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    Clinical Trial Results:
    A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects

    Summary
    EudraCT number
    		 2013-001694-24
    Trial protocol
    		 ES   IT   BG   Outside EU/EEA   HU   GB   DE   PL   BE   FR  
    Global end of trial date
    17 Oct 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    27 Jun 2019
    First version publication date
    21 Apr 2019
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    update with corrected data for the non-serious adverse event section

    Trial information

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    Trial identification
    Sponsor protocol code
    D1050302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01914393
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001230-PIP01-11
    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
    17 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety, tolerability, and effectiveness of lurasidone (20, 40, 60 or 80 mg/day, flexibly dosed) in pediatric subjects who have completed a prior lurasidone study.
    Protection of trial subjects
    The study was conducted according to the protocol, International Council for Harmonisation (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
    18 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 77
    Country: Number of subjects enrolled
    Mexico: 38
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    United States: 332
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 10
    Country: Number of subjects enrolled
    Philippines: 6
    Country: Number of subjects enrolled
    Ukraine: 131
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    Malaysia: 4
    Country: Number of subjects enrolled
    Colombia: 23
    Country: Number of subjects enrolled
    Bulgaria: 37
    Country: Number of subjects enrolled
    Hungary: 12
    Worldwide total number of subjects
    701
    EEA total number of subjects
    80
    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)
    111
    Adolescents (12-17 years)
    565
    Adults (18-64 years)
    25
    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 participation in the preceding double-blind efficacy and safety studies (D1050301, D1050325, or D1050326) were eligible for enrollment in this study. Treatment groups in study D1050301: Placebo, Lurasidone 40 mg/day, Lurasidone 80 mg/day. Treatment groups in study D1050325: Placebo, Lurasidone 20 mg/day, Lurasidone 60 mg/d

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

    Arms
    Arm title
    		 lurasidone
    Arm description
    		 Lurasidone 20, 40, 60, 80 mg, flexibly dosed
    Arm type
    		 Experimental

    Investigational medicinal product name
    lurasidone
    Investigational medicinal product code
    Other name
    Latuda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lurasidone 20, 40, 60, 80 mg, flexibly dosed once daily

    Number of subjects in period 1
    		lurasidone
    Started
    701
    Completed
    378
    Not completed
    323
         Consent withdrawn by subject
    105
         no reason given
    38
         Adverse event, non-fatal
    78
         Lost to follow-up
    37
         Lack of efficacy
    32
         Protocol deviation
    33

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    		 -

    Reporting group values
    		 lurasidone Total
    Number of subjects
    		 701 701
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 111 111
        Adolescents (12-17 years)
    		 565 565
        Adults (18-64 years)
    		 25 25
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.3 ( 2.66 ) -
    Gender categorical
    Units: Subjects
        Female
    		 276 276
        Male
    		 425 425
    Country
    Units: Subjects
        Bulgaria
    		 37 37
        Colombia
    		 23 23
        Spain
    		 1 1
        France
    		 3 3
        Hungary
    		 12 12
        South Korea
    		 10 10
        Mexico
    		 38 38
        Malaysia
    		 4 4
        Philippines
    		 6 6
        Poland
    		 12 12
        Romania
    		 15 15
        Russia
    		 77 77
        Ukraine
    		 131 131
        United States
    		 332 332
    Subject analysis sets

    Subject analysis set title
    Rollover from D1050301
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rollover from D1050301

    Subject analysis set title
    Rollover from study D1050325
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rollover from study D1050325

    Subject analysis set title
    Rollover from study D1050326
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rollover from study D1050326

    Subject analysis sets values
    		 Rollover from D1050301 Rollover from study D1050325 Rollover from study D1050326
    Number of subjects
    271
    125
    306
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    75
    36
        Adolescents (12-17 years)
    257
    50
    258
        Adults (18-64 years)
    14
    0
    11
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    15.5 ( 1.44 )
    11.1 ( 3.12 )
    14.4 ( 2.18 )
    Gender categorical
    Units: Subjects
        Female
    101
    23
    152
        Male
    170
    102
    153
    Country
    Units: Subjects
        Bulgaria
    21
    0
    16
        Colombia
    11
    0
    12
        Spain
    1
    0
    0
        France
    2
    0
    1
        Hungary
    2
    0
    10
        South Korea
    3
    0
    7
        Mexico
    10
    0
    28
        Malaysia
    4
    0
    0
        Philippines
    4
    0
    2
        Poland
    7
    0
    5
        Romania
    15
    0
    0
        Russia
    41
    0
    36
        Ukraine
    68
    0
    63
        United States
    82
    125
    125

    End points

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    End points reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    		 Lurasidone 20, 40, 60, 80 mg, flexibly dosed

    Subject analysis set title
    Rollover from D1050301
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rollover from D1050301

    Subject analysis set title
    Rollover from study D1050325
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rollover from study D1050325

    Subject analysis set title
    Rollover from study D1050326
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Rollover from study D1050326

    Primary: Number of subjects with adverse events (AEs), discontinuations due to AEs and serious AEs (SAEs)

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    End point title
    		 Number of subjects with adverse events (AEs), discontinuations due to AEs and serious AEs (SAEs) [1]
    End point description
    The Safety population consists of all subjects who received at least one dose of study drug in this study.
    End point type
    Primary
    End point timeframe
    During 104 Weeks (2-years) treatment period
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point
    End point values
    		 Rollover from D1050301 Rollover from study D1050325 Rollover from study D1050326
    Number of subjects analysed
    271
    125
    305
    Units: subjects
        Subjects with at least one treatment emergent AE
    214
    106
    252
        Sujbects with at least one treatment emergent SAE
    28
    13
    37
        Subjects with AEs leading to discontinuation
    28
    18
    31
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score

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    End point title
    		 Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score
    End point description
    Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score for subjects continued from study D1050301.
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from D1050301
    Number of subjects analysed
    271
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open Label Baseline
    76.0 ( 17.72 )
        Week 28
    -11.9 ( 13.74 )
        Week 52
    -15.6 ( 14.97 )
        Week 104
    -18.4 ( 16.73 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS Positive Subscale Score

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    End point title
    		 Change from Baseline in PANSS Positive Subscale Score
    End point description
    Change from Baseline in PANSS Positive Subscale Score for subjects continued from study D1050301
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from D1050301
    Number of subjects analysed
    271
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open Label baseline
    17.9 ( 5.51 )
        Week 28
    -3.9 ( 4.68 )
        Week 52
    -5.1 ( 5.13 )
        Week 104
    -5.4 ( 5.66 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS Negative Subscale Score

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    End point title
    		 Change from Baseline in PANSS Negative Subscale Score
    End point description
    Change from Baseline in PANSS Negative Subscale Score for subjects continued from study D1050301
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from D1050301
    Number of subjects analysed
    271
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open Label baseline
    20.5 ( 4.91 )
        Week 28
    -2.6 ( 4.16 )
        Week 52
    -3.4 ( 4.34 )
        Week 104
    -4.3 ( 4.77 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS General Psychopathology Subscale Score

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    End point title
    		 Change from Baseline in PANSS General Psychopathology Subscale Score
    End point description
    Change from Baseline in PANSS General Psychopathology Subscale Score for subjects continued from study D1050301
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from D1050301
    Number of subjects analysed
    271
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    37.5 ( 9.38 )
        Week 28
    -5.4 ( 7.28 )
        Week 52
    -7.2 ( 7.65 )
        Week 104
    -8.7 ( 8.68 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in PANSS Excitability Subscale Score

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    End point title
    		 Change from Baseline in PANSS Excitability Subscale Score
    End point description
    Change from Baseline in PANSS Excitability Subscale Score for subjects continued from study D1050301
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from D1050301
    Number of subjects analysed
    271
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    9.0 ( 3.73 )
        Week 28
    -1.3 ( 3.09 )
        Week 52
    -1.7 ( 3.31 )
        week 104
    -2.1 ( 3.63 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Clinical Global Impression -Severity Score

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    End point title
    		 Change from Baseline in the Clinical Global Impression -Severity Score
    End point description
    Change from Baseline in the Clinical Global Impression -Severity Score for subjects continued from study D1050301
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from D1050301
    Number of subjects analysed
    271
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    4.0 ( 0.97 )
        Week 28
    -0.87 ( 0.941 )
        Week 52
    -1.10 ( 1.084 )
        Week 104
    -1.31 ( 1.196 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score

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    End point title
    		 Change from Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score
    End point description
    Change from Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score for subjects continued from study D1050301
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from D1050301
    Number of subjects analysed
    271
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    55.0 ( 11.96 )
        Week 28
    10.94 ( 11.943 )
        Week 52
    14.28 ( 12.814 )
        Week 104
    17.85 ( 15.155 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score

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    End point title
    		 Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
    End point description
    Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score for subjects continued from study D1050301
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from D1050301
    Number of subjects analysed
    271
    Units: percent of score
    arithmetic mean (standard deviation)
        Open label baseline
    57.14 ( 14.850 )
        Week 28
    7.48 ( 13.336 )
        Week 52
    9.98 ( 13.541 )
        Week 104
    11.74 ( 15.783 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score

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    End point title
    		 Change from Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score
    End point description
    Change from Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score for subjects continued from study D1050325
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050325
    Number of subjects analysed
    125
    Units: score
    arithmetic mean (standard deviation)
        Open label baseline
    19.0 ( 10.63 )
        Week 28
    -2.1 ( 9.16 )
        Week 52
    -2.9 ( 9.85 )
        Week 104
    -4.2 ( 11.62 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score

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    End point title
    		 Change from Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score
    End point description
    Change from Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score for subjects continued from study D1050325
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050325
    Number of subjects analysed
    125
    Units: score
    median (standard deviation)
        Open label baseline
    10.3 ( 9.48 )
        Week 28
    -0.7 ( 7.01 )
        Week 52
    -1.1 ( 6.94 )
        Week 104
    -1.1 ( 6.57 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score

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    End point title
    		 Change from Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score
    End point description
    Change from Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score for subjects continued from study D1050325
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050325
    Number of subjects analysed
    125
    Units: score
    arithmetic mean (standard deviation)
        Open label baseline
    6.1 ( 5.87 )
        Week 28
    -0.9 ( 3.55 )
        Week 52
    -0.9 ( 4.53 )
        Week 104
    -1.1 ( 4.41 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score

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    End point title
    		 Change from Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score
    End point description
    Change from Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score for subjects continued from study D1050325
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050325
    Number of subjects analysed
    125
    Units: score
    arithmetic mean (standard deviation)
        Open label baseline
    24.1 ( 12.19 )
        Week 28
    -3.8 ( 10.16 )
        Week 52
    -4.3 ( 11.24 )
        Week 104
    -5.6 ( 12.84 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score

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    End point title
    		 Change from Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score
    End point description
    Change from Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score for subjects continued from study D1050325
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050325
    Number of subjects analysed
    125
    Units: score
    arithmetic mean (standard deviation)
        Open label baseline
    5.2 ( 3.61 )
        Week 28
    -0.7 ( 2.75 )
        Week 52
    -0.7 ( 2.88 )
        Week 104
    -0.5 ( 3.00 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impression (CGI) – Severity Score

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    End point title
    		 Change from Baseline in Clinical Global Impression (CGI) – Severity Score
    End point description
    Change from Baseline in Clinical Global Impression (CGI) – Severity Score for subjects continued from study D1050325
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050325
    Number of subjects analysed
    125
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    3.9 ( 1.25 )
        Week 28
    -0.43 ( 0.984 )
        Week 52
    -0.71 ( 1.078 )
        Week 104
    -0.78 ( 1.313 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)

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    End point title
    		 Change from Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)
    End point description
    Change from Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS) for subjects continued from study D1050325
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050325
    Number of subjects analysed
    125
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    10.2 ( 5.43 )
        Week 28
    -2.2 ( 3.39 )
        Week 52
    -2.3 ( 4.32 )
        Week 104
    -3.2 ( 4.58 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score

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    End point title
    		 Change from Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score
    End point description
    Change from Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score for subjects continued from study D1050325
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050325
    Number of subjects analysed
    125
    Units: score
    arithmetic mean (standard deviation)
        Open label baseline
    7.95 ( 2.213 )
        Week 28
    -0.48 ( 1.887 )
        Week 52
    -0.60 ( 2.032 )
        Week 104
    -0.63 ( 2.123 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score

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    End point title
    		 Change from Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score
    End point description
    Change from Baseline in CDRS-R Total Score for subjects continued from study D1050326
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050326
    Number of subjects analysed
    305
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    39.2 ( 13.38 )
        Week 28
    -9.9 ( 13.48 )
        Week 52
    -13.4 ( 13.01 )
        Week 104
    -16.4 ( 13.24 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score

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    End point title
    		 Change from Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score
    End point description
    Change from Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score for subjects continued from study D1050326
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050326
    Number of subjects analysed
    305
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    3.2 ( 1.09 )
        Week 28
    -1.10 ( 1.140 )
        Week 52
    -1.36 ( 1.184 )
        Week 104
    -1.61 ( 1.153 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS) Score

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    End point title
    		 Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS) Score
    End point description
    Change from Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS) Score for subjects continued from study D1050326
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050326
    Number of subjects analysed
    305
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    61.1 ( 12.54 )
        Week 28
    11.17 ( 13.893 )
        Week 52
    14.67 ( 14.347 )
        Week 104
    18.96 ( 14.898 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score

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    End point title
    		 Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score
    End point description
    Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score for subjects continued from study D1050326
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050326
    Number of subjects analysed
    305
    Units: score
    arithmetic mean (standard deviation)
        Open label baseline
    59.52 ( 15.569 )
        Week 28
    8.16 ( 16.345 )
        Week 52
    11.37 ( 16.343 )
        Week 104
    14.75 ( 16.744 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score

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    End point title
    		 Change from Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score
    End point description
    Change from Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score for subjects continued from study D1050326
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050326
    Number of subjects analysed
    305
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    8.0 ( 6.94 )
        Week 28
    -2.7 ( 5.41 )
        Week 52
    -3.2 ( 5.97 )
        Week 104
    -4.9 ( 6.41 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score

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    End point title
    		 Change from Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score
    End point description
    Change from Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score for subjects continued from study D1050326
    End point type
    Secondary
    End point timeframe
    Open-Label Baseline, Week 28, Week 52, and Week 104
    End point values
    		 Rollover from study D1050326
    Number of subjects analysed
    305
    Units: units on a scale
    arithmetic mean (standard deviation)
        Open label baseline
    9.4 ( 10.58 )
        Week 28
    -2.2 ( 6.29 )
        Week 52
    -2.4 ( 5.83 )
        Week 104
    -3.3 ( 6.24 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    An AE onset on or after the start of the open-label treatment period (treatment duration: 104 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    lurasidone
    Reporting group description
    		 Lurasidone 20, 40, 60, 80 mg, flexibly dosed- (All indications)

    Reporting group title
    Rollover from D1050301
    Reporting group description
    		 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050301

    Reporting group title
    Rollover from D1050325
    Reporting group description
    		 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050325 (Lurasidone (autistic disorder))

    Reporting group title
    Rollover from D1050326
    Reporting group description
    		 Lurasidone flexibly dosed (20, 40, 60 or 80 mg/day) for subjects continued from study D1050326 (Lurasidone (bipolar depression) )

    Serious adverse events
    		 lurasidone Rollover from D1050301 Rollover from D1050325 Rollover from D1050326
    Total subjects affected by serious adverse events
         subjects affected / exposed
    78 / 701 (11.13%)
    28 / 271 (10.33%)
    13 / 125 (10.40%)
    37 / 305 (12.13%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ovarian tumour
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    3 / 701 (0.43%)
    0 / 271 (0.00%)
    1 / 125 (0.80%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    3 / 701 (0.43%)
    2 / 271 (0.74%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    2 / 701 (0.29%)
    0 / 271 (0.00%)
    1 / 125 (0.80%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    1 / 125 (0.80%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured coccyx
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    1 / 125 (0.80%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frostbite
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral nerve injury
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    1 / 125 (0.80%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    2 / 701 (0.29%)
    0 / 271 (0.00%)
    1 / 125 (0.80%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Akathisia
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    1 / 125 (0.80%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    1 / 125 (0.80%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bezoar
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    14 / 701 (2.00%)
    8 / 271 (2.95%)
    1 / 125 (0.80%)
    5 / 305 (1.64%)
         occurrences causally related to treatment / all
    1 / 16
    1 / 10
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    11 / 701 (1.57%)
    11 / 271 (4.06%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    1 / 12
    1 / 12
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    8 / 701 (1.14%)
    1 / 271 (0.37%)
    1 / 125 (0.80%)
    6 / 305 (1.97%)
         occurrences causally related to treatment / all
    2 / 9
    0 / 2
    0 / 1
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    6 / 701 (0.86%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    6 / 305 (1.97%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 0
    0 / 0
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    5 / 701 (0.71%)
    5 / 271 (1.85%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    3 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    4 / 701 (0.57%)
    1 / 271 (0.37%)
    3 / 125 (2.40%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    4 / 701 (0.57%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    4 / 305 (1.31%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    4 / 701 (0.57%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    3 / 305 (0.98%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    2 / 701 (0.29%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abnormal behaviour
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressive symptom
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emotional disorder
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional drug misuse
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Violence-related symptom
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    1 / 125 (0.80%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematinuria
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    3 / 701 (0.43%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    2 / 305 (0.66%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 701 (0.14%)
    0 / 271 (0.00%)
    0 / 125 (0.00%)
    1 / 305 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 701 (0.14%)
    1 / 271 (0.37%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 lurasidone Rollover from D1050301 Rollover from D1050325 Rollover from D1050326
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    560 / 701 (79.89%)
    208 / 271 (76.75%)
    104 / 125 (83.20%)
    248 / 305 (81.31%)
    Investigations
    Weight increased
         subjects affected / exposed
    70 / 701 (9.99%)
    21 / 271 (7.75%)
    20 / 125 (16.00%)
    29 / 305 (9.51%)
         occurrences all number
    73
    22
    21
    30
    Nervous system disorders
    Headache
         subjects affected / exposed
    156 / 701 (22.25%)
    65 / 271 (23.99%)
    18 / 125 (14.40%)
    73 / 305 (23.93%)
         occurrences all number
    281
    126
    31
    124
    Somnolence
         subjects affected / exposed
    68 / 701 (9.70%)
    24 / 271 (8.86%)
    14 / 125 (11.20%)
    30 / 305 (9.84%)
         occurrences all number
    73
    26
    17
    30
    Akathisia
         subjects affected / exposed
    49 / 701 (6.99%)
    22 / 271 (8.12%)
    8 / 125 (6.40%)
    19 / 305 (6.23%)
         occurrences all number
    72
    33
    12
    27
    Dizziness
         subjects affected / exposed
    33 / 701 (4.71%)
    17 / 271 (6.27%)
    2 / 125 (1.60%)
    14 / 305 (4.59%)
         occurrences all number
    47
    23
    2
    22
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    36 / 701 (5.14%)
    12 / 271 (4.43%)
    12 / 125 (9.60%)
    12 / 305 (3.93%)
         occurrences all number
    48
    15
    17
    16
    Fatigue
         subjects affected / exposed
    33 / 701 (4.71%)
    5 / 271 (1.85%)
    10 / 125 (8.00%)
    18 / 305 (5.90%)
         occurrences all number
    39
    5
    14
    20
    Pyrexia
         subjects affected / exposed
    24 / 701 (3.42%)
    7 / 271 (2.58%)
    7 / 125 (5.60%)
    10 / 305 (3.28%)
         occurrences all number
    34
    12
    9
    13
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    17 / 701 (2.43%)
    4 / 271 (1.48%)
    8 / 125 (6.40%)
    5 / 305 (1.64%)
         occurrences all number
    18
    4
    9
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    93 / 701 (13.27%)
    34 / 271 (12.55%)
    9 / 125 (7.20%)
    50 / 305 (16.39%)
         occurrences all number
    156
    59
    16
    81
    Vomiting
         subjects affected / exposed
    68 / 701 (9.70%)
    16 / 271 (5.90%)
    27 / 125 (21.60%)
    25 / 305 (8.20%)
         occurrences all number
    108
    21
    41
    46
    Diarrhoea
         subjects affected / exposed
    38 / 701 (5.42%)
    13 / 271 (4.80%)
    7 / 125 (5.60%)
    18 / 305 (5.90%)
         occurrences all number
    49
    17
    8
    24
    Toothache
         subjects affected / exposed
    27 / 701 (3.85%)
    19 / 271 (7.01%)
    2 / 125 (1.60%)
    6 / 305 (1.97%)
         occurrences all number
    37
    26
    3
    8
    Constipation
         subjects affected / exposed
    25 / 701 (3.57%)
    14 / 271 (5.17%)
    4 / 125 (3.20%)
    7 / 305 (2.30%)
         occurrences all number
    32
    18
    6
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    39 / 701 (5.56%)
    11 / 271 (4.06%)
    14 / 125 (11.20%)
    14 / 305 (4.59%)
         occurrences all number
    44
    12
    16
    16
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    75 / 701 (10.70%)
    35 / 271 (12.92%)
    14 / 125 (11.20%)
    26 / 305 (8.52%)
         occurrences all number
    111
    53
    23
    35
    Insomnia
         subjects affected / exposed
    58 / 701 (8.27%)
    23 / 271 (8.49%)
    13 / 125 (10.40%)
    22 / 305 (7.21%)
         occurrences all number
    76
    32
    18
    26
    Agitation
         subjects affected / exposed
    45 / 701 (6.42%)
    20 / 271 (7.38%)
    14 / 125 (11.20%)
    11 / 305 (3.61%)
         occurrences all number
    69
    30
    24
    15
    Depression
         subjects affected / exposed
    38 / 701 (5.42%)
    18 / 271 (6.64%)
    7 / 125 (5.60%)
    13 / 305 (4.26%)
         occurrences all number
    46
    23
    8
    15
    Schizophrenia
         subjects affected / exposed
    24 / 701 (3.42%)
    24 / 271 (8.86%)
    0 / 125 (0.00%)
    0 / 305 (0.00%)
         occurrences all number
    42
    42
    0
    0
    Aggression
         subjects affected / exposed
    9 / 701 (1.28%)
    1 / 271 (0.37%)
    7 / 125 (5.60%)
    1 / 305 (0.33%)
         occurrences all number
    10
    1
    8
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    78 / 701 (11.13%)
    24 / 271 (8.86%)
    28 / 125 (22.40%)
    26 / 305 (8.52%)
         occurrences all number
    106
    30
    42
    34
    Upper respiratory tract infection
         subjects affected / exposed
    36 / 701 (5.14%)
    10 / 271 (3.69%)
    14 / 125 (11.20%)
    12 / 305 (3.93%)
         occurrences all number
    43
    10
    18
    15
    Viral infection
         subjects affected / exposed
    31 / 701 (4.42%)
    17 / 271 (6.27%)
    2 / 125 (1.60%)
    12 / 305 (3.93%)
         occurrences all number
    65
    33
    2
    30
    Pharyngitis streptococcal
         subjects affected / exposed
    11 / 701 (1.57%)
    1 / 271 (0.37%)
    8 / 125 (6.40%)
    2 / 305 (0.66%)
         occurrences all number
    11
    1
    8
    2
    Rhinitis
         subjects affected / exposed
    30 / 701 (4.28%)
    11 / 271 (4.06%)
    0 / 125 (0.00%)
    19 / 305 (6.23%)
         occurrences all number
    39
    15
    0
    24

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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