Influenza
Conditions
Brief summary
This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.
Interventions
DRUGOseltamivir
Participants may receive treatment at the discretion of the investigator according to local practice standards, and there is no protocol-specified intervention. However, analyses will be presented separately for participants treated with oseltamivir during the course of the study.
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants greater than or equal to (≥) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness (during Years 1 to 5) * Participants less than or equal to (≤) 12 years of age with a positive diagnostic test of influenza and displaying symptoms suggestive of influenza-like illness and who are being or, according to local standard of care, will be treated with an influenza antiviral (during Years 6 and 7)
Exclusion criteria
* Allergy to any potential influenza therapy * Living in the same household or residential/care home as another study participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Genotypic Resistance | Baseline (Day 1) and post-Baseline (Days 3, 6, 10) | Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, H stands for hemagglutinin and N stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.) |
| Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7 | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | Day 6 | — |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir | Day 10 | — |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir | Baseline (Day 1) | — |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir | Day 3 | — |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir | Day 6 | — |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir | Day 10 | — |
| Time to Non-Detection of Viral RNA | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. |
| Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. |
| Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. |
| Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections | From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) | Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days. |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | Baseline (Day 1) | — |
| Viral Load Among Children Treated With Oseltamivir | Days 1, 3, 6, 10 | Viral load was determined for those with detectable virus above the LLQ of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 vp/mL. |
| Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses | Day 6 | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as 50% inhibitory concentration (IC50) more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants with mild or absent symptoms on Day 6 was reported and stratified by resistant and susceptible viruses. |
| Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Days 3, 6, 10 | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants by earliest post-Baseline test day on which viral RNA was not detected was reported and stratified by resistant and susceptible viruses. |
| Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Baseline (Day 1) | Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The mean viral load from each sample was expressed in log10 vp/mL and stratified by resistant and susceptible viruses. |
| Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Days 1, 6, 10 | Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and fatigue on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms. |
| Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Days 1, 6, 10 | Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and energy/tiredness on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms. |
| Body Temperature Among Adults Treated With Oseltamivir | Days 1, 10 | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius. |
| Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir | Baseline (Day 1) to Day 10 | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius. |
| Body Temperature Among Children Treated With Oseltamivir | Days 1, 10 | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius. |
| Change From Baseline in Body Temperature Among Children Treated With Oseltamivir | Baseline (Day 1) to Day 10 | Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius. |
| Viral Load Among Adults Treated With Oseltamivir | Days 1, 3, 6, 10 | Viral load was determined for those with detectable virus above the lower limit of quantification (LLQ) of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 of the number of viral particles per milliliter (log10 vp/mL). |
| Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | Day 3 | — |
Countries
Australia, France, Germany, Hong Kong, Netherlands, Norway, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Otherwise Healthy Participants Infected With Influenza Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes. | 4,553 |
| Total | 4,553 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 143 |
| Overall Study | Other | 12 |
| Overall Study | Withdrawal by Subject | 89 |
Baseline characteristics
| Characteristic | Otherwise Healthy Participants Infected With Influenza |
|---|---|
| Age, Continuous | 19.5 years STANDARD_DEVIATION 19.24 |
| Sex: Female, Male Female | 2331 Participants |
| Sex: Female, Male Male | 2222 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2,578 | 0 / 1,975 |
| serious Total, serious adverse events | 24 / 2,578 | 11 / 1,975 |
Outcome results
Primary
Number of Participants With Genotypic Resistance
Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, H stands for hemagglutinin and N stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.)
Time frame: Baseline (Day 1) and post-Baseline (Days 3, 6, 10)
Population: All Laboratory-Confirmed Influenza Participants (ALCIP) Population: All with confirmed influenza by positive RT-PCR at Baseline. The Number of Participants Analyzed reflects the total of participants who provided evaluable data for their viral RNA subtype. The number who provided data for each viral RNA subtype in each timeframe (n) is shown.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Baseline, H1N1 Seasonal (n=47) | 44 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Baseline, H1N1pdm09 (n=1240) | 1 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Baseline, H3N2 (n=1432) | 0 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Baseline, Influenza B (n=1006) | 2 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Baseline, All Types/Subtypes (n=3725) | 47 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Post-Baseline, H1N1 Seasonal (n=47) | 0 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Post-Baseline, H1N1pdm09 (n=1240) | 39 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Post-Baseline, H3N2 (n=1432) | 18 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Post-Baseline, Influenza B (n=1006) | 0 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Genotypic Resistance | Post-Baseline, All Types/Subtypes (n=3725) | 57 participants |
Primary
Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections
Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported.
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7
Population: ALCIP Population. The Number of Participants Analyzed reflects combined H3N2 or H1N1pdm09-infected participants across all study years who provided an analyzable post-Baseline sample for their viral RNA subtype. The number of participants who provided evaluable data for each viral RNA subtype in the specified timeframe (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 1, H3N2 (n=0,1,1,2,2,4) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H1N1pdm09 (n=0,15,5,20,0,20) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H1N1pdm09 (n=11,33,25,69,0,69) | 36.4 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H3N2 (n=8,94,115,217,0,217) | 0 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H3N2 (n=0,0,0,0,22,22) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H3N2 (n=0,82,80,162,187,349) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H1N1pdm09 (n=0,58,30,88,148,236) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H1N1pdm09 (n=0,54,81,135,108,243) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H1N1pdm09 (n=0,29,8,37,41,78) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H3N2 (n=0,37,43,80,122,202) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H1N1pdm09 (n=0,6,6,12,16,28) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H3N2 (n=0,19,17,36,67,103) | NA percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H3N2 (n=1,45,27,73,0,73) | 0 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H1N1pdm09 (n=11,33,25,69,0,69) | 6.1 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H1N1pdm09 (n=0,58,30,88,148,236) | 20.7 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H1N1pdm09 (n=0,29,8,37,41,78) | 20.7 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 1, H3N2 (n=0,1,1,2,2,4) | 0 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H3N2 (n=1,45,27,73,0,73) | 0 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H1N1pdm09 (n=0,54,81,135,108,243) | 1.9 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H1N1pdm09 (n=0,6,6,12,16,28) | 16.7 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H3N2 (n=0,19,17,36,67,103) | 10.5 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H1N1pdm09 (n=0,15,5,20,0,20) | 33.3 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H3N2 (n=8,94,115,217,0,217) | 1.1 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H3N2 (n=0,82,80,162,187,349) | 8.5 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H3N2 (n=0,37,43,80,122,202) | 2.7 percentage of participants |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H3N2 (n=0,0,0,0,22,22) | NA percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H3N2 (n=0,37,43,80,122,202) | 0 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H1N1pdm09 (n=0,29,8,37,41,78) | 12.5 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H1N1pdm09 (n=0,58,30,88,148,236) | 3.3 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H3N2 (n=0,19,17,36,67,103) | 11.8 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 1, H3N2 (n=0,1,1,2,2,4) | 0 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H3N2 (n=0,82,80,162,187,349) | 1.3 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H1N1pdm09 (n=0,15,5,20,0,20) | 0 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H1N1pdm09 (n=0,54,81,135,108,243) | 0 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H1N1pdm09 (n=0,6,6,12,16,28) | 0 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H3N2 (n=8,94,115,217,0,217) | 0.9 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H3N2 (n=0,0,0,0,22,22) | NA percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H3N2 (n=1,45,27,73,0,73) | 0 percentage of participants |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H1N1pdm09 (n=11,33,25,69,0,69) | 4.0 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 1, H3N2 (n=0,1,1,2,2,4) | 0 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H1N1pdm09 (n=0,54,81,135,108,243) | 0.7 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H3N2 (n=0,0,0,0,22,22) | NA percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H1N1pdm09 (n=0,58,30,88,148,236) | 14.8 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H1N1pdm09 (n=0,6,6,12,16,28) | 8.3 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H3N2 (n=0,19,17,36,67,103) | 11.1 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H3N2 (n=1,45,27,73,0,73) | 0 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H1N1pdm09 (n=0,15,5,20,0,20) | 25.0 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H3N2 (n=8,94,115,217,0,217) | 0.9 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H3N2 (n=0,37,43,80,122,202) | 1.3 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H1N1pdm09 (n=0,29,8,37,41,78) | 18.9 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H3N2 (n=0,82,80,162,187,349) | 4.9 percentage of participants |
| Children Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H1N1pdm09 (n=11,33,25,69,0,69) | 10.1 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H3N2 (n=1,45,27,73,0,73) | NA percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H1N1pdm09 (n=11,33,25,69,0,69) | NA percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H3N2 (n=0,19,17,36,67,103) | 0 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 1, H3N2 (n=0,1,1,2,2,4) | 0 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H3N2 (n=0,37,43,80,122,202) | 0.8 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H1N1pdm09 (n=0,6,6,12,16,28) | 0 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H1N1pdm09 (n=0,58,30,88,148,236) | 1.4 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H1N1pdm09 (n=0,29,8,37,41,78) | 4.9 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H3N2 (n=0,0,0,0,22,22) | 0 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H3N2 (n=8,94,115,217,0,217) | NA percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H3N2 (n=0,82,80,162,187,349) | 1.1 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H1N1pdm09 (n=0,54,81,135,108,243) | 0.9 percentage of participants |
| Adults Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H1N1pdm09 (n=0,15,5,20,0,20) | NA percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H3N2 (n=1,45,27,73,0,73) | 0 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H1N1pdm09 (n=0,29,8,37,41,78) | 11.5 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H3N2 (n=0,19,17,36,67,103) | 3.9 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H1N1pdm09 (n=0,15,5,20,0,20) | 25.0 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H1N1pdm09 (n=0,54,81,135,108,243) | 0.8 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 6, H1N1pdm09 (n=11,33,25,69,0,69) | 10.1 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H3N2 (n=0,37,43,80,122,202) | 1.0 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 4, H1N1pdm09 (n=0,6,6,12,16,28) | 3.6 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 1, H3N2 (n=0,1,1,2,2,4) | 0 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 3, H1N1pdm09 (n=0,58,30,88,148,236) | 6.4 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 5, H3N2 (n=0,82,80,162,187,349) | 2.9 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 2, H3N2 (n=0,0,0,0,22,22) | 0 percentage of participants |
| Participants Treated With Oseltamivir | Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections | Year 7, H3N2 (n=8,94,115,217,0,217) | 0.9 percentage of participants |
Secondary
Body Temperature Among Adults Treated With Oseltamivir
Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.
Time frame: Days 1, 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Adults Treated With Oseltamivir | Day 1, Total (n=960) | 38.0 degrees Celsius | Standard Deviation 0.91 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Adults Treated With Oseltamivir | Day 1, H1N1 Seasonal (n=12) | 37.8 degrees Celsius | Standard Deviation 1.1 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Adults Treated With Oseltamivir | Day 1, H3N2 (n=418) | 37.8 degrees Celsius | Standard Deviation 0.89 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Adults Treated With Oseltamivir | Day 1, H1N1pdm09 (n=323) | 38.2 degrees Celsius | Standard Deviation 0.88 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Adults Treated With Oseltamivir | Day 1, Influenza B (n=207) | 38.0 degrees Celsius | Standard Deviation 0.9 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Adults Treated With Oseltamivir | Day 10, Total (n=827) | 36.6 degrees Celsius | Standard Deviation 0.4 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Adults Treated With Oseltamivir | Day 10, H3N2 (n=356) | 36.6 degrees Celsius | Standard Deviation 0.4 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Adults Treated With Oseltamivir | Day 10, H1N1pdm09 (n=282) | 36.6 degrees Celsius | Standard Deviation 0.38 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Adults Treated With Oseltamivir | Day 10, Influenza B (n=189) | 36.6 degrees Celsius | Standard Deviation 0.41 |
Secondary
Body Temperature Among Children Treated With Oseltamivir
Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.
Time frame: Days 1, 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Children Treated With Oseltamivir | Day 1, Total (n=1282) | 38.3 degrees Celsius | Standard Deviation 0.93 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Children Treated With Oseltamivir | Day 1, H3N2 (n=583) | 38.3 degrees Celsius | Standard Deviation 0.98 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Children Treated With Oseltamivir | Day 1, H1N1pdm09 (n=370) | 38.3 degrees Celsius | Standard Deviation 0.91 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Children Treated With Oseltamivir | Day 1, Influenza B (n=329) | 38.2 degrees Celsius | Standard Deviation 0.87 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Children Treated With Oseltamivir | Day 10, Total (n=1223) | 36.7 degrees Celsius | Standard Deviation 0.38 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Children Treated With Oseltamivir | Day 10, H3N2 (n=560) | 36.6 degrees Celsius | Standard Deviation 0.37 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Children Treated With Oseltamivir | Day 10, H1N1pdm09 (n=346) | 36.7 degrees Celsius | Standard Deviation 0.4 |
| Otherwise Healthy Participants Infected With Influenza | Body Temperature Among Children Treated With Oseltamivir | Day 10, Influenza B (n=317) | 36.6 degrees Celsius | Standard Deviation 0.38 |
Secondary
Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir
Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.
Time frame: Baseline (Day 1) to Day 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir | Total (n=826) | -1.4 degrees Celsius | Standard Deviation 0.96 |
| Otherwise Healthy Participants Infected With Influenza | Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir | H3N2 (n=355) | -1.2 degrees Celsius | Standard Deviation 0.94 |
| Otherwise Healthy Participants Infected With Influenza | Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir | H1N1pdm09 (n=282) | -1.7 degrees Celsius | Standard Deviation 0.93 |
| Otherwise Healthy Participants Infected With Influenza | Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir | Influenza B (n=189) | -1.4 degrees Celsius | Standard Deviation 0.95 |
Secondary
Change From Baseline in Body Temperature Among Children Treated With Oseltamivir
Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.
Time frame: Baseline (Day 1) to Day 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Change From Baseline in Body Temperature Among Children Treated With Oseltamivir | Total (n=1222) | -1.6 degrees Celsius | Standard Deviation 0.98 |
| Otherwise Healthy Participants Infected With Influenza | Change From Baseline in Body Temperature Among Children Treated With Oseltamivir | H3N2 (n=560) | -1.6 degrees Celsius | Standard Deviation 1.02 |
| Otherwise Healthy Participants Infected With Influenza | Change From Baseline in Body Temperature Among Children Treated With Oseltamivir | H1N1pdm09 (n=345) | -1.5 degrees Celsius | Standard Deviation 0.97 |
| Otherwise Healthy Participants Infected With Influenza | Change From Baseline in Body Temperature Among Children Treated With Oseltamivir | Influenza B (n=317) | -1.6 degrees Celsius | Standard Deviation 0.91 |
Secondary
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir
Time frame: Day 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir | Total (n=833) | 88 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir | H3N2 (n=362) | 44 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir | H1N1pdm09 (n=283) | 33 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir | Influenza B (n=188) | 11 participants |
Secondary
Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir
Time frame: Day 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir | H1N1pdm09 (n=351) | 64 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir | Influenza B (n=317) | 60 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir | Total (n=1228) | 197 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir | H3N2 (n=560) | 73 participants |
Secondary
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir
Time frame: Baseline (Day 1)
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | Total | 961 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | H1N1 Seasonal | 12 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | H3N2 | 419 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | H1N1pdm09 | 323 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir | Influenza B | 207 participants |
Secondary
Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir
Time frame: Baseline (Day 1)
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir | Total | 1283 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir | H3N2 | 583 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir | H1N1pdm09 | 371 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir | Influenza B | 329 participants |
Secondary
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir
Time frame: Day 3
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | Total (n=912) | 781 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | H1N1 Seasonal (n=11) | 10 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | H3N2 (n=398) | 341 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | H1N1pdm09 (n=308) | 258 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir | Influenza B (n=195) | 172 participants |
Secondary
Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir
Time frame: Day 3
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir | Total (n=1238) | 1050 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir | H3N2 (n=562) | 453 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir | H1N1pdm09 (n=358) | 315 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir | Influenza B (n=318) | 282 participants |
Secondary
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir
Time frame: Day 6
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | Total (n=889) | 317 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | H1N1 Seasonal (n=9) | 4 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | H3N2 (n=382) | 144 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | H1N1pdm09 (n=308) | 110 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir | Influenza B (n=190) | 59 participants |
Secondary
Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir
Time frame: Day 6
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir | Total (n=1250) | 628 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir | H3N2 (n=567) | 271 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir | H1N1pdm09 (n=362) | 181 participants |
| Otherwise Healthy Participants Infected With Influenza | Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir | Influenza B (n=321) | 176 participants |
Secondary
Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses
Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants by earliest post-Baseline test day on which viral RNA was not detected was reported and stratified by resistant and susceptible viruses.
Time frame: Days 3, 6, 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the specified visit. The number of participants who provided evaluable data for each resistance status at the specified visit (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Day 3, Total (n=1682) | 15.3 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Day 3, Resistant (n=59) | 0 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Day 3, Susceptible (n=1623) | 15.8 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Day 6, Total (n=1682) | 40.5 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Day 6, Resistant (n=59) | 10.2 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Day 6, Susceptible (n=1623) | 41.7 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Day 10, Total (n=1682) | 30.4 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Day 10, Resistant (n=59) | 59.3 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses | Day 10, Susceptible (n=1623) | 29.4 percentage of participants |
Comparison: Resistant versus Susceptiblep-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load
Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The mean viral load from each sample was expressed in log10 vp/mL and stratified by resistant and susceptible viruses.
Time frame: Baseline (Day 1)
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data. The number of participants who provided evaluable data for each resistance status at Baseline (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Viral Load 5.89 to 6.61, Resistant (n=457) | 3.1 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Viral Load 5.89 to 6.61, Susceptible (n=457) | 96.9 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Viral Load >6.61, Resistant (n=443) | 3.8 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Total, Resistant (n=1802) | 3.2 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Total, Susceptible (n=1802) | 96.8 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Viral Load <4.95, Resistant (n=452) | 2.0 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Viral Load <4.95, Susceptible (n=452) | 98.0 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Viral Load 4.95 to 5.89, Resistant (n=450) | 3.8 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Viral Load 4.95 to 5.89, Susceptible (n=450) | 96.2 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load | Viral Load >6.61, Susceptible (n=443) | 96.2 percentage of participants |
Comparison: Resistant versus Susceptiblep-value: 0.2499Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses
Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as 50% inhibitory concentration (IC50) more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants with mild or absent symptoms on Day 6 was reported and stratified by resistant and susceptible viruses.
Time frame: Day 6
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the Day 6 visit. The number of participants who provided evaluable data for each resistance status at the Day 6 visit (n) is shown in the table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses | Total (n=1730) | 61.2 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses | Resistant (n=59) | 55.9 percentage of participants |
| Otherwise Healthy Participants Infected With Influenza | Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses | Susceptible (n=1671) | 61.4 percentage of participants |
Comparison: Resistant versus Susceptiblep-value: 0.4464Cochran-Mantel-Haenszel
Secondary
Time to Non-Detection of Viral RNA
Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Population: ALCIP Population. The Number of Participants Analyzed reflects the number of participants who provided sufficient post-Baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Time to Non-Detection of Viral RNA | 9.7 days |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Time to Non-Detection of Viral RNA | 8.2 days |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Time to Non-Detection of Viral RNA | 7.9 days |
p-value: <0.0001Kruskal-Wallis
p-value: <0.01Pairwise Wilcoxon
p-value: <0.01Pairwise Wilcoxon
Secondary
Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections
Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Population: ALCIP Population. The Number of Participants Analyzed reflects the number of participants with H1N1pdm09 infection who provided sufficient post-Baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections | 9.9 days |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections | 8.0 days |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections | 8.0 days |
p-value: 0.0005Kruskal-Wallis
p-value: 0.008Pairwise Wilcoxon
p-value: <0.0001Pairwise Wilcoxon
Secondary
Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections
Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Population: ALCIP Population. The Number of Participants Analyzed reflects the number of participants with H3N2 infection who provided sufficient post-Baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections | 9.5 days |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections | 8.0 days |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections | 8.0 days |
p-value: 0.015Kruskal-Wallis
p-value: 0.009Pairwise Wilcoxon
p-value: 0.03Pairwise Wilcoxon
Secondary
Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections
Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.
Time frame: From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)
Population: ALCIP Population. The Number of Participants Analyzed reflects the number of participants with influenza B infection who provided sufficient post-Baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections | 9.8 days |
| Children 1 to 5 Years of Age Treated With Oseltamivir | Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections | 10.0 days |
| Children 6 to 12 Years of Age Treated With Oseltamivir | Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections | 7.4 days |
p-value: 0.0002Kruskal-Wallis
p-value: 0.008Pairwise Wilcoxon
p-value: <0.0001Pairwise Wilcoxon
Secondary
Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir
Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and fatigue on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.
Time frame: Days 1, 6, 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 1, H3N2 (n=419) | 11.2 units on a scale | Standard Deviation 5.41 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 10, Total (n=827) | 2.0 units on a scale | Standard Deviation 2.51 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 10, H3N2 (n=357) | 2.1 units on a scale | Standard Deviation 2.6 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 10, H1N1pdm09 (n=281) | 1.9 units on a scale | Standard Deviation 2.36 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 10, Influenza B (n=189) | 2.1 units on a scale | Standard Deviation 2.57 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 1, Total (n=960) | 12.3 units on a scale | Standard Deviation 5.03 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 1, H1N1 Seasonal (n=12) | 11.4 units on a scale | Standard Deviation 6.02 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 1, H1N1pdm09 (n=323) | 13.2 units on a scale | Standard Deviation 4.28 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 1, Influenza B (n=206) | 13.4 units on a scale | Standard Deviation 4.76 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 6, Total (n=890) | 3.7 units on a scale | Standard Deviation 3.27 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 6, H1N1 Seasonal (n=9) | 2.8 units on a scale | Standard Deviation 2.91 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 6, H3N2 (n=383) | 3.4 units on a scale | Standard Deviation 3.03 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 6, H1N1pdm09 (n=307) | 3.8 units on a scale | Standard Deviation 3.28 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir | Day 6, Influenza B (n=191) | 4.1 units on a scale | Standard Deviation 3.66 |
Secondary
Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir
Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and energy/tiredness on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.
Time frame: Days 1, 6, 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 1, Total (n=1283) | 12.4 units on a scale | Standard Deviation 3.92 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 1, H3N2 (n=583) | 12.3 units on a scale | Standard Deviation 3.77 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 1, H1N1pdm09 (n=371) | 11.9 units on a scale | Standard Deviation 4.02 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 6, H3N2 (n=567) | 3.2 units on a scale | Standard Deviation 2.57 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 1, Influenza B (n=329) | 13.0 units on a scale | Standard Deviation 3.98 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 6, Total (n=1252) | 3.3 units on a scale | Standard Deviation 2.83 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 6, H1N1pdm09 (n=364) | 3.2 units on a scale | Standard Deviation 2.6 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 6, Influenza B (n=321) | 3.5 units on a scale | Standard Deviation 3.44 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 10, Total (n=1228) | 1.3 units on a scale | Standard Deviation 1.59 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 10, H3N2 (n=562) | 1.3 units on a scale | Standard Deviation 1.59 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 10, H1N1pdm09 (n=350) | 1.4 units on a scale | Standard Deviation 1.54 |
| Otherwise Healthy Participants Infected With Influenza | Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir | Day 10, Influenza B (n=316) | 1.3 units on a scale | Standard Deviation 1.63 |
Secondary
Viral Load Among Adults Treated With Oseltamivir
Viral load was determined for those with detectable virus above the lower limit of quantification (LLQ) of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 of the number of viral particles per milliliter (log10 vp/mL).
Time frame: Days 1, 3, 6, 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 1, Total (n=959) | 5.8 log10 vp/mL | Standard Deviation 1.18 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 1, H1N1 Seasonal (n=12) | 5.7 log10 vp/mL | Standard Deviation 1.22 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 1, H1N1pdm09 (n=323) | 5.7 log10 vp/mL | Standard Deviation 1.15 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 1, Influenza B (n=207) | 5.9 log10 vp/mL | Standard Deviation 1.09 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 3, Total (n=781) | 4.2 log10 vp/mL | Standard Deviation 1.17 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 3, H1N1 Seasonal (n=10) | 4.2 log10 vp/mL | Standard Deviation 1.34 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 3, H3N2 (n=341) | 3.9 log10 vp/mL | Standard Deviation 1.15 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 3, H1N1pdm09 (n=258) | 4.1 log10 vp/mL | Standard Deviation 1.07 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 3, Influenza B (n=172) | 4.7 log10 vp/mL | Standard Deviation 1.19 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 6, Total (n=317) | 3.3 log10 vp/mL | Standard Deviation 1.05 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 6, H1N1 Seasonal (n=4) | 4.1 log10 vp/mL | Standard Deviation 0.48 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 10, H3N2 (n=44) | 2.9 log10 vp/mL | Standard Deviation 0.87 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 6, H3N2 (n=144) | 3.2 log10 vp/mL | Standard Deviation 1.06 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 6, H1N1pdm09 (n=110) | 3.1 log10 vp/mL | Standard Deviation 0.93 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 6, Influenza B (n=59) | 3.9 log10 vp/mL | Standard Deviation 1.04 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 10, Total (n=88) | 3.0 log10 vp/mL | Standard Deviation 0.88 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 1, H3N2 (n=417) | 5.8 log10 vp/mL | Standard Deviation 1.23 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 10, H1N1pdm09 (n=33) | 2.8 log10 vp/mL | Standard Deviation 0.79 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Adults Treated With Oseltamivir | Day 10, Influenza B (n=11) | 3.7 log10 vp/mL | Standard Deviation 0.84 |
Secondary
Viral Load Among Children Treated With Oseltamivir
Viral load was determined for those with detectable virus above the LLQ of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 vp/mL.
Time frame: Days 1, 3, 6, 10
Population: ALCIP Population. The Number of Participants Analyzed reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 3, Influenza B (n=282) | 5.2 log10 vp/mL | Standard Deviation 1.19 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 6, Total (n=628) | 3.8 log10 vp/mL | Standard Deviation 1.18 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 6, H3N2 (n=271) | 3.6 log10 vp/mL | Standard Deviation 1.19 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 6, H1N1pdm09 (n=181) | 3.7 log10 vp/mL | Standard Deviation 1.21 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 10, Influenza B (n=60) | 3.6 log10 vp/mL | Standard Deviation 1.04 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 10, H1N1pdm09 (n=64) | 3.1 log10 vp/mL | Standard Deviation 0.84 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 1, Total (n=1283) | 5.8 log10 vp/mL | Standard Deviation 1.15 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 1, H3N2 (n=583) | 5.6 log10 vp/mL | Standard Deviation 1.22 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 1, H1N1pdm09 (n=371) | 5.7 log10 vp/mL | Standard Deviation 1.13 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 1, Influenza B (n=329) | 6.1 log10 vp/mL | Standard Deviation 0.98 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 3, Total (n=1050) | 4.5 log10 vp/mL | Standard Deviation 1.25 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 3, H3N2 (n=453) | 4.1 log10 vp/mL | Standard Deviation 1.16 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 3, H1N1pdm09 (n=315) | 4.3 log10 vp/mL | Standard Deviation 1.12 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 6, Influenza B (n=176) | 4.1 log10 vp/mL | Standard Deviation 1.08 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 10, Total (n=197) | 3.3 log10 vp/mL | Standard Deviation 0.99 |
| Otherwise Healthy Participants Infected With Influenza | Viral Load Among Children Treated With Oseltamivir | Day 10, H3N2 (n=73) | 3.1 log10 vp/mL | Standard Deviation 1.01 |