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    Clinical Trial Results:
    Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects with Primary Immune Thrombocytopenia (ITP)

    Summary
    EudraCT number
    		 2014-001429-33
    Trial protocol
    		 GB   PL  
    Global end of trial date
    22 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Feb 2019
    First version publication date
    02 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM140-103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium,
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to assess the overall safety and tolerability of multiple doses of BMS-986004, when administered in subjects with chronic ITP.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Georgia: 4
    Country: Number of subjects enrolled
    Moldova, Republic of: 3
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    26
    EEA total number of subjects
    8
    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)
    21
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 46 subjects were enrolled in the study and 26 subjects entered the treatment period. Of the 20 who did not enter the treatment period, 19 did not meet study criteria and 1 experienced an adverse event.

    Period 1
    Period 1 title
    Short Term Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS 75mg
    Arm description
    		 BMS-986004 dose level 75 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986004
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    75 mg intravenous

    Arm title
    		 BMS 225mg
    Arm description
    		 BMS-986004 dose level 225 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986004
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    225 mg intravenous

    Arm title
    		 BMS 675 mg
    Arm description
    		 BMS-986004 dose level 675 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986004
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    675 mg intravenous

    Arm title
    		 BMS 1500 mg
    Arm description
    		 BMS-986004 dose level 1500 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986004
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    1500 mg intravenous

    Number of subjects in period 1
    		BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Started
    5
    6
    5
    10
    Completed
    0
    0
    1
    4
    Not completed
    5
    6
    4
    6
         ST complete, not entering LTE
    4
    6
    4
    5
         Lost to follow-up
    1
    -
    -
    -
         Lack of efficacy
    -
    -
    -
    1
    Period 2
    Period 2 title
    Long Term Extension
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS 675 mg
    Arm description
    		 BMS-986004 dose level 675 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986004
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    675 mg intravenous

    Arm title
    		 BMS 1500 mg
    Arm description
    		 BMS-986004 dose level 1500 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986004
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    1500 mg intravenous

    Number of subjects in period 2
    		BMS 675 mg BMS 1500 mg
    Started
    1
    4
    Completed
    1
    3
    Not completed
    0
    1
         Adverse event, serious fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BMS 75mg
    Reporting group description
    		 BMS-986004 dose level 75 mg

    Reporting group title
    BMS 225mg
    Reporting group description
    		 BMS-986004 dose level 225 mg

    Reporting group title
    BMS 675 mg
    Reporting group description
    		 BMS-986004 dose level 675 mg

    Reporting group title
    BMS 1500 mg
    Reporting group description
    		 BMS-986004 dose level 1500 mg

    Reporting group values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg Total
    Number of subjects
    		 5 6 5 10 26
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 4 6 5 6 21
        From 65-84 years
    		 1 0 0 4 5
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 52.8 ± 20.58 43.2 ± 16.33 34.2 ± 16.93 55.3 ± 16.09 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 2 2 4 4 12
        Male
    		 3 4 1 6 14
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 1 0 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 1 1
        White
    		 4 5 5 7 21
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 1 0 0 1 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0
        Not Hispanic or Latino
    		 1 4 4 8 17
        Unknown or Not Reported
    		 4 2 1 2 9

    End points

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    End points reporting groups
    Reporting group title
    BMS 75mg
    Reporting group description
    		 BMS-986004 dose level 75 mg

    Reporting group title
    BMS 225mg
    Reporting group description
    		 BMS-986004 dose level 225 mg

    Reporting group title
    BMS 675 mg
    Reporting group description
    		 BMS-986004 dose level 675 mg

    Reporting group title
    BMS 1500 mg
    Reporting group description
    		 BMS-986004 dose level 1500 mg
    Reporting group title
    BMS 675 mg
    Reporting group description
    		 BMS-986004 dose level 675 mg

    Reporting group title
    BMS 1500 mg
    Reporting group description
    		 BMS-986004 dose level 1500 mg

    Primary: Number of subjects with adverse events (AEs) and serious adverse events (SAEs): Short term and Long term

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    End point title
    		 Number of subjects with adverse events (AEs) and serious adverse events (SAEs): Short term and Long term [1]
    End point description
    The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods
    End point type
    Primary
    End point timeframe
    Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
    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: Only summary statistics were planned for this endpoint
    End point values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Number of subjects analysed
    5
    6
    5
    10
    Units: Subjects
        Number of subjects with AEs|
    1
    5
    5
    9
        Number of subjects with SAEs|
    0
    0
    1
    1
    No statistical analyses for this end point

    Primary: Number of ECG abnormalities

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    End point title
    		 Number of ECG abnormalities [2]
    End point description
    The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate)
    End point type
    Primary
    End point timeframe
    Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
    Notes
    [2] - 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: Only summary statistics were planned for this endpoint
    End point values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Number of subjects analysed
    5
    6
    5
    10
    Units: Events
        Screening
    1
    3
    2
    3
        Day 1
    1
    2
    2
    3
        Day 71
    0
    2
    0
    0
        Day 72
    1
    0
    1
    1
        End of Treatment
    1
    3
    2
    1
        Long term Day 1
    0
    0
    0
    2
        Long term Day 71
    0
    0
    0
    2
        End of Long term
    0
    0
    0
    1
    No statistical analyses for this end point

    Primary: Number of laboratory abnormalities of Safety biomarkers: d-Dimer and Thrombin anti-Thrombin (TAT)

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    End point title
    		 Number of laboratory abnormalities of Safety biomarkers: d-Dimer and Thrombin anti-Thrombin (TAT) [3]
    End point description
    D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of Thromboembolism (TE) risk.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
    Notes
    [3] - 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: Only summary statistics were planned for this endpoint
    End point values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Number of subjects analysed
    5
    6
    5
    10
    Units: Events
        # of events: d-Dimer, Normal
    56
    81
    60
    106
        # of events: d-Dimer, High
    12
    14
    15
    17
        # of events: TAT Complex, Normal
    52
    71
    46
    112
        # of events: TAT Complex, High
    21
    30
    31
    28
    No statistical analyses for this end point

    Secondary: Response rate (RR) of BMS-986004: Short term and Long term

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    End point title
    		 Response rate (RR) of BMS-986004: Short term and Long term
    End point description
    RR is defined as the proportion of subjects who are responders
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
    End point values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Number of subjects analysed
    5
    6
    5
    10
    Units: No units
    number (not applicable)
        RR during ST
    0.2
    0.3
    0.4
    0.4
        RR during LTE (# analyzed = 0, 0, 1, 4)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Maximum observed serum concentration (Cmax) of BMS-986004

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    End point title
    		 Maximum observed serum concentration (Cmax) of BMS-986004
    End point description
    Pharmacokinetic parameter (Cmax) of BMS-986004, derived from serum concentration versus time. Pharmacokinetic Population is defined as all subjects who receive any study medication and have any available concentration-time data. Additionally, the evaluable PK Population is defined as subjects who have adequate PK profiles.
    End point type
    Secondary
    End point timeframe
    Day 1 till Day 141
    End point values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Number of subjects analysed
    5
    6
    5
    10
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax Day 1| (Subjects analyzed per arm = 2,6,4,9)
    19353.5 ± 6131.32
    59478.8 ± 10021.04
    177706.3 ± 37924.30
    296561.9 ± 119530.86
        Cmax Day 71| (Subjects analyzed per arm =0,4,6,13)
    9999 ± 9999
    62469.8 ± 27336.64
    186981.0 ± 22216.82
    373588.9 ± 89833.77
    No statistical analyses for this end point

    Secondary: Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986004

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    End point title
    		 Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986004
    End point description
    Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. AUC(TAU) = Area under the concentration-time curve in one dosing interval. Pharmacokinetic (PK) Population, defined as all subjects who receive any study medication and have any available concentration-time data. Additionally, the evaluable PK Population is defined as subjects who have adequate PK profiles.
    End point type
    Secondary
    End point timeframe
    From Day 1 till Day 141
    End point values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Number of subjects analysed
    5
    6
    5
    10
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        AUC(TAU) Day 1| (Subjects per arm = 2,6,4,9)
    915500 ± 196460
    3445000 ± 708290
    11440000 ± 3041300
    18370000 ± 7351000
        AUC(TAU) Day 71| (Subjects per arm = 0,4,6,13)
    9999 ± 9999
    4408000 ± 3313000
    11460000 ± 2124900
    26500000 ± 9366800
    No statistical analyses for this end point

    Secondary: Trough observed serum concentration (Ctrough) of BMS-986004

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    End point title
    		 Trough observed serum concentration (Ctrough) of BMS-986004
    End point description
    Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. Ctrough = Trough observed serum concentration. Pharmacokinetic Population is defined as all subjects who receive any study medication and have any available concentration-time data. Additionally, the evaluable PK Population is defined as subjects who have adequate PK profiles.
    End point type
    Secondary
    End point timeframe
    From Day 1 till Day 141
    End point values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Number of subjects analysed
    5
    6
    5
    10
    Units: ng/mL
    arithmetic mean (standard deviation)
        Ctrough, Day 15| (Subjects per arm: 5,6,5,10)
    978.0 ± 1080.82
    2373.0 ± 1182.00
    7556.4 ± 1952.53
    15282.5 ± 9710.77
        Ctrough, Day 29| (Subjects per arm:5,6,5,10)
    1011.4 ± 999.13
    3157.7 ± 1458.85
    10236.0 ± 3737.42
    21353.6 ± 14144.90
        Ctrough, Day 43|(Subjects per arm: 5,6,5,9)
    1207.0 ± 852.88
    3527.7 ± 1576.34
    9416.2 ± 4410.57
    19105.3 ± 14980.50
        Ctrough, Day 57|(Subjects per arm: 0,4,6,14)
    9999 ± 9999
    25339.5 ± 49053.16
    3360.5 ± 1082.75
    20553.1 ± 19099.39
        Ctrough, Day 71|(Subjects per arm: 0,4,6,13)
    9999 ± 9999
    3466.0 ± 3209.75
    8347.7 ± 3215.32
    25057.3 ± 18007.59
        Ctrough, Day 85|(Subjects per arm:0,4,6,13)
    9999 ± 9999
    4018.8 ± 4099.35
    9075.7 ± 4268.76
    24308.9 ± 19213.61
    No statistical analyses for this end point

    Secondary: Total body clearance (CLT) of BMS-986004

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    End point title
    		 Total body clearance (CLT) of BMS-986004
    End point description
    Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data.Pharmacokinetic Population, defined as all subjects who receive any study medication and have any available concentration-time data. Additionally, the evaluable PK Population is defined as subjects who have adequate PK profiles.
    End point type
    Secondary
    End point timeframe
    From Day 1 till Day 141
    End point values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Number of subjects analysed
    5
    6
    5
    10
    Units: L/H
    arithmetic mean (standard deviation)
        CLT Day 1| (Subjects per arm:2,6,4,8)
    0.0789 ± 0.01514
    0.0618 ± 0.01617
    0.0561 ± 0.01395
    0.0860 ± 0.03037
        CLT Day 71|(Subjects per arm:0,4,6,13)
    9999 ± 9999
    0.0716 ± 0.04106
    0.0611 ± 0.01449
    0.0628 ± 0.02061
    No statistical analyses for this end point

    Secondary: AUC accumulation index (AI_AUC) of BMS-986004

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    End point title
    		 AUC accumulation index (AI_AUC) of BMS-986004
    End point description
    AUC accumulation index (AI_AUC) = ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986004. Pharmacokinetic Population, defined as all subjects who receive any study medication and have any available concentration-time data. Additionally, the evaluable PK Population is defined as subjects who have adequate PK profiles.
    End point type
    Secondary
    End point timeframe
    Day 1 till Day 141
    End point values
    		 BMS 75mg BMS 225mg BMS 675 mg BMS 1500 mg
    Number of subjects analysed
    5
    6
    5
    10
    Units: Tau
    arithmetic mean (standard deviation)
        AI_AUC(TAU) (Subjects per arm: 0,0,0,12)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    1.7996 ± 0.597881
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All non-serious adverse events (NSAEs) and serious adverse events (SAEs) are reported from short-term period (Day 1 to Day 141) and long-term extension period (Day 1 to Day 398).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    BMS-986004 75 mg
    Reporting group description
    		 Subjects with received BMS-986004 75 milligram (mg) as intravenous (IV) solution.

    Reporting group title
    BMS-986004 675 mg
    Reporting group description
    		 Subjects with primary ITP received BMS-986004 675 mg as IV solution.

    Reporting group title
    BMS-986004 1500 mg
    Reporting group description
    		 Subjects with primary ITP received BMS-986004 1500 mg as IV solution.

    Reporting group title
    BMS-986004 225 mg
    Reporting group description
    		 Subjects with primary ITP received BMS-986004 225 mg as IV solution.

    Serious adverse events
    		 BMS-986004 75 mg BMS-986004 675 mg BMS-986004 1500 mg BMS-986004 225 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (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 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BMS-986004 75 mg BMS-986004 675 mg BMS-986004 1500 mg BMS-986004 225 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    5 / 5 (100.00%)
    9 / 10 (90.00%)
    5 / 6 (83.33%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    4 / 10 (40.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Feeling cold
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injection site reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Social circumstances
    Exercise lack of
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    0
    3
    0
    0
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngeal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Neurosis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Stress
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Heart sounds abnormal
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Platelet count increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Weight decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Migraine
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    1 / 10 (10.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    1
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Microcytic anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Mouth haemorrhage
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Petechiae
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Purpura
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    2 / 10 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Arthralgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    1
    Arthritis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    1
    Muscular weakness
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    1
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Osteoporosis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Periodontitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Phlebitis infective
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Aug 2016
    The purpose of this amendment is to add Long Term Extension (LTE) period to the study

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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