number
    4
    10
    Seizure
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Sinus headache
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Speech disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    1 / 244 (0.41%)
    5 / 484 (1.03%)
         occurrences all number
    1
    6
    Tension headache
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Transient global amnesia
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    0 / 244 (0.00%)
    7 / 484 (1.45%)
         occurrences all number
    0
    9
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    43 / 244 (17.62%)
    306 / 484 (63.22%)
         occurrences all number
    83
    921
    Anaemia macrocytic
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Febrile neutropenia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Haemorrhagic disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Immune thrombocytopenic purpura
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Leukocytosis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    13 / 244 (5.33%)
    57 / 484 (11.78%)
         occurrences all number
    27
    145
    Lymphadenitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    3
    Lymphopenia
         subjects affected / exposed
    0 / 244 (0.00%)
    12 / 484 (2.48%)
         occurrences all number
    0
    40
    Macrocytosis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    16 / 244 (6.56%)
    126 / 484 (26.03%)
         occurrences all number
    32
    366
    Thrombocytopenia
         subjects affected / exposed
    9 / 244 (3.69%)
    210 / 484 (43.39%)
         occurrences all number
    12
    549
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Deafness
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Ear congestion
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Ear discomfort
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Ear haemorrhage
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    4 / 244 (1.64%)
    6 / 484 (1.24%)
         occurrences all number
    4
    6
    Ear pruritus
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Excessive cerumen production
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    External ear pain
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Hypoacusis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Meniere's disease
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Motion sickness
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Paraesthesia ear
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Tinnitus
         subjects affected / exposed
    4 / 244 (1.64%)
    11 / 484 (2.27%)
         occurrences all number
    6
    11
    Vertigo
         subjects affected / exposed
    6 / 244 (2.46%)
    13 / 484 (2.69%)
         occurrences all number
    7
    13
    Vertigo positional
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vestibular disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Blepharospasm
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Cataract
         subjects affected / exposed
    2 / 244 (0.82%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Cataract nuclear
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    3
    Diplopia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Dry eye
         subjects affected / exposed
    1 / 244 (0.41%)
    11 / 484 (2.27%)
         occurrences all number
    1
    12
    Eye disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Eye haemorrhage
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Eye oedema
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    1
    5
    Eye swelling
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Eyelid oedema
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Eyelid sensory disorder
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Hypermetropia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    2
    Myopia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Ocular discomfort
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    5
    Photophobia
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Photopsia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Retinal exudates
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Retinal haemorrhage
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Scleral disorder
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    2 / 244 (0.82%)
    5 / 484 (1.03%)
         occurrences all number
    2
    5
    Visual acuity reduced
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Visual impairment
         subjects affected / exposed
    1 / 244 (0.41%)
    5 / 484 (1.03%)
         occurrences all number
    1
    5
    Vitreous floaters
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    11 / 244 (4.51%)
    15 / 484 (3.10%)
         occurrences all number
    11
    19
    Abdominal distension
         subjects affected / exposed
    30 / 244 (12.30%)
    32 / 484 (6.61%)
         occurrences all number
    36
    36
    Abdominal hernia
         subjects affected / exposed
    2 / 244 (0.82%)
    4 / 484 (0.83%)
         occurrences all number
    2
    5
    Abdominal mass
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    74 / 244 (30.33%)
    105 / 484 (21.69%)
         occurrences all number
    102
    146
    Abdominal pain lower
         subjects affected / exposed
    13 / 244 (5.33%)
    15 / 484 (3.10%)
         occurrences all number
    17
    16
    Abdominal pain upper
         subjects affected / exposed
    21 / 244 (8.61%)
    41 / 484 (8.47%)
         occurrences all number
    26
    59
    Abdominal tenderness
         subjects affected / exposed
    2 / 244 (0.82%)
    4 / 484 (0.83%)
         occurrences all number
    2
    6
    Abnormal faeces
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Aerophagia
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Anal haemorrhage
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Anal incontinence
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Anal pruritus
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Anorectal discomfort
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    3
    1
    Aphthous ulcer
         subjects affected / exposed
    1 / 244 (0.41%)
    5 / 484 (1.03%)
         occurrences all number
    1
    5
    Ascites
         subjects affected / exposed
    8 / 244 (3.28%)
    3 / 484 (0.62%)
         occurrences all number
    8
    3
    Cheilitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Chronic gastritis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Coeliac disease
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Constipation
         subjects affected / exposed
    46 / 244 (18.85%)
    189 / 484 (39.05%)
         occurrences all number
    52
    262
    Defaecation urgency
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Dental caries
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Diaphragmatic hernia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    55 / 244 (22.54%)
    91 / 484 (18.80%)
         occurrences all number
    82
    132
    Diverticulum intestinal
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Dry mouth
         subjects affected / exposed
    6 / 244 (2.46%)
    40 / 484 (8.26%)
         occurrences all number
    8
    46
    Dyspepsia
         subjects affected / exposed
    14 / 244 (5.74%)
    34 / 484 (7.02%)
         occurrences all number
    16
    43
    Dysphagia
         subjects affected / exposed
    1 / 244 (0.41%)
    6 / 484 (1.24%)
         occurrences all number
    1
    10
    Epigastric discomfort
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Eructation
         subjects affected / exposed
    3 / 244 (1.23%)
    3 / 484 (0.62%)
         occurrences all number
    3
    3
    Faecaloma
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Faeces discoloured
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    3
    Faeces soft
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    3
    Flatulence
         subjects affected / exposed
    7 / 244 (2.87%)
    17 / 484 (3.51%)
         occurrences all number
    12
    20
    Frequent bowel movements
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Gastric disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Gastritis
         subjects affected / exposed
    2 / 244 (0.82%)
    5 / 484 (1.03%)
         occurrences all number
    2
    5
    Gastritis erosive
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Gastrointestinal pain
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    7 / 244 (2.87%)
    25 / 484 (5.17%)
         occurrences all number
    8
    28
    Gingival bleeding
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Gingival pain
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Glossitis
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Glossodynia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Haematochezia
         subjects affected / exposed
    3 / 244 (1.23%)
    3 / 484 (0.62%)
         occurrences all number
    5
    3
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    4 / 244 (1.64%)
    5 / 484 (1.03%)
         occurrences all number
    4
    6
    Hiatus hernia
         subjects affected / exposed
    2 / 244 (0.82%)
    4 / 484 (0.83%)
         occurrences all number
    2
    4
    Intestinal mass
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Intestinal obstruction
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Large intestine polyp
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Lip blister
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Lip disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Lip swelling
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    3
    Melaena
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4
    Mouth haemorrhage
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Mouth ulceration
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    1
    5
    Nausea
         subjects affected / exposed
    67 / 244 (27.46%)
    278 / 484 (57.44%)
         occurrences all number
    100
    448
    Noninfective gingivitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Odynophagia
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Oesophagitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Oral contusion
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Oral dysaesthesia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Oral mucosal blistering
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    3
    Oral mucosal discolouration
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Oral pain
         subjects affected / exposed
    3 / 244 (1.23%)
    7 / 484 (1.45%)
         occurrences all number
    3
    9
    Pancreatic disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Pancreatitis chronic
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Paraesthesia oral
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Proctalgia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Rectal discharge
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    3 / 244 (1.23%)
    5 / 484 (1.03%)
         occurrences all number
    3
    7
    Rectal tenesmus
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Regurgitation
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Retching
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Salivary duct stenosis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Salivary gland calculus
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Small intestinal obstruction
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    3
    1
    Stomatitis
         subjects affected / exposed
    4 / 244 (1.64%)
    16 / 484 (3.31%)
         occurrences all number
    7
    18
    Swollen tongue
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Tongue coated
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Tooth disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Tooth impacted
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 244 (0.00%)
    6 / 484 (1.24%)
         occurrences all number
    0
    6
    Umbilical hernia
         subjects affected / exposed
    3 / 244 (1.23%)
    3 / 484 (0.62%)
         occurrences all number
    3
    3
    Vomiting
         subjects affected / exposed
    28 / 244 (11.48%)
    108 / 484 (22.31%)
         occurrences all number
    34
    153
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Biliary dilatation
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hepatic pain
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Hepatitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hepatitis toxic
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    4
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 244 (0.82%)
    2 / 484 (0.41%)
         occurrences all number
    2
    8
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Liver disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Actinic keratosis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    5 / 244 (2.05%)
    7 / 484 (1.45%)
         occurrences all number
    5
    7
    Angioedema
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Blood blister
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Dermal cyst
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Dermatitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    3
    Dermatitis acneiform
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Dermatitis contact
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    1
    4
    Drug eruption
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    11 / 244 (4.51%)
    19 / 484 (3.93%)
         occurrences all number
    12
    21
    Ecchymosis
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    1
    4
    Eczema
         subjects affected / exposed
    2 / 244 (0.82%)
    2 / 484 (0.41%)
         occurrences all number
    5
    2
    Erythema
         subjects affected / exposed
    3 / 244 (1.23%)
    6 / 484 (1.24%)
         occurrences all number
    3
    9
    Erythema dyschromicum perstans
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Erythema multiforme
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Hair texture abnormal
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Hirsutism
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Hyperhidrosis
         subjects affected / exposed
    4 / 244 (1.64%)
    8 / 484 (1.65%)
         occurrences all number
    4
    8
    Hyperkeratosis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Hypertrichosis
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Ingrowing nail
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Ingrown hair
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Macule
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Madarosis
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    3
    Nail discolouration
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Nail disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Nail growth abnormal
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Nail ridging
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    3 / 244 (1.23%)
    5 / 484 (1.03%)
         occurrences all number
    4
    5
    Onychoclasis
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Onychomadesis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Pain of skin
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Papule
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Petechiae
         subjects affected / exposed
    0 / 244 (0.00%)
    28 / 484 (5.79%)
         occurrences all number
    0
    29
    Photosensitivity reaction
         subjects affected / exposed
    2 / 244 (0.82%)
    29 / 484 (5.99%)
         occurrences all number
    2
    35
    Pityriasis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    4
    0
    Pruritus
         subjects affected / exposed
    19 / 244 (7.79%)
    13 / 484 (2.69%)
         occurrences all number
    21
    18
    Pruritus generalised
         subjects affected / exposed
    5 / 244 (2.05%)
    4 / 484 (0.83%)
         occurrences all number
    5
    4
    Psoriasis
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Purpura
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    4
    Rash
         subjects affected / exposed
    8 / 244 (3.28%)
    23 / 484 (4.75%)
         occurrences all number
    12
    29
    Rash generalised
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Rash macular
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Rash maculo-papular
         subjects affected / exposed
    8 / 244 (3.28%)
    12 / 484 (2.48%)
         occurrences all number
    8
    14
    Rash pruritic
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Rosacea
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Scar pain
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Sebaceous gland disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Skin discolouration
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Skin disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Skin exfoliation
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Skin fissures
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Skin hyperpigmentation
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Skin irritation
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Skin lesion
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Skin reaction
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Skin ulcer
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Solar dermatitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Solar lentigo
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Swelling face
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Urticaria
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Azotaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Bladder discomfort
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4
    Bladder pain
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Bladder spasm
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Chronic kidney disease
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Cystitis interstitial
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Cystitis noninfective
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Dysuria
         subjects affected / exposed
    10 / 244 (4.10%)
    21 / 484 (4.34%)
         occurrences all number
    11
    22
    Haematuria
         subjects affected / exposed
    6 / 244 (2.46%)
    5 / 484 (1.03%)
         occurrences all number
    6
    6
    Leukocyturia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Micturition disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    3
    Micturition urgency
         subjects affected / exposed
    4 / 244 (1.64%)
    3 / 484 (0.62%)
         occurrences all number
    4
    3
    Nephritis
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Nephropathy
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Nocturia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Pollakiuria
         subjects affected / exposed
    5 / 244 (2.05%)
    11 / 484 (2.27%)
         occurrences all number
    5
    11
    Polyuria
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    3
    1
    Proteinuria
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Renal colic
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Renal failure
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Renal pain
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Urethral pain
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Urinary retention
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Urinary tract pain
         subjects affected / exposed
    1 / 244 (0.41%)
    4 / 484 (0.83%)
         occurrences all number
    1
    4
    Urine odour abnormal
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hyperthyroidism
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Hypothyroidism
         subjects affected / exposed
    2 / 244 (0.82%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Thyroid cyst
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Thyroid mass
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    47 / 244 (19.26%)
    85 / 484 (17.56%)
         occurrences all number
    77
    116
    Arthritis
         subjects affected / exposed
    4 / 244 (1.64%)
    6 / 484 (1.24%)
         occurrences all number
    6
    6
    Arthropathy
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    24 / 244 (9.84%)
    64 / 484 (13.22%)
         occurrences all number
    29
    84
    Bone disorder
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Bone lesion
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Bone pain
         subjects affected / exposed
    4 / 244 (1.64%)
    2 / 484 (0.41%)
         occurrences all number
    6
    2
    Bone swelling
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Bursitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Costochondritis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Exostosis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Extremity contracture
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Flank pain
         subjects affected / exposed
    4 / 244 (1.64%)
    7 / 484 (1.45%)
         occurrences all number
    5
    8
    Gouty arthritis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Groin pain
         subjects affected / exposed
    3 / 244 (1.23%)
    5 / 484 (1.03%)
         occurrences all number
    3
    5
    Haemarthrosis
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Hypercreatinaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Joint effusion
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Joint instability
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Joint range of motion decreased
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Joint stiffness
         subjects affected / exposed
    4 / 244 (1.64%)
    4 / 484 (0.83%)
         occurrences all number
    7
    4
    Joint swelling
         subjects affected / exposed
    0 / 244 (0.00%)
    7 / 484 (1.45%)
         occurrences all number
    0
    9
    Limb discomfort
         subjects affected / exposed
    3 / 244 (1.23%)
    1 / 484 (0.21%)
         occurrences all number
    3
    1
    Muscle contracture
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Muscle fatigue
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    14 / 244 (5.74%)
    19 / 484 (3.93%)
         occurrences all number
    25
    24
    Muscle tightness
         subjects affected / exposed
    2 / 244 (0.82%)
    1 / 484 (0.21%)
         occurrences all number
    2
    1
    Muscular weakness
         subjects affected / exposed
    3 / 244 (1.23%)
    12 / 484 (2.48%)
         occurrences all number
    3
    15
    Musculoskeletal chest pain
         subjects affected / exposed
    9 / 244 (3.69%)
    12 / 484 (2.48%)
         occurrences all number
    10
    17
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Musculoskeletal disorder
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    8 / 244 (3.28%)
    12 / 484 (2.48%)
         occurrences all number
    11
    15
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 244 (0.41%)
    7 / 484 (1.45%)
         occurrences all number
    4
    8
    Myalgia
         subjects affected / exposed
    13 / 244 (5.33%)
    36 / 484 (7.44%)
         occurrences all number
    18
    49
    Myalgia intercostal
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    7 / 244 (2.87%)
    12 / 484 (2.48%)
         occurrences all number
    9
    13
    Osteoarthritis
         subjects affected / exposed
    2 / 244 (0.82%)
    8 / 484 (1.65%)
         occurrences all number
    2
    10
    Osteochondrosis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Osteonecrosis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Osteopenia
         subjects affected / exposed
    2 / 244 (0.82%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Osteoporosis
         subjects affected / exposed
    1 / 244 (0.41%)
    14 / 484 (2.89%)
         occurrences all number
    1
    15
    Pain in extremity
         subjects affected / exposed
    16 / 244 (6.56%)
    38 / 484 (7.85%)
         occurrences all number
    20
    53
    Pain in jaw
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Periarthritis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Plantar fasciitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Scleroderma
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Sjogren's syndrome
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Soft tissue disorder
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Spinal pain
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Spondylolisthesis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Synovial cyst
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Tendon pain
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Tendonitis
         subjects affected / exposed
    2 / 244 (0.82%)
    3 / 484 (0.62%)
         occurrences all number
    2
    3
    Tenosynovitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Trigger finger
         subjects affected / exposed
    3 / 244 (1.23%)
    1 / 484 (0.21%)
         occurrences all number
    4
    1
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Anal abscess
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Angular cheilitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Arthritis infective
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 244 (0.41%)
    12 / 484 (2.48%)
         occurrences all number
    1
    13
    Candida infection
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Catheter site cellulitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    3
    2
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 244 (0.41%)
    5 / 484 (1.03%)
         occurrences all number
    1
    7
    Cystitis
         subjects affected / exposed
    4 / 244 (1.64%)
    6 / 484 (1.24%)
         occurrences all number
    4
    6
    Device related infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Diverticulitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Eye infection
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4
    Folliculitis
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Fungal infection
         subjects affected / exposed
    4 / 244 (1.64%)
    0 / 484 (0.00%)
         occurrences all number
    5
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Furuncle
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Gastric infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 244 (0.41%)
    3 / 484 (0.62%)
         occurrences all number
    1
    3
    Gastroenteritis viral
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Gastrointestinal candidiasis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Genital herpes
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    2
    Gingivitis
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    3
    2
    Helicobacter gastritis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    4 / 244 (1.64%)
    5 / 484 (1.03%)
         occurrences all number
    4
    8
    Hordeolum
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4
    Infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    5 / 244 (2.05%)
    6 / 484 (1.24%)
         occurrences all number
    5
    6
    Laryngitis
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Localised infection
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Lung infection
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4
    Lymphangitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Mastitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Medical device site infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Mucosal infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Nail infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Onychomycosis
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Ophthalmic herpes simplex
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Oral fungal infection
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    3 / 244 (1.23%)
    7 / 484 (1.45%)
         occurrences all number
    4
    10
    Oral infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Paronychia
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Pharyngitis
         subjects affected / exposed
    0 / 244 (0.00%)
    5 / 484 (1.03%)
         occurrences all number
    0
    6
    Pneumonia
         subjects affected / exposed
    2 / 244 (0.82%)
    8 / 484 (1.65%)
         occurrences all number
    2
    9
    Pyelonephritis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    2 / 244 (0.82%)
    3 / 484 (0.62%)
         occurrences all number
    2
    3
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    2 / 244 (0.82%)
    9 / 484 (1.86%)
         occurrences all number
    2
    10
    Sepsis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Shigella infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Sialoadenitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    7 / 244 (2.87%)
    15 / 484 (3.10%)
         occurrences all number
    7
    27
    Skin candida
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Skin infection
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Soft tissue infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Tinea pedis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 244 (0.00%)
    7 / 484 (1.45%)
         occurrences all number
    0
    9
    Tracheitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 244 (7.38%)
    28 / 484 (5.79%)
         occurrences all number
    22
    31
    Urinary tract infection
         subjects affected / exposed
    19 / 244 (7.79%)
    44 / 484 (9.09%)
         occurrences all number
    25
    48
    Vaginal infection
         subjects affected / exposed
    2 / 244 (0.82%)
    3 / 484 (0.62%)
         occurrences all number
    2
    4
    Viral infection
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    25 / 244 (10.25%)
    49 / 484 (10.12%)
         occurrences all number
    40
    55
    Vulvitis
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Cell death
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    20 / 244 (8.20%)
    92 / 484 (19.01%)
         occurrences all number
    21
    112
    Dehydration
         subjects affected / exposed
    1 / 244 (0.41%)
    6 / 484 (1.24%)
         occurrences all number
    1
    7
    Diabetes mellitus
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    3
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Hyperalbuminaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 244 (0.41%)
    9 / 484 (1.86%)
         occurrences all number
    2
    14
    Hypercholesterolaemia
         subjects affected / exposed
    4 / 244 (1.64%)
    7 / 484 (1.45%)
         occurrences all number
    4
    7
    Hypercreatininaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    3 / 484 (0.62%)
         occurrences all number
    0
    4
    Hyperglycaemia
         subjects affected / exposed
    6 / 244 (2.46%)
    19 / 484 (3.93%)
         occurrences all number
    8
    28
    Hyperkalaemia
         subjects affected / exposed
    3 / 244 (1.23%)
    6 / 484 (1.24%)
         occurrences all number
    3
    10
    Hypermagnesaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hypernatraemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hyperphosphataemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Hyperproteinaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    3
    Hyperuricaemia
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    2
    2
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 244 (1.23%)
    8 / 484 (1.65%)
         occurrences all number
    6
    13
    Hypocalcaemia
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    4
    Hypochloraemia
         subjects affected / exposed
    1 / 244 (0.41%)
    2 / 484 (0.41%)
         occurrences all number
    1
    2
    Hypoglycaemia
         subjects affected / exposed
    2 / 244 (0.82%)
    2 / 484 (0.41%)
         occurrences all number
    3
    2
    Hypokalaemia
         subjects affected / exposed
    4 / 244 (1.64%)
    25 / 484 (5.17%)
         occurrences all number
    4
    37
    Hypomagnesaemia
         subjects affected / exposed
    12 / 244 (4.92%)
    38 / 484 (7.85%)
         occurrences all number
    18
    58
    Hyponatraemia
         subjects affected / exposed
    3 / 244 (1.23%)
    19 / 484 (3.93%)
         occurrences all number
    4
    35
    Hypophosphataemia
         subjects affected / exposed
    0 / 244 (0.00%)
    2 / 484 (0.41%)
         occurrences all number
    0
    10
    Hypoproteinaemia
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Increased appetite
         subjects affected / exposed
    3 / 244 (1.23%)
    0 / 484 (0.00%)
         occurrences all number
    3
    0
    Iron deficiency
         subjects affected / exposed
    2 / 244 (0.82%)
    0 / 484 (0.00%)
         occurrences all number
    2
    0
    Magnesium deficiency
         subjects affected / exposed
    1 / 244 (0.41%)
    1 / 484 (0.21%)
         occurrences all number
    1
    1
    Polydipsia
         subjects affected / exposed
    1 / 244 (0.41%)
    0 / 484 (0.00%)
         occurrences all number
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 244 (0.00%)
    1 / 484 (0.21%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 244 (0.00%)
    4 / 484 (0.83%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2016
    Amendment 1: Expanded inclusion criteria to include all participants with Stage III or IV ovarian cancer following front-line platinum-based chemotherapy treatment and not limit to participants of HRD status. Outcomes for next anticancer therapy following study treatment and time to first subsequent therapy were added as secondary endpoints. The relationship between HRD status and platinum sensitivity in ovarian cancer participants who have initial response to front-line platinum therapy was added as an exploratory objective. Stratification factors were revised to add administration of neoadjuvant chemotherapy (yes or no) and HRD status to complete response (CR)/partial response (PR). Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) were added as adverse events of special interest. Inclusion criteria were revised to indicate high-grade and predominantly serous or endometrioid ovarian cancers, to provide more specific guidance on the surgical and chemotherapy criteria. Exclusion criteria were revised to provide more specific guidance.
    16 Nov 2017
    Amendment 2: Revision of the dosing scheme to include a fixed dose option and an individualized dose option based on a participant weight and or platelet count. The sample size was revised from 330 expected participants to 468 expected participants based on a reduced median PFS. Secondary cancers (new malignancies other than MDS/AML), pneumonitis, and embryo-fetal toxicity were added as adverse events of special interest. Rules for dose modifications were clarified based on the new fixed and individualized starting dose structure.
    12 Feb 2018
    Amendment 3: The sample size was revised from 468 expected participants to 620 expected participants based on longer median PFS expected for participants with g-breast cancer susceptibility gene (gBRCA) mutations.
    27 Aug 2019
    Amendment 4: Changed TESARO European address and sponsor medical monitor; removed secondary endpoints of outcomes for next anticancer therapy following study treatment, and time to cancer antigen 125 (CA-125) progression as they were determined to have limited clinical utility; study endpoints updated to include OS as a key secondary endpoint- defined as time from randomization to date of death; Methodology was revised to reduce frequency of computed tomography (CT)/magnetic resonance imaging (MRI) from every 12 weeks (3 cycles) to every 24 weeks (6 cycles) for participants on treatment over 2 years to reduce ionizing radiation exposure for participants on study long term; Main criteria for inclusion updated to allow for additional HRD testing following randomization; Statistical Methods updated to include Additional statistical analysis information for secondary endpoint of OS; Disease background updated to include bevacizumab as a maintenance therapy in the United States (US); extended treatment window beyond three years for those participants who are continuing to derive clinical benefit of study treatment; Discontinuation of study updated to reflect the potential for collection of OS data from public sources where available if participant withdraws consent from the study; Concomitant Medications and restrictions updated to include a requirement for a participant to withdraw from study treatment if she develops a new malignancy and requires anticancer therapy for that neoplasm; Clinical Laboratory Assessments updated to include a requirement for neutrophil collection ; Pregnancy updated Language updated to reflect Sponsor standard safety data collection practices.

    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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