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    Clinical Trial Results:
    Circulating tumor DNA guiding (Olaparib) Lynparza® treatment in Ovarian Cancer (CLIO). Establishing the value of a ctDNA-based HRD assay for predicting olaparib response in women with relapsed ovarian cancer

    Summary
    EudraCT number
    		 2015-005838-22
    Trial protocol
    		 BE  
    Global end of trial date
    09 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Nov 2024
    First version publication date
    21 Nov 2024
    Other versions
    Summary report(s)
    		 2015-005838-22_Paper

    Trial information

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    Trial identification
    Sponsor protocol code
    CLIO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02822157
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BGOG
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Joke De Roover, UZLeuven, 32 16347419, joke.deroover@uzleuven.be
    Scientific contact
    Joke De Roover, UZLeuven, 32 16347419, joke.deroover@uzleuven.be
    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
    16 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate the value of a ctDNA-based assay for homologous recombination deficiency to predict response to olaparib monotherapy. This analysis will also be performed according to platinum-sensitivity (platinum-sensitive versus platinum-resistant).
    Protection of trial subjects
    Trial visits and assessments were balanced to ensure patients are sufficiently closely monitored. The number and type of visits and assessments requested were required to follow-up on patient safety.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 160
    Worldwide total number of subjects
    160
    EEA total number of subjects
    160
    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)
    78
    From 65 to 84 years
    81
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was solely performed in UZLeuven (Belgium). FPI was on 20Sep2016, LPI was on 04Feb2019.

    Pre-assignment
    Screening details
    		 Platinum sensitive or resistant ovarian cancer patients with measurable disease and >1 prior line of chemotherapy randomized (2:1) to Olaparib or physician's choice chemotherapy (CT). CTwas administered according to local guidelines, Olaparib continued until disease progression, toxicity or WOC. Cross-over from CT to Olaparib was possible after PD.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NAP, study was not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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
    300 mg BID

    Arm title
    		 Physician's choice chemotherapy
    Arm description
    		 Physician's choice chemotherapy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    AUC4 on day 1 of a 3-weekly schedule when combined with Gemcitabin AUC5 on day 1 of a 3-weekly schedule when combined with Paclitaxel AUC5 on day 1 of a 4-weekly schedule when combined with Caelyx

    Investigational medicinal product name
    Gemcitabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000mg/m² on day 1 and day 8 of a three-weekly schedule when combined with Carboplatin 1000mg/m² on day 1, day 8 and day 15 of a four-weekly schedule when given alone

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    175mg/m² on day 1 of a three-weekly schedule when combined with Carboplatin 80mg/m² on day 1, day 8 and day 15 of a four-weekly schedule when given alone

    Investigational medicinal product name
    Caelyx
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30mg/m² on day 1 of a 4-weekly schedule when given in combination with Carboplatin 40mg/m² on day 1 of a 4-weekly schedule when given alone

    Investigational medicinal product name
    Topotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.25mg/m² of day 1 to 5 of a three-weekly schedule

    Number of subjects in period 1
    		Olaparib Physician's choice chemotherapy
    Started
    107
    53
    Completed
    2
    0
    Not completed
    105
    53
         Adverse event, serious fatal
    2
    -
         Consent withdrawn by subject
    2
    -
         Lost to follow-up
    1
    -
         Lack of efficacy
    100
    53

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Olaparib
    Reporting group description
    		 Olaparib

    Reporting group title
    Physician's choice chemotherapy
    Reporting group description
    		 Physician's choice chemotherapy

    Reporting group values
    		 Olaparib Physician's choice chemotherapy Total
    Number of subjects
    		 107 53 160
    Age categorical
    Age
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
        Median age
    		 0
    Age continuous
    Age
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 63 (57 to 70) 63 (59 to 70) -
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 107 53 160
        Male
    		 0 0 0
    Race
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 106 53 159
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    WHO
    WHO
    Units: Subjects
        WHO score 0
    		 59 30 89
        WHO score 1
    		 46 22 68
        WHO score 2
    		 2 1 3
    Platinum sensitivity
    Platinum sensitivity
    Units: Subjects
        Platinum-resistant ovarian cancer
    		 67 33 100
        Platinum-sensitive ovarian cancer
    		 40 20 60
    Histology
    Histology
    Units: Subjects
        High-grade endometrioid ovarian cancer
    		 1 0 1
        High-grade serous ovarian cancer
    		 98 49 147
        Malignant mixed Müllerian tumor
    		 1 0 1
        Ovarian clear-cell carcinoma
    		 7 4 11
    BRCA status
    BRCA status
    Units: Subjects
        Germiline BRCA1
    		 12 2 14
        Germline BRCA2
    		 3 0 3
        Somatic BRCA1
    		 2 2 4
        Somatic BRCA2
    		 1 0 1
        None
    		 89 49 138
    Previous Bevacizumab
    Previous Bevacizumab
    Units: Subjects
        Yes
    		 57 24 81
        No
    		 50 29 79
    Previous PARP inhibitor
    Previous PARP inhibitor
    Units: Subjects
        Yes
    		 5 3 8
        No
    		 97 46 143
        Possible
    		 5 4 9
    Prior lines of systemic therapy
    Prior lines of systemic therapy
    Units: Subjects
        1 prior line of systemic therapy
    		 19 10 29
        2 prior lines of systemic therapy
    		 24 17 41
        3 prior lines of systemic therapy
    		 24 8 32
        4 prior lines of systemic therapy
    		 20 11 31
        5 prior lines of systemic therapy
    		 10 2 12
        6 prior lines of systemic therapy
    		 3 2 5
        8 prior lines of systemic therapy
    		 5 2 7
        7 prior lines of systemic therapy
    		 2 1 3
    Prior lines per category
    Prior lines per category
    Units: Subjects
        3 or less
    		 67 35 102
        4 or more
    		 40 18 58

    End points

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    End points reporting groups
    Reporting group title
    Olaparib
    Reporting group description
    		 Olaparib

    Reporting group title
    Physician's choice chemotherapy
    Reporting group description
    		 Physician's choice chemotherapy

    Primary: Overall Objective Response

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    End point title
    		 Overall Objective Response
    End point description
    Objective response rade, exclusing non-evaluable cases
    End point type
    Primary
    End point timeframe
    1 year after end inclusion
    End point values
    		 Olaparib Physician's choice chemotherapy
    Number of subjects analysed
    107
    53
    Units: %
    26
    15
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Olaparib v Physician's choice chemotherapy
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.701
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Clinical Benefit Rate

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    End point title
    		 Clinical Benefit Rate
    End point description
    Clinical benefit rate, excluding non-evaluable cases
    End point type
    Secondary
    End point timeframe
    1 year after end inclusion
    End point values
    		 Olaparib Physician's choice chemotherapy
    Number of subjects analysed
    107
    53
    Units: %
    58
    30
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 years, 6 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Olaparib
    Reporting group description
    		 Olaparib

    Reporting group title
    Physician's choice chemotherapy
    Reporting group description
    		 Physician's choice chemotherapy

    Serious adverse events
    		 Olaparib Physician's choice chemotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 107 (7.48%)
    5 / 53 (9.43%)
         number of deaths (all causes)
    3
    4
         number of deaths resulting from adverse events
    3
    4
    Surgical and medical procedures
    Surgical procedure
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Abdominal pain
         subjects affected / exposed
    2 / 107 (1.87%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General deterioration
         subjects affected / exposed
    7 / 107 (6.54%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General malaise
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    5 / 107 (4.67%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine hemorrhage
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (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
    Dyspnea
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbonarcosis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusion
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (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
    Intracranial hemorrhage
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal canal stenosis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    5 / 107 (4.67%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ascites
         subjects affected / exposed
    4 / 107 (3.74%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Capillary leak syndrome
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hemolytic uremic syndrome
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colonic hemorrhage
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon obstruction
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon perforation
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Small bowel obstruction
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastro-intestinal pain
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 107 (2.80%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Liver hematoma
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary carcinomatosis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney insufficiency
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 107 (0.93%)
    3 / 53 (5.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device-related infection
         subjects affected / exposed
    1 / 107 (0.93%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fever
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flu-like symptoms
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection of unknown origin
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatremia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Olaparib Physician's choice chemotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 107 (42.99%)
    21 / 53 (39.62%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    23 / 107 (21.50%)
    12 / 53 (22.64%)
         occurrences all number
    25
    15
    Headache
         subjects affected / exposed
    8 / 107 (7.48%)
    4 / 53 (7.55%)
         occurrences all number
    11
    5
    Abdominal bloating
         subjects affected / exposed
    4 / 107 (3.74%)
    6 / 53 (11.32%)
         occurrences all number
    5
    7
    General malaise
         subjects affected / exposed
    4 / 107 (3.74%)
    4 / 53 (7.55%)
         occurrences all number
    4
    6
    Abdominal pain
         subjects affected / exposed
    10 / 107 (9.35%)
    4 / 53 (7.55%)
         occurrences all number
    10
    5
    Alopecia
         subjects affected / exposed
    2 / 107 (1.87%)
    5 / 53 (9.43%)
         occurrences all number
    2
    5
    Ascites
         subjects affected / exposed
    5 / 107 (4.67%)
    3 / 53 (5.66%)
         occurrences all number
    7
    3
    Asthenia
         subjects affected / exposed
    3 / 107 (2.80%)
    3 / 53 (5.66%)
         occurrences all number
    3
    3
    Dizziness
         subjects affected / exposed
    6 / 107 (5.61%)
    3 / 53 (5.66%)
         occurrences all number
    6
    3
    Insomnia
         subjects affected / exposed
    6 / 107 (5.61%)
    2 / 53 (3.77%)
         occurrences all number
    6
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    12 / 107 (11.21%)
    6 / 53 (11.32%)
         occurrences all number
    13
    10
    Cough
         subjects affected / exposed
    6 / 107 (5.61%)
    9 / 53 (16.98%)
         occurrences all number
    6
    11
    Epistaxis
         subjects affected / exposed
    1 / 107 (0.93%)
    4 / 53 (7.55%)
         occurrences all number
    1
    4
    Bronchitis
         subjects affected / exposed
    7 / 107 (6.54%)
    1 / 53 (1.89%)
         occurrences all number
    7
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 107 (0.93%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 107 (1.87%)
    3 / 53 (5.66%)
         occurrences all number
    3
    3
    Nervous system disorders
    Peripheral neuropathy
         subjects affected / exposed
    4 / 107 (3.74%)
    3 / 53 (5.66%)
         occurrences all number
    4
    5
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    19 / 107 (17.76%)
    11 / 53 (20.75%)
         occurrences all number
    57
    43
    Neutropenia
         subjects affected / exposed
    5 / 107 (4.67%)
    5 / 53 (9.43%)
         occurrences all number
    5
    11
    Edema legs
         subjects affected / exposed
    6 / 107 (5.61%)
    3 / 53 (5.66%)
         occurrences all number
    8
    5
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 107 (0.93%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    27 / 107 (25.23%)
    11 / 53 (20.75%)
         occurrences all number
    33
    21
    Vomiting
         subjects affected / exposed
    22 / 107 (20.56%)
    9 / 53 (16.98%)
         occurrences all number
    31
    14
    Diarrhoea
         subjects affected / exposed
    10 / 107 (9.35%)
    8 / 53 (15.09%)
         occurrences all number
    12
    11
    Small bowel obstruction
         subjects affected / exposed
    9 / 107 (8.41%)
    3 / 53 (5.66%)
         occurrences all number
    12
    5
    Constipation
         subjects affected / exposed
    9 / 107 (8.41%)
    11 / 53 (20.75%)
         occurrences all number
    10
    11
    Abdominal cramping
         subjects affected / exposed
    5 / 107 (4.67%)
    6 / 53 (11.32%)
         occurrences all number
    6
    6
    Stomach pain
         subjects affected / exposed
    8 / 107 (7.48%)
    6 / 53 (11.32%)
         occurrences all number
    9
    6
    Pyrosis
         subjects affected / exposed
    7 / 107 (6.54%)
    2 / 53 (3.77%)
         occurrences all number
    7
    2
    Skin and subcutaneous tissue disorders
    Itch
         subjects affected / exposed
    0 / 107 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    7 / 107 (6.54%)
    5 / 53 (9.43%)
         occurrences all number
    12
    9
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 107 (5.61%)
    3 / 53 (5.66%)
         occurrences all number
    10
    3
    Arthralgia
         subjects affected / exposed
    5 / 107 (4.67%)
    2 / 53 (3.77%)
         occurrences all number
    5
    3
    Muscle cramping
         subjects affected / exposed
    5 / 107 (4.67%)
    1 / 53 (1.89%)
         occurrences all number
    5
    1
    Infections and infestations
    Common cold
         subjects affected / exposed
    4 / 107 (3.74%)
    4 / 53 (7.55%)
         occurrences all number
    6
    5
    Fever
         subjects affected / exposed
    4 / 107 (3.74%)
    4 / 53 (7.55%)
         occurrences all number
    4
    5
    Metabolism and nutrition disorders
    Hypokalemia
         subjects affected / exposed
    12 / 107 (11.21%)
    5 / 53 (9.43%)
         occurrences all number
    19
    15
    Anorexia
         subjects affected / exposed
    18 / 107 (16.82%)
    9 / 53 (16.98%)
         occurrences all number
    18
    10
    Dysgeusia
         subjects affected / exposed
    5 / 107 (4.67%)
    7 / 53 (13.21%)
         occurrences all number
    5
    10
    Hypomagnesaemia
         subjects affected / exposed
    5 / 107 (4.67%)
    2 / 53 (3.77%)
         occurrences all number
    6
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2016
    Update inclusion and exclusion criteria, physician's choice chemotherapy options and protocol assessments

    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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    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.

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