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    Clinical Trial Results:
    A 6-Month, Open-Label, Prospective, Multicenter, International, Exploratory Study of a Transition to Flexibly-Dosed Paliperidone Palmitate in Patients with Schizophrenia Previously Unsuccessfully Treated with Oral or Long-Acting Injectable Antipsychotics

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-018022-30
    Trial protocol
    		 PT   HU   DE   NL   BE   ES   GB   SE   DK   IT   LV   AT   EE   LT  
    Global end of trial date
    29 Nov 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    R092670SCH3010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01281527
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, 2340 Beerse, Belgium,
    Public contact
    Janssen-Cilag International NV, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen-Cilag International NV, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to explore the tolerability, safety and treatment response (maintained/improved efficacy); based on total Positive and Negative Syndrome Scale (PANSS) score, following a transition to flexibly dosed once-monthly paliperidone palmitate (PP) in subjects with schizophrenia previously unsuccessfully treated with oral or long-acting injectable (LAI) antipsychotics. Subjects with either acute or non-acute symptoms of schizophrenia were eligible to enter the study.
    Protection of trial subjects
    Safety and tolerability were monitored by evaluating adverse events, vital signs, physical examination, body weight/body mass index (BMI), and assessment of extrapyramidal symptoms (using the Extrapyramidal Symptom Rating Scale [ESRS]), and urine pregnancy test.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2010
    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
    Austria: 11
    Country: Number of subjects enrolled
    Belgium: 67
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Croatia: 4
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    Estonia: 9
    Country: Number of subjects enrolled
    France: 82
    Country: Number of subjects enrolled
    Germany: 114
    Country: Number of subjects enrolled
    United Kingdom: 34
    Country: Number of subjects enrolled
    Greece: 27
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Israel: 17
    Country: Number of subjects enrolled
    Italy: 123
    Country: Number of subjects enrolled
    Latvia: 56
    Country: Number of subjects enrolled
    Lithuania: 8
    Country: Number of subjects enrolled
    Portugal: 32
    Country: Number of subjects enrolled
    Spain: 170
    Country: Number of subjects enrolled
    Sweden: 16
    Country: Number of subjects enrolled
    Switzerland: 10
    Country: Number of subjects enrolled
    Turkey: 78
    Country: Number of subjects enrolled
    Ukraine: 149
    Worldwide total number of subjects
    1035
    EEA total number of subjects
    781
    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)
    1
    Adults (18-64 years)
    1009
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study consisted of a screening period, a 6-month study period, and an optional open-label extension phase. 3 groups of subjects were pre-specified with schizophrenia who transitioned to PP: Group A (600 non-acute) and C (200 acute)- subjects switched due to oral antipsychotics; Group B(200 non-acute)- subjects switched due to LAI antipsychotic.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Group A included approximately 600 non­-acute but symptomatic subjects with schizophrenia who were transitioned to PP because of prior unsuccessful treatment with an oral anti psychotic in the 4  weeks prior to enrollment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone palmitate - Extended Release (ER)
    Investigational medicinal product code
    R092670
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received intramuscular injection of PP on Day 1 at a dose of 150 milligram equivalent (mg eq.) and their second injection on Day 8 (100 mg eq.). Subsequent injections were given once monthly within the dose range of 50 to 150 mg eq. at the discretion of the investigator.

    Arm title
    		 Group B
    Arm description
    		 Group B included approximately 200 non­-acute but symptomatic subjects with schizophrenia who were transitioned to PP because of prior unsuccessful treatment with a frequently used LAI  anti psychotics (i.e., haloperidol decanoate, flupentixol decanoate, fluphenazine decanoate, zuclopenthixol decanoate, or risperidone LAI) in the 4 weeks prior to enrollment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone palmitate - Extended Release (ER)
    Investigational medicinal product code
    R092670
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received intramuscular injection of PP on Day 1 with in a range of 50 - 150 mg eq. Subsequent injections were given once monthly within the dose range of 50 to 150 mg eq. at the discretion of the investigator.

    Arm title
    		 Group C
    Arm description
    		 Group C included approximately 200 subjects with acute symptoms of schizophrenia who were transitioned to PP because of unsuccessful treatment  with an  oral  antipsychotic  in the 4 weeks  prior to  enrollment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paliperidone palmitate - Extended Release (ER)
    Investigational medicinal product code
    R092670
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received intramuscular injection of PP on Day 1 at a dose of 150 mg eq. and their second injection on Day 8 (100 mg eq.). Subsequent injections were given once monthly within the dose range of 50 to 150 mg eq. at the discretion of the investigator.

    Number of subjects in period 1
    		Group A Group B Group C
    Started
    593
    230
    212
    Completed
    442
    172
    149
    Not completed
    151
    58
    63
         Physician decision
    8
    3
    -
         Consent withdrawn by subject
    60
    19
    20
         Death
    1
    -
    2
         Other
    2
    3
    3
         Adverse event
    36
    17
    19
         Noncompliance with study drug
    4
    2
    1
         Lost to follow-up
    19
    5
    10
         Protocol deviation
    6
    2
    2
         Lack of efficacy
    15
    7
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Group A included approximately 600 non­-acute but symptomatic subjects with schizophrenia who were transitioned to PP because of prior unsuccessful treatment with an oral anti psychotic in the 4  weeks prior to enrollment.

    Reporting group title
    Group B
    Reporting group description
    		 Group B included approximately 200 non­-acute but symptomatic subjects with schizophrenia who were transitioned to PP because of prior unsuccessful treatment with a frequently used LAI  anti psychotics (i.e., haloperidol decanoate, flupentixol decanoate, fluphenazine decanoate, zuclopenthixol decanoate, or risperidone LAI) in the 4 weeks prior to enrollment.

    Reporting group title
    Group C
    Reporting group description
    		 Group C included approximately 200 subjects with acute symptoms of schizophrenia who were transitioned to PP because of unsuccessful treatment  with an  oral  antipsychotic  in the 4 weeks  prior to  enrollment.

    Reporting group values
    		 Group A Group B Group C Total
    Number of subjects
    		 593 230 212 1035
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 1 0 0 1
        Adults (18-64 years)
    		 581 220 208 1009
        From 65 to 84 years
    		 11 10 4 25
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.4 ± 11.83 42.5 ± 10.83 36.4 ± 12.06 -
    Title for Gender
    Units: subjects
        Female
    		 219 83 87 389
        Male
    		 374 147 125 646

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Group A included approximately 600 non­-acute but symptomatic subjects with schizophrenia who were transitioned to PP because of prior unsuccessful treatment with an oral anti psychotic in the 4  weeks prior to enrollment.

    Reporting group title
    Group B
    Reporting group description
    		 Group B included approximately 200 non­-acute but symptomatic subjects with schizophrenia who were transitioned to PP because of prior unsuccessful treatment with a frequently used LAI  anti psychotics (i.e., haloperidol decanoate, flupentixol decanoate, fluphenazine decanoate, zuclopenthixol decanoate, or risperidone LAI) in the 4 weeks prior to enrollment.

    Reporting group title
    Group C
    Reporting group description
    		 Group C included approximately 200 subjects with acute symptoms of schizophrenia who were transitioned to PP because of unsuccessful treatment  with an  oral  antipsychotic  in the 4 weeks  prior to  enrollment.

    Subject analysis set title
    Group A1: Subjects Switched for Efficacy Reason
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy analysis set included all Intent-to-treat (ITT) subjects who had at least one post baseline observation on any efficacy parameter.

    Subject analysis set title
    Group A2: Subjects Switched for Other Reason
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy analysis set included all ITT subjects who had at least one post baseline observation on any efficacy parameter.

    Subject analysis set title
    Group B1: Subjects Switched from Haloperidol Decanoate
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy analysis set included all ITT subjects who had at least one post baseline observation on any efficacy parameter.

    Subject analysis set title
    Group B2: Subjects Switched from Flupentixol Decanoate
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy analysis set included all ITT subjects who had at least one post baseline observation on any efficacy parameter.

    Subject analysis set title
    Group B3: Subjects Switched from Fluphenazine Decanoate
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy analysis set included all ITT subjects who had at least one post baseline observation on any efficacy parameter.

    Subject analysis set title
    Group B4: Subjects Switched from Zuclopentixol-Decanoate
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy analysis set included all ITT subjects who had at least one post baseline observation on any efficacy parameter.

    Subject analysis set title
    Group B5: Subjects Switched from Risperidone Micropsheres
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy analysis set included all ITT subjects who had at least one post baseline observation on any efficacy parameter.

    Subject analysis set title
    Group C
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Group C included approximately 200 subjects with acute symptoms of schizophrenia who were transitioned to PP because of unsuccessful treatment  with an  oral  antipsychotic  in the 4 weeks  prior to  enrollment.

    Primary: Group A1 (Non acute Patients Switched From oral Anti psychotics due to Lack of Efficacy): Percentage of Participants with Improved Efficacy in PANSS Total Score from Baseline to Month 6 LOCF

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    End point title
    		 Group A1 (Non acute Patients Switched From oral Anti psychotics due to Lack of Efficacy): Percentage of Participants with Improved Efficacy in PANSS Total Score from Baseline to Month 6 LOCF [1]
    End point description
    Improved efficacy, defined as the proportion of patients who showed an improvement in PANSS total score of at ≥20% from baseline to endpoint (LOCF). PANSS is a 30-item scale, with each item rated on a scale of 1 (absent) to 7 (extreme). The PANSS provides a total score (range, 30-210) and scores for the following 3 subscales: positive subscale (range, 7-49): sum of Items P1 to P7 in the positive subscale; negative subscale (range, 7-49): sum of Items N1 to N7 in the negative subscale; general psychopathology subscale (range, 16-112): sum of Items G1 to G16 in the general psychopathology subscale. Efficacy analysis included all subjects who received at least 1 dose of paliperidone palmitate (PP) and had at least 1 post baseline observation on any efficacy parameter.
    End point type
    Primary
    End point timeframe
    Month 6 LOCF
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Group A1: Subjects Switched for Efficacy Reason
    Number of subjects analysed
    143
    Units: percentage of participants
        median (confidence interval 95%)
    61.5 (53.4 to 69.1)
    No statistical analyses for this end point

    Primary: Group B: (Non-acute Patients Switched From Long Acting Injectable Antipsychotics): Participants with Explore Treatment Response

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    End point title
    		 Group B: (Non-acute Patients Switched From Long Acting Injectable Antipsychotics): Participants with Explore Treatment Response [2]
    End point description
    Participants with explore treatment response switched from Long Acting Injectable (LAI) anti-psychotics (haloperidol decanoate, flupentixol decanoate, fluphenazine decanoate,zuclopenthixol decanoate, risperidone LAI) defined as the proportion of subjects achieving a ≥20% improvement in PANSS total score from baseline to endpoint (LOCF). The PANSS is a 30-item scale, with each item rated on a scale of 1 (absent) to 7 (extreme). The PANSS provides a total score (range, 30-210) and scores for the following 3 subscales: positive subscale (range, 7-49): sum of Items P1 to P7 in the positive subscale; negative subscale (range, 7-49): sum of Items N1 to N7 in the negative subscale; general psychopathology subscale (range, 16-112): sum of Items G1 to G16 in the general psychopathology subscale. Efficacy analysis included all subjects who received at least 1 dose of study medication (PP) and had at least 1 post baseline observation on any efficacy parameter.
    End point type
    Primary
    End point timeframe
    Baseline and Month 6 LOCF
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Group B1: Subjects Switched from Haloperidol Decanoate Group B2: Subjects Switched from Flupentixol Decanoate Group B3: Subjects Switched from Fluphenazine Decanoate Group B4: Subjects Switched from Zuclopentixol-Decanoate Group B5: Subjects Switched from Risperidone Micropsheres
    Number of subjects analysed
    53
    34
    44
    41
    55
    Units: Percentage of participants
        median (confidence interval 95%)
    54.7 (41.4 to 67.3)
    61.8 (45 to 76.1)
    59.1 (44.4 to 72.3)
    53.7 (38.8 to 67.9)
    61.1 (47.8 to 73)
    No statistical analyses for this end point

    Primary: Group C (Acute Patients Switched From Ooral Anti psychotics): Participants with Improved Efficacy From Baseline to Month 6 LOCF

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    End point title
    		 Group C (Acute Patients Switched From Ooral Anti psychotics): Participants with Improved Efficacy From Baseline to Month 6 LOCF [3] [4]
    End point description
    participants with improved efficacy defined as the proportion of patients achieving a ≥30% improvement in PANSS total score from baseline to endpoint (LOCF). The PANSS is a 30-item scale, with each item rated on a scale of 1 (absent) to 7 (extreme). The PANSS provides a total score (range, 30-210) and scores for the following 3 subscales: positive subscale (range, 7-49): sum of Items P1 to P7 in the positive subscale; negative subscale (range, 7-49): sum of Items N1 to N7 in the negative subscale; general psychopathology subscale (range, 16-112): sum of Items G1 to G16 in the general psychopathology subscale. Efficacy analysis included all subjects who received at least 1 dose of paliperidone palmitate (PP) and had at least 1 post baseline observation on any efficacy parameter.
    End point type
    Primary
    End point timeframe
    Baseline to Month 6 LOCF
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Group C
    Number of subjects analysed
    207
    Units: Percentage of participants
        median (confidence interval 95%)
    66.7 (60 to 72.7)
    No statistical analyses for this end point

    Primary: Group A2 (Non-acute Participants Switched From Oral Anti-psychotics due to Other Reasons): Percentage of Participants With Maintained Efficacy From baseline to Month 6 LOCF

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    End point title
    		 Group A2 (Non-acute Participants Switched From Oral Anti-psychotics due to Other Reasons): Percentage of Participants With Maintained Efficacy From baseline to Month 6 LOCF [5]
    End point description
    Percentage of participants with maintained efficacy, defined as a non-inferior change in PANSS total score from baseline to endpoint based on the Schuirmann’s test. PANSS is a 30-item scale, with each item rated on a scale of 1 (absent) to 7 (extreme). The PANSS provides a total score (range, 30-210) and scores for the following 3 subscales: positive subscale (range, 7-49): sum of Items P1 to P7 in the positive subscale; negative subscale (range, 7-49): sum of Items N1 to N7 in the negative subscale; general psychopathology subscale (range, 16-112): sum of Items G1 to G16 in the general psychopathology subscale. Efficacy analysis included all subjects who received at least 1 dose of paliperidone palmitate (PP) and had at least 1 post baseline observation on any efficacy parameter.
    End point type
    Primary
    End point timeframe
    Baseline and Month 6 LOCF
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Group A2: Subjects Switched for Other Reason
    Number of subjects analysed
    446
    Units: Percentage of participants
    median (confidence interval 95%)
        Baseline
    69 (67.3 to 70)
        Month 6 (LOCF)
    -11 (-13.1 to -10.1)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impression-Severity Scale [CGI- S] at Month 6

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    End point title
    		 Change from Baseline in Clinical Global Impression-Severity Scale [CGI- S] at Month 6
    End point description
    The Clinical Global Impression-Severity Scale (CGI-S) rating scale is used to rate the severity of a subject’s psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). Efficacy analysis included all subjects who received at least 1 dose of PP and had at least 1 post baseline observation on any efficacy parameter. Here 'n' signifies number of subjects analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6 LOCF
    End point values
    		 Group A1: Subjects Switched for Efficacy Reason Group A2: Subjects Switched for Other Reason Group B1: Subjects Switched from Haloperidol Decanoate Group B2: Subjects Switched from Flupentixol Decanoate Group B3: Subjects Switched from Fluphenazine Decanoate Group B4: Subjects Switched from Zuclopentixol-Decanoate Group B5: Subjects Switched from Risperidone Micropsheres Group C
    Number of subjects analysed
    143
    446
    53
    34
    44
    41
    55
    207
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=143,442,53,34,44,41,55,205)
    4.2 ± 0.89
    3.8 ± 0.91
    4.2 ± 0.91
    3.9 ± 0.77
    4 ± 1.03
    4.1 ± 1
    3.7 ± 1.21
    5 ± 0.75
        Month 6 LOCF(n=143,442,53,34,44,41,55,205)
    -0.6 ± 0.86
    -0.6 ± 1.09
    -0.4 ± 1.1
    -0.4 ± 0.86
    -0.4 ± 0.94
    -0.5 ± 1.19
    -0.4 ± 1.19
    -1.5 ± 1.27
    No statistical analyses for this end point

    Secondary: Change from Baseline in Personal And Social Functioning (Personal and Social Performance Scale [PSP]) at Month 6

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    End point title
    		 Change from Baseline in Personal And Social Functioning (Personal and Social Performance Scale [PSP]) at Month 6
    End point description
    The PSP scale was used to assess the degree of functioning a subject exhibited within 4 domains: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. Each of the 4 domains was rated on a 6-point scale (0=absent, 1=mild, 2=manifest, 3=marked, 4=severe, and 5=very severe) and then converted to one total score (ranging from 1 to 100). A total PSP score of 71 to 100 indicated a mild degree of difficulty; a score of 31 to 70 indicated varying degrees of disability; and a score 30 indicated functioning so poor that the subject requires intensive support or supervision. Efficacy analysis included all subjects who received at least 1 dose of study medication (PP) and had at least 1 post baseline observation on any efficacy parameter. Here 'n' signifies number of subjects analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6 LOCF
    End point values
    		 Group A1: Subjects Switched for Efficacy Reason Group A2: Subjects Switched for Other Reason Group B1: Subjects Switched from Haloperidol Decanoate Group B2: Subjects Switched from Flupentixol Decanoate Group B3: Subjects Switched from Fluphenazine Decanoate Group B4: Subjects Switched from Zuclopentixol-Decanoate Group B5: Subjects Switched from Risperidone Micropsheres Group C
    Number of subjects analysed
    143
    446
    53
    34
    44
    41
    55
    207
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=139,429,53,34,44,41,55,86,197)
    55.3 ± 12.31
    59 ± 13.62
    48.7 ± 12.53
    59.6 ± 11.2
    53.5 ± 12.16
    52.9 ± 15.63
    60.1 ± 17.92
    43.9 ± 14.99
        Month 6 LOCF(n=139,429,53,34,44,41,55,197)
    5.5 ± 12.31
    8.8 ± 14.37
    5.2 ± 13
    6.1 ± 14.94
    6 ± 11.58
    6.4 ± 15.21
    5.2 ± 15.31
    19 ± 18.67
    No statistical analyses for this end point

    Secondary: Change from Baseline in Health Status (Self-Reported Health Status Questionnaire [SF-36]) at Month 6

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    End point title
    		 Change from Baseline in Health Status (Self-Reported Health Status Questionnaire [SF-36]) at Month 6
    End point description
    The SF-36 is a validated self-rated health status instrument used to assess subjects across several domains. The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems; limitations in usual role activities due to physical health problems; bodily pain; general health perception; vitality (energy and fatigue); limitations in social functioning due to physical or mental health problems; limitations in usual role activities due to personal or emotional problems; and general mental health (psychological distress and well-being). These scales are scored from 0 to 100, with higher scores indicating better health. The SF-36 was also scored as- Physical Component - Scale Score (PCS) and Mental Component - Scale Score (MCS). Higher scores indicated better health. Efficacy analysis included all subjects who received at least 1 dose of PP and had at least 1 post baseline observation on any efficacy parameter.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6 LOCF
    End point values
    		 Group A1: Subjects Switched for Efficacy Reason Group A2: Subjects Switched for Other Reason Group B1: Subjects Switched from Haloperidol Decanoate Group B2: Subjects Switched from Flupentixol Decanoate Group B3: Subjects Switched from Fluphenazine Decanoate Group B4: Subjects Switched from Zuclopentixol-Decanoate Group B5: Subjects Switched from Risperidone Micropsheres Group C
    Number of subjects analysed
    143
    446
    53
    34
    44
    41
    55
    207
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline-PCS (n=130,399,46,33,42,38,49,182)
    48 ± 9.47
    48.7 ± 8.76
    49.4 ± 7.48
    49.3 ± 9.71
    46.9 ± 9.59
    48.7 ± 9.7
    49.2 ± 9.72
    47.3 ± 9.5
        Month 6 LOCF-PCS (n=130,399,46,33,42,38,49,182)
    2.2 ± 7.7
    1.2 ± 8.22
    1.4 ± 6.5
    2.2 ± 7.43
    2.6 ± 10.27
    0 ± 7.69
    0.1 ± 8.21
    1.9 ± 8.96
        Baseline-MCS (n=130,399,46,33,42,38,49,182)
    33.5 ± 12.43
    35.9 ± 12.65
    38.1 ± 12.5
    37.8 ± 15.39
    36.6 ± 13.41
    36.2 ± 12.7
    35.8 ± 16
    28.7 ± 12.93
        Month 6 LOCF-MCS (n=130,399,46,33,42,38,49,182)
    6.6 ± 10.67
    5.4 ± 12.8
    4.4 ± 13.22
    6.8 ± 15.19
    2.9 ± 13.96
    8.7 ± 12.17
    5.4 ± 13.52
    11 ± 15.19
    No statistical analyses for this end point

    Secondary: Change from Baseline in Measure of Health Outcome (EQ-5D) Visual Analog Scale (VAS) at Month 6

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    End point title
    		 Change from Baseline in Measure of Health Outcome (EQ-5D) Visual Analog Scale (VAS) at Month 6
    End point description
    The EQ-5D is designed for self-completion by subjects and consists of 2 scales - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: 1=no problems, 2=some problems, or 3=severe problems. The EQ VAS records the subjects self-rated health on a vertical, visual analog scale, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as scored by the individual subject. Efficacy analysis included all subjects who received at least 1 dose of PP and had at least 1 post baseline observation on any efficacy parameter. Here 'n' signifies number of subjects analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6 LOCF
    End point values
    		 Group A1: Subjects Switched for Efficacy Reason Group A2: Subjects Switched for Other Reason Group B1: Subjects Switched from Haloperidol Decanoate Group B2: Subjects Switched from Flupentixol Decanoate Group B3: Subjects Switched from Fluphenazine Decanoate Group B4: Subjects Switched from Zuclopentixol-Decanoate Group B5: Subjects Switched from Risperidone Micropsheres Group C
    Number of subjects analysed
    143
    446
    53
    34
    44
    41
    55
    207
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=132,398,46,33,43,38,49,179)
    57.98 ± 21.179
    61.18 ± 19.987
    60.37 ± 20.93
    61.32 ± 21.574
    61.53 ± 22.105
    64.21 ± 18.805
    56.26 ± 28.171
    55.3 ± 22.608
        Month 6 LOCF(n=132,398,46,33,43,38,49,179)
    8.94 ± 18.89
    8.09 ± 22.543
    8.1 ± 24.876
    15.32 ± 19.729
    4.95 ± 21.94
    7.3 ± 22.765
    9.31 ± 27.865
    12.15 ± 28.022
    No statistical analyses for this end point

    Secondary: Change from Baseline in Subject well-being (Subjective Well-Being under Neuroleptics Scale [SWN-S]) at Month 6

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    End point title
    		 Change from Baseline in Subject well-being (Subjective Well-Being under Neuroleptics Scale [SWN-S]) at Month 6
    End point description
    The SWN-S is an instrument to measure the subjective changes, such as restrictions in emotionality, the clarity of thinking, and spontaneity, that are often referred as 'pharmacogenic depression' or the 'neuroleptic induced deficit syndrome'. It consist of 20 items (10 positive items and 10 negative items). Each item of the SWN -S is rated on 6-point Likert scale (1=not at all, 2=hardly at all, 3=a little, 4=somewhat, 5=much, 6=very much). There are 5 sub scores (mental functioning, social integration, emotional regulation, physical functioning and self-control) and a SWN-S total score. After reversing the score of the 10 negative items, the item scores are added to generate the subscale scores and the total score. Efficacy analysis included all subjects who received at least 1 dose of PP and had at least 1 post baseline observation on any efficacy parameter. Here 'n' signifies number of subjects analysed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Group A1: Subjects Switched for Efficacy Reason Group A2: Subjects Switched for Other Reason Group B1: Subjects Switched from Haloperidol Decanoate Group B2: Subjects Switched from Flupentixol Decanoate Group B3: Subjects Switched from Fluphenazine Decanoate Group B4: Subjects Switched from Zuclopentixol-Decanoate Group B5: Subjects Switched from Risperidone Micropsheres Group C
    Number of subjects analysed
    143
    446
    53
    34
    44
    41
    55
    207
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=129,392,46,33,43,37,47,180)
    77.2 ± 17.97
    81 ± 16.9
    83.7 ± 12.48
    83.5 ± 18.64
    81 ± 17.2
    83 ± 15.29
    80.8 ± 22.19
    73.8 ± 15.5
        Month 6 LOCF(n=129,392,46,33,43,37,47,180)
    6.6 ± 14.06
    5 ± 16.14
    3.2 ± 13.59
    8.3 ± 17.46
    2.9 ± 15.5
    4.3 ± 14.84
    3.6 ± 15.65
    9.7 ± 20.57
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Month 6
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Non-acute subjects switched from oral antipsychotics

    Reporting group title
    Group C
    Reporting group description
    		 Acute subjects switched from oral antipsychotics

    Reporting group title
    Group B
    Reporting group description
    		 Non-acute subjects switched from long acting antipsychotics

    Serious adverse events
    		 Group A Group C Group B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    90 / 593 (15.18%)
    25 / 212 (11.79%)
    34 / 230 (14.78%)
         number of deaths (all causes)
    2
    2
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung Squamous Cell Carcinoma Stage Ii
         subjects affected / exposed
    0 / 593 (0.00%)
    1 / 212 (0.47%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial Stenosis Limb
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis Obliterans
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    0 / 593 (0.00%)
    1 / 212 (0.47%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cochlea Implant
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    0 / 593 (0.00%)
    1 / 212 (0.47%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Miscarriage of Partner
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 593 (0.00%)
    1 / 212 (0.47%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal Behaviour
         subjects affected / exposed
    2 / 593 (0.34%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute Psychosis
         subjects affected / exposed
    0 / 593 (0.00%)
    1 / 212 (0.47%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcohol Abuse
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    5 / 593 (0.84%)
    0 / 212 (0.00%)
    2 / 230 (0.87%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    8 / 593 (1.35%)
    2 / 212 (0.94%)
    2 / 230 (0.87%)
         occurrences causally related to treatment / all
    4 / 9
    2 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Apathy
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed Suicide
         subjects affected / exposed
    2 / 593 (0.34%)
    1 / 212 (0.47%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    Catatonia
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delusion
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delusional Disorder, Unspecified Type
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 593 (0.17%)
    1 / 212 (0.47%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug Abuse
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination, Visual
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypochondriasis
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomania
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intentional Self-Injury
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obsessive-Compulsive Disorder
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Personality Disorder
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric Decompensation
         subjects affected / exposed
    2 / 593 (0.34%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    21 / 593 (3.54%)
    12 / 212 (5.66%)
    12 / 230 (5.22%)
         occurrences causally related to treatment / all
    9 / 25
    5 / 13
    10 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    12 / 593 (2.02%)
    4 / 212 (1.89%)
    6 / 230 (2.61%)
         occurrences causally related to treatment / all
    5 / 12
    2 / 4
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia, Paranoid Type
         subjects affected / exposed
    4 / 593 (0.67%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social Avoidant Behaviour
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    3 / 593 (0.51%)
    1 / 212 (0.47%)
    3 / 230 (1.30%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    3 / 593 (0.51%)
    2 / 212 (0.94%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tension
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thinking Abnormal
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral Neck Fracture
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Animal Bite
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Pectoris
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 593 (0.00%)
    1 / 212 (0.47%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus Tachycardia
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extrapyramidal Disorder
         subjects affected / exposed
    2 / 593 (0.34%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertonia
         subjects affected / exposed
    0 / 593 (0.00%)
    1 / 212 (0.47%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychomotor Hyperactivity
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal Prolapse
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis Haemorrhagic
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver Disorder
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 593 (0.17%)
    0 / 212 (0.00%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 593 (0.00%)
    0 / 212 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A Group C Group B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    162 / 593 (27.32%)
    65 / 212 (30.66%)
    48 / 230 (20.87%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    33 / 593 (5.56%)
    13 / 212 (6.13%)
    14 / 230 (6.09%)
         occurrences all number
    36
    22
    22
    General disorders and administration site conditions
    Injection Site Pain
         subjects affected / exposed
    73 / 593 (12.31%)
    29 / 212 (13.68%)
    14 / 230 (6.09%)
         occurrences all number
    122
    49
    19
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    51 / 593 (8.60%)
    23 / 212 (10.85%)
    15 / 230 (6.52%)
         occurrences all number
    58
    30
    15
    Anxiety
         subjects affected / exposed
    34 / 593 (5.73%)
    11 / 212 (5.19%)
    10 / 230 (4.35%)
         occurrences all number
    48
    19
    11
    Psychotic Disorder
         subjects affected / exposed
    16 / 593 (2.70%)
    11 / 212 (5.19%)
    7 / 230 (3.04%)
         occurrences all number
    18
    12
    8

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2010
    Amendment INT-1 was implemented prior to first-subject/first-visit and included the following changes: Additional clarification of the inclusion criteria regarding the definition of acute and non-acute subjects and corrections of the recruitment instructions and dosing and switching instructions.
    10 Jun 2010
    Amendment INT-2 was implemented prior to first-subject/first-visit and consisted of updates and corrections regarding the assessment scales included in the attachments.
    29 Oct 2010
    Amendment INT-3 was implemented before any subject had started the optional extension phase and consisted of the following changes: 1) The duration of the optional extension phase was changed from a maximum of 12 months per subject to a maximum of 12 months after the last subject had completed the 6-month study period, or until PP became available in the respective country; 2) Additional text was added to clarify that IEQ would only be administered in a limited number of countries, depending on availability of the scale in local languages; 3) In some countries, it is standard practice that PANSS is assessed by other qualified personnel besides the investigator (e.g. nurses specialized in psychiatry with specific PANSS training). In order to allow this type of qualified personnel to rate the PANSS, the text was updated.

    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.
    Study limitations were the open-label and single-arm design.
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