Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB – IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance

    Summary
    EudraCT number
    		 2014-004027-52
    Trial protocol
    		 DE   AT   BE   ES   DK   SE   FI   IT  
    Global end of trial date
    22 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2024
    First version publication date
    14 Feb 2024
    Other versions
    Summary report(s)
    		 Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GINECO-OV125b
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02477644
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ENGOT-ov25: ENGOT
    Sponsors
    Sponsor organisation name
    ARCAGY-RESEARCH
    Sponsor organisation address
    8 Rue Lamennais, PARIS, France, 75008
    Public contact
    Project Manager, Sophie BRUTTO, ARCAGY-RESEARCH, +33 184 85 20 20, reglementaire@arcagy.org
    Scientific contact
    Project Manager, Sophie BRUTTO, ARCAGY-RESEARCH, +33 184 85 20 20, reglementaire@arcagy.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy by progression free survival (PFS1) investigator based according to modified Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) of olaparib maintenance compared to placebo in high grade epithelial ovarian, fallopian tube, or peritoneal cancer that are in clinical complete response or partial response following first line platinum-taxane based chemotherapy plus bevacizumab, and planned to receive bevacizumab in the maintenance phase.
    Protection of trial subjects
    The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP), applicable regulatory requirements. The Informed Consent Form will incorporate (or, in some cases, be accompanied by a separate document incorporating) wording that complies with relevant data protection and privacy legislation. ARCAGY Research will not provide individual genotype results to patient, her family members, any insurance company, any employer, general physician or any other third party, unless required to do so by law. The exception to the above is the result of the tBRCA test; this will be made available to the investigator and patient. Extra precautions are taken to preserve confidentiality and prevent genetic data being linked to the identity of the patient. In exceptional circumstances, however, certain individuals might see both the genetic data and the personal identifiers of a patient. For example, in the case of a medical emergency, a sponsor physician or an investigator might know a patient’s identity and also have access to her genetic data. Also Regulatory authorities may require access to the relevant files, though the patient’s medical information and the genetic files would remain physically separate.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 May 2015
    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
    Spain: 55
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Austria: 28
    Country: Number of subjects enrolled
    Belgium: 20
    Country: Number of subjects enrolled
    Denmark: 6
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    France: 327
    Country: Number of subjects enrolled
    Germany: 251
    Country: Number of subjects enrolled
    Italy: 85
    Country: Number of subjects enrolled
    Monaco: 2
    Country: Number of subjects enrolled
    Japan: 24
    Worldwide total number of subjects
    806
    EEA total number of subjects
    780
    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)
    514
    From 65 to 84 years
    289
    85 years and over
    3

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Of the 1222 patients enrolled into the study (ie, gave informed consent), 416 patients were not randomised, with 326 patients not meeting the eligibility criteria. Of the 806 patients randomised into the study, 535 olaparib patients and 267 placebo patients received study treatment (olaparib or placebo) in addition to bevacizumab

    Pre-assignment
    Screening details
    		 Patients were randomised using an Interactive Voice Response System (IVRS)/Interactive Web Response System in a 2:1 ratio (olaparib:matching placebo) to receive either olaparib tablets orally 300 mg twice daily (bd) or matching placebo, in addition to bevacizumab.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A : Olaparib
    Arm description
    		 Olaparib
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib tablets per os 300 mg twice daily,

    Arm title
    		 Arm B : Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets per os 300 mg twice daily.

    Number of subjects in period 1
    		Arm A : Olaparib Arm B : Placebo
    Started
    537
    269
    Completed
    230
    105
    Not completed
    307
    164
         Consent withdrawn by subject
    15
    6
         Lost to follow-up
    6
    -
         Lack of efficacy
    286
    158

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Arm A : Olaparib
    Reporting group description
    		 Olaparib

    Reporting group title
    Arm B : Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Arm A : Olaparib Arm B : Placebo Total
    Number of subjects
    		 537 269 806
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 332 182 514
        From 65-84 years
    		 204 85 289
        85 years and over
    		 1 2 3
    Age continuous
    Units: years
        median (full range (min-max))
    		 61 (32 to 87) 60 (26 to 85) -
    Gender categorical
    Units: Subjects
        Female
    		 537 269 806
        Male
    		 0 0 0
    Performance status
    Units: Subjects
        ECOG 0
    		 378 189 567
        ECOG 1
    		 153 76 229
        Missing
    		 6 4 10
    Primary tumour location
    Units: Subjects
        Ovary
    		 456 238 694
        Fallopian tubes
    		 39 11 50
        Primary peritoneal
    		 42 20 62
    Histology
    Units: Subjects
        Serous
    		 519 253 772
        Endometrioid
    		 12 8 20
        Other
    		 6 8 14
    FIGO Stage
    Units: Subjects
        III
    		 378 186 564
        IV
    		 159 83 242
    History of cytoreductive surgery
    Units: Subjects
        No surgery
    		 38 21 59
        Upfront surgery - Residual macroscopic disease
    		 111 53 164
        Upfront surgery - No residual macroscopic disease
    		 160 85 245
        Interval surgery - Residual macroscopic disease
    		 65 35 100
        Interval surgery - No residual macroscopic disease
    		 163 75 238
    Response after surgery/platinum-based chemotherapy
    Units: Subjects
        No evidence of disease
    		 290 141 431
        Complete response
    		 106 53 159
        Partial response
    		 141 75 216
    Normal serum Ca-125 level
    Units: Subjects
        Yes
    		 463 234 697
        No
    		 74 34 108
        Missing
    		 0 1 1
    Deleterious tumor BRCA mutation
    Units: Subjects
        Yes
    		 161 80 241
        No
    		 376 189 565
    Tumor HRD status
    Units: Subjects
        Positive
    		 255 132 387
        Negative
    		 192 85 277
        Unknow
    		 90 52 142
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Baseline characteristics and efficacy data will be described on the Intent-to-treat (ITT) population. The Intent-to-treat (ITT) population is defined as all patients randomized in the trial, regardless of whether they actually received treatment. The treatment groups will be analyzed as randomized. FAS: all randomised patients analysed on an ITT basis.

    Subject analysis sets values
    		 ITT
    Number of subjects
    806
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    514
        From 65-84 years
    289
        85 years and over
    3
    Age continuous
    Units: years
        median (full range (min-max))
    61 (26 to 87)
    Gender categorical
    Units: Subjects
        Female
    806
        Male
    0
    Performance status
    Units: Subjects
        ECOG 0
    567
        ECOG 1
    229
        Missing
    10
    Primary tumour location
    Units: Subjects
        Ovary
    694
        Fallopian tubes
    50
        Primary peritoneal
    62
    Histology
    Units: Subjects
        Serous
    772
        Endometrioid
    20
        Other
    14
    FIGO Stage
    Units: Subjects
        III
    564
        IV
    242
    History of cytoreductive surgery
    Units: Subjects
        No surgery
    59
        Upfront surgery - Residual macroscopic disease
    164
        Upfront surgery - No residual macroscopic disease
    245
        Interval surgery - Residual macroscopic disease
    100
        Interval surgery - No residual macroscopic disease
    238
    Response after surgery/platinum-based chemotherapy
    Units: Subjects
        No evidence of disease
    431
        Complete response
    159
        Partial response
    216
    Normal serum Ca-125 level
    Units: Subjects
        Yes
    697
        No
    108
        Missing
    1
    Deleterious tumor BRCA mutation
    Units: Subjects
        Yes
    241
        No
    565
    Tumor HRD status
    Units: Subjects
        Positive
    387
        Negative
    277
        Unknow
    142

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm A : Olaparib
    Reporting group description
    		 Olaparib

    Reporting group title
    Arm B : Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Baseline characteristics and efficacy data will be described on the Intent-to-treat (ITT) population. The Intent-to-treat (ITT) population is defined as all patients randomized in the trial, regardless of whether they actually received treatment. The treatment groups will be analyzed as randomized. FAS: all randomised patients analysed on an ITT basis.

    Primary: Progression free survival in ITT population

    		 Close Top of page
    End point title
    		 Progression free survival in ITT population
    End point description
    Time from randomization to disease prgression according to RECIST1.1 or death whatever occurs first.
    End point type
    Primary
    End point timeframe
    At disease progression
    End point values
    		 Arm A : Olaparib Arm B : Placebo
    Number of subjects analysed
    537
    269
    Units: months
        median (confidence interval 95%)
    22.1 (21.8 to 24.1)
    16.6 (15.4 to 18.6)
    Statistical analysis title
    		 Median PFS
    Statistical analysis description
    Log-rank test stratified on first line treatment outcome and tBRCA status
    Comparison groups
    Arm A : Olaparib v Arm B : Placebo
    Number of subjects included in analysis
    806
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 0.72

    Secondary: Second Progression free survival (PFS2) in ITT population

    		 Close Top of page
    End point title
    		 Second Progression free survival (PFS2) in ITT population
    End point description
    Time from the date of randomization to the earliest of the progression event subsequent to that used for the primary variable PFS1, or date of death
    End point type
    Secondary
    End point timeframe
    When 411 events had been observed in ITT population, OR after a maximum duration of 1 year following the PFS1 analysis, whichever occurs first.
    End point values
    		 Arm A : Olaparib Arm B : Placebo
    Number of subjects analysed
    537
    269
    Units: Months
        median (confidence interval 95%)
    36.5 (32.2 to 42.6)
    32.6 (28.3 to 35.1)
    Statistical analysis title
    		 Median PFS
    Statistical analysis description
    Log-rank test stratified on first line treatment outcome and tBRCA status
    Comparison groups
    Arm A : Olaparib v Arm B : Placebo
    Number of subjects included in analysis
    806
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0125
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.95

    Secondary: Overall survival in ITT population

    		 Close Top of page
    End point title
    		 Overall survival in ITT population
    End point description
    Time from the date of randomization until death due to any cause.
    End point type
    Secondary
    End point timeframe
    Final OS analysis is planned to be performed when the OS data are approximately 60% mature OR after a 3-year duration from the main PFS1 analysis, whichever occurs first.
    End point values
    		 Arm A : Olaparib Arm B : Placebo
    Number of subjects analysed
    537
    269
    Units: Months
        median (confidence interval 95%)
    56.5 (49.8 to 62.2)
    51.6 (43.0 to 55.7)
    Statistical analysis title
    		 Median OS
    Statistical analysis description
    Log-rank test stratified on first line treatment outcome and tBRCA status
    Comparison groups
    Arm A : Olaparib v Arm B : Placebo
    Number of subjects included in analysis
    806
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4118
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.12

    Other pre-specified: Progression free survival in tBRCA mutated patients

    		 Close Top of page
    End point title
    		 Progression free survival in tBRCA mutated patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    When 458 events had been observed on ITT population
    End point values
    		 ITT
    Number of subjects analysed
    237 [1]
    Units: Hazard ratio
        number (confidence interval 95%)
    0.31 (0.2 to 0.47)
    Notes
    [1] - Patients with tumor BRCA mutation (tBRCAm)
    No statistical analyses for this end point

    Other pre-specified: Progression free survival in tBRCA wild type patients

    		 Close Top of page
    End point title
    		 Progression free survival in tBRCA wild type patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    When 458 events had been observed on ITT population
    End point values
    		 ITT
    Number of subjects analysed
    569 [2]
    Units: Hazard ratio
        number (confidence interval 95%)
    0.71 (0.58 to 0.88)
    Notes
    [2] - Patients with no tumor BRCA mutation (tBRCAwt)
    No statistical analyses for this end point

    Other pre-specified: Progression free survival in HRD negative patients

    		 Close Top of page
    End point title
    		 Progression free survival in HRD negative patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    When 458 events had been observed on ITT population
    End point values
    		 ITT
    Number of subjects analysed
    419
    Units: months
        median (confidence interval 95%)
    0.92 (0.72 to 1.17)
    No statistical analyses for this end point

    Other pre-specified: Progression free survival in HRD positive including tBRCAm patients

    		 Close Top of page
    End point title
    		 Progression free survival in HRD positive including tBRCAm patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    When 458 events had been observed on ITT population
    End point values
    		 ITT
    Number of subjects analysed
    387
    Units: months
        median (confidence interval 95%)
    0.33 (0.25 to 0.45)
    No statistical analyses for this end point

    Other pre-specified: Progression free survival in HRD positive, excluding tBRCAm patients

    		 Close Top of page
    End point title
    		 Progression free survival in HRD positive, excluding tBRCAm patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    When 458 events had been observed on ITT population
    End point values
    		 ITT
    Number of subjects analysed
    152
    Units: months
        median (confidence interval 95%)
    0.43 (0.28 to 0.66)
    No statistical analyses for this end point

    Other pre-specified: Second Progression free survival (PFS2) in HRD positive, including tBRCAm patients

    		 Close Top of page
    End point title
    		 Second Progression free survival (PFS2) in HRD positive, including tBRCAm patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    When 411 events had been observed in ITT population, OR after a maximum duration of 1 year following the PFS1 analysis, whichever occurs first.
    End point values
    		 ITT
    Number of subjects analysed
    387
    Units: Hazard ratio
        number (confidence interval 95%)
    0.56 (0.41 to 0.77)
    No statistical analyses for this end point

    Other pre-specified: Second Progression free survival (PFS2) in HRD positive, excluding tBRCAm patients

    		 Close Top of page
    End point title
    		 Second Progression free survival (PFS2) in HRD positive, excluding tBRCAm patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    When 411 events had been observed in ITT population, OR after a maximum duration of 1 year following the PFS1 analysis, whichever occurs first.
    End point values
    		 ITT
    Number of subjects analysed
    152
    Units: Hazard ratio
        number (confidence interval 95%)
    0.6 (0.38 to 0.96)
    No statistical analyses for this end point

    Other pre-specified: Second Progression free survival (PFS2) in HRD negative patients

    		 Close Top of page
    End point title
    		 Second Progression free survival (PFS2) in HRD negative patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    When 411 events had been observed in ITT population, OR after a maximum duration of 1 year following the PFS1 analysis, whichever occurs first.
    End point values
    		 ITT
    Number of subjects analysed
    419
    Units: Hazard ratio
        number (confidence interval 95%)
    0.98 (0.77 to 1.27)
    No statistical analyses for this end point

    Other pre-specified: Overall survival (OS) in HRD positive, including tBRCAm patients

    		 Close Top of page
    End point title
    		 Overall survival (OS) in HRD positive, including tBRCAm patients
    End point description
    Time from the date of randomization until death due to any cause.
    End point type
    Other pre-specified
    End point timeframe
    Final OS analysis is planned to be performed when the OS data are approximately 60% mature OR after a 3-year duration from the main PFS1 analysis, whichever occurs first.
    End point values
    		 ITT
    Number of subjects analysed
    387
    Units: Hazard ratio
        number (confidence interval 95%)
    0.62 (0.45 to 0.85)
    No statistical analyses for this end point

    Other pre-specified: Overall survival (OS) in tBRCAm patients

    		 Close Top of page
    End point title
    		 Overall survival (OS) in tBRCAm patients
    End point description
    Time from the date of randomization until death due to any cause.
    End point type
    Other pre-specified
    End point timeframe
    Final OS analysis is planned to be performed when the OS data are approximately 60% mature OR after a 3-year duration from the main PFS1 analysis, whichever occurs first.
    End point values
    		 ITT
    Number of subjects analysed
    237
    Units: Hazard ratio
        number (confidence interval 95%)
    0.6 (0.39 to 0.93)
    No statistical analyses for this end point

    Other pre-specified: Overall survival (OS) in HRD positive, excluding tBRCAm patients

    		 Close Top of page
    End point title
    		 Overall survival (OS) in HRD positive, excluding tBRCAm patients
    End point description
    Time from the date of randomization until death due to any cause.
    End point type
    Other pre-specified
    End point timeframe
    Final OS analysis is planned to be performed when the OS data are approximately 60% mature OR after a 3-year duration from the main PFS1 analysis, whichever occurs first.
    End point values
    		 ITT
    Number of subjects analysed
    152
    Units: Hazard ratio
        number (confidence interval 95%)
    0.71 (0.45 to 1.13)
    No statistical analyses for this end point

    Other pre-specified: Overall survival (OS) in HRD negative patients (excluding unknown)

    		 Close Top of page
    End point title
    		 Overall survival (OS) in HRD negative patients (excluding unknown)
    End point description
    Time from the date of randomization until death due to any cause.
    End point type
    Other pre-specified
    End point timeframe
    Final OS analysis is planned to be performed when the OS data are approximately 60% mature OR after a 3-year duration from the main PFS1 analysis, whichever occurs first.
    End point values
    		 ITT
    Number of subjects analysed
    277
    Units: Hazard ratio
        number (confidence interval 95%)
    1.19 (0.88 to 1.63)
    No statistical analyses for this end point

    Other pre-specified: Overall survival (OS) in HRD negative patients

    		 Close Top of page
    End point title
    		 Overall survival (OS) in HRD negative patients
    End point description
    Time from the date of randomization until death due to any cause.
    End point type
    Other pre-specified
    End point timeframe
    Final OS analysis is planned to be performed when the OS data are approximately 60% mature OR after a 3-year duration from the main PFS1 analysis, whichever occurs first.
    End point values
    		 ITT
    Number of subjects analysed
    419
    Units: Hazard ratio
        number (confidence interval 95%)
    1.14 (0.89 to 1.48)
    No statistical analyses for this end point

    Other pre-specified: Second Progression free survival (PFS2) in tBRCAm patients

    		 Close Top of page
    End point title
    		 Second Progression free survival (PFS2) in tBRCAm patients
    End point description
    End point type
    Other pre-specified
    End point timeframe
    When 411 events had been observed in ITT population, OR after a maximum duration of 1 year following the PFS1 analysis, whichever occurs first.
    End point values
    		 ITT
    Number of subjects analysed
    237
    Units: Hazard ratio
        number (confidence interval 95%)
    0.53 (0.34 to 0.83)
    No statistical analyses for this end point

    Other pre-specified: Time to first subsequent therapy (TFST) in ITT population

    		 Close Top of page
    End point title
    		 Time to first subsequent therapy (TFST) in ITT population
    End point description
    Time from randomization to first subsequent therapy or death (TFST) FST is defined as the time from the date of randomization to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death. Subsequent therapies intended to control ovarian cancer will be reported. Any patient not known to have died at the time of the analysis and not known to have had a further intervention of this type will be censored at the last known time to have not received subsequent therapy, i.e. the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of first subsequent therapy or death (TFST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    806
    Units: Hazard ratio
        number (confidence interval 95%)
    0.63 (0.54 to 0.75)
    No statistical analyses for this end point

    Other pre-specified: Time to first subsequent therapy (TFST) in HRD positive including tBRCAm patients

    		 Close Top of page
    End point title
    		 Time to first subsequent therapy (TFST) in HRD positive including tBRCAm patients
    End point description
    Time from randomization to first subsequent therapy or death (TFST) FST is defined as the time from the date of randomization to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death. Subsequent therapies intended to control ovarian cancer will be reported. Any patient not known to have died at the time of the analysis and not known to have had a further intervention of this type will be censored at the last known time to have not received subsequent therapy, i.e. the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of first subsequent therapy or death (TFST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    387
    Units: Hazard ratio
        number (confidence interval 95%)
    0.41 (0.32 to 0.52)
    No statistical analyses for this end point

    Other pre-specified: Time to first subsequent therapy (TFST) in HRD positive, excluding tBRCAm patients

    		 Close Top of page
    End point title
    		 Time to first subsequent therapy (TFST) in HRD positive, excluding tBRCAm patients
    End point description
    Time from randomization to first subsequent therapy or death (TFST) FST is defined as the time from the date of randomization to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death. Subsequent therapies intended to control ovarian cancer will be reported. Any patient not known to have died at the time of the analysis and not known to have had a further intervention of this type will be censored at the last known time to have not received subsequent therapy, i.e. the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of first subsequent therapy or death (TFST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    152
    Units: Hazard ratio
        number (confidence interval 95%)
    0.48 (0.32 to 0.7)
    No statistical analyses for this end point

    Other pre-specified: Time to first subsequent therapy (TFST) in HRD negative patients (excluding unknown)

    		 Close Top of page
    End point title
    		 Time to first subsequent therapy (TFST) in HRD negative patients (excluding unknown)
    End point description
    Time from randomization to first subsequent therapy or death (TFST) FST is defined as the time from the date of randomization to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death. Subsequent therapies intended to control ovarian cancer will be reported. Any patient not known to have died at the time of the analysis and not known to have had a further intervention of this type will be censored at the last known time to have not received subsequent therapy, i.e. the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of first subsequent therapy or death (TFST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    277
    Units: Hazard Ratio
        number (confidence interval 95%)
    1.03 (0.79 to 1.36)
    No statistical analyses for this end point

    Other pre-specified: Time to first subsequent therapy (TFST) in tBRCA mutated patients

    		 Close Top of page
    End point title
    		 Time to first subsequent therapy (TFST) in tBRCA mutated patients
    End point description
    Time from randomization to first subsequent therapy or death (TFST) FST is defined as the time from the date of randomization to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death. Subsequent therapies intended to control ovarian cancer will be reported. Any patient not known to have died at the time of the analysis and not known to have had a further intervention of this type will be censored at the last known time to have not received subsequent therapy, i.e. the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of first subsequent therapy or death (TFST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    237
    Units: Hazard Ratio
        number (confidence interval 95%)
    0.47 (0.34 to 0.65)
    No statistical analyses for this end point

    Other pre-specified: Time to second subsequent therapy (TSST) in ITT population

    		 Close Top of page
    End point title
    		 Time to second subsequent therapy (TSST) in ITT population
    End point description
    Time to start of second subsequent therapy or death (TSST) will be defined as the time from the date of randomization to the earliest of the date of event defined as start of a second subsequent anti-cancer therapy following study treatment discontinuation, or death (by any cause in the absence of start of a second new anti-cancer therapy). Patient not known to have died at the time of the analysis and not known to have started a second new anticancer therapy will be censored at the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of second subsequent therapy or death (TSST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    806
    Units: Hazard ratio
        number (confidence interval 95%)
    0.77 (0.65 to 0.92)
    No statistical analyses for this end point

    Other pre-specified: Time to second subsequent therapy (TSST) in HRD positive including tBRCAm patients

    		 Close Top of page
    End point title
    		 Time to second subsequent therapy (TSST) in HRD positive including tBRCAm patients
    End point description
    Time to start of second subsequent therapy or death (TSST) will be defined as the time from the date of randomization to the earliest of the date of event defined as start of a second subsequent anti-cancer therapy following study treatment discontinuation, or death (by any cause in the absence of start of a second new anti-cancer therapy). Patient not known to have died at the time of the analysis and not known to have started a second new anticancer therapy will be censored at the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of second subsequent therapy or death (TSST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    387
    Units: Hazard ratio
        number (confidence interval 95%)
    0.51 (0.39 to 0.68)
    No statistical analyses for this end point

    Other pre-specified: Time to second subsequent therapy (TSST) in HRD positive, excluding tBRCAm patients

    		 Close Top of page
    End point title
    		 Time to second subsequent therapy (TSST) in HRD positive, excluding tBRCAm patients
    End point description
    Time to start of second subsequent therapy or death (TSST) will be defined as the time from the date of randomization to the earliest of the date of event defined as start of a second subsequent anti-cancer therapy following study treatment discontinuation, or death (by any cause in the absence of start of a second new anti-cancer therapy). Patient not known to have died at the time of the analysis and not known to have started a second new anticancer therapy will be censored at the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of second subsequent therapy or death (TSST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    152
    Units: Hazard ratio
        number (confidence interval 95%)
    0.63 (0.42 to 0.96)
    No statistical analyses for this end point

    Other pre-specified: Time to second subsequent therapy (TSST) in HRD negative patients (excluding unknown)

    		 Close Top of page
    End point title
    		 Time to second subsequent therapy (TSST) in HRD negative patients (excluding unknown)
    End point description
    Time to start of second subsequent therapy or death (TSST) will be defined as the time from the date of randomization to the earliest of the date of event defined as start of a second subsequent anti-cancer therapy following study treatment discontinuation, or death (by any cause in the absence of start of a second new anti-cancer therapy). Patient not known to have died at the time of the analysis and not known to have started a second new anticancer therapy will be censored at the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of second subsequent therapy or death (TSST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    277
    Units: Hazard Ratio
        number (confidence interval 95%)
    1.15 (0.87 to 1.54)
    No statistical analyses for this end point

    Other pre-specified: Time to second subsequent therapy (TSST) in tBRCA mutated patients

    		 Close Top of page
    End point title
    		 Time to second subsequent therapy (TSST) in tBRCA mutated patients
    End point description
    Time to start of second subsequent therapy or death (TSST) will be defined as the time from the date of randomization to the earliest of the date of event defined as start of a second subsequent anti-cancer therapy following study treatment discontinuation, or death (by any cause in the absence of start of a second new anti-cancer therapy). Patient not known to have died at the time of the analysis and not known to have started a second new anticancer therapy will be censored at the last follow-up visit where this was confirmed.
    End point type
    Other pre-specified
    End point timeframe
    Time to start of second subsequent therapy or death (TSST) will be assessed at the time of OS analysis
    End point values
    		 ITT
    Number of subjects analysed
    237
    Units: Hazard ratio
        number (confidence interval 95%)
    0.51 (0.35 to 0.74)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events will be collected from initiation of study drug throughout the treatment period and up to and including the 30-day follow-up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Arm A: Olaparib
    Reporting group description
    		 Experimental arm

    Reporting group title
    Arm B : Placebo
    Reporting group description
    		 Control arm

    Serious adverse events
    		 Arm A: Olaparib Arm B : Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    168 / 535 (31.40%)
    84 / 267 (31.46%)
         number of deaths (all causes)
    289
    159
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute lymphocytic leukaemia
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 267 (1.12%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 3
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Basal cell carcinoma
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    7 / 535 (1.31%)
    3 / 267 (1.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis autoimmune
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 267 (1.12%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Neoplasm malignant
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus polyp
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric cancer
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery dissection
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    51 / 535 (9.53%)
    35 / 267 (13.11%)
         occurrences causally related to treatment / all
    11 / 81
    4 / 62
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cementoplasty
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eventration repair
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Allergic oedema
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast complication associated with device
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    3 / 535 (0.56%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraneoplastic dermatomyositis
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic rupture
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Interstitial lung disease
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    4 / 535 (0.75%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    3 / 535 (0.56%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site infection
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 267 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 267 (1.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prinzmetal angina
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Anaemia
         subjects affected / exposed
    33 / 535 (6.17%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    42 / 44
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cold type haemolytic anaemia
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythroblastosis
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic disorder
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphatic fistula
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye infection
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 535 (0.75%)
    2 / 267 (0.75%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 267 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 267 (0.75%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    4 / 535 (0.75%)
    4 / 267 (1.50%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (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
    8 / 535 (1.50%)
    2 / 267 (0.75%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Melaena
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (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
    0 / 535 (0.00%)
    2 / 267 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    8 / 535 (1.50%)
    3 / 267 (1.12%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 267 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal hypertension
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema nodosum
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urogenital fistula
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    ABDOMINAL ABSCESS
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONA VIRUS INFECTION
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 267 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG INFECTION
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PILONIDAL CYST
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 535 (0.56%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 267 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 267 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2.8%
    Non-serious adverse events
    		 Arm A: Olaparib Arm B : Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    531 / 535 (99.25%)
    256 / 267 (95.88%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    245 / 535 (45.79%)
    160 / 267 (59.93%)
         occurrences all number
    665
    471
    Nervous system disorders
    Headache
         subjects affected / exposed
    73 / 535 (13.64%)
    36 / 267 (13.48%)
         occurrences all number
    130
    82
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    219 / 535 (40.93%)
    27 / 267 (10.11%)
         occurrences all number
    692
    33
    Lymphopenia
         subjects affected / exposed
    126 / 535 (23.55%)
    25 / 267 (9.36%)
         occurrences all number
    339
    50
    Leukopenia
         subjects affected / exposed
    95 / 535 (17.76%)
    26 / 267 (9.74%)
         occurrences all number
    174
    37
    Neutropenia
         subjects affected / exposed
    95 / 535 (17.76%)
    42 / 267 (15.73%)
         occurrences all number
    137
    49
    Thrombocytopenia
         subjects affected / exposed
    32 / 535 (5.98%)
    7 / 267 (2.62%)
         occurrences all number
    76
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    283 / 535 (52.90%)
    86 / 267 (32.21%)
         occurrences all number
    601
    159
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    285 / 535 (53.27%)
    58 / 267 (21.72%)
         occurrences all number
    601
    96
    Vomiting
         subjects affected / exposed
    117 / 535 (21.87%)
    29 / 267 (10.86%)
         occurrences all number
    233
    47
    Diarrhoea
         subjects affected / exposed
    98 / 535 (18.32%)
    45 / 267 (16.85%)
         occurrences all number
    181
    72
    Abdominal pain
         subjects affected / exposed
    103 / 535 (19.25%)
    53 / 267 (19.85%)
         occurrences all number
    167
    86
    Constipation
         subjects affected / exposed
    53 / 535 (9.91%)
    28 / 267 (10.49%)
         occurrences all number
    66
    39
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    31 / 535 (5.79%)
    40 / 267 (14.98%)
         occurrences all number
    47
    62
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    116 / 535 (21.68%)
    64 / 267 (23.97%)
         occurrences all number
    167
    123
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    79 / 535 (14.77%)
    27 / 267 (10.11%)
         occurrences all number
    149
    37

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2015
    • Initial corrected (administrative correction) • Collect of QoL questionnaires and Pharmaco-economy information until 2 years (calculated from 1st study drug administration).
    14 Jan 2016
    • Update of the list of special interest events (adding “Pneumonitis”), • Update of the flow chart according to study schedule, • Modification of the translational research on blood samples, • Administrative correction.
    15 Feb 2016
    • Modification of selection criteria I-5 and I-8, • Modification on CT scan/RMI schedule.
    06 Jan 2017
    • New Statistical hypothesis with increase of the randomized patients number (and prolongation of inclusion period) • Modification of the Sponsor’s name • Review of anemia’s management • Addition of a new exploratory objective • Administrative update • Correction of typographical errors
    22 Dec 2017
    • Removal of the Interim Efficacy Analyses • Frequency’s modification of haemotology tests • Administrative update
    03 Oct 2018
    • Addition of details in the description of exploratory endpoints analyses • Corrections regarding the Japanese cohort • Addition of clarifications regarding the end of study treatment • Addition of details for the collection of some data • Administrative update
    28 Feb 2019
    • Modification of statistical methodology with addition of interim PFS2/OS analysis at the same time as final PFS1 analysis • Addition of visits during the Follow up of patient • Addition of clarification regarding the SAE declaration • Addition of details regarding the declaration to MR0O1 • Corrections to typographical errors • Administrative update

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31851799
    http://www.ncbi.nlm.nih.gov/pubmed/33372675
    http://www.ncbi.nlm.nih.gov/pubmed/34378365
    http://www.ncbi.nlm.nih.gov/pubmed/34952708
    http://www.ncbi.nlm.nih.gov/pubmed/36067615
    http://www.ncbi.nlm.nih.gov/pubmed/34597975
    http://www.ncbi.nlm.nih.gov/pubmed/36564284
    http://www.ncbi.nlm.nih.gov/pubmed/36634389
    http://www.ncbi.nlm.nih.gov/pubmed/38129136
    http://www.ncbi.nlm.nih.gov/pubmed/37211045
    http://www.ncbi.nlm.nih.gov/pubmed/36716415
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 07:33:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA