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    Clinical Trial Results:
    A Double-blind, Randomized, Stratified Multi-center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza

    Summary
    EudraCT number
    		 2006-002468-24
    Trial protocol
    		 GB   ES   FR   BE   HU   LT   CZ   EE   IT   GR   BG   LV   DE  
    Global end of trial date
    02 May 2017

    Results information
    Results version number
    		 v1
    This version publication date
    16 Nov 2017
    First version publication date
    16 Nov 2017
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    NV20234
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00545532
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000365-PIP08-08
    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
    02 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised subjects and characterize the effects of oseltamivir in immunocompromised subjects on the development of resistant influenza virus.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Feb 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Lithuania: 24
    Country: Number of subjects enrolled
    Latvia: 15
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Estonia: 2
    Country: Number of subjects enrolled
    Ukraine: 2
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    United States: 41
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    South Africa: 40
    Country: Number of subjects enrolled
    Argentina: 10
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Chile: 2
    Country: Number of subjects enrolled
    Guatemala: 2
    Country: Number of subjects enrolled
    Belgium: 30
    Country: Number of subjects enrolled
    Israel: 16
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Spain: 3
    Worldwide total number of subjects
    215
    EEA total number of subjects
    91
    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)
    9
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    180
    From 65 to 84 years
    18
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Immunocompromised subjects with primary or secondary immunodeficiency and symptoms suggestive of influenza-like illness were recruited for this study.

    Pre-assignment
    Screening details
    		 Rapid diagnostic test, polymerase chain reaction (PCR), or viral culture had to be positive for influenza in the 96 hours prior to first dose. Subject disposition and baseline characteristics are provided for the safety population.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Data analyst, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental: Conventional dose
    Arm description
    		 Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=13 years old) or placebo-matched to oseltamivir twice daily over 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    oseltamivir
    Investigational medicinal product code
    Other name
    Tamiflu
    Pharmaceutical forms
    Capsule, Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Dose ranging between 30 to 75 milligrams (mg) orally administered as syrup or capsules (depending on participants age and weight) twice daily for 10 days.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to oseltamivir administered orally twice daily for 10 days.

    Arm title
    		 Experimental: Double dose
    Arm description
    		 Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    oseltamivir
    Investigational medicinal product code
    Other name
    Tamiflu
    Pharmaceutical forms
    Capsule, Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Dose ranging between 60 to 150 mg orally administered as syrup or capsules (depending on participants age and weight) twice daily for 10 days.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to oseltamivir administered orally twice daily for 10 days.

    Number of subjects in period 1
    		Experimental: Conventional dose Experimental: Double dose
    Started
    105
    110
    Completed
    99
    100
    Not completed
    6
    10
         Death
    -
    1
         Withdrawal by Subject
    1
    3
         Lost to follow-up
    5
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental: Conventional dose
    Reporting group description
    		 Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=13 years old) or placebo-matched to oseltamivir twice daily over 10 days.

    Reporting group title
    Experimental: Double dose
    Reporting group description
    		 Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.

    Reporting group values
    		 Experimental: Conventional dose Experimental: Double dose Total
    Number of subjects
    		 105 110 215
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.0 ( 15.5 ) 43.9 ( 16.5 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 57 62 119
        Male
    		 48 48 96

    End points

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    End points reporting groups
    Reporting group title
    Experimental: Conventional dose
    Reporting group description
    		 Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=13 years old) or placebo-matched to oseltamivir twice daily over 10 days.

    Reporting group title
    Experimental: Double dose
    Reporting group description
    		 Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.

    Primary: Percentage of Subjects with Adverse Events

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    End point title
    		 Percentage of Subjects with Adverse Events [1]
    End point description
    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. The safety population included all subjects treated with at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Baseline up to Day 40
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No hypothesis testing was performed in this study as this study does not include a placebo control.
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    105
    110
    Units: percentage of subjects
    number (not applicable)
        On Treatment
    40.0
    47.3
        Off Treatment
    25.7
    29.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects Who Developed Viral Resistance to Oseltamivir

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    End point title
    		 Percentage of Subjects Who Developed Viral Resistance to Oseltamivir [2]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Day 40
    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: Data analyses were not available and will be released at a later time. No hypothesis testing was performed in this study as this study does not include a placebo control.
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [3] - Analyses will be released once data become available.
    [4] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Tissue Rejection or Graft Versus Host Disease (GVHD)

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    End point title
    		 Percentage of Subjects With Tissue Rejection or Graft Versus Host Disease (GVHD) [5]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Day 40
    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: Data analyses were not available and will be released at a later time. No hypothesis testing was performed in this study as this study does not include a placebo control.
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [6] - Analyses will be released once data become available.
    [7] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Time to Alleviation of All Clinical Influenza Symptoms

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    End point title
    		 Time to Alleviation of All Clinical Influenza Symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 40
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: days
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [8] - Analyses will be released once data become available.
    [9] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Viral Shedding Assessed by Culture and Reverse Transcription Polymerase Chain Reaction (RT-PCR)

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    End point title
    		 Percentage of Subjects With Viral Shedding Assessed by Culture and Reverse Transcription Polymerase Chain Reaction (RT-PCR)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 40
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [10] - Analyses will be released once data become available.
    [11] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Viral Load Assessed by Culture and RT-PCR

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    End point title
    		 Percentage of Subjects With Viral Load Assessed by Culture and RT-PCR
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 40
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [12] - Analyses will be released once data become available.
    [13] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Developed Secondary Illness (otitis media, bronchitis, pneumonia, or sinusitis)

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    End point title
    		 Percentage of Subjects Who Developed Secondary Illness (otitis media, bronchitis, pneumonia, or sinusitis)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 40
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [14] - Analyses will be released once data become available.
    [15] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics : Area Under the Concentration-Time Curve from 0 to 12 hours (AUC0-12) at Steady State

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    End point title
    		 Pharmacokinetics : Area Under the Concentration-Time Curve from 0 to 12 hours (AUC0-12) at Steady State
    End point description
    AUC0-12 will be reported at steady state as nanograms per hour per millilitre (ng*h/mL).
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: ng * h/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [16] - Analyses will be released once data become available.
    [17] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Maximum Plasma Concentration (Cmax)

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    End point title
    		 Pharmacokinetics: Maximum Plasma Concentration (Cmax)
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [18] - Analyses will be released once data become available.
    [19] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Trough Plasma Concentration (Ctrough)

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    End point title
    		 Pharmacokinetics: Trough Plasma Concentration (Ctrough)
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [20] - Analyses will be released once data become available.
    [21] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Elimination Half-life (t 1/2), if appropriate

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    End point title
    		 Pharmacokinetics: Elimination Half-life (t 1/2), if appropriate
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [22]
    0 [23]
    Units: hours
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [22] - Analyses will be released once data become available.
    [23] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Time to Maximum Concentration (tmax), if appropriate

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    End point title
    		 Pharmacokinetics: Time to Maximum Concentration (tmax), if appropriate
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [24]
    0 [25]
    Units: hours
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [24] - Analyses will be released once data become available.
    [25] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Elimination Constant (ke), if appropriate

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    End point title
    		 Pharmacokinetics: Elimination Constant (ke), if appropriate
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [26]
    0 [27]
    Units: unitless constant
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [26] - Analyses will be released once data become available.
    [27] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Apparent Clearance (CL/F), if appropriate

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    End point title
    		 Pharmacokinetics: Apparent Clearance (CL/F), if appropriate
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [28]
    0 [29]
    Units: L/hour
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [28] - Analyses will be released once data become available.
    [29] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Apparent Volume of Distribution (Vc/F), if appropriate

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    End point title
    		 Pharmacokinetics: Apparent Volume of Distribution (Vc/F), if appropriate
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [30]
    0 [31]
    Units: L/hour
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [30] - Analyses will be released once data become available.
    [31] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Apparent Total Clearance of Metabolite (CLm), if appropriate

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    End point title
    		 Pharmacokinetics: Apparent Total Clearance of Metabolite (CLm), if appropriate
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [32]
    0 [33]
    Units: L/hour
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [32] - Analyses will be released once data become available.
    [33] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Last Measureable Concentration (Clast), if appropriate

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    End point title
    		 Pharmacokinetics: Last Measureable Concentration (Clast), if appropriate
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [34]
    0 [35]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [34] - Analyses will be released once data become available.
    [35] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Time to Last Measureable Concentration (tlast), if appropriate

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    End point title
    		 Pharmacokinetics: Time to Last Measureable Concentration (tlast), if appropriate
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose (30 minutes), 1.5, 4, 8 hours (h) postdose on Day 6 or any day after the 11th dose
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [36]
    0 [37]
    Units: hours
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [36] - Analyses will be released once data become available.
    [37] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Each Individual Symptom Score

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    End point title
    		 Percentage of Subjects With Each Individual Symptom Score
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 up to Day 40
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [38]
    0 [39]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [38] - Analyses will be released once data become available.
    [39] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Initiated Antibiotic Treatment

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    End point title
    		 Percentage of Subjects Who Initiated Antibiotic Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 40
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [40]
    0 [41]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [40] - Analyses will be released once data become available.
    [41] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Hospitalized

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    End point title
    		 Percentage of Subjects Hospitalized
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 40
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [42]
    0 [43]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [42] - Analyses will be released once data become available.
    [43] - Analyses will be released once data become available.
    No statistical analyses for this end point

    Secondary: Duration of Hospitalization

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    End point title
    		 Duration of Hospitalization
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 40
    End point values
    		 Experimental: Conventional dose Experimental: Double dose
    Number of subjects analysed
    0 [44]
    0 [45]
    Units: days
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [44] - Analyses will be released once data become available.
    [45] - Analyses will be released once data become available.
    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 40
    Adverse event reporting additional description
    The safety population included all subjects who received at least one treatment with study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Experimental: Conventional dose
    Reporting group description
    		 Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=13 years old) or placebo-matched to oseltamivir twice daily over 10 days.

    Reporting group title
    Experimental: Double dose
    Reporting group description
    		 Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.

    Serious adverse events
    		 Experimental: Conventional dose Experimental: Double dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 105 (7.62%)
    10 / 110 (9.09%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Leukaemia recurrent
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases of meninges
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 105 (1.90%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 110 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 110 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 110 (0.91%)
         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: 5%
    Non-serious adverse events
    		 Experimental: Conventional dose Experimental: Double dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 105 (50.48%)
    65 / 110 (59.09%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 105 (4.76%)
    12 / 110 (10.91%)
         occurrences all number
    6
    14
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 105 (9.52%)
    11 / 110 (10.00%)
         occurrences all number
    11
    15
    Nausea
         subjects affected / exposed
    10 / 105 (9.52%)
    14 / 110 (12.73%)
         occurrences all number
    11
    18
    Vomiting
         subjects affected / exposed
    10 / 105 (9.52%)
    12 / 110 (10.91%)
         occurrences all number
    10
    14

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2008
    In Amendment B, the following significant changes were made: 1) A more timely assessment of baseline nasal and throat swab samples for oseltamivir-resistant virus was added due to the significant increase in oseltamivir-resistant viruses circulating within many countries identified by routine influenza virus surveillance during the 2007/2008 influenza season. Results of real-time PCR-based resistance testing were to be reported promptly to clinical sites to assist in determining the most appropriate treatment options for individual subjects. 2) New criterion was added for premature withdrawal of subjects from study treatment if additional antivirals were added to the patient’s treatment regimen. The protocol was modified to allow replacement of subjects identified as having oseltamivir-resistant influenza virus at baseline by enrolling subjects on a rolling basis. 3) Clarification was made to allow treatment with other antivirals, if in the best interest of the patients and provided study oseltamivir was discontinued. 4) Efficacy data from subjects receiving other antivirals after discontinuing oseltamivir treatment were excluded from efficacy analyses after the date of commencement of other antiviral treatment and these subjects considered as treatment failures. The definition of the ITTi population was revised to exclude subjects with oseltamivir-resistant influenza A H1N1 H274Y virus at baseline.
    28 Mar 2011
    In Amendment C, the following significant changes were made: 1) Because of the need to enroll subjects within 48 hours of the onset of influenza, a number of subjects were ineligible for screening. Inclusion criteria were therefore modified to broaden the time between onset of influenza-like symptoms and first dose of study drug from 48 hours to 96 hours. 2) PCR and culture were added as diagnostic tests at baseline to overcome the high screening failure rate due to low sensitivity of rapid diagnostic tests. 3) The primary objective of the study was revised to become a descriptive characterization of safety, tolerability and resistance. 4) The sample size and number of participating centers were revised to reflect the amended study primary objective. 5) The criteria for withdrawal of subjects with renal failure was stated as subjects with creatinine clearance < 60 mL/min/1.73m^2.
    28 Sep 2012
    In Amendment D, the following significant changes were made: 1) The protocol was amended to include the Southern Hemisphere and allow global enrollment into the trial. Inclusion and exclusion criteria were amended to facilitate enrollment of as much of the immunocompromised population as possible. 2) The protocol was revised to allow self-swabbing at home when there was a home visit planned, thereby allowing shipment of the sample in an expedited manner. 3) The pharmacokinetic component of the study (removed in Amendment B) was reintroduced using a sparse PK sampling schedule not requiring blood a sample collection on multiple days and which was available to subjects who provided additional consent to that of the main study.
    30 Oct 2013
    In Amendment E, the following significant changes were made: 1) The protocol was amended to provide clarity and additional guidance on the inclusion criteria regarding CD4 cell counts for subjects with human immunodeficiency virus (HIV). 2) The criteria for withdrawal of subjects with renal failure was revised to state subjects with creatinine clearance < 45 mL/min/1.73m2. A lower limit of 45 mL/min for creatinine clearance was used to allow for subjects with mild to moderate renal impairment. 3) The statistical methods section was updated to include an overview of the planned pharmacokinetic analysis. 4) Removal of exclusion criterion for subjects who “have evidence of a serious secondary respiratory or disseminated infection that may confound or overlay the diagnosis and/or symptomatology of influenza” to prevent ambiguity around the category of subjects who should not be enrolled.
    18 Jun 2014
    In Amendment F, the following significant change was made: Throughout the protocol, ‘oseltamivir’ was re-introduced to all pharmacokinetic analysis sections, as applicable as both oseltamivir (parent) and oseltamivir carboxylate (metabolite) plasma concentrations were to be determined from blood samples. The term was inadvertently removed in protocol Version E.

    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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