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    Clinical Trial Results:
    ATLAS: A Phase 2, Open-label Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

    Summary
    EudraCT number
    		 2017-004166-10
    Trial protocol
    		 FR   ES   DE   GB   IT  
    Global end of trial date
    15 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Sep 2020
    First version publication date
    05 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CO-338-085
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03397394
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 US IND: 129840
    Sponsors
    Sponsor organisation name
    Clovis Oncology UK Ltd
    Sponsor organisation address
    Granta Centre, Granta Park, Great Abington, Cambridge, United Kingdom, CB21 6GP
    Public contact
    Dr Lindsey Rolfe, Clovis Oncology UK Ltd, 44 12233645500, lrolfe@clovisoncology.com
    Scientific contact
    Dr Lindsey Rolfe, Clovis Oncology UK Ltd, 44 12233645500, lrolfe@clovisoncology.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
    22 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective for this study is: • To evaluate objective response rate (ORR) in molecularly-defined homologous recombination deficiency (HRD)-positive and intent-to-treat (ITT) populations using a prospectively defined molecular signature.
    Protection of trial subjects
    Safety was assessed by evaluating Eastern Cooperative Oncology Group performance status (ECOG PS), vital signs, hematology, serum chemistry, urinalysis, changes in physical examination, and by monitoring the incidence, severity, and relationship to rucaparib of adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2018
    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
    Spain: 19
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    United States: 58
    Worldwide total number of subjects
    97
    EEA total number of subjects
    39
    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)
    39
    From 65 to 84 years
    55
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 97 subjects were recruited from 40 sites across 5 countries.

    Pre-assignment
    Screening details
    		 This study enrolled patients with locally advanced unresectable or metastatic urothelial carcinoma who had received 1 or 2 prior treatment regimens and regardless of HRD status.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HRD Unknown
    Arm description
    		 Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rucaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients initiated treatment with oral rucaparib 600 mg BID and continued rucaparib in 28-day cycles. Patients took rucaparib with or without food.

    Arm title
    		 HRD Negative
    Arm description
    		 Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rucaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients initiated treatment with oral rucaparib 600 mg BID and continued rucaparib in 28-day cycles. Patients took rucaparib with or without food.

    Arm title
    		 HRD Positive
    Arm description
    		 Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rucaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients initiated treatment with oral rucaparib 600 mg BID and continued rucaparib in 28-day cycles. Patients took rucaparib with or without food.

    Number of subjects in period 1
    		HRD Unknown HRD Negative HRD Positive
    Started
    47
    30
    20
    Completed
    47
    30
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HRD Unknown
    Reporting group description
    		 Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.

    Reporting group title
    HRD Negative
    Reporting group description
    		 Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative.

    Reporting group title
    HRD Positive
    Reporting group description
    		 Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.

    Reporting group values
    		 HRD Unknown HRD Negative HRD Positive Total
    Number of subjects
    		 47 30 20 97
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 19 13 7 39
        From 65-84 years
    		 27 16 12 55
        85 years and over
    		 1 1 1 3
    Age continuous
    Units: years
        median (full range (min-max))
    		 66 (50 to 85) 66 (47 to 85) 71 (39 to 87) -
    Gender categorical
    Units: Subjects
        Female
    		 9 3 9 21
        Male
    		 38 27 11 76
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 4 1 12
        Not Hispanic or Latino
    		 29 23 17 69
        Unknown or Not Reported
    		 11 3 2 16
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 1
        Black or African American
    		 1 2 0 3
        White
    		 32 24 18 74
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 12 3 2 17

    End points

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    End points reporting groups
    Reporting group title
    HRD Unknown
    Reporting group description
    		 Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.

    Reporting group title
    HRD Negative
    Reporting group description
    		 Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative.

    Reporting group title
    HRD Positive
    Reporting group description
    		 Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.

    Subject analysis set title
    All Patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Includes all patients evaluated for this endpoint.

    Primary: Objective Response Rate (ORR) Per RECIST Version 1.1

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    End point title
    		 Objective Response Rate (ORR) Per RECIST Version 1.1 [1]
    End point description
    ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
    End point type
    Primary
    End point timeframe
    Time from first dose to date of progression, up to approximately 19 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per EMA feedback, the statistical analyses section can not accommodate the end point results for this study. Therefore, all statistical analyses details are provided in the End point values sections.
    End point values
    		 HRD Unknown HRD Negative HRD Positive All Patients
    Number of subjects analysed
    47
    29
    19
    95
    Units: Participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator

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    End point title
    		 Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
    End point description
    PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
    End point values
    		 HRD Unknown HRD Negative HRD Positive All Patients
    Number of subjects analysed
    47
    30
    20
    97
    Units: Months
        median (confidence interval 95%)
    1.8 (1.6 to 2.0)
    1.8 (1.5 to 2.0)
    1.4 (1.2 to 3.6)
    1.8 (1.6 to 1.9)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up (median follow-up time = 2.7 months), a descriptive summary of deaths on study (from first dose of study drug to 28 days after the last dose of study drug) and deaths during long-term follow-up are presented.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 to date of death, assessed up to 11 months
    End point values
    		 HRD Unknown HRD Negative HRD Positive All Patients
    Number of subjects analysed
    47
    30
    20
    97
    Units: Participants
        Deaths on Study
    9
    8
    7
    24
        Deaths During Long-Term Follow-Up
    6
    7
    2
    15
    No statistical analyses for this end point

    Secondary: Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations

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    End point title
    		 Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
    End point description
    Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.
    End point type
    Secondary
    End point timeframe
    From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
    End point values
    		 HRD Unknown HRD Negative HRD Positive All Patients
    Number of subjects analysed
    47 [2]
    30 [3]
    20 [4]
    97 [5]
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cycle 2 Day 1
    2354.03 ( 2173.055 )
    1927.77 ( 1352.707 )
    1853.84 ( 1533.622 )
    2129.70 ( 1831.099 )
        Cycle 3 Day 1
    2037.90 ( 1253.715 )
    1331.17 ( 357.010 )
    643.00 ( 688.722 )
    1647.33 ( 1068.270 )
        Cycle 4 Day 1
    2225.00 ( 763.348 )
    2058.00 ( 705.280 )
    1585.00 ( 487.904 )
    2032.73 ( 672.891 )
    Notes
    [2] - Cycle 2 = 24, Cycle 3 = 10, Cycle 4 = 4
    [3] - Cycle 2 = 13, Cycle 3 = 6, Cycle 4 = 5
    [4] - Cycle 2 = 10, Cycle 3 = 2, Cycle 4 = 2
    [5] - Cycle 2 = 47, Cycle 3 = 18, Cycle 4 = 11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the first dose until 28 days after last dose of study drug. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, death, or until patient was lost to follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    HRD Unknown
    Reporting group description
    		 Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.

    Reporting group title
    HRD Negative
    Reporting group description
    		 Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH < 10% were considered HRD-negative

    Reporting group title
    HRD Positive
    Reporting group description
    		 Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.

    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 HRD Unknown HRD Negative HRD Positive Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 47 (42.55%)
    14 / 30 (46.67%)
    11 / 20 (55.00%)
    45 / 97 (46.39%)
         number of deaths (all causes)
    8
    9
    6
    23
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    6 / 47 (12.77%)
    9 / 30 (30.00%)
    3 / 20 (15.00%)
    18 / 97 (18.56%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
    0 / 3
    0 / 18
         deaths causally related to treatment / all
    0 / 6
    0 / 9
    0 / 3
    0 / 18
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 30 (3.33%)
    3 / 20 (15.00%)
    5 / 97 (5.15%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    3 / 4
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Intestinal obstruction
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pubic pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 HRD Unknown HRD Negative HRD Positive Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 47 (95.74%)
    29 / 30 (96.67%)
    19 / 20 (95.00%)
    93 / 97 (95.88%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    1
    0
    1
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    4
    0
    0
    4
    Intermittent claudication
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Lymphoedema
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    12 / 47 (25.53%)
    4 / 30 (13.33%)
    1 / 20 (5.00%)
    17 / 97 (17.53%)
         occurrences all number
    16
    5
    1
    22
    Chest pain
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    1
    2
    0
    3
    Chills
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    3
    0
    1
    4
    Fatigue
         subjects affected / exposed
    21 / 47 (44.68%)
    12 / 30 (40.00%)
    7 / 20 (35.00%)
    40 / 97 (41.24%)
         occurrences all number
    26
    22
    13
    61
    Localised oedema
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    2
    2
    Mucosal inflammation
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 30 (3.33%)
    2 / 20 (10.00%)
    4 / 97 (4.12%)
         occurrences all number
    2
    1
    2
    5
    Nodule
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 30 (3.33%)
    4 / 20 (20.00%)
    8 / 97 (8.25%)
         occurrences all number
    3
    1
    5
    9
    Pain
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 30 (6.67%)
    1 / 20 (5.00%)
    7 / 97 (7.22%)
         occurrences all number
    5
    2
    1
    8
    Peripheral swelling
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 30 (6.67%)
    3 / 20 (15.00%)
    9 / 97 (9.28%)
         occurrences all number
    4
    3
    4
    11
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    1
    0
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 30 (6.67%)
    1 / 20 (5.00%)
    3 / 97 (3.09%)
         occurrences all number
    0
    3
    1
    4
    Dyspnoea
         subjects affected / exposed
    5 / 47 (10.64%)
    6 / 30 (20.00%)
    1 / 20 (5.00%)
    12 / 97 (12.37%)
         occurrences all number
    5
    8
    1
    14
    Haemoptysis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    1
    3
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 47 (14.89%)
    2 / 30 (6.67%)
    1 / 20 (5.00%)
    10 / 97 (10.31%)
         occurrences all number
    7
    2
    1
    10
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 47 (12.77%)
    2 / 30 (6.67%)
    3 / 20 (15.00%)
    11 / 97 (11.34%)
         occurrences all number
    8
    2
    6
    16
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 47 (10.64%)
    5 / 30 (16.67%)
    5 / 20 (25.00%)
    15 / 97 (15.46%)
         occurrences all number
    6
    5
    9
    20
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
    5 / 97 (5.15%)
         occurrences all number
    4
    2
    0
    6
    Blood bilirubin increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    2
    2
    Blood creatinine increased
         subjects affected / exposed
    6 / 47 (12.77%)
    11 / 30 (36.67%)
    4 / 20 (20.00%)
    21 / 97 (21.65%)
         occurrences all number
    7
    15
    5
    27
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    2 / 20 (10.00%)
    3 / 97 (3.09%)
         occurrences all number
    2
    0
    2
    4
    Neutrophil count decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    2 / 20 (10.00%)
    3 / 97 (3.09%)
         occurrences all number
    1
    0
    4
    5
    Platelet count decreased
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 30 (10.00%)
    3 / 20 (15.00%)
    8 / 97 (8.25%)
         occurrences all number
    4
    4
    5
    13
    Transaminases increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    6 / 47 (12.77%)
    7 / 30 (23.33%)
    0 / 20 (0.00%)
    13 / 97 (13.40%)
         occurrences all number
    7
    9
    0
    16
    White blood cell count decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    1
    0
    1
    2
    Injury, poisoning and procedural complications
    Back injury
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Fall
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    3 / 20 (15.00%)
    4 / 97 (4.12%)
         occurrences all number
    1
    0
    4
    5
    Head injury
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Joint injury
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Toxicity to various agents
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 47 (10.64%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    6 / 97 (6.19%)
         occurrences all number
    5
    0
    1
    6
    Dysgeusia
         subjects affected / exposed
    8 / 47 (17.02%)
    7 / 30 (23.33%)
    1 / 20 (5.00%)
    16 / 97 (16.49%)
         occurrences all number
    8
    8
    1
    17
    Paraesthesia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    1
    1
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    1
    1
    2
    Somnolence
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    4 / 97 (4.12%)
         occurrences all number
    3
    0
    1
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    16 / 47 (34.04%)
    10 / 30 (33.33%)
    8 / 20 (40.00%)
    34 / 97 (35.05%)
         occurrences all number
    25
    26
    19
    70
    Leukocytosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Neutropenia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    2
    0
    1
    3
    Thrombocytopenia
         subjects affected / exposed
    5 / 47 (10.64%)
    6 / 30 (20.00%)
    3 / 20 (15.00%)
    14 / 97 (14.43%)
         occurrences all number
    10
    9
    3
    22
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 47 (8.51%)
    5 / 30 (16.67%)
    2 / 20 (10.00%)
    11 / 97 (11.34%)
         occurrences all number
    7
    5
    2
    14
    Abdominal pain upper
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    3 / 20 (15.00%)
    4 / 97 (4.12%)
         occurrences all number
    0
    1
    3
    4
    Anorectal discomfort
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Colitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Constipation
         subjects affected / exposed
    10 / 47 (21.28%)
    5 / 30 (16.67%)
    5 / 20 (25.00%)
    20 / 97 (20.62%)
         occurrences all number
    10
    5
    5
    20
    Diarrhoea
         subjects affected / exposed
    6 / 47 (12.77%)
    5 / 30 (16.67%)
    1 / 20 (5.00%)
    12 / 97 (12.37%)
         occurrences all number
    8
    5
    2
    15
    Dyspepsia
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    4 / 97 (4.12%)
         occurrences all number
    3
    1
    0
    4
    Flatulence
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    2
    0
    2
    Dysphagia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    1
    0
    1
    2
    Nausea
         subjects affected / exposed
    26 / 47 (55.32%)
    9 / 30 (30.00%)
    6 / 20 (30.00%)
    41 / 97 (42.27%)
         occurrences all number
    35
    11
    8
    54
    Stomatitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    2 / 20 (10.00%)
    3 / 97 (3.09%)
         occurrences all number
    1
    0
    4
    5
    Swollen tongue
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Vomiting
         subjects affected / exposed
    13 / 47 (27.66%)
    6 / 30 (20.00%)
    3 / 20 (15.00%)
    22 / 97 (22.68%)
         occurrences all number
    19
    8
    4
    31
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    1
    1
    2
    Pruritus
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 30 (6.67%)
    1 / 20 (5.00%)
    4 / 97 (4.12%)
         occurrences all number
    1
    3
    1
    5
    Rash
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    3 / 97 (3.09%)
         occurrences all number
    2
    0
    3
    5
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    3 / 97 (3.09%)
         occurrences all number
    4
    0
    1
    5
    Haematuria
         subjects affected / exposed
    1 / 47 (2.13%)
    4 / 30 (13.33%)
    1 / 20 (5.00%)
    6 / 97 (6.19%)
         occurrences all number
    1
    4
    1
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 30 (6.67%)
    1 / 20 (5.00%)
    7 / 97 (7.22%)
         occurrences all number
    4
    2
    1
    7
    Back pain
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 30 (10.00%)
    1 / 20 (5.00%)
    7 / 97 (7.22%)
         occurrences all number
    3
    3
    1
    7
    Flank pain
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
    5 / 97 (5.15%)
         occurrences all number
    3
    3
    0
    6
    Groin pain
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Muscle twitching
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Muscular weakness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    2 / 20 (10.00%)
    3 / 97 (3.09%)
         occurrences all number
    2
    0
    3
    5
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    2
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    1
    2
    0
    3
    Neck pain
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    3
    0
    0
    3
    Pain in extremity
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    4
    0
    4
    Infections and infestations
    Bacterial vaginosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Lung infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Sepsis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    2
    1
    3
    Sialoadenitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 30 (10.00%)
    3 / 20 (15.00%)
    10 / 97 (10.31%)
         occurrences all number
    7
    4
    3
    14
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    14 / 47 (29.79%)
    7 / 30 (23.33%)
    7 / 20 (35.00%)
    28 / 97 (28.87%)
         occurrences all number
    20
    9
    9
    38
    Dehydration
         subjects affected / exposed
    5 / 47 (10.64%)
    4 / 30 (13.33%)
    1 / 20 (5.00%)
    10 / 97 (10.31%)
         occurrences all number
    5
    5
    1
    11
    Hyperglycaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    0
    1
    1
    2
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    2
    0
    1
    3
    Hypokalaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 30 (3.33%)
    2 / 20 (10.00%)
    4 / 97 (4.12%)
         occurrences all number
    1
    4
    2
    7
    Hypomagnesaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    2 / 97 (2.06%)
         occurrences all number
    1
    0
    1
    2
    Hyponatraemia
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 30 (0.00%)
    2 / 20 (10.00%)
    4 / 97 (4.12%)
         occurrences all number
    4
    0
    2
    6
    Hypophosphataemia
         subjects affected / exposed
    6 / 47 (12.77%)
    3 / 30 (10.00%)
    1 / 20 (5.00%)
    10 / 97 (10.31%)
         occurrences all number
    7
    5
    2
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Oct 2018
    Significant changes included: 1- Updates and clarifications to various inclusion/exclusion criteria. 2- The requirement for archival tumor tissue samples, which are tissue samples collected as part of the patient’s standard of care in the past and are separate from the mandatory screening tumor tissue samples, were revised from being optional to being required, if available.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    09 Apr 2019
    Enrollment was halted early on 09 April 2019 due to a lack of meaningful clinical benefit observed in an interim analysis as assessed by the DMC.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Data are available for 97 (of 200 planned) patients who received rucaparib 600 mg BID.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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