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    Clinical Trial Results:
    A randomised phase II trial of Olaparib maintenance versus placebo monotherapy in patients with non-small cell lung cancer

    Summary
    EudraCT number
    		 2012-003383-51
    Trial protocol
    		 GB  
    Global end of trial date
    05 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Mar 2020
    First version publication date
    02 Mar 2020
    Other versions
    Summary report(s)
    		 Final statistical analysis report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2012/VCC/0037
    Additional study identifiers
    ISRCTN number
    		 ISRCTN42518913
    US NCT number
    		 NCT01788332
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Velindre NHS Trust
    Sponsor organisation address
    Unit 2 Charnwood Court Heol Billingsley, , Parc Nantgarw, Cardiff , United Kingdom, CF15 7QZ
    Public contact
    Georgina Gardner, Centre for Trials Research, 0044 2920687581, pin@cardiff.ac.uk
    Scientific contact
    Angela Casbard, Centre for Trials Research, 0044 2920687470, CasbardAC@cardiff.ac.uk
    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
    10 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial is to establish whether treatment with Olaparib in NSCLC patients who have already responded to induction chemotherapy delays disease progression compared to placebo.
    Protection of trial subjects
    NA
    Background therapy
    		 NA
    Evidence for comparator
    		 Placebo
    Actual start date of recruitment
    22 Jul 2013
    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
    United Kingdom: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    38
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 70 patients were randomised from 23 UK centres between August 2014 and November 2017.

    Pre-assignment
    Screening details
    		 Screening criteria are listed in the protocol Section 6.2. 264 were assessed for eligibility for randomisation. 139 were not eligible and 55 were eligible but not randomised.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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
    300mg bd administered and reviewed in 21-day cycles until disease progression, unacceptable toxicity or patient withdrawal of consent.

    Arm title
    		 Olaparib
    Arm description
    		 Olaparib 300mg po bd q21 until disease progression
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Olaparib (AZD2281, KU-0059436)
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg bd administered and reviewed in 21-day cycles until disease progression, unacceptable toxicity or patient withdrawal of consent.

    Number of subjects in period 1
    		Placebo Olaparib
    Started
    38
    32
    Completed
    38
    32
    Period 2
    Period 2 title
    Treatment and follow up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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
    300mg bd administered and reviewed in 21-day cycles until disease progression, unacceptable toxicity or patient withdrawal of consent.

    Arm title
    		 Olaparib
    Arm description
    		 Olaparib 300mg po bd q21 until disease progression
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Olaparib (AZD2281, KU-0059436)
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg bd administered and reviewed in 21-day cycles until disease progression, unacceptable toxicity or patient withdrawal of consent.

    Number of subjects in period 2
    		Placebo Olaparib
    Started
    38
    32
    Completed
    38
    31
    Not completed
    0
    1
         Found to be ineligible
    -
    1

    Baseline characteristics

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

    Reporting group title
    Olaparib
    Reporting group description
    		 Olaparib 300mg po bd q21 until disease progression

    Reporting group values
    		 Placebo Olaparib Total
    Number of subjects
    		 38 32 70
    Age categorical
    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
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 63.3 (58.6 to 69.9) 64.7 (60.5 to 71.5) -
    Gender categorical
    Units: Subjects
        Female
    		 14 16 30
        Male
    		 24 16 40
    Non-small cell lung cancer type
    Units: Subjects
        Adenocarcinoma
    		 18 19 37
        Squamous
    		 18 13 31
        Large cell nos
    		 1 0 1
        Mixed adenocarcinoma/Squamous
    		 1 0 1
    T stage
    Units: Subjects
        T1
    		 2 3 5
        T2
    		 3 6 9
        T3
    		 6 10 16
        T4
    		 23 12 35
        TX
    		 3 0 3
        Missing
    		 1 1 2
    N stage
    Units: Subjects
        N0
    		 2 6 8
        N1
    		 3 1 4
        N2
    		 16 9 25
        N3
    		 15 13 28
        NX
    		 1 2 3
        Missing
    		 1 1 2
    M stage
    Units: Subjects
        M0
    		 10 10 20
        M1a
    		 15 10 25
        M1b
    		 13 11 24
        Missing
    		 0 1 1
    Stage of NSCLC
    Units: Subjects
        IIIB
    		 13 10 23
        IV
    		 25 22 47
    Sites affected
    Units: Subjects
        Adrenal gland
    		 0 1 1
        Bone metastases
    		 4 2 6
        Brain metastases
    		 1 0 1
        Chest wall; lung metastases
    		 0 1 1
        Chest wall; Mediastinum
    		 1 0 1
        Chest wall; Trachea
    		 0 1 1
        Chest wall; Trachea; Lung metastases
    		 1 0 1
        Heart pericardium; Bone metastases; Brain metastas
    		 0 1 1
        Heart pericardium; Lung metastases
    		 1 0 1
        Ipsilateral hilar, Mediastinal and supraclavicular
    		 0 1 1
        Left hilar region
    		 1 0 1
        Left lower lobe of bronchus
    		 1 0 1
        Liver metastases; Adrenal gland
    		 1 1 2
        Liver metastases; Bone metastases
    		 1 2 3
        Liver metastases; Lung metastases
    		 1 0 1
        Lung metastases
    		 7 2 9
        Lung metastases; Adrenal gland; Mediastinum
    		 0 1 1
        Lung metastases; Mediastinum
    		 0 1 1
        Lung metastases; Primary Mass
    		 0 1 1
        Lung metastases; Retroperitoneal
    		 1 0 1
        Lung metastases; side neck nodes
    		 1 0 1
        Lung metastases; sub aortic lymph node; para aorti
    		 1 0 1
        Lung; lymph node
    		 1 0 1
        Lymph nodes
    		 1 0 1
        None
    		 2 5 7
        Oesophagus; Pleura; Liver metastases
    		 0 1 1
        Oesophagus; Trachea
    		 1 0 1
        Pericardial effusion
    		 1 0 1
        Pleura
    		 0 1 1
        Pleura; Bone metastases
    		 1 0 1
        Pleura; Heart pericardium; Pulmonary Artery; Right
    		 1 0 1
        Pleura; Liver metastases; Lung metastases; Bone me
    		 0 1 1
        Pleura; Lung metastases
    		 1 2 3
        Pleura; Lymph node
    		 0 1 1
        Pleura; Regional nodes; Distant nodes.
    		 0 1 1
        Right upper lobe
    		 3 1 4
        Rib
    		 0 1 1
        RIGHT HILAR LESION
    		 0 1 1
        Right Neck Lymph Nodes
    		 1 0 1
        Right upper lobe; mediastinal lymphadenopathy
    		 0 1 1
        Spleen
    		 1 0 1
        Trachea; Adrenal gland
    		 1 0 1
        Trachea; Lung metastases; right hilar
    		 0 1 1
    Type of induction chemotherapy
    Units: Subjects
        Carboplatin
    		 1 0 1
        Carboplatin; Vinorelbine
    		 3 1 4
        Cisplatin
    		 0 1 1
        Cisplatin; Carboplatin
    		 1 0 1
        Cisplatin; Pemetrexed
    		 5 4 9
        Cisplatin; Vinorelbine
    		 1 1 2
        Gemcitabine
    		 2 3 5
        Gemcitabine; Carboplatin
    		 11 6 17
        Gemcitabine; Docetaxel
    		 1 0 1
        Gemcitabine; Pemetrexed
    		 0 1 1
        Not known
    		 1 3 4
        Paclitaxel
    		 0 1 1
        Pemetrexed
    		 5 3 8
        Pemetrexed; Carboplatin
    		 7 8 15
    Response to induction chemotherapy
    Units: Subjects
        Complete response
    		 1 2 3
        Partial response
    		 34 28 62
        Other evidence of tumour shrinkage/Mixed stable
    		 3 2 5
    Smoking history
    Units: Subjects
        Never smoked
    		 3 3 6
        Ever smoked
    		 35 29 64
    ECOG status
    Units: Subjects
        Zero
    		 13 9 22
        One
    		 25 23 48
    Site of target tumour
    Units: Subjects
        Anterior mediastinal mass; Left anterior lung mass
    		 0 1 1
        Aortopulmonary soft tissue mass; Splenic lesion
    		 1 0 1
        Apical segment, posteriorly right lower lobe; righ
    		 0 1 1
        Central left lung mass; paracardiac chest wall mas
    		 1 0 1
        Left Adrenal; Left Hilum
    		 0 1 1
        Left basal; Liver mets
    		 1 0 1
        Left hilar mass
    		 2 1 3
        Left hilar; left upper lobe mass
    		 1 0 1
        Left lower lobe
    		 0 1 1
        Left lung
    		 1 2 3
        Left lung; liver
    		 1 1 2
        LEFT PERIHILAR LUNG LESION; SUBCARINAL LYMPH NODE
    		 1 0 1
        LEFT PERIHILAR MASS; RIGHT UPPER LOBE LESION
    		 1 0 1
        Left posterior lower zone; Left anterior upper zon
    		 1 0 1
        Left supraclavicular region; right lung base
    		 0 1 1
        Left upper lobe
    		 4 2 6
        Left upper lobe; Apical left lower lobe metastases
    		 1 0 1
        Left upper lobe; Apical right lower lobe
    		 0 1 1
        Left upper lobe; left hilar
    		 1 1 2
        Left upper lobe; liver
    		 0 1 1
        Left upper lobe; right hilar
    		 1 0 1
        Low right paratrachael / precarninal node; Subcari
    		 1 0 1
        Mediastinal mass
    		 1 0 1
        Not known
    		 2 2 4
        Pleural deposit adjacent to aortic arch; Pleural d
    		 1 0 1
        POSTERIOR RIGHT PERIHILAR LUNG LESION; ANTERIOR RI
    		 0 1 1
        Right apical lower lobe; Left upper lobe mass
    		 0 1 1
        RIGHT HILAR ANTERIOR; RIGHT HILAR POSTERIOR
    		 0 1 1
        RIGHT HILAR LESION; RIGHT UPPER POLE RENAL LESION
    		 0 1 1
        Right Hilar Mass; Pretracheal
    		 1 0 1
        Right hilar mass; right adrenal mass
    		 1 0 1
        Right lower lobe
    		 1 3 4
        RIGHT LOWER LOBE CAVITY; CONGLOMERATE OF MEDIASTIN
    		 1 0 1
        Right paratracheal lymph node
    		 0 1 1
        Right peri hilar mass
    		 1 0 1
        Right upper lobe
    		 6 3 9
        RIGHT UPPER LOBE LUNG LESION; RIGHT OBLIQUE FISSUR
    		 0 1 1
        Right upper lobe; left adrenal gland
    		 0 1 1
        Right upper lobe; Right lower paratracheal lymph n
    		 1 0 1
        Rt Paratrachael LN; Right upper lobe
    		 0 1 1
        SEGMENT 5; INFERIOR TIP
    		 0 1 1
        Soft tissue anterior; subcarinal node
    		 1 0 1
        Sub pleural left lung lesion
    		 0 1 1
        Subcarinal node
    		 1 0 1
        Sub-carinal node; Right hilar node
    		 1 0 1
    Number of cycles of induction chemotherapy
    Units: Number
        median (inter-quartile range (Q1-Q3))
    		 4 (4 to 4) 4 (4 to 4) -
    Systolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 132 (124 to 146) 133 (123.5 to 150) -
    Diastolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 76.5 (73.0 to 87.0) 73.5 (69.5 to 86.5) -
    Oxygen saturation
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    		 97 (96 to 98) 97.5 (97 to 98) -
    Pulse
    Units: Bpm
        median (inter-quartile range (Q1-Q3))
    		 86.0 (77.0 to 95.0) 80.0 (74.0 to 88.5) -
    Weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 74.9 (62.3 to 93.8) 75.7 (63.3 to 83.6) -
    ECG Resting QTc
    Units: msec
        median (inter-quartile range (Q1-Q3))
    		 431.0 (417.0 to 445.0) 425.5 (413.0 to 439.0) -
    Longest diameter of tumours: Primary
    Units: mm
        median (inter-quartile range (Q1-Q3))
    		 39.5 (24.0 to 55.5) 29.5 (15.0 to 40.0) -
    Longest diameter of tumours: Lymph node
    Units: mm
        median (inter-quartile range (Q1-Q3))
    		 16.0 (10.0 to 19.0) 16.5 (13.5 to 19.0) -
    Longest diameter of tumours: Liver
    Units: mm
        median (inter-quartile range (Q1-Q3))
    		 26.0 (26.0 to 26.0) 14.0 (14.0 to 14.0) -
    Longest diameter of tumours: Adrenal glands
    Units: mm
        median (inter-quartile range (Q1-Q3))
    		 15.5 (11.0 to 20.0) 47.5 (36.0 to 59.0) -
    Longest diameter of tumours: Other
    Units: mm
        median (inter-quartile range (Q1-Q3))
    		 35.0 (24.5 to 46.0) 34.5 (30.0 to 39.0) -
    Target tumours: Sum of longest diameters
    Units: mm
        median (inter-quartile range (Q1-Q3))
    		 44.5 (33.0 to 62.5) 53.5 (30.0 to 69.0) -

    End points

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

    Reporting group title
    Olaparib
    Reporting group description
    		 Olaparib 300mg po bd q21 until disease progression
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Olaparib
    Reporting group description
    		 Olaparib 300mg po bd q21 until disease progression

    Primary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    End point type
    Primary
    End point timeframe
    From date of randomisation to date of disease progression or death, whichever comes first
    End point values
    		 Placebo Olaparib
    Number of subjects analysed
    38
    32
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    12.0 (5.6 to 18.7)
    16.6 (7.1 to 21.7)
    Statistical analysis title
    		 PFS unadjusted
    Statistical analysis description
    Unadjusted analysis
    Comparison groups
    Placebo v Olaparib
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.15
    Notes
    [1] - Sample size calculation based on 80% power and a one-sided α (type I error) of 0.2. Result not statistically significant.
    Statistical analysis title
    		 PFS adjusted
    Statistical analysis description
    Adjusted for smoking history and histology
    Comparison groups
    Placebo v Olaparib
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.11 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.73
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.02
    Notes
    [2] - Sample size calculation based on 80% power and a one-sided α (type I error) of 0.2. Result statistically significant.

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Measured from date of randomisation to date of death, with those still alive censored at date last seen.
    End point values
    		 Placebo Olaparib
    Number of subjects analysed
    38
    32
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    31.3 (22.4 to 58.6)
    59.4 (38.7 to 67.9)
    Statistical analysis title
    		 Overall survival
    Comparison groups
    Placebo v Olaparib
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.22 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.26
    Notes
    [3] - Two-sided p-value

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    End point type
    Secondary
    End point timeframe
    From date of randomisation to RECIST assessment at 6 weeks post randomisation (end of Cycle 2).
    End point values
    		 Placebo Olaparib
    Number of subjects analysed
    38
    32
    Units: Subjects
    number (not applicable)
        Complete response
    0
    0
        Partial response
    1
    0
        Stable disease
    22
    20
        Progressive disease
    12
    7
        Not evaluable
    0
    1
        RECIST assessment not done
    0
    1
        Did not reach end of cycle 2 RECIST timepoint
    3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline screening assessments to disease progression or death (whichever comes first) or if still alive and not progressed date data collection ended.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Olaparib
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Olaparib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 38 (26.32%)
    9 / 31 (29.03%)
         number of deaths (all causes)
    25
    18
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pathological fracture imminent
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Pericardial effusion
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (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
    Headache
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dysphagia
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Device occlusion
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (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
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reaspiratory tract haemorrhage
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lung infection
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
    alternative dictionary used: MedDRA 19
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 31 (3.23%)
         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: 0.05%
    Non-serious adverse events
    		 Placebo Olaparib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 38 (100.00%)
    31 / 31 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 38 (23.68%)
    3 / 31 (9.68%)
         occurrences all number
    18
    15
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences all number
    3
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 38 (15.79%)
    6 / 31 (19.35%)
         occurrences all number
    6
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 38 (26.32%)
    15 / 31 (48.39%)
         occurrences all number
    26
    45
    Lymphopenia
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 31 (6.45%)
         occurrences all number
    2
    7
    Neutropenia
         subjects affected / exposed
    0 / 38 (0.00%)
    4 / 31 (12.90%)
         occurrences all number
    0
    6
    Thrombocytopenia
         subjects affected / exposed
    1 / 38 (2.63%)
    4 / 31 (12.90%)
         occurrences all number
    3
    12
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    25 / 38 (65.79%)
    29 / 31 (93.55%)
         occurrences all number
    66
    50
    Oedema peripheral
         subjects affected / exposed
    4 / 38 (10.53%)
    3 / 31 (9.68%)
         occurrences all number
    6
    8
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    4 / 38 (10.53%)
    4 / 31 (12.90%)
         occurrences all number
    7
    9
    Diarrhoea
         subjects affected / exposed
    7 / 38 (18.42%)
    4 / 31 (12.90%)
         occurrences all number
    12
    12
    Dry mouth
         subjects affected / exposed
    4 / 38 (10.53%)
    1 / 31 (3.23%)
         occurrences all number
    5
    1
    Dyspepsia
         subjects affected / exposed
    7 / 38 (18.42%)
    3 / 31 (9.68%)
         occurrences all number
    13
    4
    Flatulence
         subjects affected / exposed
    5 / 38 (13.16%)
    1 / 31 (3.23%)
         occurrences all number
    3
    1
    Nausea
         subjects affected / exposed
    11 / 38 (28.95%)
    17 / 31 (54.84%)
         occurrences all number
    21
    44
    Vomiting
         subjects affected / exposed
    4 / 38 (10.53%)
    7 / 31 (22.58%)
         occurrences all number
    5
    17
    Respiratory, thoracic and mediastinal disorders
    Coughing
         subjects affected / exposed
    22 / 38 (57.89%)
    11 / 31 (35.48%)
         occurrences all number
    47
    33
    Dyspnoea
         subjects affected / exposed
    15 / 38 (39.47%)
    13 / 31 (41.94%)
         occurrences all number
    35
    28
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 31 (9.68%)
         occurrences all number
    1
    3
    Rash
         subjects affected / exposed
    3 / 38 (7.89%)
    4 / 31 (12.90%)
         occurrences all number
    3
    10
    Pruritus
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 31 (9.68%)
         occurrences all number
    2
    10
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 38 (15.79%)
    2 / 31 (6.45%)
         occurrences all number
    8
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 31 (9.68%)
         occurrences all number
    3
    4
    Back pain
         subjects affected / exposed
    8 / 38 (21.05%)
    5 / 31 (16.13%)
         occurrences all number
    10
    6
    Dizziness
         subjects affected / exposed
    3 / 38 (7.89%)
    6 / 31 (19.35%)
         occurrences all number
    3
    6
    Infections and infestations
    Upper respiratory infection
         subjects affected / exposed
    5 / 38 (13.16%)
    4 / 31 (12.90%)
         occurrences all number
    9
    7
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    12 / 38 (31.58%)
    11 / 31 (35.48%)
         occurrences all number
    21
    22
    Hyponatremia
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 31 (9.68%)
         occurrences all number
    3
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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