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    Clinical Trial Results:
    A Long-Term, Open-Label, Safety Study of Oral Olanzapine in Adolescents with Bipolar I Disorder (Manic or Mixed Episodes) or Schizophrenia

    Summary
    EudraCT number
    		 2009-010276-16
    Trial protocol
    		 DE  
    Global end of trial date
    07 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    F1D-MC-HGMX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00982020
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 12117, Trial Alias: F1D-MC-HGMX
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    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
    07 May 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to assess in adolescent patients with bipolar I disorder (manic or mixed episode) or schizophrenia: 1) the overall safety of olanzapine for up to approximately 52 weeks of treatment, and 2) whether an Intense behavioral weight intervention program was superior to a Standard behavioral weight intervention program in mitigation of weight gain as assessed by overall mean change from baseline body mass index (BMI).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    Russian Federation: 55
    Country: Number of subjects enrolled
    United States: 107
    Country: Number of subjects enrolled
    Puerto Rico: 20
    Worldwide total number of subjects
    203
    EEA total number of subjects
    21
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    203
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No text entered

    Pre-assignment
    Screening details
    		 No text entered

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Olanzapine/standard behavioral weight intervention
    Arm description
    		 Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olanzapine
    Investigational medicinal product code
    Other name
    Zyprexa, LY170053
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only

    Arm title
    		 Olanzapine/intense behavioral weight intervention
    Arm description
    		 Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olanzapine
    Investigational medicinal product code
    Other name
    Zyprexa, LY170053
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

    Number of subjects in period 1
    		Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention
    Started
    102
    101
    Received at least 1 dose of study drug
    102
    101
    Completed
    45
    37
    Not completed
    57
    64
         Parent/Caregiver Decision
    5
    5
         Physician decision
    2
    5
         Consent withdrawn by subject
    11
    14
         Clinical Relapse
    -
    1
         Adverse event, non-fatal
    19
    15
         Protocol Violation
    -
    2
         Treatment Non-compliance
    3
    6
         Lost to follow-up
    5
    11
         Entry Criteria Not Met
    2
    1
         Lack of efficacy
    10
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Olanzapine/standard behavioral weight intervention
    Reporting group description
    		 Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only

    Reporting group title
    Olanzapine/intense behavioral weight intervention
    Reporting group description
    		 Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

    Reporting group values
    		 Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention Total
    Number of subjects
    		 102 101 203
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 102 101 203
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.86 ± 1.49 15.66 ± 1.52 -
    Gender, Male/Female
    Units: participants
        Female
    		 50 47 97
        Male
    		 52 54 106
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 15 9 24
        Not Hispanic or Latino
    		 87 92 179
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 2 1 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 12 14 26
        White
    		 84 80 164
        More than one race
    		 4 5 9
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Germany
    		 2 1 3
        Poland
    		 6 12 18
        Russian Federation
    		 28 27 55
        United States
    		 53 54 107
        Puerto Rico
    		 13 7 20

    End points

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    End points reporting groups
    Reporting group title
    Olanzapine/standard behavioral weight intervention
    Reporting group description
    		 Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only

    Reporting group title
    Olanzapine/intense behavioral weight intervention
    Reporting group description
    		 Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits

    Primary: Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants

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    End point title
    		 Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention
    Number of subjects analysed
    102 [1]
    101 [2]
    Units: kilograms per meter squared (kg/m^2)
        least squares mean (standard error)
    3.64 ± 0.39
    2.83 ± 0.4
    Notes
    [1] - Randomized subjects who received ≥ 1 dose of study drug. Mixed model repeated measures (MMRM)
    [2] - Randomized subjects who received ≥ 1 dose of study drug. Mixed model repeated measures (MMRM)
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 1
    Comparison groups
    Olanzapine/intense behavioral weight intervention v Olanzapine/standard behavioral weight intervention
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.15
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [3] - Mixed model repeated measures analysis terms included baseline BMI, baseline age, gender, intervention group, visit, region, intervention group*visit.

    Secondary: Mean change from baseline to Endpoint in Body Mass Index (BMI) for participants with duration of treatment of at least 6 months

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    End point title
    		 Mean change from baseline to Endpoint in Body Mass Index (BMI) for participants with duration of treatment of at least 6 months
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention
    Number of subjects analysed
    54 [4]
    55 [5]
    Units: kg/m^2
        least squares mean (standard error)
    3.36 ± 0.41
    2.99 ± 0.4
    Notes
    [4] - Received ≥ 1 dose of study drug with ≥ 6 months data. Last observation carried forward (LOCF)
    [5] - Received ≥ 1 dose of study drug with ≥ 6 months data. Last observation carried forward (LOCF)
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 2
    Comparison groups
    Olanzapine/intense behavioral weight intervention v Olanzapine/standard behavioral weight intervention
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.52
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [6] - ANCOVA model terms included: baseline, baseline age, gender, intervention group, and region.

    Secondary: Time to event for 7%, 15%, and 25% weight gain for all participants

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    End point title
    		 Time to event for 7%, 15%, and 25% weight gain for all participants
    End point description
    Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set). 65 participants (32%; 34% in Standard Group [SG], 30% in Intense Group [IG]) did not meet 7% weight gain criterion [WGC] by the time they discontinued. 122 participants (60%; 58% in SG, 62% in IG) did not meet 15% WGC by the time they discontinued. 161 participants (79%; 76% in SG, 82% in IG) did not meet 25% WGC by the time they discontinued.
    End point type
    Secondary
    End point timeframe
    Baseline up to 52 weeks
    End point values
    		 Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention
    Number of subjects analysed
    102 [7]
    101 [8]
    Units: days
    median (confidence interval 95%)
        Time to First 7% Weight Gain
    57 (44 to 84)
    57 (44 to 84)
        Time to First 15% Weight Gain
    197 (140 to 359)
    198 (141 to 999999)
        Time to First 25% Weight Gain
    999999 (999999 to 999999)
    99999999 (99999999 to 99999999)
    Notes
    [7] - Insufficient # of events of 25% weight gain in the Standard group to compute.
    [8] - Insufficient # of events of 15% and 25% weight gain in the Intense group to compute.
    No statistical analyses for this end point

    Secondary: Mean change from baseline to 52 weeks in Adolescent Structured YoungMania Rating Scale (YMRS) for participants with Bipolar I disorder

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    End point title
    		 Mean change from baseline to 52 weeks in Adolescent Structured YoungMania Rating Scale (YMRS) for participants with Bipolar I disorder
    End point description
    The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe).
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention
    Number of subjects analysed
    58 [9]
    58 [10]
    Units: units on a scale
        least squares mean (standard error)
    -17.66 ± 1.75
    -12.05 ± 1.92
    Notes
    [9] - Subjects with bipolar I disorder, who received ≥ 1 dose of study drug. MMRM used
    [10] - Subjects with bipolar I disorder, who received ≥ 1 dose of study drug. MMRM used
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 4
    Comparison groups
    Olanzapine/standard behavioral weight intervention v Olanzapine/intense behavioral weight intervention
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.008
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [11] - MMRM analysis terms included baseline, intervention group, visit, region, and intervention group visit.

    Secondary: Mean Clinical Global Impression of Improvement (CGI-I) at 52 weeks for All Participants

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    End point title
    		 Mean Clinical Global Impression of Improvement (CGI-I) at 52 weeks for All Participants
    End point description
    The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse).
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention
    Number of subjects analysed
    102 [12]
    101 [13]
    Units: units on a scale
        least squares mean (standard error)
    2.04 ± 0.15
    2.29 ± 0.16
    Notes
    [12] - Subjects who received ≥ 1 dose of study drug. MMRM used
    [13] - Subjects who received ≥ 1 dose of study drug. MMRM used
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 5
    Comparison groups
    Olanzapine/intense behavioral weight intervention v Olanzapine/standard behavioral weight intervention
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [14]
    P-value
    		 = 0.266
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [14] - MMRM analysis terms included intervention group, visit, region, and intervention group visit.

    Secondary: Mean change from baseline to 52 weeks in waist circumference for all participants

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    End point title
    		 Mean change from baseline to 52 weeks in waist circumference for all participants
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention
    Number of subjects analysed
    102 [15]
    101 [16]
    Units: centimeters (cm)
        least squares mean (standard error)
    7.22 ± 1.06
    7.31 ± 1.11
    Notes
    [15] - Subjects who received ≥ 1 dose of study drug.
    [16] - Subjects who received ≥ 1 dose of study drug.
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 6
    Comparison groups
    Olanzapine/intense behavioral weight intervention v Olanzapine/standard behavioral weight intervention
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.954
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [17] - MMRM analysis terms included baseline, baseline age, gender, intervention group, visit, region, and intervention group visit.

    Secondary: Mean change from baseline to 52 weeks in Clinical Global Impression - Severity (CGI-S) for All Participants

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    End point title
    		 Mean change from baseline to 52 weeks in Clinical Global Impression - Severity (CGI-S) for All Participants
    End point description
    The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention
    Number of subjects analysed
    102 [18]
    101 [19]
    Units: units on a scale
        least squares mean (standard error)
    -2.06 ± 0.14
    -1.74 ± 0.14
    Notes
    [18] - Subjects who received ≥ 1 dose of study drug. MMRM used
    [19] - Subjects who received ≥ 1 dose of study drug. MMRM used
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 7
    Comparison groups
    Olanzapine/intense behavioral weight intervention v Olanzapine/standard behavioral weight intervention
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [20]
    P-value
    		 = 0.103
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [20] - MMRM analysis terms included baseline, intervention group, visit, region, and intervention group*visit.

    Secondary: Mean change from baseline to 52 weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for participants with schizophrenia

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    End point title
    		 Mean change from baseline to 52 weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for participants with schizophrenia
    End point description
    The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 Olanzapine/standard behavioral weight intervention Olanzapine/intense behavioral weight intervention
    Number of subjects analysed
    44 [21]
    43 [22]
    Units: units on a scale
        least squares mean (standard error)
    -28 ± 2.83
    -30.96 ± 2.67
    Notes
    [21] - Subjects with schizophrenia who received ≥ 1 dose of study drug. MMRM used
    [22] - Subjects with schizophrenia who received ≥ 1 dose of study drug. MMRM used
    Statistical analysis title
    		 Statistical Analysis 1 for End Point 8
    Comparison groups
    Olanzapine/standard behavioral weight intervention v Olanzapine/intense behavioral weight intervention
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    P-value
    		 = 0.436
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [23] - MMRM analysis terms included baseline, intervention group, visit, region, and intervention group visit.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    F1D-MC-HGMX
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Olanzapine/intense behavioral weight intervention
    Reporting group description
    		 -

    Reporting group title
    Olanzapine/standard behavioral weight intervention
    Reporting group description
    		 -

    Serious adverse events
    		 Olanzapine/intense behavioral weight intervention Olanzapine/standard behavioral weight intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 101 (19.80%)
    13 / 102 (12.75%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    acetabulum fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clavicle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    craniocerebral injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    facial bones fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    humerus fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    jaw fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    multiple injuries
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    traumatic liver injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    traumatic lung injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    neuroleptic malignant syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    irritability
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastroduodenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    pneumothorax
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    abnormal behaviour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aggression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bipolar i disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bipolar disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    drug abuse
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hallucination, auditory
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mental disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    psychotic disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    schizophrenia, paranoid type
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    schizophrenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    3 / 102 (2.94%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    gastroenteritis viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Olanzapine/intense behavioral weight intervention Olanzapine/standard behavioral weight intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 101 (80.20%)
    81 / 102 (79.41%)
    Vascular disorders
    haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    cyst removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    wisdom teeth removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Pregnancy, puerperium and perinatal conditions
    pregnancy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [1]
    1 / 47 (2.13%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    3 / 102 (2.94%)
         occurrences all number
    2
    3
    chills
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
         occurrences all number
    2
    2
    chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 101 (5.94%)
    9 / 102 (8.82%)
         occurrences all number
    6
    10
    gait disturbance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    influenza like illness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    irritability
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    5 / 102 (4.90%)
         occurrences all number
    5
    5
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    2
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    4 / 102 (3.92%)
         occurrences all number
    3
    4
    thirst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Immune system disorders
    seasonal allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
         occurrences all number
    3
    2
    Reproductive system and breast disorders
    amenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [2]
    1 / 47 (2.13%)
    2 / 50 (4.00%)
         occurrences all number
    1
    2
    breast pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    breast enlargement
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    dysmenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [3]
    1 / 47 (2.13%)
    3 / 50 (6.00%)
         occurrences all number
    4
    18
    menstruation irregular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [4]
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    metrorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [5]
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    premenstrual cramps
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [6]
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    7 / 102 (6.86%)
         occurrences all number
    5
    8
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    epistaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 101 (4.95%)
    2 / 102 (1.96%)
         occurrences all number
    6
    2
    nasal congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    4 / 102 (3.92%)
         occurrences all number
    4
    4
    oropharyngeal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    4 / 102 (3.92%)
         occurrences all number
    5
    4
    pharyngeal inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    respiratory disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    respiratory tract congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    rhinorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    sinus congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    throat tightness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Psychiatric disorders
    abnormal behaviour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    affect lability
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    affective disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    aggression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    1 / 102 (0.98%)
         occurrences all number
    3
    1
    agitation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    anhedonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    anxiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    6 / 102 (5.88%)
         occurrences all number
    4
    6
    delusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    2
    depressed mood
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
         occurrences all number
    2
    2
    dermatillomania
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    distractibility
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    dysphoria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    emotional distress
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    emotional poverty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    hallucination, visual
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    hallucination
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    impulsive behaviour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    initial insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 101 (4.95%)
    5 / 102 (4.90%)
         occurrences all number
    5
    6
    intentional self-injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    4 / 102 (3.92%)
         occurrences all number
    1
    5
    middle insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    mood altered
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    mood swings
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    nightmare
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    obsessive thoughts
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    panic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    psychotic disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    restlessness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    4 / 102 (3.92%)
         occurrences all number
    4
    4
    schizophrenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
         occurrences all number
    2
    2
    self injurious behaviour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    stereotypy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    thought blocking
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    tachyphrenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    3 / 102 (2.94%)
         occurrences all number
    3
    3
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 102 (2.94%)
         occurrences all number
    1
    3
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    blood cholesterol increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 101 (4.95%)
    7 / 102 (6.86%)
         occurrences all number
    6
    9
    blood glucose decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    blood glucose increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    blood iron decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    blood insulin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 101 (6.93%)
    10 / 102 (9.80%)
         occurrences all number
    7
    11
    blood insulin decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
         occurrences all number
    2
    2
    blood pressure increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    blood prolactin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    4 / 102 (3.92%)
         occurrences all number
    2
    4
    blood triglycerides increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 101 (4.95%)
    4 / 102 (3.92%)
         occurrences all number
    5
    5
    body mass index increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    body temperature increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 102 (2.94%)
         occurrences all number
    1
    4
    cardiac murmur
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    eosinophil count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 102 (2.94%)
         occurrences all number
    1
    3
    erythroblast morphology abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    glycosylated haemoglobin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    hepatic enzyme increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    heart rate increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    hepatitis c antibody positive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    liver function test abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    low density lipoprotein increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    3
    0
    neutrophil count decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    nitrite urine present
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    transaminases increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    waist circumference increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    weight increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    21 / 101 (20.79%)
    31 / 102 (30.39%)
         occurrences all number
    21
    31
    white blood cell count decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    concussion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    1 / 102 (0.98%)
         occurrences all number
    2
    1
    face injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    hand fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    intentional overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
         occurrences all number
    3
    2
    joint injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    laceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    ligament sprain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    3 / 102 (2.94%)
         occurrences all number
    0
    3
    limb injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    0 / 102 (0.00%)
         occurrences all number
    4
    0
    meniscus injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    nerve injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    scar
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    sunburn
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    wound
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    wrist fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    sinus tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    5 / 102 (4.90%)
         occurrences all number
    1
    5
    Nervous system disorders
    akathisia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    5 / 102 (4.90%)
         occurrences all number
    5
    6
    bradykinesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    convulsion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 102 (0.00%)
         occurrences all number
    3
    0
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    7 / 102 (6.86%)
         occurrences all number
    2
    7
    drooling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    dyskinesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 102 (1.96%)
         occurrences all number
    2
    2
    disturbance in attention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    extrapyramidal disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    3 / 102 (2.94%)
         occurrences all number
    2
    7
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    20 / 101 (19.80%)
    19 / 102 (18.63%)
         occurrences all number
    30
    49
    head titubation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    hypersomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    4 / 102 (3.92%)
         occurrences all number
    2
    5
    lethargy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    migraine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    petit mal epilepsy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    restless legs syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    sedation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    8 / 102 (7.84%)
         occurrences all number
    5
    8
    somnolence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    24 / 101 (23.76%)
    19 / 102 (18.63%)
         occurrences all number
    28
    22
    tremor
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 101 (4.95%)
    3 / 102 (2.94%)
         occurrences all number
    5
    3
    Blood and lymphatic system disorders
    agranulocytosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    leukopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    2 / 102 (1.96%)
         occurrences all number
    4
    2
    lymphadenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    lymphocytosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    lymphadenopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    neutropenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    ear disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    ear pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    external ear disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    vertigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Eye disorders
    blepharospasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    conjunctivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    eye discharge
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    eye haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    lacrimation increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    5 / 102 (4.90%)
         occurrences all number
    4
    5
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    abdominal discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    4 / 102 (3.92%)
         occurrences all number
    0
    6
    abnormal faeces
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    anal fissure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    constipation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    1 / 102 (0.98%)
         occurrences all number
    4
    1
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    5 / 102 (4.90%)
         occurrences all number
    5
    6
    dry mouth
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    6 / 102 (5.88%)
         occurrences all number
    4
    6
    dysphagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    dyspepsia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    3 / 102 (2.94%)
         occurrences all number
    2
    3
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    glossitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    lip disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    3 / 102 (2.94%)
         occurrences all number
    4
    3
    salivary hypersecretion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    toothache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 102 (2.94%)
         occurrences all number
    1
    3
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    7 / 102 (6.86%)
         occurrences all number
    7
    8
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    4 / 102 (3.92%)
         occurrences all number
    1
    4
    alopecia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    hyperhidrosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    pruritus generalised
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 102 (2.94%)
         occurrences all number
    1
    5
    seborrhoeic dermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    skin irritation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    urticaria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    dysuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    enuresis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    pollakiuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    back pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 102 (1.96%)
         occurrences all number
    1
    2
    joint stiffness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    medial tibial stress syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    muscle rigidity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    muscle spasms
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    1 / 102 (0.98%)
         occurrences all number
    3
    1
    musculoskeletal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    2 / 102 (1.96%)
         occurrences all number
    3
    2
    myalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    pain in extremity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    Infections and infestations
    acute tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    bacterial infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 101 (3.96%)
    3 / 102 (2.94%)
         occurrences all number
    5
    3
    chronic tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    cystitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    ear infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    1 / 102 (0.98%)
         occurrences all number
    2
    1
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    2
    gastroenteritis rotavirus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    gastroenteritis viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 102 (2.94%)
         occurrences all number
    1
    3
    herpes zoster
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    influenza
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    3 / 102 (2.94%)
         occurrences all number
    2
    3
    localised infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 101 (10.89%)
    14 / 102 (13.73%)
         occurrences all number
    11
    16
    otitis externa
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    pharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
         occurrences all number
    1
    1
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    4 / 102 (3.92%)
         occurrences all number
    1
    4
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    respiratory tract infection viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    1 / 102 (0.98%)
         occurrences all number
    2
    1
    sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 102 (2.94%)
         occurrences all number
    1
    4
    tinea pedis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    4 / 102 (3.92%)
         occurrences all number
    2
    4
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 101 (2.97%)
    2 / 102 (1.96%)
         occurrences all number
    3
    3
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [7]
    0 / 47 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
         occurrences all number
    2
    2
    hypercholesterolaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences all number
    2
    0
    hyperinsulinaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    hyperlipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    0
    2
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
         occurrences all number
    2
    2
    increased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    13 / 101 (12.87%)
    16 / 102 (15.69%)
         occurrences all number
    14
    16
    insulin resistance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    0
    1
    obesity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
         occurrences all number
    2
    2
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

    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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