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    Clinical Trial Results:
    A Double-blind, Randomized, Placebo Controlled, Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients

    Summary
    EudraCT number
    		 2006-002473-47
    Trial protocol
    		 HU   DE   LT   FR   CZ   BE   EE   IT   PL   GB   ES  
    Global end of trial date
    26 May 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2016
    First version publication date
    20 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NV20235
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00412737
    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
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, 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)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jun 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate prospectively the efficacy of oseltamivir in the seasonal prophylaxis of influenza as measured by the relative incidence of laboratory confirmed clinical influenza in the two treatment groups.
    Protection of trial subjects
    This study was conducted in full conformance with the International Conference on Harmonization (ICH) E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research is conducted, whichever afforded the greater protection to the individual. The study complied with the requirements of the ICH E2A guideline (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). Study also complied with the EU Clinical Trial Directive (2001/20/EC).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jan 2007
    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
    Spain: 21
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Belgium: 43
    Country: Number of subjects enrolled
    Estonia: 17
    Country: Number of subjects enrolled
    France: 40
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Hungary: 99
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Lithuania: 36
    Country: Number of subjects enrolled
    Israel: 49
    Country: Number of subjects enrolled
    United States: 139
    Worldwide total number of subjects
    475
    EEA total number of subjects
    287
    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)
    3
    Children (2-11 years)
    14
    Adolescents (12-17 years)
    9
    Adults (18-64 years)
    377
    From 65 to 84 years
    72
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Out of total 477 participants who were randomized to receive study treatments, 2 participants were not included in the study population due to lack of efficacy data. Thus, results are reported only for 475 participants.

    Pre-assignment
    Screening details
    		 One participant was randomized to placebo group but received oseltamivir for the first 9 weeks of the study. This participant was included in the placebo group in the Intention-to-treat (ITT) analysis population, but in the oseltamivir group in the safety analysis population.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.

    Arm title
    		 Oseltamivir
    Arm description
    		 Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oseltamivir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.

    Number of subjects in period 1
    		Placebo Oseltamivir
    Started
    237
    238
    Completed
    221
    232
    Not completed
    16
    6
         Adverse event, non-fatal
    3
    2
         Refused Treatment
    6
    2
         Death
    1
    -
         Failure to Return
    6
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.

    Reporting group title
    Oseltamivir
    Reporting group description
    		 Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.

    Reporting group values
    		 Placebo Oseltamivir Total
    Number of subjects
    		 237 238 475
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.9 ( 15.67 ) 49.4 ( 15.47 ) -
    Gender categorical
    Units: Subjects
        Female
    		 86 74 160
        Male
    		 151 164 315

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.

    Reporting group title
    Oseltamivir
    Reporting group description
    		 Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment.

    Subject analysis set title
    Oseltamivir
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment.

    Primary: Number of Participants With Laboratory Confirmed Clinical Influenza, ITT Population

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    End point title
    		 Number of Participants With Laboratory Confirmed Clinical Influenza, ITT Population
    End point description
    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study. ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. Participants were analyzed as per initial randomization.
    End point type
    Primary
    End point timeframe
    From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
    End point values
    		 Placebo Oseltamivir
    Number of subjects analysed
    238 [1]
    237 [2]
    Units: participants
    7
    5
    Notes
    [1] - Please see information in Pre-Assignment Details.
    [2] - Please see information in Pre-Assignment Details.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The null hypothesis tested was that there was no difference between the proportions of participants who met the primary endpoint in the two treatment groups. Relative Risk Reduction = (1.0 - Relative Risk).
    Comparison groups
    Placebo v Oseltamivir
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.772
    Method
    		 Fisher exact
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    0.283
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 4.1

    Secondary: Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population

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    End point title
    		 Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population
    End point description
    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study. Per-Protocol (PP) population was defined as the subset of the ITT population who did not have any major protocol violations which would impact the assessment of efficacy.
    End point type
    Secondary
    End point timeframe
    From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
    End point values
    		 Placebo Oseltamivir
    Number of subjects analysed
    208
    220
    Units: participants
    6
    4
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Relative Risk Reduction = (1.0 - Relative Risk).
    Comparison groups
    Oseltamivir v Placebo
    Number of subjects included in analysis
    428
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.534
    Method
    		 Fisher exact
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 4.5

    Secondary: Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population

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    End point title
    		 Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population
    End point description
    Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study. ITTNAB population was defined as the subset of the ITT population who were culture negative at baseline.
    End point type
    Secondary
    End point timeframe
    From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
    End point values
    		 Placebo Oseltamivir
    Number of subjects analysed
    231
    232
    Units: participants
    7
    4
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Relative Risk Reduction = (1.0 - Relative Risk).
    Comparison groups
    Placebo v Oseltamivir
    Number of subjects included in analysis
    463
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.381
    Method
    		 Fisher exact
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    0.431
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 4.6

    Secondary: Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population

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    End point title
    		 Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population
    End point description
    RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study. ITT population.
    End point type
    Secondary
    End point timeframe
    From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
    End point values
    		 Placebo Oseltamivir
    Number of subjects analysed
    238 [3]
    237 [4]
    Units: participants
    7
    2
    Notes
    [3] - Please see information in Pre-Assignment Details.
    [4] - Please see information in Pre-Assignment Details.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Relative Risk Reduction = (1.0 - Relative Risk).
    Comparison groups
    Placebo v Oseltamivir
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    0.713
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 5.2

    Secondary: Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population

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    End point title
    		 Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population
    End point description
    RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study. ITTNAB population.
    End point type
    Secondary
    End point timeframe
    From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
    End point values
    		 Placebo Oseltamivir
    Number of subjects analysed
    231
    232
    Units: participants
    7
    1
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Relative Risk Reduction = (1.0 - Relative Risk).
    Comparison groups
    Placebo v Oseltamivir
    Number of subjects included in analysis
    463
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    0.858
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 5.7

    Secondary: Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population

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    End point title
    		 Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population
    End point description
    RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study. ITT population.
    End point type
    Secondary
    End point timeframe
    From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
    End point values
    		 Placebo Oseltamivir
    Number of subjects analysed
    238 [5]
    237 [6]
    Units: participants
    8
    5
    Notes
    [5] - Please see information in Pre-Assignment Details.
    [6] - Please see information in Pre-Assignment Details.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Relative Risk Reduction = (1.0 - Relative Risk).
    Comparison groups
    Placebo v Oseltamivir
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    0.372
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 4.6

    Secondary: Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population

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    End point title
    		 Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population
    End point description
    RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study. ITTNAB population.
    End point type
    Secondary
    End point timeframe
    From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)
    End point values
    		 Placebo Oseltamivir
    Number of subjects analysed
    231
    232
    Units: participants
    8
    4
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Relative Risk Reduction = (1.0 - Relative Risk).
    Comparison groups
    Placebo v Oseltamivir
    Number of subjects included in analysis
    463
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    0.502
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 5.1

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to 2 days after the last dose of study drug (maximum up to 86 days)
    Adverse event reporting additional description
    The safety population included all participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. Participants were analyzed as per actual treatment received.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.

    Reporting group title
    Oseltamivir
    Reporting group description
    		 Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.

    Serious adverse events
    		 Placebo Oseltamivir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 237 (9.70%)
    18 / 238 (7.56%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         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
    Drug interaction
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant rejection
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchitis chronic
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Pelvic fracture
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Abnormal sensation in eye
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephropathy
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 237 (0.00%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 237 (0.42%)
    4 / 238 (1.68%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 237 (1.27%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Oseltamivir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 237 (16.88%)
    42 / 238 (17.65%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 237 (5.06%)
    11 / 238 (4.62%)
         occurrences all number
    15
    14
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 237 (2.95%)
    12 / 238 (5.04%)
         occurrences all number
    7
    12
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    18 / 237 (7.59%)
    15 / 238 (6.30%)
         occurrences all number
    21
    18
    Nausea
         subjects affected / exposed
    9 / 237 (3.80%)
    13 / 238 (5.46%)
         occurrences all number
    9
    14

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Nov 2006
    Modified the exclusion criterion for the time period from influenza vaccination to randomization from 6 weeks to 4 weeks; modified the exclusion criteria to allow participation by a wider range of transplant recipients; specified that antiviral treatments with activity against influenza (for example, amantadine, rimantidine, zanamivir, ribavirin, and additional oseltamivir) and probenecid were not allowed during the study; specified a window to allow prior administration of lymphocytedepleting monoclonal antibodies; specified the exclusion of intravenous immunoglobulins during the conduct of the study.

    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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