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    Clinical Trial Results:
    A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer

    Summary
    EudraCT number
    		 2017-004009-42
    Trial protocol
    		 GB   ES   BE   IT  
    Global end of trial date
    03 Oct 2020

    Results information
    Results version number
    		 v3(current)
    This version publication date
    02 Sep 2022
    First version publication date
    14 Jun 2020
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    DCR

    Trial information

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    Trial identification
    Sponsor protocol code
    I4D-MC-JTJN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03414047
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16712
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    03 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Apr 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
    Korea, Republic of: 13
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    United States: 32
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Israel: 20
    Country: Number of subjects enrolled
    Australia: 34
    Country: Number of subjects enrolled
    Spain: 19
    Worldwide total number of subjects
    169
    EEA total number of subjects
    50
    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)
    169
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Completers included participants who died from any cause and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.

    Pre-assignment
    Screening details
    		 Only 169 participants were assigned to one of the 4 cohorts in this study. Data is not available for 3 participants who discontinued before the start of the treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prexasertib Cohort 1
    Arm description
    		 Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prexasertib
    Investigational medicinal product code
    Other name
    LY2606368
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 105 mg/m² prexasertib as an IV infusion.

    Arm title
    		 Prexasertib Cohort 2
    Arm description
    		 Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prexasertib
    Investigational medicinal product code
    Other name
    LY2606368
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 105 mg/m² prexasertib as an IV infusion.

    Arm title
    		 Prexasertib Cohort 3
    Arm description
    		 Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prexasertib
    Investigational medicinal product code
    Other name
    LY2606368
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 105 mg/m² prexasertib as an IV infusion.

    Arm title
    		 Prexasertib Cohort 4
    Arm description
    		 Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prexasertib
    Investigational medicinal product code
    Other name
    LY2606368
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 105 mg/m² prexasertib as an IV infusion.

    Number of subjects in period 1
    		Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Started
    53
    46
    41
    29
    Received at least one dose of study drug
    53
    46
    41
    29
    Completed
    51
    46
    38
    27
    Not completed
    2
    0
    3
    2
         Consent withdrawn by subject
    1
    -
    2
    -
         Physician decision
    1
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prexasertib Cohort 1
    Reporting group description
    		 Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.

    Reporting group title
    Prexasertib Cohort 2
    Reporting group description
    		 Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy.

    Reporting group title
    Prexasertib Cohort 3
    Reporting group description
    		 Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.

    Reporting group title
    Prexasertib Cohort 4
    Reporting group description
    		 Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.

    Reporting group values
    		 Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4 Total
    Number of subjects
    		 53 46 41 29 169
    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
        arithmetic mean (standard deviation)
    		 61.3 ( 9.4 ) 62.3 ( 9.4 ) 59.5 ( 8.6 ) 59.0 ( 13.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 53 46 41 29 169
        Male
    		 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 3 0 0 4
        Not Hispanic or Latino
    		 48 40 39 28 155
        Unknown or Not Reported
    		 4 3 2 1 10
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 6 8 4 3 21
        Native Hawaiian or Other Pacific Islander
    		 1 1 0 0 2
        Black or African American
    		 0 1 0 1 2
        White
    		 46 36 37 25 144
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0
    Region of Enrollment
    Units: Subjects
        South Korea
    		 4 5 2 2 13
        Belgium
    		 4 1 3 0 8
        United States
    		 6 13 3 10 32
        United Kingdom
    		 6 9 4 1 20
        Italy
    		 4 4 8 7 23
        Israel
    		 6 3 7 4 20
        Australia
    		 14 7 10 3 34
        Spain
    		 9 4 4 2 19

    End points

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    End points reporting groups
    Reporting group title
    Prexasertib Cohort 1
    Reporting group description
    		 Participants received 105 milligram per square meter (mg/m²) prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, breast cancer susceptibility gene (BRCA) negative and have received ≥3 lines of prior therapy.

    Reporting group title
    Prexasertib Cohort 2
    Reporting group description
    		 Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA negative and have received <3 lines of prior therapy.

    Reporting group title
    Prexasertib Cohort 3
    Reporting group description
    		 Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum-resistant disease, BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.

    Reporting group title
    Prexasertib Cohort 4
    Reporting group description
    		 Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. Participants were with platinum refractory disease, BRCA positive or negative, no restriction on number of lines of prior therapy.

    Subject analysis set title
    Prexasertib
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 105 mg/m² prexasertib as an approximately 60 (+10) minute IV infusion on Day 1 and 15 of a 28-day cycle. (Participants combined from all the Cohorts 1 to 4)

    Primary: Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)

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    End point title
    		 Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR) [1]
    End point description
    Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Analysis Population Description (APD): All randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline through Disease Progression (Up to 6 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 SAP no inferential data planned for this outcome.
    End point values
    		 Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Number of subjects analysed
    53
    46
    41
    29
    Units: Percentage of Participants
        number (confidence interval 95%)
    11.3 (4.3 to 23.0)
    13.0 (4.9 to 26.3)
    12.2 (4.1 to 26.2)
    6.9 (0.8 to 22.8)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib

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    End point title
    		 Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib
    End point description
    Pharmacokinetics(PK): Maximum Plasma Concentration of Prexasertib. The same dose was administered to Cohort 1, 2, 3 and 4 and were combined for analysis. APD: All randomized participants who received at least one dose of study drug and had evaluable PK data. Cohort 1, 2, 3 and 4 received the same dose and were combined per protocol.
    End point type
    Secondary
    End point timeframe
    Cycle 1, Cycle 2, Cycle 4, Cycle 6 (Day 1 (End of prexasertib infusion (+15 min), 1-2 hours following end of prexasertib infusion), Cycle 2, day 1(Prior to start of prexasertib infusion)
    End point values
    		 Prexasertib
    Number of subjects analysed
    151
    Units: nanograms per milliliter(ng/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1
    668 ( 50 )
        Cycle 2
    718 ( 62 )
        Cycle 4
    678 ( 61 )
        Cycle 6
    672 ( 42 )
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months

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    End point title
    		 Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months
    End point description
    DCR is defined as the number of participants who achieve a best overall response of CR, PR or SD for ≥4 months as determined by per RECIST version 1.1. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100. APD: All randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline through Disease Progression (up to 6 months)
    End point values
    		 Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Number of subjects analysed
    53
    46
    41
    29
    Units: Percentage of participants
        number (confidence interval 95%)
    45.3 (31.6 to 59.6)
    32.6 (19.5 to 48.0)
    31.7 (18.1 to 48.1)
    31.0 (15.3 to 50.8)
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment. APD: All randomized participants who received at least one dose of study drug and had CR or PR responses. Number of participants censored Cohort 1 = 0, Cohort 2 = 1, Cohort 3 = 0 and Cohort 4 = 0.
    End point type
    Secondary
    End point timeframe
    Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (up to 26 months)
    End point values
    		 Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Number of subjects analysed
    6 [2]
    5 [3]
    5
    2 [4]
    Units: Months
        median (confidence interval 95%)
    8.57 (5.55 to 99999)
    3.84 (2.79 to 99999)
    5.55 (3.65 to 9.36)
    5.31 (5.06 to 99999)
    Notes
    [2] - 99999-The upper 95% confidence interval was not achieved due to high censoring rate.
    [3] - 99999-The upper 95% confidence interval was not achieved due to high censoring rate.
    [4] - 99999-The upper 95% confidence interval was not achieved due to high censoring rate.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline

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    End point title
    		 Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline
    End point description
    CA-125 response is defined as ≥50% reduction in CA-125 levels from a pretreatment sample. The response must be confirmed and maintained for ≥28 days according to GCIG criteria. Participants must have a pretreatment sample that is ≥2 times the upper limit of the reference range and obtained within 2 weeks before starting the treatment. APD: All randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, 4 Weeks
    End point values
    		 Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Number of subjects analysed
    53
    46
    41
    29
    Units: Percentage of participants
        number (not applicable)
    39.6
    34.8
    17.1
    37.9
    No statistical analyses for this end point

    Secondary: Progression-Free Survival

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    End point title
    		 Progression-Free Survival
    End point description
    Progression-Free Survival (PFS) is defined as the time from the date of enrollment until the first occurrence of documented disease progression per RECIST 1.1, or death from any cause in the absence of progressive disease (PD). Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment. APD: All randomized participants who received at least one dose of study drug. Number of participants censored Cohort 1 = 6, Cohort 2 = 4, Cohort 3 = 4 and Cohort 4 = 4.
    End point type
    Secondary
    End point timeframe
    Baseline to Disease Progression or Death from any Cause (Up to 26 months)
    End point values
    		 Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Number of subjects analysed
    47
    42
    37
    25
    Units: Months
        median (confidence interval 95%)
    3.91 (3.68 to 5.68)
    3.71 (3.12 to 4.70)
    3.58 (1.87 to 3.91)
    3.71 (1.77 to 4.70)
    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) is defined as the time from the date of enrollment until death from any cause. If the participant is alive, lost to follow-up or withdrawn from study at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. APD: All randomized participants who received at least one dose of study drug and had overall survival data. Number of participants censored Cohort 1 = 18, Cohort 2 = 12, Cohort 3 = 12 and Cohort 4 = 4.
    End point type
    Secondary
    End point timeframe
    Baseline to Date of Death from Any Cause (Up to 15 months)
    End point values
    		 Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Number of subjects analysed
    35
    34
    29
    25
    Units: Months
        median (confidence interval 95%)
    13.04 (7.46 to 19.25)
    14.32 (11.76 to 16.46)
    11.14 (7.23 to 16.43)
    8.18 (6.18 to 11.93)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline, upto 26 Months
    Adverse event reporting additional description
    All randomized participants who received at least one dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Prexasertib Cohort 1
    Reporting group description
    		 -

    Reporting group title
    Prexasertib Cohort 2
    Reporting group description
    		 -

    Reporting group title
    Prexasertib Cohort 3
    Reporting group description
    		 -

    Reporting group title
    Prexasertib Cohort 4
    Reporting group description
    		 -

    Serious adverse events
    		 Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 53 (43.40%)
    17 / 46 (36.96%)
    19 / 41 (46.34%)
    15 / 29 (51.72%)
         number of deaths (all causes)
    2
    1
    1
    1
         number of deaths resulting from adverse events
    1
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    acute myeloid leukaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral artery thrombosis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chills
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    death
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    generalised oedema
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyperpyrexia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral swelling
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    5 / 46 (10.87%)
    1 / 41 (2.44%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypoxia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pleuritic pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    device dislocation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    blood creatinine increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    neutrophil count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    11 / 11
    0 / 0
    6 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    platelet count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    troponin increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    white blood cell count increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal stoma complication
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal compression fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    atrioventricular block
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pericardial effusion
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sinus tachycardia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    encephalopathy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 46 (4.35%)
    2 / 41 (4.88%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 46 (6.52%)
    5 / 41 (12.20%)
    4 / 29 (13.79%)
         occurrences causally related to treatment / all
    5 / 5
    4 / 4
    5 / 5
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    leukopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 46 (6.52%)
    4 / 41 (9.76%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    4 / 4
    3 / 3
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    1 / 41 (2.44%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ascites
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    constipation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 46 (4.35%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 46 (4.35%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    duodenal obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    large intestinal obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    large intestine perforation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 46 (2.17%)
    2 / 41 (4.88%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    obstruction gastric
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 46 (6.52%)
    1 / 41 (2.44%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    4 / 46 (8.70%)
    1 / 41 (2.44%)
    3 / 29 (10.34%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 4
    1 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    biliary dilatation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pollakiuria
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    diverticulitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    escherichia urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis viral
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    localised infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    neutropenic sepsis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 46 (4.35%)
    1 / 41 (2.44%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 46 (2.17%)
    2 / 41 (4.88%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    septic shock
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    soft tissue infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    staphylococcal bacteraemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tonsillitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 46 (6.52%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urosepsis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    viral infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 46 (4.35%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypoalbuminaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    		 Prexasertib Cohort 1 Prexasertib Cohort 2 Prexasertib Cohort 3 Prexasertib Cohort 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 53 (100.00%)
    44 / 46 (95.65%)
    39 / 41 (95.12%)
    28 / 29 (96.55%)
    Vascular disorders
    flushing
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 46 (2.17%)
    2 / 41 (4.88%)
    2 / 29 (6.90%)
         occurrences all number
    1
    1
    3
    2
    hot flush
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    3 / 41 (7.32%)
    0 / 29 (0.00%)
         occurrences all number
    0
    4
    3
    0
    hypertension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 53 (9.43%)
    2 / 46 (4.35%)
    3 / 41 (7.32%)
    1 / 29 (3.45%)
         occurrences all number
    5
    2
    4
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    8 / 53 (15.09%)
    8 / 46 (17.39%)
    10 / 41 (24.39%)
    4 / 29 (13.79%)
         occurrences all number
    19
    16
    38
    13
    catheter site pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    1 / 41 (2.44%)
    2 / 29 (6.90%)
         occurrences all number
    0
    1
    1
    2
    fatigue
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    21 / 53 (39.62%)
    19 / 46 (41.30%)
    12 / 41 (29.27%)
    12 / 29 (41.38%)
         occurrences all number
    84
    37
    17
    20
    mucosal inflammation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 53 (9.43%)
    1 / 46 (2.17%)
    3 / 41 (7.32%)
    1 / 29 (3.45%)
         occurrences all number
    8
    1
    5
    1
    non-cardiac chest pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    3 / 41 (7.32%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    6
    1
    oedema peripheral
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 46 (6.52%)
    3 / 41 (7.32%)
    1 / 29 (3.45%)
         occurrences all number
    5
    3
    3
    1
    pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 53 (7.55%)
    2 / 46 (4.35%)
    5 / 41 (12.20%)
    3 / 29 (10.34%)
         occurrences all number
    4
    3
    6
    3
    pyrexia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    13 / 53 (24.53%)
    5 / 46 (10.87%)
    7 / 41 (17.07%)
    8 / 29 (27.59%)
         occurrences all number
    17
    6
    16
    9
    Reproductive system and breast disorders
    pelvic pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 46 (0.00%)
    3 / 41 (7.32%)
    0 / 29 (0.00%)
         occurrences all number
    5
    0
    3
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 53 (9.43%)
    2 / 46 (4.35%)
    4 / 41 (9.76%)
    1 / 29 (3.45%)
         occurrences all number
    8
    2
    4
    1
    dyspnoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 53 (11.32%)
    7 / 46 (15.22%)
    4 / 41 (9.76%)
    4 / 29 (13.79%)
         occurrences all number
    10
    8
    5
    4
    oropharyngeal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 53 (9.43%)
    2 / 46 (4.35%)
    3 / 41 (7.32%)
    0 / 29 (0.00%)
         occurrences all number
    6
    2
    3
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    2
    0
    0
    3
    insomnia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 46 (6.52%)
    2 / 41 (4.88%)
    4 / 29 (13.79%)
         occurrences all number
    0
    3
    2
    4
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 46 (6.52%)
    3 / 41 (7.32%)
    2 / 29 (6.90%)
         occurrences all number
    1
    3
    4
    3
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 46 (6.52%)
    1 / 41 (2.44%)
    2 / 29 (6.90%)
         occurrences all number
    3
    3
    1
    3
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 46 (6.52%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    2
    3
    0
    1
    blood creatinine increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 46 (4.35%)
    3 / 41 (7.32%)
    0 / 29 (0.00%)
         occurrences all number
    4
    2
    5
    0
    neutrophil count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    9 / 46 (19.57%)
    5 / 41 (12.20%)
    1 / 29 (3.45%)
         occurrences all number
    11
    13
    9
    1
    platelet count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    8 / 53 (15.09%)
    7 / 46 (15.22%)
    7 / 41 (17.07%)
    3 / 29 (10.34%)
         occurrences all number
    37
    17
    28
    4
    weight decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 46 (6.52%)
    1 / 41 (2.44%)
    2 / 29 (6.90%)
         occurrences all number
    2
    4
    1
    2
    white blood cell count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 46 (6.52%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences all number
    1
    7
    1
    0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    infusion related reaction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 53 (9.43%)
    6 / 46 (13.04%)
    4 / 41 (9.76%)
    2 / 29 (6.90%)
         occurrences all number
    5
    9
    5
    2
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    5 / 46 (10.87%)
    1 / 41 (2.44%)
    4 / 29 (13.79%)
         occurrences all number
    1
    8
    1
    4
    headache
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    8 / 53 (15.09%)
    10 / 46 (21.74%)
    3 / 41 (7.32%)
    1 / 29 (3.45%)
         occurrences all number
    9
    21
    7
    1
    neuropathy peripheral
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 46 (6.52%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    20 / 53 (37.74%)
    17 / 46 (36.96%)
    15 / 41 (36.59%)
    12 / 29 (41.38%)
         occurrences all number
    64
    38
    40
    26
    febrile neutropenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 46 (0.00%)
    2 / 41 (4.88%)
    3 / 29 (10.34%)
         occurrences all number
    1
    0
    2
    3
    leukopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 46 (2.17%)
    6 / 41 (14.63%)
    4 / 29 (13.79%)
         occurrences all number
    7
    2
    10
    7
    neutropenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    19 / 53 (35.85%)
    10 / 46 (21.74%)
    11 / 41 (26.83%)
    10 / 29 (34.48%)
         occurrences all number
    40
    26
    24
    15
    thrombocytopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    17 / 53 (32.08%)
    14 / 46 (30.43%)
    14 / 41 (34.15%)
    7 / 29 (24.14%)
         occurrences all number
    83
    36
    34
    18
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 46 (4.35%)
    0 / 41 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    3
    3
    0
    3
    abdominal distension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 46 (6.52%)
    2 / 41 (4.88%)
    5 / 29 (17.24%)
         occurrences all number
    4
    3
    2
    7
    abdominal pain lower
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 46 (4.35%)
    3 / 41 (7.32%)
    1 / 29 (3.45%)
         occurrences all number
    1
    4
    3
    1
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    14 / 53 (26.42%)
    18 / 46 (39.13%)
    11 / 41 (26.83%)
    10 / 29 (34.48%)
         occurrences all number
    18
    40
    15
    14
    abdominal pain upper
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    4 / 46 (8.70%)
    2 / 41 (4.88%)
    4 / 29 (13.79%)
         occurrences all number
    3
    6
    2
    4
    ascites
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    5 / 46 (10.87%)
    2 / 41 (4.88%)
    2 / 29 (6.90%)
         occurrences all number
    1
    11
    3
    3
    constipation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    13 / 53 (24.53%)
    12 / 46 (26.09%)
    8 / 41 (19.51%)
    5 / 29 (17.24%)
         occurrences all number
    19
    15
    13
    5
    diarrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    19 / 53 (35.85%)
    15 / 46 (32.61%)
    7 / 41 (17.07%)
    8 / 29 (27.59%)
         occurrences all number
    57
    19
    11
    20
    dry mouth
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 46 (6.52%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    3
    0
    0
    dyspepsia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 46 (4.35%)
    4 / 41 (9.76%)
    0 / 29 (0.00%)
         occurrences all number
    3
    4
    4
    0
    mouth ulceration
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 46 (2.17%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences all number
    5
    1
    1
    0
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    19 / 53 (35.85%)
    24 / 46 (52.17%)
    15 / 41 (36.59%)
    16 / 29 (55.17%)
         occurrences all number
    54
    56
    33
    25
    small intestinal obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 46 (4.35%)
    1 / 41 (2.44%)
    4 / 29 (13.79%)
         occurrences all number
    4
    2
    2
    5
    vomiting
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    21 / 53 (39.62%)
    13 / 46 (28.26%)
    11 / 41 (26.83%)
    14 / 29 (48.28%)
         occurrences all number
    29
    20
    36
    25
    Skin and subcutaneous tissue disorders
    erythema
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    pruritus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 46 (6.52%)
    2 / 41 (4.88%)
    1 / 29 (3.45%)
         occurrences all number
    5
    3
    3
    1
    rash
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 46 (10.87%)
    6 / 41 (14.63%)
    2 / 29 (6.90%)
         occurrences all number
    3
    9
    7
    2
    Renal and urinary disorders
    pollakiuria
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    1
    0
    2
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    8 / 53 (15.09%)
    5 / 46 (10.87%)
    2 / 41 (4.88%)
    0 / 29 (0.00%)
         occurrences all number
    11
    6
    2
    0
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    11 / 53 (20.75%)
    8 / 46 (17.39%)
    6 / 41 (14.63%)
    6 / 29 (20.69%)
         occurrences all number
    13
    14
    7
    7
    bone pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 46 (0.00%)
    3 / 41 (7.32%)
    3 / 29 (10.34%)
         occurrences all number
    4
    0
    4
    3
    groin pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    1
    0
    3
    muscle spasms
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 46 (4.35%)
    2 / 41 (4.88%)
    1 / 29 (3.45%)
         occurrences all number
    13
    2
    3
    1
    muscular weakness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    5 / 46 (10.87%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    5
    0
    1
    myalgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 46 (6.52%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences all number
    2
    4
    1
    0
    Infections and infestations
    cellulitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 46 (6.52%)
    3 / 41 (7.32%)
    1 / 29 (3.45%)
         occurrences all number
    1
    3
    3
    1
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    7 / 53 (13.21%)
    2 / 46 (4.35%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    9
    2
    0
    1
    urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 46 (6.52%)
    0 / 41 (0.00%)
    4 / 29 (13.79%)
         occurrences all number
    9
    5
    0
    4
    viral infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 46 (0.00%)
    2 / 41 (4.88%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    4
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    12 / 53 (22.64%)
    12 / 46 (26.09%)
    9 / 41 (21.95%)
    7 / 29 (24.14%)
         occurrences all number
    14
    21
    12
    8
    dehydration
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    1
    0
    2
    hypoalbuminaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 46 (6.52%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences all number
    0
    3
    2
    0
    hypokalaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 46 (4.35%)
    5 / 41 (12.20%)
    1 / 29 (3.45%)
         occurrences all number
    4
    11
    10
    1
    hypomagnesaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 46 (6.52%)
    2 / 41 (4.88%)
    2 / 29 (6.90%)
         occurrences all number
    3
    12
    4
    2
    hyponatraemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 46 (6.52%)
    3 / 41 (7.32%)
    0 / 29 (0.00%)
         occurrences all number
    6
    3
    6
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jun 2018
    1) A criterion explicitly excluding patients that have known factors that may increase the risk of infection while on study drug treatment was added. 2) A statement indicating that strong P-gp and BRCP inhibitors should be used with caution was added.

    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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