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    Clinical Trial Results:
    A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects with Schizophrenia

    Summary
    EudraCT number
    		 2016-001556-21
    Trial protocol
    		 HU  
    Global end of trial date
    29 Jan 2019

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SEP361-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02970929
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sunovion Pharmaceuticals Inc.
    Sponsor organisation address
    84 Waterford Drive, Marlboro, United States, 01752
    Public contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., +1 866-503-6351, clinicaltrialdisclosure@sunovion.com
    Scientific contact
    CNS Medical Director, Sunovion Pharmaceuticals Inc., +1 866-503-6351, clinicaltrialdisclosure@sunovion.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
    29 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the long-term safety and tolerability of flexibly dosed SEP-363856 (25, 50, or 75 mg/day [ie, once daily]) in adult subjects with schizophrenia who have completed Study SEP361-201 by the incidence of overall adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
    Protection of trial subjects
    This study was conducted according to the protocol, ICH Good Clinical Practice (GCP), ICH guidelines and the ethical principles that have their origin in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 2017
    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
    Hungary: 8
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    Russian Federation: 68
    Country: Number of subjects enrolled
    Ukraine: 54
    Country: Number of subjects enrolled
    United States: 20
    Worldwide total number of subjects
    156
    EEA total number of subjects
    14
    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)
    156
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 157 subjects rolled over from SEP361-201 to the current study. One subject was not dosed and thus excluded from the analysis population. The data on the 156 dosed subjects are presented in the form.

    Pre-assignment
    Screening details
    		 Subjects must have completed the 4 week double-blind treatment phase of Study SEP361-201 to enter this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This study was open-label. No blinding was implemented.

    Arms
    Arm title
    		 SEP-363856
    Arm description
    		 SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    SEP-363856
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily

    Number of subjects in period 1
    		SEP-363856
    Started
    156
    Completed
    105
    Not completed
    51
         Consent withdrawn by subject
    16
         Adverse event, non-fatal
    18
         Other
    8
         non-compliance with study drug
    1
         Lack of efficacy
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SEP-363856
    Reporting group description
    		 SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily

    Reporting group values
    		 SEP-363856 Total
    Number of subjects
    		 156 156
    Age Categorical
    Units: Participants
        <=18 years
    		 2 2
        Between 18 and 65 years
    		 154 154
        >=65 years
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.2 ± 6.03 -
    Gender, Male/Female
    Units: Participants
        Female
    		 54 54
        Male
    		 102 102
    Age, Customized
    Units: Subjects
        >=18 - <25 years
    		 38 38
        >=25 - <=40 years
    		 118 118
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 4 4
        Asian
    		 0 0
        Black or African American
    		 15 15
        More than one race
    		 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Unknown or Not Reported
    		 0 0
        White
    		 136 136
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 5
        Not Hispanic or Latino
    		 151 151
        Unknown or Not Reported
    		 0 0
    Country
    Units: Subjects
        Hungary
    		 8 8
        Romania
    		 6 6
        Russia
    		 68 68
        Ukraine
    		 54 54
        United States
    		 20 20
    Region of Enrollment
    Units: Subjects
        Non-US
    		 136 136
        United States
    		 20 20
    DB Baseline BMI Group
    Units: Subjects
        <18.5 kg/m^2
    		 2 2
        >=18.5 - <25.0 kg/m^2
    		 80 80
        >=25.0 - <30.0 kg/m^2
    		 55 55
        >=30.0 kg/m^2
    		 19 19
    OL Baseline BMI Group
    Units: Subjects
        <18.5 kg/m^2
    		 3 3
        >=18.5 - <25.0 kg/m^2
    		 82 82
        >=25.0 - <30.0 kg/m^2
    		 53 53
        >=30.0 kg/m^2
    		 18 18
    DB Baseline Height (cm)
    Units: cm
        arithmetic mean (standard deviation)
    		 173.1 ± 7.73 -
    DB Baseline Weight (kg)
    Units: kg
        arithmetic mean (standard deviation)
    		 75.38 ± 13.873 -
    DB Baseline Body Mass Index (kg/m^2)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 25.07 ± 3.863 -
    DB Baseline Waist Circumference (cm)
    Units: cm
        arithmetic mean (standard deviation)
    		 85.36 ± 13.508 -
    OL Baseline Height (cm)
    Units: cm
        arithmetic mean (standard deviation)
    		 173.1 ± 7.73 -
    OL Baseline Weight (kg)
    Units: kg
        arithmetic mean (standard deviation)
    		 75.32 ± 13.987 -
    OL Baseline Body Mass Index (kg/m^2)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 25.05 ± 3.890 -
    OL Baseline Waist Circumference (cm)
    Units: cm
        arithmetic mean (standard deviation)
    		 85.20 ± 13.467 -
    Subject analysis sets

    Subject analysis set title
    PBO-SEP
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who received Placebo in study SEP361-201 and SEP-363856 in study SEP361-202

    Subject analysis set title
    SEP-SEP
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202

    Subject analysis sets values
    		 PBO-SEP SEP-SEP
    Number of subjects
    79
    77
    Age Categorical
    Units: Participants
        <=18 years
    2
    0
        Between 18 and 65 years
    77
    77
        >=65 years
    0
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    30.2 ± 6.37
    30.2 ± 5.70
    Gender, Male/Female
    Units: Participants
        Female
    29
    25
        Male
    50
    52
    Age, Customized
    Units: Subjects
        >=18 - <25 years
    21
    17
        >=25 - <=40 years
    58
    60
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    1
    3
        Asian
    0
    0
        Black or African American
    5
    10
        More than one race
    0
    1
        Native Hawaiian or Other Pacific Islander
    0
    0
        Unknown or Not Reported
    0
    0
        White
    73
    63
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    4
    1
        Not Hispanic or Latino
    75
    76
        Unknown or Not Reported
    0
    0
    Country
    Units: Subjects
        Hungary
    5
    3
        Romania
    3
    3
        Russia
    36
    32
        Ukraine
    29
    25
        United States
    6
    14
    Region of Enrollment
    Units: Subjects
        Non-US
    73
    63
        United States
    6
    14
    DB Baseline BMI Group
    Units: Subjects
        <18.5 kg/m^2
    1
    1
        >=18.5 - <25.0 kg/m^2
    46
    34
        >=25.0 - <30.0 kg/m^2
    27
    28
        >=30.0 kg/m^2
    5
    14
    OL Baseline BMI Group
    Units: Subjects
        <18.5 kg/m^2
    2
    1
        >=18.5 - <25.0 kg/m^2
    48
    34
        >=25.0 - <30.0 kg/m^2
    25
    28
        >=30.0 kg/m^2
    4
    14
    DB Baseline Height (cm)
    Units: cm
        arithmetic mean (standard deviation)
    173.2 ± 7.53
    173.0 ± 7.98
    DB Baseline Weight (kg)
    Units: kg
        arithmetic mean (standard deviation)
    73.14 ± 10.849
    77.68 ± 16.159
    DB Baseline Body Mass Index (kg/m^2)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    24.36 ± 3.221
    25.80 ± 4.328
    DB Baseline Waist Circumference (cm)
    Units: cm
        arithmetic mean (standard deviation)
    83.68 ± 11.612
    87.08 ± 15.093
    OL Baseline Height (cm)
    Units: cm
        arithmetic mean (standard deviation)
    173.2 ± 7.53
    173.0 ± 7.98
    OL Baseline Weight (kg)
    Units: kg
        arithmetic mean (standard deviation)
    72.83 ± 10.968
    77.88 ± 16.200
    OL Baseline Body Mass Index (kg/m^2)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    24.25 ± 3.213
    25.87 ± 4.350
    OL Baseline Waist Circumference (cm)
    Units: cm
        arithmetic mean (standard deviation)
    83.01 ± 11.764
    87.44 ± 14.759

    End points

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    End points reporting groups
    Reporting group title
    SEP-363856
    Reporting group description
    		 SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily

    Subject analysis set title
    PBO-SEP
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who received Placebo in study SEP361-201 and SEP-363856 in study SEP361-202

    Subject analysis set title
    SEP-SEP
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202

    Primary: The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation

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    End point title
    		 The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation [1]
    End point description
    End point type
    Primary
    End point timeframe
    From first dose of study drug to last study visit (27 weeks)
    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 study was an open label study no statistical analysis was performed
    End point values
    		 SEP-363856
    Number of subjects analysed
    156
    Units: Participants
        All Adverse Events
    88
        Serious Adverse Events
    15
        Adverse Events Leading to Discontinuation
    18
        Adverse Events Discontinuation of study medication
    18
    No statistical analyses for this end point

    Secondary: Severity of suicidal ideation and suicidal behavior using the Columbia – Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Severity of suicidal ideation and suicidal behavior using the Columbia – Suicide Severity Rating Scale (C-SSRS)
    End point description
    End point type
    Secondary
    End point timeframe
    Overall post-OL Baseline treatment period (26 weeks)
    End point values
    		 SEP-363856
    Number of subjects analysed
    156 [2]
    Units: Participants
        SI: Wish to be dead
    2
        SI: Non-specific active suicidal thoughts
    2
        SI: Any methods (not plan) without intent to act
    0
        SI: Some intent to act, without specific plan
    0
        SI: Specific plan and intent
    0
        SB: Preparatory acts or behavior
    0
        SB: Aborted attempt
    1
        SB: Interrupted attempt
    0
        SB: Actual attempt (non-fatal)
    0
        SB: Completed suicide
    0
    Notes
    [2] - SI: Suicidal ideation. SB: Suicidal behavior.
    No statistical analyses for this end point

    Secondary: Frequency of suicidal ideation and suicidal behavior using the Columbia – Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Frequency of suicidal ideation and suicidal behavior using the Columbia – Suicide Severity Rating Scale (C-SSRS)
    End point description
    End point type
    Secondary
    End point timeframe
    Overall post-OL Baseline treatment period (26 weeks)
    End point values
    		 SEP-363856
    Number of subjects analysed
    156
    Units: Participants
        Any suicidal ideation
    3
        Any suicidal behavior
    1
        Any suicidality
    3
    No statistical analyses for this end point

    Secondary: Rate of relapse during the 26-week OL period for subjects who demonstrated a clinical response to 4 weeks of treatment with SEP-363856

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    End point title
    		 Rate of relapse during the 26-week OL period for subjects who demonstrated a clinical response to 4 weeks of treatment with SEP-363856
    End point description
    Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3 - Re-hospitalization for worsening of psychosis - Emergence of suicidality, homicidality, and/or risk of harm to self or others
    End point type
    Secondary
    End point timeframe
    From the time of clinical response to relapse or censor (one day after the last study drug dose)
    End point values
    		 PBO-SEP SEP-SEP
    Number of subjects analysed
    59 [3]
    51 [4]
    Units: Participants
    12
    11
    Notes
    [3] - Subjects demonstrating clinical response to 4-week treatment with SEP-363856 included in analysis.
    [4] - Subjects demonstrating clinical response to 4-week treatment with SEP-363856 included in analysis.
    No statistical analyses for this end point

    Secondary: Changes from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) total score and subscale scores (positive, negative, and general psychopathology)

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    End point title
    		 Changes from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) total score and subscale scores (positive, negative, and general psychopathology)
    End point description
    End point type
    Secondary
    End point timeframe
    DB Baseline, OL Baseline, Week 26
    End point values
    		 SEP-363856
    Number of subjects analysed
    156 [5]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Total Score: DB BLN Observed
    101.5 ± 7.99
        Total Score: OL BLN Observed
    83.1 ± 15.03
        Total Score: Wk 26 Observed
    59.3 ± 12.45
        Total Score: Chg from DB BLN at Wk 26
    -41.8 ± 13.98
        Total Score: Chg from OL BLN at Wk 26
    -22.6 ± 15.48
        Positive SS: DB BLN Observed
    25.7 ± 3.22
        Positive SS: OL BLN Observed
    19.8 ± 4.96
        Positive SS: Wk 26 Observed
    12.2 ± 3.72
        Positive SS: Chg from DB BLN at Wk 26
    -13.5 ± 4.75
        Positive SS: Chg from OL BLN at Wk 26
    -7.3 ± 5.37
        Negative SS: DB BLN Observed
    25.4 ± 4.03
        Negative SS: OL BLN Observed
    22.3 ± 4.38
        Negative SS: Wk 26 Observed
    17.2 ± 4.10
        Negative SS: Chg from DB BLN at Wk 26
    -8.4 ± 4.48
        Negative SS: Chg from OL BLN at Wk 26
    -5.2 ± 4.20
        Gen-Psychopathology SS: DB BLN Observed
    50.4 ± 5.01
        Gen-Psychopathology SS: OL BLN Observed
    41.1 ± 7.93
        Gen-Psychopathology SS: Wk 26 Observed
    30.0 ± 6.77
        Gen-Psychopathology SS: Chg from DB BLN at Wk 26
    -19.9 ± 7.86
        Gen-Psychopathology SS: Chg from OL BLN at Wk 26
    -10.2 ± 8.31
    Notes
    [5] - Subjects with missing PANSS data did not contribute to summary. SS: Subscale Score. Gen: General.
    No statistical analyses for this end point

    Secondary: Change from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) score

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    End point title
    		 Change from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) score
    End point description
    End point type
    Secondary
    End point timeframe
    DB Baseline, OL Baseline, Week 26
    End point values
    		 SEP-363856
    Number of subjects analysed
    156 [6]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        CGI-S Score: DB Baseline Observed
    5.0 ± 0.42
        CGI-S Score: OL Baseline Observed
    4.0 ± 0.84
        CGI-S Score: Week 26 Observed
    3.0 ± 0.74
        CGI-S Score: Change from DB Baseline at Week 26
    -2.0 ± 0.82
        CGI-S Score: Change from OL Baseline at Week 26
    -1.0 ± 0.91
    Notes
    [6] - Subjects with missing CGI-S score data did not contribute to the summary.
    No statistical analyses for this end point

    Secondary: Change from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) total score

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    End point title
    		 Change from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) total score
    End point description
    End point type
    Secondary
    End point timeframe
    DB Baseline, OL Baseline, Week 26
    End point values
    		 SEP-363856
    Number of subjects analysed
    156 [7]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Total Score: DB Baseline Observed
    38.4 ± 11.94
        Total Score: OL Baseline Observed
    33.0 ± 11.41
        Total Score: Week 26 Observed
    22.5 ± 11.83
        Total Score: Change from DB Baseline at Week 26
    -16.8 ± 12.42
        Total Score: Change from OL Baseline at Week 26
    -11.3 ± 9.69
    Notes
    [7] - Subjects with missing BNSS score data did not contribute to the summary.
    No statistical analyses for this end point

    Secondary: Change from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) total score

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    End point title
    		 Change from DB Baseline of Study SEP361-201 and OL Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) total score
    End point description
    End point type
    Secondary
    End point timeframe
    DB Baseline, OL Baseline, Week 26
    End point values
    		 SEP-363856
    Number of subjects analysed
    156 [8]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Total Score: DB Baseline Observed
    12.6 ± 7.25
        Total Score: OL Baseline Observed
    9.2 ± 6.33
        Total Score: Week 26 Observed
    4.4 ± 4.72
        Total Score: Change from DB Baseline at Week 26
    -8.1 ± 6.44
        Total Score: Change from OL Baseline at Week 26
    -4.5 ± 5.28
    Notes
    [8] - Subjects with missing MADRS data did not contribute to summary.
    No statistical analyses for this end point

    Secondary: Proportion of subjects who achieved a response, defined as a 20% or greater improvement in PANSS total score from DB Baseline of Study SEP361-201

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    End point title
    		 Proportion of subjects who achieved a response, defined as a 20% or greater improvement in PANSS total score from DB Baseline of Study SEP361-201
    End point description
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 PBO-SEP SEP-SEP
    Number of subjects analysed
    53 [9]
    51 [10]
    Units: Participants
        number (not applicable)
    52
    49
    Notes
    [9] - Subjects with PANSS total score data available at DB Baseline and Week 26 are included in analysis.
    [10] - Subjects with PANSS total score data available at DB Baseline and Week 26 are included in analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug to last study visit (27 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    SEP-363856
    Reporting group description
    		 SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily

    Serious adverse events
    		 SEP-363856
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 156 (9.62%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Reproductive system and breast disorders
    Uterine haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Acute psychosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychotic disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Schizophrenia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    11 / 156 (7.05%)
         occurrences causally related to treatment / all
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SEP-363856
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 156 (25.00%)
    Nervous system disorders
    Headache
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    18 / 156 (11.54%)
         occurrences all number
    36
    Psychiatric disorders
    Anxiety
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    8 / 156 (5.13%)
         occurrences all number
    36
    Insomnia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    13 / 156 (8.33%)
         occurrences all number
    24
    Schizophrenia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    10 / 156 (6.41%)
         occurrences all number
    12

    More information

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

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

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