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    Clinical Trial Results:
    An Open-label, Multicenter, Phase 1/2 Study of JNJ-40346527, an FMS Inhibitor, in Subjects with Relapsed or Refractory Hodgkin Lymphoma

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2011-005795-42
    Trial protocol
    		 DE  
    Global end of trial date
    13 Aug 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Jul 2016
    First version publication date
    03 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    40346527HKL1001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01572519
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Archimedesweg 29-2333CM, Leiden, Netherlands, B235-0
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    13 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in participants with relapsed or refractory Hodgkin lymphoma. To establish the recommended Phase 2 dose for JNJ-40346527.
    Protection of trial subjects
    Safety was evaluated based on the variables like adverse events, Clinical laboratory tests (hematology, serum chemistry, and urinalysis), Vital sign measurements, Physical examinations, Electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) performance status.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2012
    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
    Germany: 10
    Country: Number of subjects enrolled
    France: 11
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    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)
    18
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 21 participants were enrolled and treated with JNJ 40346527.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 150 mg once daily (QD)
    Arm description
    		 Participants received JNJ-40346527, 150 milligram (mg) capsules once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-40346527
    Investigational medicinal product code
    JNJ-40346527-AAC
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    JNJ-40346527 Capsules 150 mg once daily

    Arm title
    		 300 mg QD
    Arm description
    		 Participants received JNJ-40346527, 300 mg capsules once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-40346527
    Investigational medicinal product code
    JNJ-40346527-AAC
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    JNJ-40346527 Capsules 300 mg once daily

    Arm title
    		 450 mg QD
    Arm description
    		 Participants received JNJ-40346527, 450 mg capsules once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-40346527
    Investigational medicinal product code
    JNJ-40346527-AAC
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    JNJ-40346527 Capsules 450 mg once daily

    Arm title
    		 600 mg QD
    Arm description
    		 Participants received JNJ-40346527, 600 mg capsules once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-40346527
    Investigational medicinal product code
    JNJ-40346527-AAC
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    JNJ-40346527 Capsules 600 mg once daily

    Arm title
    		 150 mg twice daily (BID)
    Arm description
    		 Participants received JNJ-40346527, 150 mg capsules twice daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-40346527
    Investigational medicinal product code
    JNJ-40346527-AAC
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    JNJ-40346527 Capsules 150 mg twice daily

    Number of subjects in period 1
    		150 mg once daily (QD) 300 mg QD 450 mg QD 600 mg QD 150 mg twice daily (BID)
    Started
    3
    5
    3
    3
    7
    Completed
    0
    0
    0
    0
    0
    Not completed
    3
    5
    3
    3
    7
         Physician decision
    1
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    -
    1
         Other
    1
    -
    -
    -
    -
         Lack of efficacy
    1
    5
    3
    3
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    150 mg once daily (QD)
    Reporting group description
    		 Participants received JNJ-40346527, 150 milligram (mg) capsules once daily.

    Reporting group title
    300 mg QD
    Reporting group description
    		 Participants received JNJ-40346527, 300 mg capsules once daily.

    Reporting group title
    450 mg QD
    Reporting group description
    		 Participants received JNJ-40346527, 450 mg capsules once daily.

    Reporting group title
    600 mg QD
    Reporting group description
    		 Participants received JNJ-40346527, 600 mg capsules once daily.

    Reporting group title
    150 mg twice daily (BID)
    Reporting group description
    		 Participants received JNJ-40346527, 150 mg capsules twice daily.

    Reporting group values
    		 150 mg once daily (QD) 300 mg QD 450 mg QD 600 mg QD 150 mg twice daily (BID) Total
    Number of subjects
    		 3 5 3 3 7 21
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 2 5 2 3 6 18
        From 65 to 84 years
    		 1 0 1 0 1 3
        85 years and over
    		 0 0 0 0 0 0
    Title for AgeContinuous
    Units: Years
        arithmetic mean (standard deviation)
    		 48 ( 24.88 ) 33.4 ( 9.99 ) 49 ( 18.52 ) 29.3 ( 10.5 ) 38.6 ( 18.57 ) -
    Title for Gender
    Units: subjects
        Female
    		 0 1 2 2 5 10
        Male
    		 3 4 1 1 2 11

    End points

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    End points reporting groups
    Reporting group title
    150 mg once daily (QD)
    Reporting group description
    		 Participants received JNJ-40346527, 150 milligram (mg) capsules once daily.

    Reporting group title
    300 mg QD
    Reporting group description
    		 Participants received JNJ-40346527, 300 mg capsules once daily.

    Reporting group title
    450 mg QD
    Reporting group description
    		 Participants received JNJ-40346527, 450 mg capsules once daily.

    Reporting group title
    600 mg QD
    Reporting group description
    		 Participants received JNJ-40346527, 600 mg capsules once daily.

    Reporting group title
    150 mg twice daily (BID)
    Reporting group description
    		 Participants received JNJ-40346527, 150 mg capsules twice daily.

    Subject analysis set title
    JNJ-40346527
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received at least one dose of study medication.

    Subject analysis set title
    Evaluable Participant Population (EPP)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Evaluable Participant Population includes Participants who received at least 1 dose of the study treatment, and had baseline and at least one post- treatment tumor assessment.

    Subject analysis set title
    Safety Analysis Set (SAS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who received at least one dose of study medication.

    Primary: Recommended Phase 2 dose (RP2D) for JNJ-40346527

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    End point title
    		 Recommended Phase 2 dose (RP2D) for JNJ-40346527 [1]
    End point description
    RP2D will be determined based on pharmacodynamics, biomarker response or clinical response, as well as the incidence rate and nature of the toxicities observed.
    End point type
    Primary
    End point timeframe
    Up to 24 hours after last dose administration
    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 were performed for this endpoint.
    End point values
    		 JNJ-40346527
    Number of subjects analysed
    21 [2]
    Units: milligram (mg)
        number (not applicable)
    150
    Notes
    [2] - EPP
    No statistical analyses for this end point

    Primary: Number of Participants with Overall Response Rate

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    End point title
    		 Number of Participants with Overall Response Rate [3]
    End point description
    Overall response rate is defined as the number of participants who achieve complete response or partial response, during or after study treatment. Here 'N' signifies number of subjects who were analysed for this outcome measure.
    End point type
    Primary
    End point timeframe
    Up to 6 months after the last subject is enrolled
    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: No statistical analysis were performed for this endpoint.
    End point values
    		 150 mg once daily (QD) 300 mg QD 450 mg QD 600 mg QD 150 mg twice daily (BID)
    Number of subjects analysed
    3 [4]
    5 [5]
    3 [6]
    3 [7]
    6 [8]
    Units: Participants
    number (not applicable)
        Complete Response (CR)
    1
    0
    0
    0
    0
        Partial Response (PR)
    0
    0
    0
    0
    0
    Notes
    [4] - EPP
    [5] - EPP
    [6] - EPP
    [7] - EPP
    [8] - EPP
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events
    End point description
    A treatment-emergent adverse event (TEAE) was defined as an event that occurred up to 30 days after the last dose of study medication treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and even if the event continued to be present.
    End point type
    Secondary
    End point timeframe
    Up to 30 days after the last dose of study medication
    End point values
    		 JNJ-40346527
    Number of subjects analysed
    21 [9]
    Units: participants
        number (not applicable)
    19
    Notes
    [9] - SAS
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of JNJ-40346527

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    End point title
    		 Maximum Plasma Concentration (Cmax) of JNJ-40346527
    End point description
    Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Here 'n' signifies number of subjects who were analysed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 21
    End point values
    		 150 mg once daily (QD) 300 mg QD 450 mg QD 600 mg QD 150 mg twice daily (BID)
    Number of subjects analysed
    3 [10]
    5 [11]
    3 [12]
    3 [13]
    7 [14]
    Units: nanogram per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Day 1 (n= 3, 5, 3, 3, 7)
    278 ( 71.4 )
    552 ( 198 )
    552 ( 655 )
    358 ( 244 )
    313 ( 86.9 )
        Day 21 (n= 2, 3, 3, 3, 6)
    304 ( 321 )
    598 ( 156 )
    1157 ( 409 )
    843 ( 394 )
    483 ( 182 )
    Notes
    [10] - EPP
    [11] - EPP
    [12] - EPP
    [13] - EPP
    [14] - EPP
    No statistical analyses for this end point

    Secondary: Minimum Plasma Concentration (Cmin) of JNJ-40346527

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    End point title
    		 Minimum Plasma Concentration (Cmin) of JNJ-40346527
    End point description
    Cmin refers to the lowest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Here 'N' signifies number of subjects who were analysed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 21
    End point values
    		 150 mg once daily (QD) 300 mg QD 450 mg QD 600 mg QD 150 mg twice daily (BID)
    Number of subjects analysed
    2 [15]
    3 [16]
    3 [17]
    3 [18]
    6 [19]
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    100 ( 101 )
    160 ( 63.2 )
    277 ( 89 )
    129 ( 45.4 )
    196 ( 41 )
    Notes
    [15] - EPP
    [16] - EPP
    [17] - EPP
    [18] - EPP
    [19] - EPP
    No statistical analyses for this end point

    Secondary: Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-40346527

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    End point title
    		 Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-40346527
    End point description
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. Here 'n' signifies number of subjects who were analysed for this outcome measure
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 21
    End point values
    		 150 mg once daily (QD) 300 mg QD 450 mg QD 600 mg QD 150 mg twice daily (BID)
    Number of subjects analysed
    3 [20]
    5 [21]
    3 [22]
    3 [23]
    7 [24]
    Units: hours
    median (full range (min-max))
        Day 1 (n= 3, 5, 3, 3, 7)
    4.1 (1 to 4.5)
    3 (2 to 4)
    2.1 (2.1 to 2.1)
    3 (2 to 4)
    1 (1 to 6)
        Day 21 (n= 2, 3, 3, 3, 6)
    1 (1 to 3.1)
    4.1 (4 to 5.9)
    3 (2 to 4.5)
    3.9 (3 to 4)
    2.5 (1.9 to 8)
    Notes
    [20] - EPP
    [21] - EPP
    [22] - EPP
    [23] - EPP
    [24] - EPP
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-40346527

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-40346527
    End point description
    The AUC (0-24) calculated by trapezoidal summation [time t is the time 24 hours after dose administration). Here 'n' signifies number of subjects who were analysed for this outcome measure. The value '99999' indicates that the data were not reported at specific time points.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 21
    End point values
    		 150 mg once daily (QD) 300 mg QD 450 mg QD 600 mg QD 150 mg twice daily (BID)
    Number of subjects analysed
    3 [25]
    5 [26]
    3 [27]
    3 [28]
    6 [29]
    Units: nanogram * hour per milliliter (ng*h/mL)
    arithmetic mean (standard deviation)
        Day 1 (n= 3, 5, 3, 3, 7)
    1931 ( 404 )
    3935 ( 2001 )
    2536 ( 4135 )
    2657 ( 1255 )
    99999 ( 99999 )
        Day 21 (n= 2, 3, 3, 3, 6)
    3417 ( 3436 )
    7588 ( 2248 )
    12804 ( 4875 )
    6961 ( 2656 )
    7471 ( 2349 )
    Notes
    [25] - EPP
    [26] - EPP
    [27] - EPP
    [28] - EPP
    [29] - EPP
    No statistical analyses for this end point

    Secondary: Total drug Clearance of JNJ-40346527 (CL/F)

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    End point title
    		 Total drug Clearance of JNJ-40346527 (CL/F)
    End point description
    The CL is a quantitative measure of the rate at which a drug substance is removed from the body. Here 'N' signifies number of subjects who were analysed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 21
    End point values
    		 150 mg once daily (QD) 300 mg QD 450 mg QD 600 mg QD 150 mg twice daily (BID)
    Number of subjects analysed
    2 [30]
    3 [31]
    3 [32]
    3 [33]
    6 [34]
    Units: Litre per hour
        arithmetic mean (standard deviation)
    43.7 ( 43.9 )
    42.4 ( 14.5 )
    39.4 ( 17 )
    97.7 ( 45.6 )
    49.3 ( 16.8 )
    Notes
    [30] - EPP
    [31] - EPP
    [32] - EPP
    [33] - EPP
    [34] - EPP
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 days after the last dose of study medication
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    300 mg QD
    Reporting group description
    		 Participants received JNJ-40346527, 300 mg capsules once daily.

    Reporting group title
    150 mg once daily (QD)
    Reporting group description
    		 Participants received JNJ-40346527, 150 milligram (mg) capsules once daily.

    Reporting group title
    600 mg QD
    Reporting group description
    		 Participants received JNJ-40346527, 600 mg capsules once daily.

    Reporting group title
    150 mg twice daily (BID)
    Reporting group description
    		 Participants received JNJ-40346527, 150 mg capsules twice daily.

    Reporting group title
    450 mg QD
    Reporting group description
    		 Participants received JNJ-40346527, 450 mg capsules once daily.

    Serious adverse events
    		 300 mg QD 150 mg once daily (QD) 600 mg QD 150 mg twice daily (BID) 450 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Acute Phase Reaction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Obstruction Gastric
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Disorder
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 300 mg QD 150 mg once daily (QD) 600 mg QD 150 mg twice daily (BID) 450 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 5 (80.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    6 / 7 (85.71%)
    2 / 3 (66.67%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Chills
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Oedema Peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    4 / 5 (80.00%)
    3 / 3 (100.00%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    1 / 3 (33.33%)
         occurrences all number
    5
    6
    1
    3
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Laryngeal Inflammation
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pleural Effusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 7 (42.86%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    3
    1
    Investigations
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
         occurrences all number
    0
    6
    0
    1
    1
    Eosinophil Count Increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Weight Decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Ankle Fracture
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Procedural Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
         occurrences all number
    3
    5
    1
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    1 / 3 (33.33%)
         occurrences all number
    1
    0
    1
    5
    2
    Lymph Node Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Eye disorders
    Eczema Eyelids
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    1
    3
    0
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    1
    2
    0
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    Dyspepsia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
         occurrences all number
    3
    1
    1
    3
    0
    Oral Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Tongue Ulceration
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    3
    1
    4
    2
    0
    Hepatobiliary disorders
    Hepatic Function Abnormal
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    2
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Night Sweats
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Back Pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Torticollis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Fungal Skin Infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Furuncle
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Herpes Virus Infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    1
    1
    1
    Oral Candidiasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oral Herpes
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Otitis Media
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Scrotal Infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Dehydration
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Enzyme Abnormality
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    1
    2
    Hyperamylasaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hyperlipasaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0

    More information

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

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

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