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    Clinical Trial Results:
    A Multicenter 26-Week Extension Study to Evaluate the Safety and Clinical Effects of Prolonged Exposure to 1 and 2 mg Doses of EVP-6124, an Alpha- 7 Nicotinic Acetylcholine Receptor Agonist, as an Adjunctive Pro-cognitive Treatment in Subjects with Schizophrenia on Chronic Stable Atypical Antipsychotic Therapy

    Summary
    EudraCT number
    		 2012-003228-19
    Trial protocol
    		 ES   DE   IT   GB   PL  
    Global end of trial date
    16 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2016
    First version publication date
    31 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EVP-6124-017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND Number: 076939
    Sponsors
    Sponsor organisation name
    Forum Pharmaceuticals, Inc.
    Sponsor organisation address
    500 Arsenal Street, Watertown, MA, United States, 02472
    Public contact
    Regulatory Project Manager, INC Research, +44 1276481000, SM_Regaffairs_eu_ap@incresearch.com
    Scientific contact
    Regulatory Project Manager, INC Research, +44 1276481000, SM_Regaffairs_eu_ap@incresearch.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
    12 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Oct 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the long-term safety of 1 and 2 mg doses of EVP-6124 tablets administered once daily for up to 52 weeks in subjects who received EVP-6124 in both the pivotal and extension studies and up to 26 weeks in subjects who were randomized from placebo to EVP-6124 upon entry into this extension study.
    Protection of trial subjects
    There were no specific measures as the only 'invasive' measures were blood sample analyses.
    Background therapy
    		 Patients were enrolled into the antecedent studies (015 and 016) that were stably treated with atypical anti-psychotic agents. These are the standard treatment of choice for this patient population. Only the anti-psychotic clozapine was excluded. This was for two reasons: clozapine treated patients are uniquely ‘sicker’ as it remains a second or third line treatment choice and clozapine has safety concerns which require special monitoring procedures that would more difficult to incorporate into the studies.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jun 2013
    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
    Poland: 23
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Argentina: 37
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Canada: 26
    Country: Number of subjects enrolled
    Colombia: 29
    Country: Number of subjects enrolled
    Mexico: 25
    Country: Number of subjects enrolled
    Romania: 30
    Country: Number of subjects enrolled
    Russian Federation: 60
    Country: Number of subjects enrolled
    Serbia: 7
    Country: Number of subjects enrolled
    Singapore: 2
    Country: Number of subjects enrolled
    Ukraine: 127
    Country: Number of subjects enrolled
    United States: 403
    Worldwide total number of subjects
    827
    EEA total number of subjects
    109
    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)
    827
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who completed double-blind treatment (ie, completion of the Day 182 Visit) in Studies EVP-6124-015 or EVP-6124-016 and who fulfilled all inclusion/exclusion criteria for this extension study were eligible for enrollment.

    Pre-assignment period milestones
    Number of subjects started
    		 827
    Number of subjects completed
    		 827

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EVP-6124, 1 mg
    Arm description
    		 Subjects who received EVP-6124 during the previous study (EVP-6124-015 or EVP-6124-016) will remain on the same dose. Subjects who received placebo during the pivotal study (EVP-6124-015 or EVP-6124-016) will be randomized (1:1 ratio) to once daily EVP-6124 1 or 2 mg tablets for up to 26 weeks (Days 1-182).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Encenicline
    Investigational medicinal product code
    EVP-6124
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Throughout the study (Days 1-182), all subjects will be instructed to take 1 tablet of study medication once daily, preferably at the same time (between 8 to 10 AM if feasible) every morning, with an adequate amount of water with or without food (after morning meal is preferred).

    Arm title
    		 EVP-6124, 2 mg
    Arm description
    		 Subjects who received EVP-6124 during the previous study (EVP-6124-015 or EVP-6124-016) will remain on the same dose. Subjects who received placebo during the pivotal study (EVP-6124-015 or EVP-6124-016) will be randomized (1:1 ratio) to once daily EVP-6124 1 or 2 mg tablets for up to 26 weeks (Days 1-182).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Encenicline
    Investigational medicinal product code
    EVP-6124
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Throughout the study (Days 1-182), all subjects will be instructed to take 1 tablet of study medication once daily, preferably at the same time (between 8 to 10 AM if feasible) every morning, with an adequate amount of water with or without food (after morning meal is preferred).

    Number of subjects in period 1
    		EVP-6124, 1 mg EVP-6124, 2 mg
    Started
    428
    399
    Completed
    248
    223
    Not completed
    180
    176
         Physician decision
    1
    1
         Consent withdrawn by subject
    14
    12
         Adverse event, non-fatal
    13
    17
         Medication Prohibited by Protocol
    2
    1
         Subject Incarceration
    2
    1
         Substance Abuse
    -
    1
         Sponsor Decision
    136
    129
         Lost to follow-up
    9
    10
         Protocol deviation
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EVP-6124, 1 mg
    Reporting group description
    		 Subjects who received EVP-6124 during the previous study (EVP-6124-015 or EVP-6124-016) will remain on the same dose. Subjects who received placebo during the pivotal study (EVP-6124-015 or EVP-6124-016) will be randomized (1:1 ratio) to once daily EVP-6124 1 or 2 mg tablets for up to 26 weeks (Days 1-182).

    Reporting group title
    EVP-6124, 2 mg
    Reporting group description
    		 Subjects who received EVP-6124 during the previous study (EVP-6124-015 or EVP-6124-016) will remain on the same dose. Subjects who received placebo during the pivotal study (EVP-6124-015 or EVP-6124-016) will be randomized (1:1 ratio) to once daily EVP-6124 1 or 2 mg tablets for up to 26 weeks (Days 1-182).

    Reporting group values
    		 EVP-6124, 1 mg EVP-6124, 2 mg Total
    Number of subjects
    		 428 399 827
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 428 399 827
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 37.4 (18 to 51) 37 (18 to 51) -
    Gender categorical
    Units: Subjects
        Female
    		 151 138 289
        Male
    		 277 261 538

    End points

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    End points reporting groups
    Reporting group title
    EVP-6124, 1 mg
    Reporting group description
    		 Subjects who received EVP-6124 during the previous study (EVP-6124-015 or EVP-6124-016) will remain on the same dose. Subjects who received placebo during the pivotal study (EVP-6124-015 or EVP-6124-016) will be randomized (1:1 ratio) to once daily EVP-6124 1 or 2 mg tablets for up to 26 weeks (Days 1-182).

    Reporting group title
    EVP-6124, 2 mg
    Reporting group description
    		 Subjects who received EVP-6124 during the previous study (EVP-6124-015 or EVP-6124-016) will remain on the same dose. Subjects who received placebo during the pivotal study (EVP-6124-015 or EVP-6124-016) will be randomized (1:1 ratio) to once daily EVP-6124 1 or 2 mg tablets for up to 26 weeks (Days 1-182).

    Primary: Treatment emergent adverse events (TEAEs)

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    End point title
    		 Treatment emergent adverse events (TEAEs) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Throughout the study
    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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: Subjects with any TEAEs
    164
    149
    No statistical analyses for this end point

    Primary: Columbia-Suicide Severity Rating Scale (C-SSRS) (Day 182)

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    End point title
    		 Columbia-Suicide Severity Rating Scale (C-SSRS) (Day 182) [2]
    End point description
    End point type
    Primary
    End point timeframe
    On Days 14, 28, 56, 84, 112, 140, and 182, or ET.
    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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: Subjects who had any suicidal ideation
    4
    1
    No statistical analyses for this end point

    Primary: Calgary Depression Scale for Schizophrenia (CDSS) (change from baseline)

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    End point title
    		 Calgary Depression Scale for Schizophrenia (CDSS) (change from baseline) [3]
    End point description
    End point type
    Primary
    End point timeframe
    The CDSS will be completed at Day 182 or ET. The CDSS was performed at the final study visit (Day 182) for the previous study (EVP-6124-015 or EVP-6124-016), and this value will serve as the baseline assessment.
    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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: n/a
        arithmetic mean (full range (min-max))
    -0.1 (-12 to 10)
    0 (-9 to 9)
    No statistical analyses for this end point

    Primary: Simpson-Angus Scale (SAS) (change from baseline)

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    End point title
    		 Simpson-Angus Scale (SAS) (change from baseline) [4]
    End point description
    End point type
    Primary
    End point timeframe
    On Days 56, 112, and 182, or ET.
    Notes
    [4] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: n/a
        arithmetic mean (full range (min-max))
    0 (-4 to 4)
    0 (-4 to 3)
    No statistical analyses for this end point

    Primary: Heart rate (change from baseline)

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    End point title
    		 Heart rate (change from baseline) [5]
    End point description
    End point type
    Primary
    End point timeframe
    On Days 28, 56, 112, and 182, or ET.
    Notes
    [5] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: beats/min
        arithmetic mean (full range (min-max))
    2.1 (-42 to 43)
    0.4 (-39 to 37)
    No statistical analyses for this end point

    Primary: QT duration (change from baseline)

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    End point title
    		 QT duration (change from baseline) [6]
    End point description
    End point type
    Primary
    End point timeframe
    On Days 28, 56, 112, and 182, or ET.
    Notes
    [6] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: msec
        arithmetic mean (full range (min-max))
    -3.5 (-87 to 83)
    -1.2 (-82 to 88)
    No statistical analyses for this end point

    Primary: QTcF - Fridericia's Correction (change from baseline)

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    End point title
    		 QTcF - Fridericia's Correction (change from baseline) [7]
    End point description
    End point type
    Primary
    End point timeframe
    On Days 28, 56, 112, and 182, or ET.
    Notes
    [7] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: msec
        arithmetic mean (full range (min-max))
    0 (-49 to 50)
    -0.8 (-43 to 61)
    No statistical analyses for this end point

    Primary: QRS Duration (change from baseline)

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    End point title
    		 QRS Duration (change from baseline) [8]
    End point description
    End point type
    Primary
    End point timeframe
    On Days 28, 56, 112, and 182, or ET.
    Notes
    [8] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: msec
        arithmetic mean (full range (min-max))
    0.1 (-23 to 22)
    0.2 (-21 to 19)
    No statistical analyses for this end point

    Primary: PR Duration (change from baseline)

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    End point title
    		 PR Duration (change from baseline) [9]
    End point description
    End point type
    Primary
    End point timeframe
    On Days 28, 56, 112, and 182, or ET.
    Notes
    [9] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: msec
        arithmetic mean (full range (min-max))
    -2 (-65 to 73)
    0.5 (-26 to 51)
    No statistical analyses for this end point

    Primary: RR duration (change from baseline)

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    End point title
    		 RR duration (change from baseline) [10]
    End point description
    End point type
    Primary
    End point timeframe
    On Days 28, 56, 112, and 182, or ET.
    Notes
    [10] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: msec
        arithmetic mean (full range (min-max))
    -22.7 (-472 to 468)
    -2 (-567 to 346)
    No statistical analyses for this end point

    Primary: Basophils (change from baseline)

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    End point title
    		 Basophils (change from baseline) [11]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [11] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0.001 (-0.09 to 0.1)
    0 (-0.05 to 0.08)
    No statistical analyses for this end point

    Primary: Eosinophils (change from baseline)

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    End point title
    		 Eosinophils (change from baseline) [12]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [12] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    -0.005 (-0.44 to 0.4)
    -0.008 (-0.63 to 0.56)
    No statistical analyses for this end point

    Primary: Erythrocytes (change from baseline)

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    End point title
    		 Erythrocytes (change from baseline) [13]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [13] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: 10^12/L
        arithmetic mean (full range (min-max))
    -0.009 (-1.03 to 1.79)
    0.018 (-1.02 to 2.46)
    No statistical analyses for this end point

    Primary: Hematocrit (change from baseline)

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    End point title
    		 Hematocrit (change from baseline) [14]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [14] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: percent
        arithmetic mean (full range (min-max))
    0.23 (-7.8 to 15.4)
    0.23 (-10.5 to 12.4)
    No statistical analyses for this end point

    Primary: Hemoglobin (change from baseline)

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    End point title
    		 Hemoglobin (change from baseline) [15]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [15] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: g/dL
        arithmetic mean (full range (min-max))
    0.01 (-3 to 5.2)
    0 (-4.1 to 3.2)
    No statistical analyses for this end point

    Primary: Leukocytes (change from baseline)

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    End point title
    		 Leukocytes (change from baseline) [16]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [16] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0.023 (-5.66 to 6.84)
    -0.094 (-5.3 to 5.75)
    No statistical analyses for this end point

    Primary: Lymphocytes (change from baseline)

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    End point title
    		 Lymphocytes (change from baseline) [17]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [17] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0.027 (-1.5 to 2.1)
    0.004 (-1.34 to 2.16)
    No statistical analyses for this end point

    Primary: Monocytes (change from baseline)

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    End point title
    		 Monocytes (change from baseline) [18]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [18] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    -0.021 (-0.78 to 0.66)
    -0.018 (-0.6 to 0.41)
    No statistical analyses for this end point

    Primary: Neutrophils (change from baseline)

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    End point title
    		 Neutrophils (change from baseline) [19]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [19] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0.01 (-6.6 to 6.64)
    -0.112 (-4.75 to 4.42)
    No statistical analyses for this end point

    Primary: Platelets (change from baseline)

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    End point title
    		 Platelets (change from baseline) [20]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [20] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: 10^9/L
        arithmetic mean (full range (min-max))
    0.6 (-126 to 225)
    0.2 (-145 to 162)
    No statistical analyses for this end point

    Primary: Alanine Aminotransferase (change from baseline)

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    End point title
    		 Alanine Aminotransferase (change from baseline) [21]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [21] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: IU/L
        arithmetic mean (full range (min-max))
    -0.4 (-67 to 112)
    1.2 (-87 to 234)
    No statistical analyses for this end point

    Primary: Albumin (change from baseline)

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    End point title
    		 Albumin (change from baseline) [22]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [22] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: g/dL
        arithmetic mean (full range (min-max))
    -0.03 (-0.9 to 1.1)
    -0.05 (-0.9 to 0.7)
    No statistical analyses for this end point

    Primary: Alkaline Phosphatase (change from baseline)

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    End point title
    		 Alkaline Phosphatase (change from baseline) [23]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [23] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: IU/L
        arithmetic mean (full range (min-max))
    -1 (-51 to 85)
    0.5 (-91 to 57)
    No statistical analyses for this end point

    Primary: Aspartate Aminotransferase (change from baseline)

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    End point title
    		 Aspartate Aminotransferase (change from baseline) [24]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [24] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: IU/L
        arithmetic mean (full range (min-max))
    0.5 (-56 to 217)
    1 (-74 to 111)
    No statistical analyses for this end point

    Primary: Bicarbonate (change from baseline)

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    End point title
    		 Bicarbonate (change from baseline) [25]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [25] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mEq/L
        arithmetic mean (full range (min-max))
    -0.5 (-9 to 8)
    -0.5 (-7 to 6)
    No statistical analyses for this end point

    Primary: Bilirubin (change from baseline)

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    End point title
    		 Bilirubin (change from baseline) [26]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [26] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0.02 (-0.5 to 2.3)
    -0.01 (-1.1 to 1.1)
    No statistical analyses for this end point

    Primary: Blood Urea Nitrogen (change from baseline)

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    End point title
    		 Blood Urea Nitrogen (change from baseline) [27]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [27] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0 (-8 to 25)
    -0.4 (-16 to 9)
    No statistical analyses for this end point

    Primary: Calcium (change from baseline)

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    End point title
    		 Calcium (change from baseline) [28]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [28] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mg/dL
        arithmetic mean (full range (min-max))
    -0.01 (-1.2 to 1.7)
    0.01 (-1.2 to 1.4)
    No statistical analyses for this end point

    Primary: Chloride (change from baseline)

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    End point title
    		 Chloride (change from baseline) [29]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [29] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mEq/L
        arithmetic mean (full range (min-max))
    -0.2 (-17 to 8)
    -0.1 (-10 to 6)
    No statistical analyses for this end point

    Primary: Creatine Kinase (change from baseline)

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    End point title
    		 Creatine Kinase (change from baseline) [30]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [30] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: IU/L
        arithmetic mean (full range (min-max))
    29.9 (-953 to 4605)
    8.9 (-1359 to 4853)
    No statistical analyses for this end point

    Primary: Creatinine (change from baseline)

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    End point title
    		 Creatinine (change from baseline) [31]
    End point description
    End point type
    Primary
    End point timeframe
    Visits 1, 2, 3, 5 and 7
    Notes
    [31] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0.016 (-0.46 to 1.51)
    0.003 (-0.47 to 0.39)
    No statistical analyses for this end point

    Primary: Gamma Glutamyl Transferase (change from baseline)

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    End point title
    		 Gamma Glutamyl Transferase (change from baseline) [32]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [32] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: IU/L
        arithmetic mean (full range (min-max))
    0.1 (-109 to 167)
    1.1 (-229 to 78)
    No statistical analyses for this end point

    Primary: Glomerular Filtration Rate (change from baseline)

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    End point title
    		 Glomerular Filtration Rate (change from baseline) [33]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [33] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mL/min/1.73m2
        arithmetic mean (full range (min-max))
    -0.2 (-32 to 5)
    0 (-5 to 5)
    No statistical analyses for this end point

    Primary: Glucose (change from baseline)

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    End point title
    		 Glucose (change from baseline) [34]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [34] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mg/dL
        arithmetic mean (full range (min-max))
    -1.3 (-215 to 175)
    3.3 (-142 to 208)
    No statistical analyses for this end point

    Primary: Magnesium (change from baseline)

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    End point title
    		 Magnesium (change from baseline) [35]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [35] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0 (-0.5 to 1)
    -0.01 (-0.5 to 0.4)
    No statistical analyses for this end point

    Primary: Phosphate (change from baseline)

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    End point title
    		 Phosphate (change from baseline) [36]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [36] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mg/dL
        arithmetic mean (full range (min-max))
    -0.02 (-2 to 5.8)
    -0.03 (-1.9 to 2.2)
    No statistical analyses for this end point

    Primary: Potassium (change from baseline)

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    End point title
    		 Potassium (change from baseline) [37]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [37] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mEq/L
        arithmetic mean (full range (min-max))
    0.02 (-1.6 to 1.7)
    0.08 (-1.1 to 1.2)
    No statistical analyses for this end point

    Primary: Prolactin (change from baseline)

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    End point title
    		 Prolactin (change from baseline) [38]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [38] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: ug/L
        arithmetic mean (full range (min-max))
    1.88 (-149.1 to 175)
    -2.25 (-88.9 to 74.8)
    No statistical analyses for this end point

    Primary: Protein (change from baseline)

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    End point title
    		 Protein (change from baseline) [39]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [39] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: g/dL
        arithmetic mean (full range (min-max))
    -0.05 (-2.1 to 1.2)
    -0.04 (-1.7 to 1.1)
    No statistical analyses for this end point

    Primary: Sodium (change from baseline)

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    End point title
    		 Sodium (change from baseline) [40]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [40] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mEq/L
        arithmetic mean (full range (min-max))
    0.5 (-7 to 11)
    0.6 (-7 to 10)
    No statistical analyses for this end point

    Primary: Urate (change from baseline)

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    End point title
    		 Urate (change from baseline) [41]
    End point description
    End point type
    Primary
    End point timeframe
    These non-fasting laboratory tests will be performed on Days 28, 56, 112, and 182, or ET.
    Notes
    [41] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mg/dL
        arithmetic mean (full range (min-max))
    0.05 (-4.8 to 4.9)
    -0.04 (-4.8 to 3)
    No statistical analyses for this end point

    Primary: Systolic Blood Pressure (change from baseline)

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    End point title
    		 Systolic Blood Pressure (change from baseline) [42]
    End point description
    End point type
    Primary
    End point timeframe
    At all study visits (except Day 14 telephone call).
    Notes
    [42] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mmHg
        arithmetic mean (full range (min-max))
    0.4 (-40 to 41)
    0.2 (-31 to 32)
    No statistical analyses for this end point

    Primary: Diastolic Blood Pressure (change from baseline)

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    End point title
    		 Diastolic Blood Pressure (change from baseline) [43]
    End point description
    End point type
    Primary
    End point timeframe
    At all study visits (except Day 14 telephone call).
    Notes
    [43] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: mmHg
        arithmetic mean (full range (min-max))
    0.1 (-32 to 42)
    0.7 (-30 to 33)
    No statistical analyses for this end point

    Primary: Pulse Rate (change from baseline)

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    End point title
    		 Pulse Rate (change from baseline) [44]
    End point description
    End point type
    Primary
    End point timeframe
    At all study visits (except Day 14 telephone call).
    Notes
    [44] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: beats/min
        arithmetic mean (full range (min-max))
    2.3 (-33 to 46)
    0.9 (-29 to 27)
    No statistical analyses for this end point

    Primary: Respiratory Rate (change from baseline)

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    End point title
    		 Respiratory Rate (change from baseline) [45]
    End point description
    End point type
    Primary
    End point timeframe
    At all study visits (except Day 14 telephone call).
    Notes
    [45] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: breaths/min
        arithmetic mean (full range (min-max))
    0.2 (-4 to 12)
    -0.2 (-6 to 8)
    No statistical analyses for this end point

    Primary: Temperature (change from baseline)

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    End point title
    		 Temperature (change from baseline) [46]
    End point description
    End point type
    Primary
    End point timeframe
    At all study visits (except Day 14 telephone call).
    Notes
    [46] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: celsius temperature
        arithmetic mean (full range (min-max))
    0.02 (-1.3 to 1)
    0.02 (-1.4 to 1.6)
    No statistical analyses for this end point

    Primary: Weight (change from baseline)

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    End point title
    		 Weight (change from baseline) [47]
    End point description
    End point type
    Primary
    End point timeframe
    At all study visits (except Day 14 telephone call).
    Notes
    [47] - 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: This was a safety extension study, so there were no pre-defined statistical analysis.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    428
    399
    Units: kilogram(s)
        arithmetic mean (full range (min-max))
    -0.45 (-19.9 to 13.5)
    -0.04 (-19.1 to 11.3)
    No statistical analyses for this end point

    Secondary: CGI-S severity scores (change from baseline)

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    End point title
    		 CGI-S severity scores (change from baseline)
    End point description
    End point type
    Secondary
    End point timeframe
    On Days 56, 112, and 182, or ET.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    421
    388
    Units: n/a
        arithmetic mean (full range (min-max))
    -0.1 (-2 to 2)
    -0.1 (-2 to 3)
    No statistical analyses for this end point

    Secondary: CGI-C change scores (Day 182)

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    End point title
    		 CGI-C change scores (Day 182)
    End point description
    End point type
    Secondary
    End point timeframe
    On Days 56, 112, and 182, or ET.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    421
    388
    Units: n/a
        arithmetic mean (full range (min-max))
    3.1 (1 to 6)
    3.1 (1 to 7)
    No statistical analyses for this end point

    Other pre-specified: Concentration of EVP-6124 (Day 182)

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    End point title
    		 Concentration of EVP-6124 (Day 182)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    On Days 28, 56, 112, and 182, or ET.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    427
    394
    Units: ng/ml
        arithmetic mean (full range (min-max))
    1.59224 (0 to 5.06)
    3.13547 (0 to 9.45)
    No statistical analyses for this end point

    Other pre-specified: Concentration of EVP-6124 N-Oxide Metabolite (Day 182)

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    End point title
    		 Concentration of EVP-6124 N-Oxide Metabolite (Day 182)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    On Days 28, 56, 112, and 182, or ET.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    427
    394
    Units: ng/ml
        arithmetic mean (full range (min-max))
    0.17276 (0 to 0.778)
    0.30632 (0 to 1.05)
    No statistical analyses for this end point

    Other pre-specified: Concentration of EVP-6124 Acid Metabolite (Day 182)

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    End point title
    		 Concentration of EVP-6124 Acid Metabolite (Day 182)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    On Days 28, 56, 112, and 182, or ET.
    End point values
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Number of subjects analysed
    427
    394
    Units: ng/ml
        arithmetic mean (full range (min-max))
    0.22055 (0 to 0.678)
    0.44114 (0 to 2.24)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    EVP-6124, 1 mg
    Reporting group description
    		 Subjects who received EVP-6124 during the previous study (EVP-6124-015 or EVP-6124-016) will remain on the same dose. Subjects who received placebo during the pivotal study (EVP-6124-015 or EVP-6124-016) will be randomized (1:1 ratio) to once daily EVP-6124 1 or 2 mg tablets for up to 26 weeks (Days 1-182).

    Reporting group title
    EVP-6124, 2 mg
    Reporting group description
    		 Subjects who received EVP-6124 during the previous study (EVP-6124-015 or EVP-6124-016) will remain on the same dose. Subjects who received placebo during the pivotal study (EVP-6124-015 or EVP-6124-016) will be randomized (1:1 ratio) to once daily EVP-6124 1 or 2 mg tablets for up to 26 weeks (Days 1-182).

    Serious adverse events
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 428 (2.80%)
    20 / 399 (5.01%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Burns third degree
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Homicide
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychiatric decompensation
         subjects affected / exposed
    7 / 428 (1.64%)
    7 / 399 (1.75%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranoia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 EVP-6124, 1 mg EVP-6124, 2 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    164 / 428 (38.32%)
    149 / 399 (37.34%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 428 (0.47%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Hyperaemia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 428 (0.47%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Fatigue
         subjects affected / exposed
    2 / 428 (0.47%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Chest pain
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Drug withdrawal syndrome
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Feeling jittery
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Hernia
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Inflammation
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Injection site swelling
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Malaise
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Oedema peripheral
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Pain
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Peripheral swelling
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Seasonal allergy
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Social circumstances
    Homicide
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 428 (0.47%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Amenorrhoea
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Erectile dysfunction
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Menstrual disorder
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 428 (0.93%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Rhinorrhoea
         subjects affected / exposed
    1 / 428 (0.23%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Nasal congestion
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Oropharyngeal pain
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Allergic pharyngitis
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Asthma
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Dyspnoea
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Epistaxis
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Nasal polyps
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Nocturnal dyspnoea
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Oropharyngeal discomfort
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Productive cough
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Respiratory disorder
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Respiratory distress
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Rhinitis allergic
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Sneezing
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    14 / 428 (3.27%)
    8 / 399 (2.01%)
         occurrences all number
    164
    149
    Psychiatric decompensation
         subjects affected / exposed
    8 / 428 (1.87%)
    14 / 399 (3.51%)
         occurrences all number
    164
    149
    Anxiety
         subjects affected / exposed
    10 / 428 (2.34%)
    5 / 399 (1.25%)
         occurrences all number
    164
    149
    Depression
         subjects affected / exposed
    5 / 428 (1.17%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Psychotic disorder
         subjects affected / exposed
    3 / 428 (0.70%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Suicidal ideation
         subjects affected / exposed
    3 / 428 (0.70%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Irritability
         subjects affected / exposed
    2 / 428 (0.47%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Panic attack
         subjects affected / exposed
    3 / 428 (0.70%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Initial insomnia
         subjects affected / exposed
    2 / 428 (0.47%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Agitation
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Delusion
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Depressed mood
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Restlessness
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Abnormal dreams
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Affect lability
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Aggression
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Bruxism
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Hallucination
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Hallucination, auditory
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Hallucination, visual
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Homicidal ideation
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Middle insomnia
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Paranoia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Sleep disorder
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Sleep terror
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Stress
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Substance abuse
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Suicidal behaviour
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Tension
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Investigations
    Weight increased
         subjects affected / exposed
    10 / 428 (2.34%)
    7 / 399 (1.75%)
         occurrences all number
    164
    149
    Weight decreased
         subjects affected / exposed
    4 / 428 (0.93%)
    6 / 399 (1.50%)
         occurrences all number
    164
    149
    Blood creatine phosphokinase increased
         subjects affected / exposed
    5 / 428 (1.17%)
    4 / 399 (1.00%)
         occurrences all number
    164
    149
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 428 (0.93%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Blood glucose increased
         subjects affected / exposed
    1 / 428 (0.23%)
    4 / 399 (1.00%)
         occurrences all number
    164
    149
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 428 (0.47%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Urine leukocyte esterase positive
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    White blood cell count increased
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Blood bilirubin increased
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Blood creatinine increased
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Blood potassium decreased
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Blood pressure increased
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Electrocardiogram ST segment depression
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Neutrophil count increased
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    White blood cells urine positive
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 428 (0.47%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Laceration
         subjects affected / exposed
    1 / 428 (0.23%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Sunburn
         subjects affected / exposed
    3 / 428 (0.70%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Fall
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Multiple injuries
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Road traffic accident
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Skin abrasion
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Wound
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Arthropod bite
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Burns first degree
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Burns third degree
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Excoriation
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Intentional overdose
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Joint dislocation
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Ligament injury
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Ligament sprain
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Meniscus injury
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Nail injury
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Spinal fracture
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Toxicity to various agents
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Upper limb fracture
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Periorbital contusion
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Tachycardia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 428 (5.61%)
    12 / 399 (3.01%)
         occurrences all number
    164
    149
    Dizziness
         subjects affected / exposed
    6 / 428 (1.40%)
    4 / 399 (1.00%)
         occurrences all number
    164
    149
    Tremor
         subjects affected / exposed
    2 / 428 (0.47%)
    4 / 399 (1.00%)
         occurrences all number
    164
    149
    Somnolence
         subjects affected / exposed
    3 / 428 (0.70%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Paraesthesia
         subjects affected / exposed
    2 / 428 (0.47%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Akathisia
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Memory impairment
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Mental impairment
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Bradykinesia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Disturbance in attention
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Hypersomnia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Hypoaesthesia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Intercostal neuralgia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Lethargy
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Restless legs syndrome
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Tension headache
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Leukopenia
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Vertigo
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 428 (0.23%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Dry eye
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Iritis
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Oculogyric crisis
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Scleral hyperaemia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Vitreous floaters
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    11 / 428 (2.57%)
    14 / 399 (3.51%)
         occurrences all number
    164
    149
    Diarrhoea
         subjects affected / exposed
    6 / 428 (1.40%)
    9 / 399 (2.26%)
         occurrences all number
    164
    149
    Nausea
         subjects affected / exposed
    8 / 428 (1.87%)
    3 / 399 (0.75%)
         occurrences all number
    164
    149
    Toothache
         subjects affected / exposed
    4 / 428 (0.93%)
    4 / 399 (1.00%)
         occurrences all number
    164
    149
    Abdominal pain upper
         subjects affected / exposed
    5 / 428 (1.17%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Dyspepsia
         subjects affected / exposed
    2 / 428 (0.47%)
    4 / 399 (1.00%)
         occurrences all number
    164
    149
    Abdominal pain
         subjects affected / exposed
    1 / 428 (0.23%)
    3 / 399 (0.75%)
         occurrences all number
    164
    149
    Vomiting
         subjects affected / exposed
    3 / 428 (0.70%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Dry mouth
         subjects affected / exposed
    2 / 428 (0.47%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Food poisoning
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Abdominal hernia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Dental caries
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Dysphagia
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Faeces hard
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Faeces soft
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Haemorrhoids
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Large intestine polyp
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Lip blister
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Lip pain
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Salivary hypersecretion
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Tooth impacted
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Volvulus
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Alopecia
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Eczema
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Hyperhidrosis
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Rash
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Rash papular
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Skin exfoliation
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Swelling face
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Urticaria
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Renal and urinary disorders
    Hypertonic bladder
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Pollakiuria
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Bladder disorder
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Enuresis
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Haematuria
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Urine flow decreased
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Endocrine disorders
    Hyperprolactinaemia
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Goitre
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Hypothyroidism
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 428 (0.47%)
    6 / 399 (1.50%)
         occurrences all number
    164
    149
    Arthralgia
         subjects affected / exposed
    2 / 428 (0.47%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Muscle spasms
         subjects affected / exposed
    2 / 428 (0.47%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Pain in extremity
         subjects affected / exposed
    1 / 428 (0.23%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Arthritis
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Myalgia
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Coccydynia
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Muscle rigidity
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Musculoskeletal pain
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Periarthritis
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 428 (3.04%)
    20 / 399 (5.01%)
         occurrences all number
    164
    149
    Influenza
         subjects affected / exposed
    3 / 428 (0.70%)
    7 / 399 (1.75%)
         occurrences all number
    164
    149
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 428 (1.87%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Urinary tract infection
         subjects affected / exposed
    7 / 428 (1.64%)
    3 / 399 (0.75%)
         occurrences all number
    164
    149
    Bronchitis
         subjects affected / exposed
    4 / 428 (0.93%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Ear infection
         subjects affected / exposed
    2 / 428 (0.47%)
    3 / 399 (0.75%)
         occurrences all number
    164
    149
    Pharyngitis
         subjects affected / exposed
    2 / 428 (0.47%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Gastroenteritis
         subjects affected / exposed
    1 / 428 (0.23%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Abscess limb
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Cellulitis
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Gastroenteritis viral
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Pneumonia
         subjects affected / exposed
    2 / 428 (0.47%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Respiratory tract infection
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Sinusitis
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Appendicitis
         subjects affected / exposed
    0 / 428 (0.00%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Conjunctivitis
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Diverticulitis
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Folliculitis
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Furuncle
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Gingivitis
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Helicobacter gastritis
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Hordeolum
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Infected bites
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Laryngitis
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Otitis externa
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Otitis media
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Skin candida
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Subcutaneous abscess
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Tonsillitis
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Tooth abscess
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Tooth infection
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Varicella
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    2 / 428 (0.47%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Increased appetite
         subjects affected / exposed
    1 / 428 (0.23%)
    2 / 399 (0.50%)
         occurrences all number
    164
    149
    Vitamin D deficiency
         subjects affected / exposed
    1 / 428 (0.23%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149
    Decreased appetite
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Food craving
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Gout
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Hyperlipidaemia
         subjects affected / exposed
    1 / 428 (0.23%)
    0 / 399 (0.00%)
         occurrences all number
    164
    149
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 428 (0.00%)
    1 / 399 (0.25%)
         occurrences all number
    164
    149

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2013
    Protocol Amendment 1 (08 March 2013)
    02 Aug 2013
    Protocol Amendment 2 (02 August 2013)
    26 Aug 2014
    Protocol Amendment 2.1 (26 August 2014)

    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.

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