Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 2 Study of LY2606368 in Patients with Extensive Stage Disease Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2015-005069-21
    Trial protocol
    		 NL   DE   GR   GB   ES  
    Global end of trial date
    28 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Feb 2020
    First version publication date
    24 Feb 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I4D-MC-JTJH
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02735980
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, United States, 46285
    Public contact
    Available Mon-Fri 9AM -5 PM EST, Eli Lilly and Company, 877 CTLilly,
    Scientific contact
    Available Mon-Fri 9 AM -5 PM EST, Eli Lilly and Company, 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
    28 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cohort 1: To estimate the Overall Response Rate (ORR) when a dose of 105 mg/m2 LY2606368 every 14 days is administered to patients with ED-SCLC that have platinum-sensitive disease. Cohort 2: To estimate the ORR when a dose of 105 mg/m2 LY2606368 every 14 days is administered in patients with Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) that have platinum resistant/refractory disease.
    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
    11 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 8
    Country: Number of subjects enrolled
    Turkey: 21
    Country: Number of subjects enrolled
    United States: 45
    Country: Number of subjects enrolled
    Ukraine: 2
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Greece: 4
    Worldwide total number of subjects
    133
    EEA total number of subjects
    57
    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)
    83
    From 65 to 84 years
    49
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 No text entered

    Pre-assignment
    Screening details
    		 No text entered

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 105 mg/m^2 Prexasertib (Platinum Sensitive Disease)
    Arm description
    		 Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prexasertib
    Investigational medicinal product code
    Other name
    LY2606368
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    105 mg/m^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy).

    Arm title
    		 105 mg/m^2 Prexasertib (Platinum Resistant Disease)
    Arm description
    		 105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prexasertib
    Investigational medicinal product code
    Other name
    LY2606368
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).

    Arm title
    		 40 mg/m2 Prexasertib Exploratory Addendum
    Arm description
    		 40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prexasertib
    Investigational medicinal product code
    Other name
    LY2606368
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg/m^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease.

    Number of subjects in period 1
    		105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Started
    58
    60
    15
    Received at least 1 dose of study drug
    56
    60
    15
    Completed
    48
    49
    14
    Not completed
    10
    11
    1
         Physician decision
    3
    1
    -
         Consent withdrawn by subject
    1
    2
    -
         death
    5
    4
    -
         screen failure
    1
    -
    -
         Adverse event, non-fatal
    -
    4
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    105 mg/m^2 Prexasertib (Platinum Sensitive Disease)
    Reporting group description
    		 Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle

    Reporting group title
    105 mg/m^2 Prexasertib (Platinum Resistant Disease)
    Reporting group description
    		 105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).

    Reporting group title
    40 mg/m2 Prexasertib Exploratory Addendum
    Reporting group description
    		 40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle

    Reporting group values
    		 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum Total
    Number of subjects
    		 58 60 15 133
    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)
    		 64.17 ( 9.21 ) 61.45 ( 7.20 ) 61.67 ( 7.33 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 10 4 37
        Male
    		 35 50 11 96
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0
        Not Hispanic or Latino
    		 52 53 15 120
        Unknown or not reported
    		 6 7 0 13
    Subject analysis sets

    Subject analysis set title
    PK population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters. Cohort 1 and Cohort 2 received the same dose and were combined per protocol.

    Subject analysis sets values
    		 PK population
    Number of subjects
    99
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
        Not Hispanic or Latino
    99
        Unknown or not reported
    0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    105 mg/m^2 Prexasertib (Platinum Sensitive Disease)
    Reporting group description
    		 Intravenous (IV) prexasertib (LY2606368)administered on day 1 of every 14 day cycle

    Reporting group title
    105 mg/m^2 Prexasertib (Platinum Resistant Disease)
    Reporting group description
    		 105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).

    Reporting group title
    40 mg/m2 Prexasertib Exploratory Addendum
    Reporting group description
    		 40 mg/m2 IV prexasertib (LY2606368) administered on Days 1, 2 and 3 of a 14-day cycle

    Subject analysis set title
    PK population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters. Cohort 1 and Cohort 2 received the same dose and were combined per protocol.

    Primary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

    		 Close Top of page
    End point title
    		 Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) [1]
    End point description
    ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
    End point type
    Primary
    End point timeframe
    Baseline to 10 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: No statistical analysis performed
    End point values
    		 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Number of subjects analysed
    58 [2]
    60 [3]
    15 [4]
    Units: participants
        number (confidence interval 95%)
    5.2 (0.7 to 9.6)
    0 (0.0 to 3.7)
    0 (0.0 to 14.8)
    Notes
    [2] - All randomized participants who received at least 1 dose of study drug.
    [3] - All randomized participants who received at least 1 dose of study drug.
    [4] - All randomized participants who received at least 1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2

    		 Close Top of page
    End point title
    		 Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
    End point description
    Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis. All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters. Cohort 1 and Cohort 2 received the same dose and were combined per protocol.
    End point type
    Secondary
    End point timeframe
    Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
    End point values
    		 PK population
    Number of subjects analysed
    99 [5]
    Units: nanogram per milliliter
    geometric mean (geometric coefficient of variation)
        Cycle 1
    722 ( 64 )
        Cycle 3
    735 ( 71 )
        Cycle 5
    732 ( 69 )
        Cycle 7
    1230 ( 22 )
    Notes
    [5] - Cohort 1 and 2 were combined, Cycle 3, 5 and 7 had 53, 16 and 5 participants respectively.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)

    		 Close Top of page
    End point title
    		 Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda) [6]
    End point description
    Pharmacokinetics(PK): Maximum Concentration of Prexasertib
    End point type
    Secondary
    End point timeframe
    Cycle 1: Day 3 prior to infusion and within 10 minutes of end of infusion
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis performed
    End point values
    		 40 mg/m2 Prexasertib Exploratory Addendum
    Number of subjects analysed
    15 [7]
    Units: nanograms per milliliter
        geometric mean (geometric coefficient of variation)
    227 ( 68 )
    Notes
    [7] - Al randomized participants with at least 1 dose of study drug and evaluable parameters.
    No statistical analyses for this end point

    Secondary: Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)

    		 Close Top of page
    End point title
    		 Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
    End point description
    Disease Control Rate is the time from the date measurement criteria for Complete Response (CR), Partial Response (PR) or Stable Disease (SD) divided by the total number of participants enrolled in the corresponding cohort.
    End point type
    Secondary
    End point timeframe
    Baseline through Disease Progression or Death from Any Cause to 28 months
    End point values
    		 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Number of subjects analysed
    56 [8]
    60 [9]
    15 [10]
    Units: participants
        number (confidence interval 95%)
    31 (12.6 to 31.4)
    20.0 (6.6 to 20.6)
    40.0 (10.2 to 48.4)
    Notes
    [8] - All randomized participants who received at least 1 dose of study drug.
    [9] - All randomized participants who received at least 1 dose of study drug.
    [10] - All randomized participants who received at least 1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

    		 Close Top of page
    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
    End point type
    Secondary
    End point timeframe
    Baseline to Disease Progression or Death or to 9 months
    End point values
    		 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Number of subjects analysed
    58 [11]
    60 [12]
    15 [13]
    Units: participants
        median (confidence interval 95%)
    31 (12.6 to 31.4)
    20.0 (6.6 to 20.6)
    40.0 (10.2 to 48.4)
    Notes
    [11] - All randomized participants who received at least 1 dose of study drug.
    [12] - All randomized participants who received at least 1 dose of study drug.
    [13] - All randomized participants who received at least 1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

    		 Close Top of page
    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
    End point type
    Secondary
    End point timeframe
    Baseline to Disease Progression or Death (up to 9 months)
    End point values
    		 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Number of subjects analysed
    58 [14]
    60 [15]
    15 [16]
    Units: participants
        median (confidence interval 95%)
    1.41 (1.31 to 1.64)
    1.36 (1.25 to 1.45)
    1.58 (1.38 to 3.12)
    Notes
    [14] - All randomized participants who received at least 1 dose of study drug.
    [15] - All randomized participants who received at least 1 dose of study drug.
    [16] - All randomized participants who received at least 1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point description
    OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
    End point type
    Secondary
    End point timeframe
    Baseline to 9 months
    End point values
    		 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease) 40 mg/m2 Prexasertib Exploratory Addendum
    Number of subjects analysed
    58 [17]
    60 [18]
    15 [19]
    Units: months
        median (confidence interval 95%)
    5.42 (3.75 to 8.51)
    3.15 (2.27 to 5.52)
    7.26 (2.00 to 9.49)
    Notes
    [17] - All randomized participants.
    [18] - All randomized participants
    [19] - All randomized participants.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)

    		 Close Top of page
    End point title
    		 Change From Baseline in Lung Cancer Symptom Scale Score (LCSS) [20]
    End point description
    LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).
    End point type
    Secondary
    End point timeframe
    All randomized participants in Cohort 1 and 2.
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis performed
    End point values
    		 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease)
    Number of subjects analysed
    58 [21]
    60 [22]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -2.8 ( 12.3 )
    -4.0 ( 10.2 )
    Notes
    [21] - All participants in Cohort 1 and Cohort 2.
    [22] - All participants in Cohort 1 and Cohort 2.
    No statistical analyses for this end point

    Secondary: Change From Baseline on the Average Symptom Burden Index (ASBI)

    		 Close Top of page
    End point title
    		 Change From Baseline on the Average Symptom Burden Index (ASBI) [23]
    End point description
    ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).
    End point type
    Secondary
    End point timeframe
    Baseline to 9 months
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis performed
    End point values
    		 105 mg/m^2 Prexasertib (Platinum Sensitive Disease) 105 mg/m^2 Prexasertib (Platinum Resistant Disease)
    Number of subjects analysed
    58 [24]
    60 [25]
    Units: units on a scale
        geometric mean (standard deviation)
    -3.0 ( 11.9 )
    -4.4 ( 11.1 )
    Notes
    [24] - All randomized participants in Cohort 1 and 2.
    [25] - All randomized participants in Cohort 1 and 2.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    10 months
    Adverse event reporting additional description
    I4D-MC-JTJH
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Prexasertib (Platinum Sensitive Disease)
    Reporting group description
    		 -

    Reporting group title
    Prexasertib (Platinum Resistant Disease)
    Reporting group description
    		 -

    Reporting group title
    Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
    Reporting group description
    		 -

    Serious adverse events
    		 Prexasertib (Platinum Sensitive Disease) Prexasertib (Platinum Resistant Disease) Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 56 (37.50%)
    16 / 60 (26.67%)
    6 / 15 (40.00%)
         number of deaths (all causes)
    4
    4
    2
         number of deaths resulting from adverse events
    2
    1
    1
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    orthostatic hypotension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    multiple organ dysfunction syndrome
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory failure
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    atelectasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    4 / 60 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    epistaxis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    haemoptysis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 60 (3.33%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    productive cough
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    blood bilirubin increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    blood creatinine increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    electrocardiogram qt prolonged
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    neutrophil count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    platelet count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    4 / 60 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    7 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    white blood cell count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    subdural haematoma
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiac disorders
    pericardial effusion
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    cauda equina syndrome
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    encephalopathy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lethargy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 60 (3.33%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    8 / 56 (14.29%)
    1 / 60 (1.67%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    9 / 9
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    leukopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ascites
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    colitis ischaemic
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    stomatitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    muscular weakness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 60 (1.67%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    escherichia bacteraemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    parainfluenzae virus infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 56 (8.93%)
    0 / 60 (0.00%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    2 / 9
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    pneumonia haemophilus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 60 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prexasertib (Platinum Sensitive Disease) Prexasertib (Platinum Resistant Disease) Prexasertib Exploratory Addendum (Platinum Sensitive Disease)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 56 (100.00%)
    59 / 60 (98.33%)
    15 / 15 (100.00%)
    Vascular disorders
    hypotension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    8 / 56 (14.29%)
    5 / 60 (8.33%)
    2 / 15 (13.33%)
         occurrences all number
    9
    7
    9
    catheter site pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    fatigue
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    16 / 56 (28.57%)
    18 / 60 (30.00%)
    6 / 15 (40.00%)
         occurrences all number
    25
    25
    8
    influenza like illness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    2
    non-cardiac chest pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    7 / 56 (12.50%)
    5 / 60 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    8
    5
    0
    oedema peripheral
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 56 (7.14%)
    1 / 60 (1.67%)
    1 / 15 (6.67%)
         occurrences all number
    5
    1
    1
    pyrexia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 56 (7.14%)
    5 / 60 (8.33%)
    3 / 15 (20.00%)
         occurrences all number
    4
    7
    3
    Respiratory, thoracic and mediastinal disorders
    bronchial haemorrhage
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    cough
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    16 / 56 (28.57%)
    9 / 60 (15.00%)
    0 / 15 (0.00%)
         occurrences all number
    21
    9
    0
    dyspnoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    11 / 56 (19.64%)
    13 / 60 (21.67%)
    2 / 15 (13.33%)
         occurrences all number
    13
    14
    2
    productive cough
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    4 / 60 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    4
    0
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    1
    depression
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    1
    insomnia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 60 (5.00%)
    1 / 15 (6.67%)
         occurrences all number
    3
    3
    1
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 56 (3.57%)
    4 / 60 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    3
    8
    2
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    5 / 60 (8.33%)
    2 / 15 (13.33%)
         occurrences all number
    3
    5
    2
    blood cholesterol increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    blood creatinine increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    4 / 60 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    4
    5
    0
    blood uric acid increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    electrocardiogram qt prolonged
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 56 (3.57%)
    5 / 60 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    5
    6
    0
    lipase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    lymphocyte count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    7 / 56 (12.50%)
    6 / 60 (10.00%)
    3 / 15 (20.00%)
         occurrences all number
    18
    16
    5
    neutrophil count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    23 / 56 (41.07%)
    26 / 60 (43.33%)
    7 / 15 (46.67%)
         occurrences all number
    62
    68
    38
    platelet count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    18 / 56 (32.14%)
    23 / 60 (38.33%)
    9 / 15 (60.00%)
         occurrences all number
    49
    44
    36
    weight decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 56 (8.93%)
    3 / 60 (5.00%)
    1 / 15 (6.67%)
         occurrences all number
    5
    6
    1
    white blood cell count decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    14 / 56 (25.00%)
    18 / 60 (30.00%)
    5 / 15 (33.33%)
         occurrences all number
    34
    59
    9
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 60 (1.67%)
    2 / 15 (13.33%)
         occurrences all number
    5
    1
    2
    encephalopathy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    headache
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    5 / 60 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    3
    6
    2
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    28 / 56 (50.00%)
    20 / 60 (33.33%)
    9 / 15 (60.00%)
         occurrences all number
    46
    36
    30
    febrile neutropenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 56 (8.93%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    5
    0
    1
    leukopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    6 / 60 (10.00%)
    0 / 15 (0.00%)
         occurrences all number
    4
    11
    0
    neutropenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    18 / 56 (32.14%)
    18 / 60 (30.00%)
    4 / 15 (26.67%)
         occurrences all number
    30
    39
    11
    thrombocytopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    13 / 56 (23.21%)
    9 / 60 (15.00%)
    4 / 15 (26.67%)
         occurrences all number
    27
    27
    11
    Eye disorders
    eye haematoma
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 60 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    constipation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    7 / 56 (12.50%)
    6 / 60 (10.00%)
    1 / 15 (6.67%)
         occurrences all number
    9
    6
    1
    diarrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    10 / 56 (17.86%)
    5 / 60 (8.33%)
    3 / 15 (20.00%)
         occurrences all number
    14
    12
    3
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    15 / 56 (26.79%)
    12 / 60 (20.00%)
    3 / 15 (20.00%)
         occurrences all number
    17
    16
    3
    stomatitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 60 (3.33%)
    3 / 15 (20.00%)
         occurrences all number
    4
    2
    3
    vomiting
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    8 / 56 (14.29%)
    7 / 60 (11.67%)
    3 / 15 (20.00%)
         occurrences all number
    11
    11
    3
    Skin and subcutaneous tissue disorders
    pruritus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 60 (5.00%)
    2 / 15 (13.33%)
         occurrences all number
    1
    3
    3
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    7 / 56 (12.50%)
    5 / 60 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    7
    6
    0
    bone pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 60 (1.67%)
    0 / 15 (0.00%)
         occurrences all number
    5
    2
    0
    muscular weakness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 60 (5.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    3
    2
    myalgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 60 (1.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    2
    pain in extremity
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    4 / 60 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    4
    5
    0
    Infections and infestations
    oral candidiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    2
    0
    1
    oral herpes
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    pharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    rhinitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    tooth infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 60 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    3
    2
    1
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    13 / 56 (23.21%)
    14 / 60 (23.33%)
    6 / 15 (40.00%)
         occurrences all number
    18
    20
    7
    dehydration
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 56 (10.71%)
    2 / 60 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    7
    3
    2
    hyperuricaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 60 (3.33%)
    0 / 15 (0.00%)
         occurrences all number
    4
    3
    0
    hypokalaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 56 (7.14%)
    3 / 60 (5.00%)
    2 / 15 (13.33%)
         occurrences all number
    4
    7
    2
    hypomagnesaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 60 (3.33%)
    0 / 15 (0.00%)
         occurrences all number
    3
    2
    0
    hyponatraemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 56 (7.14%)
    2 / 60 (3.33%)
    1 / 15 (6.67%)
         occurrences all number
    5
    2
    5

    More information

    		 Close Top of page

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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.

    European Medicines Agency © 1995-Sat Apr 27 06:38:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA