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    Clinical Trial Results:
    A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

    Summary
    EudraCT number
    		 2017-004556-27
    Trial protocol
    		 ES  
    Global end of trial date
    15 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 May 2022
    First version publication date
    05 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D933IC00003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03459846
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca Clinical Study Information Center
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, 1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, 1 877-240-9479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of durvalumab + olaparib combination therapy compared with durvalumab + placebo in terms of PFS
    Protection of trial subjects
    Patients given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 2018
    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
    Russian Federation: 40
    Country: Number of subjects enrolled
    Taiwan: 26
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    Vietnam: 20
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 30
    Worldwide total number of subjects
    154
    EEA total number of subjects
    20
    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)
    40
    From 65 to 84 years
    104
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening was performed no more than 28 days before the date of randomization and, ideally, was performed as close as possible to and prior to the date of randomization

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Durva + Olaparib
    Arm description
    		 Durva + 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
    100 and 150 mg tablets

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500-mg vial solution for infusion after dilution. 50 mg/mL solution

    Arm title
    		 Durva + Placebo
    Arm description
    		 Durva + 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
    100 and 150 mg matching tablets

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500-mg vial solution for infusion after dilution. 50 mg/mL solution

    Number of subjects in period 1
    		Durva + Olaparib Durva + Placebo
    Started
    78
    76
    Completed
    0
    0
    Not completed
    78
    76
         Adverse event, serious fatal
    52
    46
         Consent withdrawn by subject
    2
    2
         Study terminated by sponsor
    24
    28

    Baseline characteristics

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

    Reporting group title
    Durva + Placebo
    Reporting group description
    		 Durva + Placebo

    Reporting group values
    		 Durva + Olaparib Durva + Placebo Total
    Number of subjects
    		 78 76 154
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 19 21 40
        From 65-84 years
    		 52 52 104
        85 years and over
    		 7 3 10
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 73.4 ± 10.8 70.2 ± 10.26 -
    Sex: Female, Male
    Units: Participants
        Female
    		 22 21 43
        Male
    		 56 55 111
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 3 3 6
        Not Hispanic or Latino
    		 75 73 148

    End points

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

    Reporting group title
    Durva + Placebo
    Reporting group description
    		 Durva + Placebo

    Primary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS)
    End point description
    Progression-free survival based on investigator assessments according to RECIST 1.1
    End point type
    Primary
    End point timeframe
    Tumor assessments every 8 weeks after randomization for the first 48 weeks and then every 12 weeks thereafter until clinical progression with or without RECIST 1.1-defined radiological progression
    End point values
    		 Durva + Olaparib Durva + Placebo
    Number of subjects analysed
    78
    76
    Units: Months
        median (confidence interval 95%)
    4.2 (3.6 to 5.6)
    3.5 (1.9 to 5.1)
    Statistical analysis title
    		 Progression-free survival (PFS)
    Comparison groups
    Durva + Olaparib v Durva + Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.789
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.641
         upper limit
    		 1.387

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Number of Participants with Overall Survival (OS)
    End point type
    Secondary
    End point timeframe
    Approximately 31 months after the first patient was randomised.
    End point values
    		 Durva + Olaparib Durva + Placebo
    Number of subjects analysed
    78
    76
    Units: Participants
        Died
    52
    46
        Censored
    26
    30
    Statistical analysis title
    		 Overall Survival (OS)
    Comparison groups
    Durva + Olaparib v Durva + Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.728
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.719
         upper limit
    		 1.606

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR is the number (%) of patients with at least one visit response of Complete response (CR) or Partial response (PR)
    End point type
    Secondary
    End point timeframe
    Up until progression, or last evaluable assessment in the absence in progression
    End point values
    		 Durva + Olaparib Durva + Placebo
    Number of subjects analysed
    78
    76
    Units: Participants
        Response
    22
    14
        No Response
    56
    62
    Statistical analysis title
    		 Objective Response Rate (ORR)
    Comparison groups
    Durva + Olaparib v Durva + Placebo
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.142
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.821
         upper limit
    		 3.778

    Secondary: Duration of Response (DoR)

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    End point title
    		 Duration of Response (DoR)
    End point description
    Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression
    End point type
    Secondary
    End point timeframe
    Tumor assessments every 8 weeks after randomization for the first 48 weeks and then every 12 weeks thereafter until clinical progression with or without RECIST 1.1-defined radiological progression
    End point values
    		 Durva + Olaparib Durva + Placebo
    Number of subjects analysed
    22
    14
    Units: Months
        median (inter-quartile range (Q1-Q3))
    8.9 (4.7 to 12.1)
    14.8 (7.5 to 17.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of the patient signing the informed consent form until the follow-up period is completed (90 days after the last dose of the Investigational Product)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Durva + Placebo
    Reporting group description
    		 Durva + Placebo

    Reporting group title
    Durva + Olaparib
    Reporting group description
    		 Durva + Olaparib

    Serious adverse events
    		 Durva + Placebo Durva + Olaparib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 76 (34.21%)
    37 / 76 (48.68%)
         number of deaths (all causes)
    46
    52
         number of deaths resulting from adverse events
    5
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of prostate
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 76 (1.32%)
    2 / 76 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 76 (1.32%)
    2 / 76 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Genital haemorrhage
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balanoposthitis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (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
    Immune-mediated pneumonitis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Myasthenia gravis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 76 (1.32%)
    5 / 76 (6.58%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 5
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nausea
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 76 (0.00%)
    4 / 76 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Haematuria
         subjects affected / exposed
    1 / 76 (1.32%)
    3 / 76 (3.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 76 (1.32%)
    3 / 76 (3.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    3 / 76 (3.95%)
    2 / 76 (2.63%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (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
    Urinary tract infection
         subjects affected / exposed
    6 / 76 (7.89%)
    6 / 76 (7.89%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    2 / 76 (2.63%)
    3 / 76 (3.95%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Kidney infection
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 Durva + Placebo Durva + Olaparib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    63 / 76 (82.89%)
    65 / 76 (85.53%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 76 (7.89%)
    1 / 76 (1.32%)
         occurrences all number
    6
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    13 / 76 (17.11%)
    22 / 76 (28.95%)
         occurrences all number
    13
    25
    Asthenia
         subjects affected / exposed
    2 / 76 (2.63%)
    10 / 76 (13.16%)
         occurrences all number
    2
    11
    Pyrexia
         subjects affected / exposed
    7 / 76 (9.21%)
    7 / 76 (9.21%)
         occurrences all number
    9
    7
    Oedema peripheral
         subjects affected / exposed
    4 / 76 (5.26%)
    3 / 76 (3.95%)
         occurrences all number
    5
    3
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    4 / 76 (5.26%)
    0 / 76 (0.00%)
         occurrences all number
    5
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 76 (3.95%)
    7 / 76 (9.21%)
         occurrences all number
    3
    7
    Cough
         subjects affected / exposed
    6 / 76 (7.89%)
    6 / 76 (7.89%)
         occurrences all number
    6
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 76 (5.26%)
    3 / 76 (3.95%)
         occurrences all number
    4
    3
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    4 / 76 (5.26%)
    8 / 76 (10.53%)
         occurrences all number
    4
    9
    Amylase increased
         subjects affected / exposed
    2 / 76 (2.63%)
    4 / 76 (5.26%)
         occurrences all number
    2
    5
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    4 / 76 (5.26%)
    1 / 76 (1.32%)
         occurrences all number
    4
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 76 (3.95%)
    7 / 76 (9.21%)
         occurrences all number
    3
    7
    Headache
         subjects affected / exposed
    4 / 76 (5.26%)
    3 / 76 (3.95%)
         occurrences all number
    7
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    21 / 76 (27.63%)
    34 / 76 (44.74%)
         occurrences all number
    22
    50
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 76 (7.89%)
    20 / 76 (26.32%)
         occurrences all number
    6
    23
    Constipation
         subjects affected / exposed
    12 / 76 (15.79%)
    13 / 76 (17.11%)
         occurrences all number
    15
    14
    Diarrhoea
         subjects affected / exposed
    5 / 76 (6.58%)
    10 / 76 (13.16%)
         occurrences all number
    7
    12
    Vomiting
         subjects affected / exposed
    2 / 76 (2.63%)
    7 / 76 (9.21%)
         occurrences all number
    3
    8
    Abdominal pain
         subjects affected / exposed
    2 / 76 (2.63%)
    6 / 76 (7.89%)
         occurrences all number
    2
    6
    Abdominal pain upper
         subjects affected / exposed
    1 / 76 (1.32%)
    4 / 76 (5.26%)
         occurrences all number
    1
    4
    Dyspepsia
         subjects affected / exposed
    4 / 76 (5.26%)
    2 / 76 (2.63%)
         occurrences all number
    4
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 76 (7.89%)
    7 / 76 (9.21%)
         occurrences all number
    6
    9
    Pruritus
         subjects affected / exposed
    8 / 76 (10.53%)
    6 / 76 (7.89%)
         occurrences all number
    8
    6
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    6 / 76 (7.89%)
    7 / 76 (9.21%)
         occurrences all number
    6
    8
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    4 / 76 (5.26%)
    7 / 76 (9.21%)
         occurrences all number
    5
    7
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 76 (9.21%)
    8 / 76 (10.53%)
         occurrences all number
    7
    8
    Arthralgia
         subjects affected / exposed
    1 / 76 (1.32%)
    5 / 76 (6.58%)
         occurrences all number
    1
    7
    Pain in extremity
         subjects affected / exposed
    5 / 76 (6.58%)
    1 / 76 (1.32%)
         occurrences all number
    6
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 76 (5.26%)
    9 / 76 (11.84%)
         occurrences all number
    4
    11
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    10 / 76 (13.16%)
    19 / 76 (25.00%)
         occurrences all number
    10
    22
    Hyperglycaemia
         subjects affected / exposed
    2 / 76 (2.63%)
    4 / 76 (5.26%)
         occurrences all number
    2
    4
    Hypokalaemia
         subjects affected / exposed
    4 / 76 (5.26%)
    3 / 76 (3.95%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jul 2018
    Sections updated to reflect the change in the number of patients randomized from approximately 256 to 150 patients and the change in the stratification factors to include the patient’s homologous recombination repair (HRR) status (mutant versus wildtype). Section 3 (Objectives and Endpoints) was updated to reflect the revised study objectives and endpoints in light of the change in the analysis plan to analyse the Full Analysis Set as the primary analysis population rather than the HRR mutant subgroup population.
    15 Nov 2019
    Updated throughout the protocol: PFS will not be updated at the time of the final OS analysis for the HRRm subgroup.

    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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    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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