Trial Outcomes & Findings for A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants. (NCT NCT00545532)
NCT ID: NCT00545532
Last Updated: 2018-07-12
Results Overview
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
COMPLETED
PHASE3
228 participants
Baseline up to Day 40
2018-07-12
Participant Flow
Participant flow is provided for the safety analysis population, which was the primary analysis population for evaluation of safety. Safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization. Participants were reported under the actual treatment received.
Participant milestones
| Measure |
Conventional Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
110
|
|
Overall Study
COMPLETED
|
99
|
100
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
| Measure |
Conventional Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
Baseline characteristics by cohort
| Measure |
Conventional Dose
n=105 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=110 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 16.5 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 40Population: The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Conventional Dose
n=105 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=110 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Percentage of Participants With Adverse Events
Off Treatment
|
25.7 percentage of participants
|
29.1 percentage of participants
|
|
Percentage of Participants With Adverse Events
On Treatment
|
40.0 percentage of participants
|
47.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 40Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Resistance was defined as the presence of oseltamivir resistance mutations in viruses isolated from nasopharyngeal swab samples, identified by sequencing of the neuraminidase (NA) and hemagglutinin (HA) genes (genotypic resistance) and/or determination of the oseltamivir concentration at which the response is reduced by half (IC50) in an NA inhibition assay (phenotypic resistance). Reported are post-baseline phenotypic and genotypic resistance in adults \>/= 18 years and children and adolescents \<18 years in the modified Intent-to-Treat infected (mITTi) population.
Outcome measures
| Measure |
Conventional Dose
n=81 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Percentage of Participants Who Developed Viral Resistance to Oseltamivir
Post-BL Phenotypic Resist, >/= 18 years
|
8.2 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants Who Developed Viral Resistance to Oseltamivir
Post-BL Genotypic Resist, < 18 years
|
25.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Who Developed Viral Resistance to Oseltamivir
Post-BL Genotypic Resist, >/= 18 years
|
9.6 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants Who Developed Viral Resistance to Oseltamivir
Post-BL Phenotypic Resist, < 18 years
|
25.0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 40Population: The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.
The percentage of transplant patients in the safety population who experienced tissue rejection and/or GvHD is reported.
Outcome measures
| Measure |
Conventional Dose
n=105 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=110 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Percentage of Participants With Tissue Rejection or Graft Versus Host Disease (GVHD)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 40Population: mITTi: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline, and for whom data were available.
TTR of all clinical influenza symptoms was defined as the time from treatment initiation to the start of the 24-hour period in which all 7 influenza symptoms had scores \</= 1 (mild) and remained \</=1 for at least 21.5 hours. . Reported are TTRs in adults \>/= 18 years, adults and adolescents \>/= 13 years and children \<13 years in the mITTi population.
Outcome measures
| Measure |
Conventional Dose
n=82 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Time to Resolution (TTR) of All Clinical Influenza Symptoms
Adults >/= 18 years
|
103.3 hours
Interval 69.0 to 112.7
|
103.6 hours
Interval 57.1 to 140.0
|
|
Time to Resolution (TTR) of All Clinical Influenza Symptoms
Adults and adolescents >/= 13 years
|
103.4 hours
Interval 75.4 to 122.7
|
107.2 hours
Interval 63.9 to 140.0
|
|
Time to Resolution (TTR) of All Clinical Influenza Symptoms
Children < 13 years
|
32.1 hours
Interval 20.2 to
Not Available due to insufficient number of data points.
|
115.9 hours
Interval 45.5 to 495.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 40Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
The overall extent and severity of illness was quantified by the AUE of the total symptom scores over the duration of illness, i.e., from the start of treatment to the time symptoms first alleviated. Total symptom scores were calculated from the sum of seven individual symptom scores with each individual symptom scored from 0 (healthy) to 3 (worst sickness) and a maximum total symptom score of 21. The AUE of these average scores was then calculated for each participant using the trapezoidal rule (the trapezoidal rule calculates the area under any curve by adding up all trapezoids under such a curve). A larger area indicates more severe disease. In this study participants were treated for 10 days. If a participant had scored 21 on every visit then AUE would have been 21 score x 10 days x 24 hours/day =5040 score x hours units, which is the highest possible score. The lowest possible score is 0. Reported are results for adults \>/= 18 years in the mITTi population.
Outcome measures
| Measure |
Conventional Dose
n=59 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=67 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Total Symptom Score Area Under the Efficacy Curve (AUE)
|
774.7 score * hour
Interval 60.8 to 11435.5
|
811.5 score * hour
Interval 63.0 to 8648.1
|
SECONDARY outcome
Timeframe: Baseline up to Day 40Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Fever was defined as temperature \>/= 37.8 degrees Celsius at any time point during the study. TTR of fever was determined in Adults \>/= 18 years, Adults and adolescents \>/= 13 years and Children \< 13 years of the mITTi population.
Outcome measures
| Measure |
Conventional Dose
n=38 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=35 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Time to Resolution of Fever
Children < 13 years
|
NA hours
Not Available: participant censored for analysis
|
26.0 hours
CI not available for only 2 participants: actual measure values for these participants were 0.0 and 51.9.
|
|
Time to Resolution of Fever
Adults >/= 18 years
|
11.0 hours
Interval 0.0 to 16.2
|
0.5 hours
Interval 0.0 to 8.8
|
|
Time to Resolution of Fever
Adults and adolescents >/= 13 years
|
11.0 hours
Interval 0.0 to 16.2
|
0.5 hours
Interval 0.0 to 8.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Nasopharyngeal swab samples were cultured in Madin-Darby Canine Kidney cells. Culture supernatants were harvested after 2 weeks, or after a full-blown cytopathic effect was observed. Presence of infectious viruses in the cell culture supernatants (viral titer), expressed as log10 50% Tissue Culture Infectious Dose/milliliter (TCID50/mL), was determined by hemagglutination assay using turkey erythrocytes for H1 and B viruses or by detection of the virus nucleoprotein (NP) using ELISA for H3 viruses. A value of \< 0.5 log10 TCID50/mL was interpreted as negative. Data are reported for adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=81 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Change From Baseline in Viral Load Assessed by Culture
>/= 18 years, Baseline (BL)
|
3.38 TCID50/mL
Interval 0.5 to 6.0
|
3.75 TCID50/mL
Interval 0.5 to 6.3
|
|
Change From Baseline in Viral Load Assessed by Culture
>/= 18 years, Change from BL on Day 2/3
|
-1.50 TCID50/mL
Interval -5.3 to 0.8
|
-1.50 TCID50/mL
Interval -5.0 to 1.5
|
|
Change From Baseline in Viral Load Assessed by Culture
>/= 18 years, Change from BL on Day 15
|
-3.00 TCID50/mL
Interval -5.5 to 0.3
|
-3.25 TCID50/mL
Interval -5.8 to 0.0
|
|
Change From Baseline in Viral Load Assessed by Culture
>/= 18 years, Change from BL on Day 40
|
-3.00 TCID50/mL
Interval -5.5 to 0.0
|
-3.25 TCID50/mL
Interval -5.8 to 0.0
|
|
Change From Baseline in Viral Load Assessed by Culture
< 18 years, BL
|
3.13 TCID50/mL
Interval 0.8 to 6.0
|
4.00 TCID50/mL
Interval 1.8 to 5.3
|
|
Change From Baseline in Viral Load Assessed by Culture
< 18 years, Change from BL on Day 2/3
|
-1.00 TCID50/mL
Interval -2.3 to 0.8
|
-2.00 TCID50/mL
Interval -3.3 to 0.0
|
|
Change From Baseline in Viral Load Assessed by Culture
>/= 18 years, Change from BL on Day 6
|
-2.50 TCID50/mL
Interval -5.5 to 0.0
|
-3.00 TCID50/mL
Interval -5.8 to 1.0
|
|
Change From Baseline in Viral Load Assessed by Culture
>/= 18 years, Change from BL on Day 8
|
-2.75 TCID50/mL
Interval -5.5 to 0.0
|
-3.25 TCID50/mL
Interval -5.8 to 0.0
|
|
Change From Baseline in Viral Load Assessed by Culture
>/= 18 years, Change from BL on Day 11
|
-2.88 TCID50/mL
Interval -5.5 to 0.0
|
-3.25 TCID50/mL
Interval -5.8 to 0.3
|
|
Change From Baseline in Viral Load Assessed by Culture
< 18 years, Change from BL on Day 6
|
-2.00 TCID50/mL
Interval -3.3 to -0.3
|
-3.50 TCID50/mL
Interval -4.8 to -2.3
|
|
Change From Baseline in Viral Load Assessed by Culture
< 18 years, Change from BL on Day 8
|
-2.50 TCID50/mL
Interval -3.3 to -0.3
|
-3.50 TCID50/mL
Interval -4.8 to -1.3
|
|
Change From Baseline in Viral Load Assessed by Culture
< 18 years, Change from BL on Day 11
|
-2.50 TCID50/mL
Interval -5.3 to 0.0
|
-3.50 TCID50/mL
Interval -4.8 to -2.3
|
|
Change From Baseline in Viral Load Assessed by Culture
< 18 years, Change from BL on Day 15
|
-2.50 TCID50/mL
Interval -5.3 to 1.0
|
-3.50 TCID50/mL
Interval -4.8 to -2.3
|
|
Change From Baseline in Viral Load Assessed by Culture
< 18 years, Change from BL on Day 40
|
-2.50 TCID50/mL
Interval -5.3 to 0.3
|
-3.50 TCID50/mL
Interval -4.8 to -1.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the percentage of participants with viral shedding over time in adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=81 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
>/= 18 years, Baseline
|
91.4 percentage of participants
|
84.2 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
>/= 18 years, Day 2/3
|
67.2 percentage of participants
|
58.9 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
>/= 18 years, Day 6
|
15.4 percentage of participants
|
18.3 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
>/= 18 years, Day 8
|
3.2 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
>/= 18 years, Day 11
|
1.5 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
>/= 18 years, Day 15
|
7.9 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
>/= 18 years, Day 40
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
< 18 years, Baseline
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
< 18 years, Day 2/3
|
71.4 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
< 18 years, Day 6
|
42.9 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
< 18 years, Day 8
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
< 18 years, Day 11
|
14.3 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
< 18 years, Day 15
|
28.6 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by Culture Over Time
< 18 years, Day 40
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 40Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the time to cessation of viral shedding over time in adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=81 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Time to Cessation of Viral Shedding by Cell Culture
>/= 18 years
|
105.0 hours
Interval 98.3 to 109.2
|
105.4 hours
Interval 83.0 to 107.7
|
|
Time to Cessation of Viral Shedding by Cell Culture
< 18 years
|
150.3 hours
Interval 34.2 to 891.3
|
94.9 hours
Interval 8.6 to 109.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Nasopharyngeal swab samples were tested for influenza A and B RNA using semi-quantitative RT-PCR specific for influenza A and B matrix gene, respectively, after viral RNA isolation. Cycle threshold (Ct) value was determined for each sample. Conversion of Ct values into viral load, expressed as log10 virus particles/mL (vp/mL), was obtained using external standard curves ran in parallel in all RT-PCR experiments. A value of \< 2.6 log10 vp/mL for Flu A strains and \< 3.0 log10 vp/mL for Flu B strains was interpreted as a negative result. Data are reported for adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=81 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
>/= 18 years, Baseline (BL)
|
6.47 log10 vp/mL
Interval 2.7 to 8.8
|
6.52 log10 vp/mL
Interval 2.8 to 8.5
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
>/= 18 years, Change from BL on Day 2/3
|
-1.20 log10 vp/mL
Interval -6.4 to 1.6
|
-1.35 log10 vp/mL
Interval -4.6 to 1.1
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
>/= 18 years, Change from BL on Day 6
|
-2.36 log10 vp/mL
Interval -8.0 to 0.1
|
-2.34 log10 vp/mL
Interval -7.7 to 0.1
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
>/= 18 years, Change from BL on Day 8
|
-2.66 log10 vp/mL
Interval -5.4 to -0.3
|
-2.62 log10 vp/mL
Interval -7.8 to -0.3
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
>/= 18 years, Change from BL on Day 11
|
-3.51 log10 vp/mL
Interval -7.3 to -2.2
|
-2.96 log10 vp/mL
Interval -4.5 to 1.3
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
>/= 18 years, Change from BL on Day 15
|
-3.63 log10 vp/mL
Interval -8.0 to -0.9
|
-2.60 log10 vp/mL
Interval -3.4 to 0.0
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
>/= 18 years, Change from BL on Day 40
|
-4.80 log10 vp/mL
Interval -5.4 to 0.8
|
-7.71 log10 vp/mL
Interval -7.71 to -7.71
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
< 18 years, BL
|
5.88 log10 vp/mL
Interval 2.8 to 7.7
|
5.96 log10 vp/mL
Interval 5.5 to 7.3
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
< 18 years, Change from BL on Day 2/3
|
-0.66 log10 vp/mL
Interval -2.7 to 1.4
|
-0.71 log10 vp/mL
Interval -5.6 to 0.4
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
< 18 years, Change from BL on Day 6
|
-1.97 log10 vp/mL
Interval -2.7 to 0.3
|
-1.73 log10 vp/mL
Interval -2.7 to -1.2
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
< 18 years, Change from BL on Day 8
|
1.56 log10 vp/mL
Interval 1.56 to 1.56
|
-2.26 log10 vp/mL
Interval -2.9 to -1.5
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
< 18 years, Change from BL on Day 11
|
-0.89 log10 vp/mL
Interval -3.2 to 1.4
|
-2.41 log10 vp/mL
Interval -2.41 to -2.41
|
|
Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
< 18 years, Change from BL on Day 15
|
1.26 log10 vp/mL
Interval -2.9 to 1.9
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the percentage of subjects with viral shedding over time in adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=81 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
>/= 18 years, Baseline
|
100.0 percentage of participants
|
97.4 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
>/= 18 years, Day 2/3
|
92.8 percentage of participants
|
88.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
>/= 18 years, Day 6
|
56.7 percentage of participants
|
49.3 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
>/= 18 years, Day 8
|
41.5 percentage of participants
|
23.4 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
>/= 18 years, Day 11
|
25.4 percentage of participants
|
21.9 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
>/= 18 years, Day 15
|
10.6 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
>/= 18 years, Day 40
|
1.5 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
< 18 years, Baseline
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
< 18 years, Day 2/3
|
85.7 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
< 18 years, Day 6
|
85.7 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
< 18 years, Day 8
|
20.0 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
< 18 years, Day 11
|
28.6 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
< 18 years, Day 15
|
42.9 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time
< 18 years, Day 40
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 40Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the time to cessation of viral shedding over time in adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=81 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Time to Cessation of Viral Shedding by RT-PCR
>/= 18 years
|
178.0 hours
Interval 152.2 to 227.0
|
154.1 hours
Interval 128.5 to 171.0
|
|
Time to Cessation of Viral Shedding by RT-PCR
< 18 years
|
181.0 hours
Interval 106.2 to 943.7
|
180.5 hours
Interval 8.6 to 247.8
|
SECONDARY outcome
Timeframe: Baseline to Day 11 (EOT)Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Persistent shedding was defined as a viral load reduction \<1 log10 vp/mL at end of treatment compared with baseline. Reported is the percentage of participants with persistent viral shedding at end of treatment in adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=81 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Percentage of Participants With Persistent Viral Shedding
|
1.2 percentage of participants
|
4.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 40Population: mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with at least one event in adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=81 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Percentage of Participants Who Developed Secondary Illness
>/=18 years
|
8.2 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants Who Developed Secondary Illness
< 18 years
|
12.5 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 40Population: The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.
Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with secondary illness, who initiated antibiotic treatment, in adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=105 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=110 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Percentage of Participants Who Initiated Antibiotic Treatment
>/= 18 years
|
8.2 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants Who Initiated Antibiotic Treatment
< 18 years
|
14.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 40Population: The ITTi population included all participants randomized and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Reported is the percentage of participants, who required hospitalization at any time between treatment initiation and the end of the study period, in adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=83 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Percentage of Participants Hospitalized
>/= 18 years
|
6.8 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants Hospitalized
< 18 years
|
11.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 40Population: The ITTi population included all participants randomized and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline.
Reported is the duration of hospitalization at any time between treatment initiation and the end of the study period, in adults \>/= 18 years and adolescents and children \< 18 years.
Outcome measures
| Measure |
Conventional Dose
n=83 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=86 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Duration of Hospitalization
>/= 18 years
|
7.0 days
Interval 5.0 to 14.0
|
6.50 days
Interval 4.0 to 32.0
|
|
Duration of Hospitalization
< 18 years
|
5.0 days
Interval 5.0 to 5.0
|
NA days
N/A=not available as no hospitalization occurred in this arm.
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The pharmacokinetic evaluable patient (PKEP) population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir Cmax data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults
|
65.5 nanograms per milliliter (ng/mL)
Standard Deviation 26.8
|
149 nanograms per milliliter (ng/mL)
Standard Deviation 80.7
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir Ctrough data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults
|
2.33 ng/mL
Standard Deviation 0.641
|
6.98 ng/mL
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
AUC0-12 was reported at steady state as nanograms per hour per milliliter. (ng\*hr/mL). Reported here are oseltamivir AUC0-12 data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics : Area Under the Concentration-Time Curve From 0 to 12 Hours (AUC0-12) at Steady State of Oseltamivir in Adults
|
197 ng*hr/mL
Standard Deviation 49.7
|
501 ng*hr/mL
Standard Deviation 320
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir tmax data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults
|
1.08 hour
Standard Deviation 0.484
|
1.08 hour
Standard Deviation 0.504
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir ke data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults
|
5.15 1/hr
Standard Deviation 0.497
|
4.79 1/hr
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir CL/F data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults
|
402 liter/hour (L/hr)
Standard Deviation 96.0
|
367 liter/hour (L/hr)
Standard Deviation 126
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir Vc/F data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults
|
77.5 liter (L)
Standard Deviation 13.6
|
75.4 liter (L)
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate Cmax data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults
|
655 ng/mL
Standard Deviation 276
|
1420 ng/mL
Standard Deviation 574
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate Ctrough data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults
|
363 ng/mL
Standard Deviation 167
|
831 ng/mL
Standard Deviation 358
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all particiants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate AUC0-12 data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults
|
6240 ng*hr/mL
Standard Deviation 2710
|
13800 ng*hr/mL
Standard Deviation 5670
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate tmax data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults
|
3.83 hour
Standard Deviation 1.08
|
3.96 hour
Standard Deviation 0.841
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oxeltamivir carboxylate ke data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults
|
1.67 1/hr
Standard Deviation 0.681
|
1.61 1/hr
Standard Deviation 0.915
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate CL/F data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults
|
14.0 L/hr
Standard Deviation 5.72
|
13.5 L/hr
Standard Deviation 7.66
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate Vc/F data for adults \>/= 18 years.
Outcome measures
| Measure |
Conventional Dose
n=9 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=13 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults
|
8.39 liter (L)
Standard Deviation 0.00
|
8.39 liter (L)
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir Cmax data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children
Conventional Dose: 60 mg
|
61.9 ng/mL
|
—
|
|
Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children
Conventional Dose: 75 mg
|
45.9 ng/mL
|
—
|
|
Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children
Double Dose: 90 mg
|
107 ng/mL
|
—
|
|
Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children
Double Dose: 150 mg
|
86.6 ng/mL
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir Ctrough data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children
Conventional Dose: 60 mg
|
2.84 ng/mL
|
—
|
|
Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children
Conventional Dose: 75 mg
|
3.37 ng/mL
|
—
|
|
Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children
Double Dose: 90 mg
|
6.65 ng/mL
|
—
|
|
Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children
Double Dose: 150 mg
|
3.88 ng/mL
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all subjects in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
AUC0-12 will be reported at steady state as ng\*hr/mL. Reported here are oseltamivir AUC0-12 data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children
Conventional Dose: 60 mg
|
229 ng*hr/mL
|
—
|
|
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children
Conventional Dose: 75 mg
|
171 ng*hr/mL
|
—
|
|
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children
Double Dose: 90 mg
|
425 ng*hr/mL
|
—
|
|
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children
Double Dose: 150 mg
|
339 ng*hr/mL
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children
Conventional Dose: 60 mg
|
1 hour
|
—
|
|
Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children
Conventional Dose: 75 mg
|
1 hour
|
—
|
|
Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children
Double Dose: 90 mg
|
1 hour
|
—
|
|
Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children
Double Dose: 150 mg
|
1.25 hour
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate Cmax data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 60 mg
|
363 ng/mL
|
—
|
|
Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 75 mg
|
848 ng/mL
|
—
|
|
Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 90 mg
|
770 ng/mL
|
—
|
|
Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 150 mg
|
906 ng/mL
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate Ctrough data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 60 mg
|
215 ng/mL
|
—
|
|
Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 75 mg
|
459 ng/mL
|
—
|
|
Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 90 mg
|
445 ng/mL
|
—
|
|
Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 150 mg
|
464 ng/mL
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
AUC0-12 will be reported at steady state as ng\*hr/mL. Reported here are oseltamivir carboxylate AUC0-12 data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 60 mg
|
3550 ng*hr/mL
|
—
|
|
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 75 mg
|
8010 ng*hr/mL
|
—
|
|
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 90 mg
|
7460 ng*hr/mL
|
—
|
|
Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 150 mg
|
8420 ng*hr/mL
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate tmax data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 60 mg
|
3.75 hour
|
—
|
|
Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 75 mg
|
4 hour
|
—
|
|
Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 90 mg
|
4 hour
|
—
|
|
Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 150 mg
|
4 hour
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir ke data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children
Conventional Dose: 60 mg
|
4.22 1/hr
|
—
|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children
Conventional Dose: 75 mg
|
4.56 1/hr
|
—
|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children
Double Dose: 90 mg
|
3.40 1/hr
|
—
|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children
Double Dose: 150 mg
|
5.74 1/hr
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir CL/F data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children
Conventional Dose: 60 mg
|
263 L/hr
|
—
|
|
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children
Conventional Dose: 75 mg
|
439 L/hr
|
—
|
|
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children
Double Dose: 90 mg
|
212 L/hr
|
—
|
|
Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children
Double Dose: 150 mg
|
442 L/hr
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir Vc/F data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children
Conventional Dose: 60 mg
|
62.3 Liter (L)
|
—
|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children
Conventional Dose: 75 mg
|
96.4 Liter (L)
|
—
|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children
Double Dose: 90 mg
|
62.3 Liter (L)
|
—
|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children
Double Dose: 150 mg
|
76.9 Liter (L)
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate ke data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 150 mg
|
2.12 1/hr
|
—
|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 60 mg
|
2.01 1/hr
|
—
|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 75 mg
|
1.12 1/hr
|
—
|
|
Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 90 mg
|
1.44 1/hr
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate CL/F data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 60 mg
|
16.9 L/hr
|
—
|
|
Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 75 mg
|
9.36 L/hr
|
—
|
|
Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 90 mg
|
12.1 L/hr
|
—
|
|
Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 150 mg
|
17.8 L/hr
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dosePopulation: The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point.
Reported here are oseltamivir carboxylate Vc/F data for adolescents and children \< 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Outcome measures
| Measure |
Conventional Dose
n=4 Participants
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 60 mg
|
8.39 Liter (L)
|
—
|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children
Conventional Dose: 75 mg
|
8.39 Liter (L)
|
—
|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 90 mg
|
8.39 Liter (L)
|
—
|
|
Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children
Double Dose: 150 mg
|
8.39 Liter (L)
|
—
|
Adverse Events
Conventional Dose
Double Dose
Serious adverse events
| Measure |
Conventional Dose
n=105 participants at risk
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=110 participants at risk
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.9%
2/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
1.8%
2/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Oral herpes
|
0.95%
1/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.00%
0/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.95%
1/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.00%
0/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Septic shock
|
0.95%
1/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.00%
0/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.95%
1/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.95%
1/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.00%
0/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Asthenia
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.95%
1/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.00%
0/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
0.91%
1/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
Other adverse events
| Measure |
Conventional Dose
n=105 participants at risk
Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.
|
Double Dose
n=110 participants at risk
Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
10/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
10.0%
11/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Nausea
|
9.5%
10/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
12.7%
14/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
10/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
10.9%
12/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
|
Nervous system disorders
Headache
|
4.8%
5/105 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
10.9%
12/110 • Baseline up to Day 40
The safety population included all participants who received at least one treatment with study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER