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    Clinical Trial Results:
    Multicenter, Open-Label, Safety, Tolerability, and Pharmacokinetic Study to Evaluate Single Ascending Doses and Subsequent Short-Term Administration of Fixed Doses of Desvenlafaxine Succinate Sustained-Release Tablets in the Treatment of Child and Adolescent Outpatients With Major Depressive Disorder.

    Summary
    EudraCT number
    		 2008-002066-57
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Nov 2009

    Results information
    Results version number
    		 v1
    This version publication date
    13 Jun 2016
    First version publication date
    31 Jul 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    3151A6-2000
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00619619
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias ID: B2061012
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Apr 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To investigate the safety and tolerability of single ascending doses of Desvenlafaxine Sustained Release (DVS SR) in children and adolescents with Major Depressive Disorder (MDD). 2) To characterize the Pharmacokinetics (PK) profile of single ascending doses of DVS SR in children and adolescents with MDD.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2008
    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
    United States: 59
    Worldwide total number of subjects
    59
    EEA total number of subjects
    0
    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)
    29
    Adolescents (12-17 years)
    30
    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
    		 Treatment to be given at only 1 dose level at a time for at least the first 6 subjects per dose group. Approximately 6 to 8 subjects were to be enrolled in each of the dose cohorts; 4 dose levels were to be evaluated per age stratum in sequential manner and ascending order (10 to 100 milligrams [mg] for children; 25 to 200 mg for adolescents).

    Pre-assignment
    Screening details
    		 Screening period 6 to 14 days followed by treatment period (up to 3.5 day inpatient and up to 7.5 week outpatient phase). Subjects who enter outpatient period but do not continue 6-month open-label extension study (NCT00669110 [2008-002067-14]) will participate in taper period of 0 to 2 weeks depending on dose of assigned study treatment.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Desvenlafaxine 10 mg Children
    Arm description
    		 Desvenlafaxine sustained release 10 mg tablet.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered Desvenlafaxine sustained release 10 mg tablet.

    Arm title
    		 Desvenlafaxine 25 mg Children
    Arm description
    		 Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.

    Arm title
    		 Desvenlafaxine 50 mg Children
    Arm description
    		 Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.

    Arm title
    		 Desvenlafaxine 100 mg Children
    Arm description
    		 Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.

    Arm title
    		 Desvenlafaxine 25 mg Adolescent
    Arm description
    		 Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.

    Arm title
    		 Desvenlafaxine 50 mg Adolescent
    Arm description
    		 Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.

    Arm title
    		 Desvenlafaxine 100 mg Adolescent
    Arm description
    		 Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.

    Arm title
    		 Desvenlafaxine 200 mg Adolescent
    Arm description
    		 Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desvenlafaxine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.

    Number of subjects in period 1
    		Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Started
    6
    7
    9
    7
    7
    7
    8
    8
    Entered the Extension Study
    6
    5 [1]
    8
    3 [2]
    7
    6 [3]
    6 [4]
    7
    Completed
    6
    7
    8
    6
    5
    7
    7
    5
    Not completed
    0
    0
    1
    1
    2
    0
    1
    3
         Physician decision
    -
    -
    1
    -
    -
    -
    -
    -
         Adverse Event
    -
    -
    -
    -
    2
    -
    -
    2
         Protocol Violation
    -
    -
    -
    1
    -
    -
    1
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects in this milestone represents those subjects who enter the extension study.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects in this milestone represents those subjects who enter the extension study.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects in this milestone represents those subjects who enter the extension study.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects in this milestone represents those subjects who enter the extension study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Desvenlafaxine 10 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 10 mg tablet.

    Reporting group title
    Desvenlafaxine 25 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.

    Reporting group title
    Desvenlafaxine 50 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 100 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 25 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.

    Reporting group title
    Desvenlafaxine 50 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 100 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 200 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.

    Reporting group values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent Total
    Number of subjects
    		 6 7 9 7 7 7 8 8 59
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.33 ± 1.33 9.57 ± 1.13 9.89 ± 1.27 9.71 ± 0.95 15 ± 1.83 13.14 ± 1.46 14.25 ± 1.67 14 ± 1.6 -
    Gender categorical
    Units: Subjects
        Female
    		 4 3 3 4 4 3 3 5 29
        Male
    		 2 4 6 3 3 4 5 3 30
    Children's Depression Ratings Scale- Revised (CDRS-R) total score
    CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.
    Units: scores on a scale
        arithmetic mean (standard deviation)
    		 57.5 ± 4.89 52.43 ± 5.13 49.89 ± 7.3 46.43 ± 4.35 64.86 ± 11.87 57.71 ± 1.98 57.88 ± 9.19 48.63 ± 6.25 -

    End points

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    End points reporting groups
    Reporting group title
    Desvenlafaxine 10 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 10 mg tablet.

    Reporting group title
    Desvenlafaxine 25 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.

    Reporting group title
    Desvenlafaxine 50 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 100 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 25 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.

    Reporting group title
    Desvenlafaxine 50 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 100 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 200 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.

    Subject analysis set title
    Desvenlafaxine – Combined Children Cohorts
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg children cohort dose levels.

    Subject analysis set title
    Desvenlafaxine – Combined Adolescent Cohorts
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg adolescent cohort dose levels.

    Subject analysis set title
    Desvenlafaxine - Combined Children and Adolescent Cohorts
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg children cohort dose levels and Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg adolescent cohort dose levels.

    Primary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect. Safety population includes all treatment-assigned subjects who have taken at least 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    Baseline to Follow-up (up to Day 77)
    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: Only descriptive data was planned to be reported.
    End point values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Number of subjects analysed
    6
    7
    9
    7
    7
    7
    8
    8
    Units: subjects
        Serious Adverse Events
    0
    0
    0
    0
    1
    0
    0
    0
        Non-serious Adverse Events
    1
    3
    3
    7
    4
    2
    7
    7
    No statistical analyses for this end point

    Primary: Maximum Observed Plasma Concentration (Cmax)

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) [2]
    End point description
    Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL). PK population: all subjects in the Safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.
    End point type
    Primary
    End point timeframe
    Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
    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: Only descriptive data was planned to be reported.
    End point values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Number of subjects analysed
    6
    7
    9
    7
    7
    7
    8
    8
    Units: ng/mL
        arithmetic mean (standard deviation)
    33.9 ± 12.1
    98 ± 60.5
    108 ± 27
    263 ± 66
    46.1 ± 15.9
    93.9 ± 15.5
    202 ± 92
    449 ± 126
    No statistical analyses for this end point

    Primary: Time to Reach Maximum Observed Plasma Concentration (Tmax)

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) [3]
    End point description
    Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr). PK population: all subjects in the safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.
    End point type
    Primary
    End point timeframe
    Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
    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: Only descriptive data was planned to be reported.
    End point values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Number of subjects analysed
    6
    7
    9
    7
    7
    7
    8
    8
    Units: hr
        arithmetic mean (standard deviation)
    4.7 ± 2.1
    4.3 ± 1.4
    5.1 ± 3
    5 ± 2
    4.3 ± 0.7
    8.7 ± 7.1
    7.6 ± 3.4
    7.5 ± 4.1
    No statistical analyses for this end point

    Primary: Plasma Decay Half-Life (t1/2)

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    End point title
    		 Plasma Decay Half-Life (t1/2) [4]
    End point description
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hr. PK population: all subjects in the safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.
    End point type
    Primary
    End point timeframe
    Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported.
    End point values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Number of subjects analysed
    6
    7
    9
    7
    7
    7
    8
    8
    Units: hr
        arithmetic mean (standard deviation)
    7.8 ± 1.4
    8.6 ± 1.6
    9.4 ± 2.7
    9 ± 2
    12 ± 3
    10.2 ± 3.7
    9.6 ± 2
    9.8 ± 2.7
    No statistical analyses for this end point

    Primary: Area Under the Curve From Time Zero to Infinity (AUC0-∞)

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    End point title
    		 Area Under the Curve From Time Zero to Infinity (AUC0-∞) [5]
    End point description
    AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL). PK population: all subjects in the safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.
    End point type
    Primary
    End point timeframe
    Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
    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: Only descriptive data was planned to be reported.
    End point values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Number of subjects analysed
    6
    7
    9
    7
    7
    7
    8
    8
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    628 ± 346
    1704 ± 553
    2414 ± 924
    6732 ± 3031
    1123 ± 361
    2281 ± 689
    5290 ± 2188
    11730 ± 3113
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method

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    End point title
    		 Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method
    End point description
    Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose ([ng*hr/mL]/mg of dose). PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 28, and Day 56
    End point values
    		 Desvenlafaxine – Combined Children Cohorts Desvenlafaxine – Combined Adolescent Cohorts
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: ng*hr/mL/mg of dose
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [6] - AUC/D values were not summarized as descriptive statistics.
    [7] - AUC/D values were not summarized as descriptive statistics.
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method

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    End point title
    		 Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method
    End point description
    Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose ([ng*hr/mL]/mg of dose). PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 28, and Day 56
    End point values
    		 Desvenlafaxine - Combined Children and Adolescent Cohorts
    Number of subjects analysed
    0 [8]
    Units: ng*hr/mL/mg of dose
        arithmetic mean (standard deviation)
    ±
    Notes
    [8] - AUC/D values were not summarized as descriptive statistics.
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score

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    End point title
    		 Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score
    End point description
    CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Intent To Treat (ITT): all treatment-assigned subjects with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after the first dose of study treatment.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
    End point values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Number of subjects analysed
    6
    7
    9
    7
    7
    7
    8
    8
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Inpatient Days 1 to 4
    -6.83 ± 6.15
    -9.86 ± 5.4
    -2.78 ± 3.07
    -6.43 ± 10
    -7 ± 18.18
    -4.57 ± 2.99
    -8.25 ± 4.33
    -10.38 ± 13.45
        Outpatient Days 5 to 7
    -10.67 ± 6.44
    -13.86 ± 8.51
    -10.44 ± 10.79
    -7.86 ± 8.28
    -8 ± 13.88
    -8.29 ± 4.27
    -9.5 ± 8.11
    -11.25 ± 14
        Outpatient Week 2
    -17.67 ± 6.92
    -18.86 ± 10.51
    -14.44 ± 12.68
    -9.57 ± 10.83
    -8.29 ± 13.46
    -11.29 ± 5.53
    -18.13 ± 11.12
    -13.13 ± 14.88
        Outpatient Week 3
    -19.67 ± 6.77
    -18.57 ± 7.93
    -16.89 ± 13.49
    -10.43 ± 9.11
    -11.71 ± 13.23
    -14.57 ± 6.19
    -21.25 ± 10.99
    -13.13 ± 11.47
        Outpatient Week 4
    -19.5 ± 6.5
    -20.86 ± 10.98
    -17.56 ± 15.99
    -10 ± 4.69
    -14.57 ± 14.06
    -19.43 ± 9.43
    -23.5 ± 10.69
    -12.5 ± 9.41
        Outpatient Week 5
    -19.5 ± 6.5
    -23 ± 8.56
    -19.56 ± 13.46
    -10.29 ± 4.39
    -14.57 ± 14.06
    -19.43 ± 9.43
    -23.88 ± 10.36
    -12.5 ± 9.41
        Outpatient Week 6
    -21.83 ± 6.77
    -19.86 ± 9.94
    -18.44 ± 13.79
    -12 ± 5.48
    -20.57 ± 18.98
    -17.14 ± 6.2
    -24.63 ± 8.99
    -14.38 ± 9.93
        Outpatient Week 7
    -21.83 ± 6.77
    -20.43 ± 10.06
    -19.11 ± 13.2
    -12 ± 5.48
    -20.57 ± 18.98
    -17.14 ± 6.2
    -25.38 ± 7.87
    -14.5 ± 9.89
        Outpatient Week 8
    -22 ± 7.01
    -20.29 ± 7.18
    -19.78 ± 14.49
    -14.14 ± 6.52
    -21.43 ± 19.86
    -22.29 ± 3.09
    -27.25 ± 6.78
    -15.38 ± 8.65
        Outpatient Week >8
    -22 ± 7.01
    -20 ± 7.05
    19.89 ± 14.51
    -14.14 ± 6.52
    -21.43 ± 19.86
    -22.29 ± 3.09
    -26.75 ± 7.42
    -15.38 ± 8.65
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score

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    End point title
    		 Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score
    End point description
    HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states. ITT: all treatment-assigned subjects with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after the first dose of study treatment.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
    End point values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Number of subjects analysed
    6
    7
    9
    7
    7
    7
    8
    8
    Units: score on a scale
    arithmetic mean (standard deviation)
        Inpatient Days 1 to 4
    -6 ± 5.73
    -5.43 ± 4.31
    -0.33 ± 1.94
    -2.43 ± 6.92
    -2.29 ± 7.45
    -0.57 ± 1.13
    -1.5 ± 4.54
    -5.63 ± 7.42
        Outpatient Days 5 to 7
    -6 ± 5.73
    -5.43 ± 4.31
    -0.33 ± 1.94
    -2.43 ± 6.92
    -2 ± 7.59
    -0.57 ± 1.13
    -1.5 ± 4.54
    -5.63 ± 7.42
        Outpatient Week 2
    -9.33 ± 7
    -10.71 ± 4.61
    -6.11 ± 2.67
    -5.57 ± 4.2
    -2.71 ± 4.27
    -5.71 ± 3.4
    -8.13 ± 4.91
    -9.38 ± 7.41
        Outpatient Week 3
    -9.33 ± 7
    -10.29 ± 5.41
    -6.11 ± 2.67
    -5.57 ± 4.2
    -2.71 ± 4.27
    -5.71 ± 3.4
    -8.13 ± 4.91
    -8.88 ± 6.33
        Outpatient Week 4
    -11 ± 5.62
    -13 ± 6.3
    -7.22 ± 5.61
    -7.57 ± 3.05
    -7.29 ± 5.19
    -7.57 ± 2.99
    -12.13 ± 5.69
    -9 ± 5.24
        Outpatient Week 5
    -11 ± 5.62
    -14.14 ± 4.1
    -7.56 ± 5.64
    -9 ± 1.91
    -7.29 ± 5.19
    -7.57 ± 2.99
    -12.25 ± 5.73
    -9 ± 5.24
        Outpatient Week 8
    -12.17 ± 6.01
    -14 ± 4.62
    -8.44 ± 6.88
    -11.14 ± 4.14
    -11.14 ± 9.56
    -9.86 ± 3.93
    -14.25 ± 3.96
    -11.63 ± 5.4
        Outpatient Week >8
    -12.17 ± 6.01
    -13.86 ± 4.81
    -9.11 ± 6.68
    -11.14 ± 4.14
    -11.14 ± 9.56
    -9.86 ± 3.93
    -13 ± 5.37
    -11.63 ± 5.4
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With a Categorical Clinical Global Impressions Scale- Severity (CGI-S) Score at Every Visit

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    End point title
    		 Percentage of Subjects With a Categorical Clinical Global Impressions Scale- Severity (CGI-S) Score at Every Visit
    End point description
    CGI-S: 7-point clinician rated scale to assess severity of subjects current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. ITT; no subjects had a CGI-S score of 6 or 7, therefore only scores 1 through 5 are reported.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
    End point values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Number of subjects analysed
    6
    7
    9
    7
    7
    7
    8
    8
    Units: percentage of subjects
    number (not applicable)
        Inpatient Days 1 to 4: not ill at all
    0
    0
    0
    0
    0
    0
    0
    0
        Inpatient Days 1 to 4: borderline ill
    0
    0
    0
    0
    0
    0
    0
    0
        Inpatient Days 1 to 4: mildly ill
    0
    0
    0
    14.3
    0
    0
    0
    12.5
        Inpatient Days 1 to 4: moderately ill
    100
    100
    88.9
    85.7
    100
    100
    100
    87.5
        Inpatient Days 1 to 4: markedly ill
    0
    0
    11.1
    0
    0
    0
    0
    0
        Outpatient Days 5 to 7: not ill at all
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Days 5 to 7: borderline ill
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Days 5 to 7: mildly ill
    0
    42.9
    44.4
    0
    0
    14.3
    0
    12.5
        Outpatient Days 5 to 7: moderately ill
    100
    57.1
    55.6
    100
    100
    85.7
    100
    87.5
        Outpatient Days 5 to 7: markedly ill
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 2: not ill at all
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 2: borderline ill
    0
    14.3
    11.1
    0
    0
    0
    0
    0
        Outpatient Week 2: mildly ill
    66.7
    57.1
    55.6
    0
    0
    28.6
    50
    12.5
        Outpatient Week 2: moderately ill
    33.3
    28.6
    33.3
    100
    100
    71.4
    50
    87.5
        Outpatient Week 2: markedly ill
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 3: not ill at all
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 3: borderline ill
    0
    57.1
    0
    0
    0
    0
    25
    0
        Outpatient Week 3: mildly ill
    66.7
    42.9
    88.9
    0
    28.6
    57.1
    37.5
    12.5
        Outpatient Week 3: moderately ill
    33.3
    0
    11.1
    100
    71.4
    42.9
    37.5
    87.5
        Outpatient Week 3: markedly ill
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 4: not ill at all
    0
    14.3
    0
    0
    0
    0
    0
    0
        Outpatient Week 4: borderline ill
    16.7
    57.1
    11.1
    0
    0
    0
    50
    0
        Outpatient Week 4: mildly ill
    66.7
    28.6
    66.7
    14.3
    28.6
    85.7
    12.5
    37.5
        Outpatient Week 4: moderately ill
    16.7
    0
    22.2
    85.7
    71.4
    14.3
    37.5
    62.5
        Outpatient Week 4: markedly ill
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 5: not ill at all
    0
    14.3
    11.1
    0
    0
    0
    0
    0
        Outpatient Week 5: borderline ill
    16.7
    57.1
    11.1
    0
    0
    0
    50
    0
        Outpatient Week 5: mildly ill
    66.7
    28.6
    55.6
    14.3
    28.6
    85.7
    12.5
    37.5
        Outpatient Week 5: moderately ill
    16.7
    0
    22.2
    85.7
    71.4
    14.3
    37.5
    62.5
        Outpatient Week 5: markedly ill
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 6: not ill at all
    0
    0
    11.1
    0
    0
    0
    0
    0
        Outpatient Week 6: borderline ill
    50
    57.1
    11.1
    0
    0
    14.3
    62.5
    0
        Outpatient Week 6: mildly ill
    50
    42.9
    66.7
    28.6
    57.1
    57.1
    12.5
    50
        Outpatient Week 6: moderately ill
    0
    0
    11.1
    71.4
    42.9
    28.6
    25
    50
        Outpatient Week 6: markedly ill
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 7: not ill at all
    0
    0
    11.1
    0
    0
    0
    0
    0
        Outpatient Week 7: borderline ill
    50
    42.9
    11.1
    0
    0
    14.3
    62.5
    0
        Outpatient Week 7: mildly ill
    50
    57.1
    77.8
    28.6
    57.1
    57.1
    25
    50
        Outpatient Week 7: moderately ill
    0
    0
    0
    71.4
    42.9
    28.6
    12.5
    50
        Outpatient Week 7: markedly ill
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 8: not ill at all
    0
    0
    11.1
    0
    0
    0
    12.5
    0
        Outpatient Week 8: borderline ill
    66.7
    42.9
    22.2
    0
    0
    28.6
    50
    0
        Outpatient Week 8: mildly ill
    33.3
    57.1
    66.7
    71.4
    57.1
    71.4
    25
    62.5
        Outpatient Week 8: moderately ill
    0
    0
    0
    28.6
    42.9
    0
    12.5
    37.5
        Outpatient Week 8: markedly ill
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week >8: not ill at all
    0
    0
    11.1
    0
    0
    0
    12.5
    0
        Outpatient Week >8: borderline ill
    66.7
    57.1
    33.3
    0
    0
    28.6
    50
    0
        Outpatient Week >8: mildly ill
    33.3
    42.9
    55.6
    71.4
    57.1
    71.4
    25
    62.5
        Outpatient Week >8: moderately ill
    0
    0
    0
    28.6
    42.9
    0
    12.5
    37.5
        Outpatient Week >8: markedly ill
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects With a Categorical Clinical Global Impressions Scale- Improvement (CGI-I) Score at Every Visit

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    End point title
    		 Percentage of Subjects With a Categorical Clinical Global Impressions Scale- Improvement (CGI-I) Score at Every Visit
    End point description
    CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline. ITT; no subjects had a CGI-I score of 6 or 7, therefore only scores 1 through 5 are reported.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)
    End point values
    		 Desvenlafaxine 10 mg Children Desvenlafaxine 25 mg Children Desvenlafaxine 50 mg Children Desvenlafaxine 100 mg Children Desvenlafaxine 25 mg Adolescent Desvenlafaxine 50 mg Adolescent Desvenlafaxine 100 mg Adolescent Desvenlafaxine 200 mg Adolescent
    Number of subjects analysed
    6
    7
    9
    7
    7
    7
    8
    8
    Units: percentage of subjects
    number (not applicable)
        Inpatient Days 1 to 4: very much improved
    0
    0
    0
    0
    0
    0
    0
    0
        Inpatient Days 1 to 4: much improved
    0
    0
    0
    14.3
    14.3
    0
    0
    12.5
        Inpatient Days 1 to 4: minimally improved
    0
    0
    11.1
    0
    0
    0
    12.5
    37.5
        Inpatient Days 1 to 4: no change
    100
    100
    88.9
    85.7
    85.7
    100
    87.5
    50
        Inpatient Days 1 to 4: minimally worse
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Days 5 to 7: very much improved
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Days 5 to 7: much improved
    0
    14.3
    11.1
    0
    0
    0
    0
    12.5
        Outpatient Days 5 to 7: minimally improved
    50
    14.3
    55.6
    42.9
    42.9
    57.1
    25
    25
        Outpatient Days 5 to 7: no change
    50
    71.4
    33.3
    57.1
    57.1
    42.9
    75
    62.5
        Outpatient Days 5 to 7: minimally worse
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 2: very much improved
    0
    0
    11.1
    0
    0
    0
    0
    0
        Outpatient Week 2: much improved
    33.3
    28.6
    44.4
    14.3
    0
    0
    0
    25
        Outpatient Week 2: minimally improved
    50
    42.9
    11.1
    42.9
    42.9
    57.1
    75
    50
        Outpatient Week 2: no change
    16.7
    28.6
    33.3
    42.9
    57.1
    42.9
    25
    25
        Outpatient Week 2: minimally worse
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 3: very much improved
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 3: much improved
    50
    85.7
    44.4
    14.3
    28.6
    0
    37.5
    25
        Outpatient Week 3: minimally improved
    50
    14.3
    44.4
    57.1
    57.1
    71.4
    37.5
    62.5
        Outpatient Week 3: no change
    0
    0
    11.1
    28.6
    14.3
    28.6
    25
    12.5
        Outpatient Week 3: minimally worse
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 4: very much improved
    0
    14.3
    0
    0
    0
    0
    0
    0
        Outpatient Week 4: much improved
    50
    71.4
    55.6
    28.6
    28.6
    0
    50
    37.5
        Outpatient Week 4: minimally improved
    50
    14.3
    22.2
    57.1
    57.1
    85.7
    37.5
    37.5
        Outpatient Week 4: no change
    0
    0
    11.1
    14.3
    14.3
    14.3
    12.5
    12.5
        Outpatient Week 4: minimally worse
    0
    0
    11.1
    0
    0
    0
    0
    12.5
        Outpatient Week 5: very much improved
    0
    14.3
    11.1
    0
    0
    0
    0
    0
        Outpatient Week 5: much improved
    50
    85.7
    55.6
    28.6
    28.6
    0
    50
    37.5
        Outpatient Week 5: minimally improved
    50
    0
    22.2
    71.4
    57.1
    85.7
    37.5
    37.5
        Outpatient Week 5: no change
    0
    0
    0
    0
    14.3
    14.3
    12.5
    12.5
        Outpatient Week 5: minimally worse
    0
    0
    11.1
    0
    0
    0
    0
    12.5
        Outpatient Week 6: very much improved
    0
    14.3
    11.1
    0
    0
    0
    0
    0
        Outpatient Week 6: much improved
    50
    57.1
    66.7
    28.6
    57.1
    71.4
    75
    50
        Outpatient Week 6: minimally improved
    50
    28.6
    22.2
    71.4
    28.6
    28.6
    12.5
    25
        Outpatient Week 6: no change
    0
    0
    0
    0
    14.3
    0
    12.5
    25
        Outpatient Week 6: minimally worse
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 7: very much improved
    0
    14.3
    11.1
    0
    0
    0
    0
    0
        Outpatient Week 7: much improved
    50
    42.9
    55.6
    28.6
    57.1
    71.4
    75
    50
        Outpatient Week 7: minimally improved
    50
    42.9
    33.3
    71.4
    28.6
    28.6
    12.5
    37.5
        Outpatient Week 7: no change
    0
    0
    0
    0
    14.3
    0
    12.5
    12.5
        Outpatient Week 7: minimally worse
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week 8: very much improved
    0
    14.3
    22.2
    0
    0
    0
    12.5
    0
        Outpatient Week 8: much improved
    83.3
    71.4
    22.2
    71.4
    57.1
    71.4
    75
    62.5
        Outpatient Week 8: minimally improved
    16.7
    14.3
    55.6
    28.6
    28.6
    28.6
    0
    37.5
        Outpatient Week 8: no change
    0
    0
    0
    0
    14.3
    0
    12.5
    0
        Outpatient Week 8: minimally worse
    0
    0
    0
    0
    0
    0
    0
    0
        Outpatient Week >8: very much improved
    0
    14.3
    22.2
    0
    0
    0
    12.5
    0
        Outpatient Week >8: much improved
    83.3
    71.4
    33.3
    71.4
    57.1
    71.4
    75
    62.5
        Outpatient Week >8: minimally improved
    16.7
    14.3
    44.4
    28.6
    28.6
    28.6
    0
    37.5
        Outpatient Week >8: no change
    0
    0
    0
    0
    14.3
    0
    12.5
    0
        Outpatient Week >8: minimally worse
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Day 77
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events.An event may be categorized as serious in 1 subject and as non-serious in another, or 1 subject may have experienced both serious, non-serious event during study. EU BR specific AE tables were generated separately as per EU format using latest coding.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Desvenlafaxine 25 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.

    Reporting group title
    Desvenlafaxine 10 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 10 milligram (mg) tablet.

    Reporting group title
    Desvenlafaxine 50 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 50 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 200 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 25 mg Adolescent
    Reporting group description
    		 Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.

    Reporting group title
    Desvenlafaxine 100 mg Children
    Reporting group description
    		 Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.

    Reporting group title
    Desvenlafaxine 100 mg Adolescent
    Reporting group description
    		 DesvenlafaDesvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.

    Serious adverse events
    		 Desvenlafaxine 25 mg Children Desvenlafaxine 10 mg Children Desvenlafaxine 50 mg Adolescent Desvenlafaxine 50 mg Children Desvenlafaxine 200 mg Adolescent Desvenlafaxine 25 mg Adolescent Desvenlafaxine 100 mg Children Desvenlafaxine 100 mg Adolescent
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Psychiatric disorders
    Suicidal behaviour
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Desvenlafaxine 25 mg Children Desvenlafaxine 10 mg Children Desvenlafaxine 50 mg Adolescent Desvenlafaxine 50 mg Children Desvenlafaxine 200 mg Adolescent Desvenlafaxine 25 mg Adolescent Desvenlafaxine 100 mg Children Desvenlafaxine 100 mg Adolescent
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    3 / 9 (33.33%)
    8 / 8 (100.00%)
    4 / 7 (57.14%)
    7 / 7 (100.00%)
    7 / 8 (87.50%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Feeling jittery
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Infusion site extravasation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    3
    0
    Nasal congestion
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    4
    0
    Sinus congestion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    3
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Asthma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    4
    Investigations
    Heart rate increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Intentional overdose
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    3 / 7 (42.86%)
    2 / 8 (25.00%)
         occurrences all number
    0
    1
    2
    6
    1
    2
    3
    2
    Somnolence
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 9 (11.11%)
    4 / 8 (50.00%)
    2 / 7 (28.57%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    2
    10
    4
    3
    3
    Nerve compression
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 9 (22.22%)
    2 / 8 (25.00%)
    2 / 7 (28.57%)
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    2
    2
    2
    2
    0
    Constipation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    Nausea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 9 (11.11%)
    5 / 8 (62.50%)
    1 / 7 (14.29%)
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    1
    8
    1
    4
    0
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    2
    8
    0
    5
    0
    Diarrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Faeces discoloured
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    Rash
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    0
    Skin irritation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Muscle spasms
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Infectious mononucleosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 May 2008
    The Laboratory Determinations section was updated to reflect that additional UDS testing for known therapeutic drug(s) may be completed during the study, at the discretion of the investigator.
    07 Apr 2009
    The protocol was primarily updated to study 2 additional dose cohorts: 100 mg DVS SR in subjects in the child age stratum and 200 mg DVS SR in subjects in the adolescent age stratum. As a result of this change, dosing and test article information throughout the protocol has been updated. Additionally, the total number of planned subjects and study duration information were 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.
    None reported
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