Trial Outcomes & Findings for A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection (NCT NCT00988325)
NCT ID: NCT00988325
Last Updated: 2017-03-20
Results Overview
Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 was estimated for oseltamivir and oseltamivir carboxylate by linear trapezoidal rule
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1
Results posted on
2017-03-20
Participant Flow
The study was conducted across 11 centers in Spain, Italy, France, Germany, Belgium, and Poland from 10 January 2011 to 04 April 2012. A total of 65 participants were screened.
Participant milestones
| Measure |
Oseltamivir 3 mg/kg
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
|
Oseltamivir 2.5 mg/kg
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
5
|
|
Overall Study
COMPLETED
|
40
|
20
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection
Baseline characteristics by cohort
| Measure |
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
|
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
223.2 Days
STANDARD_DEVIATION 79.41 • n=5 Participants
|
57.0 Days
STANDARD_DEVIATION 17.24 • n=7 Participants
|
25.2 Days
STANDARD_DEVIATION 5.36 • n=5 Participants
|
156.8 Days
STANDARD_DEVIATION 105.62 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration
Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 was estimated for oseltamivir and oseltamivir carboxylate by linear trapezoidal rule
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir, n=37, 17, 4
|
194 hour (h)*nanogram(ng)/milliliter (mL)
Geometric Coefficient of Variation 47.8
|
142 hour (h)*nanogram(ng)/milliliter (mL)
Geometric Coefficient of Variation 48.8
|
277 hour (h)*nanogram(ng)/milliliter (mL)
Geometric Coefficient of Variation 36.2
|
|
Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate, n=18,11, 2
|
4920 hour (h)*nanogram(ng)/milliliter (mL)
Geometric Coefficient of Variation 35.3
|
NA hour (h)*nanogram(ng)/milliliter (mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not calculated for 2 participants analyzed. Individual data are not reported due to privacy concerns
|
4990 hour (h)*nanogram(ng)/milliliter (mL)
Geometric Coefficient of Variation 27.4
|
PRIMARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration
Oseltamivir carboxylate is an active metabolite of oseltamivir. Cmax was estimated for both oseltamivir and Oseltamivir carboxylate by non-compartmental analysis.
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Steady-state Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir
|
62.5 ng/mL
Geometric Coefficient of Variation 69.1
|
25.2 ng/mL
Geometric Coefficient of Variation 211.6
|
80.8 ng/mL
Geometric Coefficient of Variation 47
|
|
Steady-state Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate
|
530 ng/mL
Geometric Coefficient of Variation 33.1
|
501 ng/mL
Geometric Coefficient of Variation 22.2
|
464 ng/mL
Geometric Coefficient of Variation 37.7
|
PRIMARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration.
Oseltamivir carboxylate is active metabolite of oseltamivir. Cmin was estimated for both oseltamivir and oseltamivir carboxylate by non-compartmental analysis
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Steady-state Minimum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir
|
2.09 ng/mL
Geometric Coefficient of Variation 52.6
|
2.56 ng/mL
Geometric Coefficient of Variation 90.0
|
2.88 ng/mL
Geometric Coefficient of Variation 65.4
|
|
Steady-state Minimum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate
|
248 ng/mL
Geometric Coefficient of Variation 51.5
|
169 ng/mL
Geometric Coefficient of Variation 96.4
|
238 ng/mL
Geometric Coefficient of Variation 43.8
|
SECONDARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration
Oseltamivir carboxylate is an active metabolite of oseltamivir.Tmax was estimated using non-compartmental methods
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Time to the Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir
|
1.08 hours
Interval 0.0 to 2.92
|
1.08 hours
Interval 1.0 to 3.0
|
1.08 hours
Interval 0.88 to 3.08
|
|
Time to the Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate
|
2.88 hours
Interval 0.0 to 6.67
|
5.83 hours
Interval 2.58 to 6.67
|
5.04 hours
Interval 2.08 to 7.0
|
SECONDARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/-15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration
Elimination half-life is defined as the time required for elimination of a drug to half its plasma concentration and was computed using non-compartmental method
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Apparent Elimination Half Life of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir, n= 37, 17, 4
|
2.01 hours
Geometric Coefficient of Variation 49.3
|
1.66 hours
Geometric Coefficient of Variation 41.5
|
2.02 hours
Geometric Coefficient of Variation 38.5
|
|
Apparent Elimination Half Life of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate, n=18, 11, 2
|
11.3 hours
Geometric Coefficient of Variation 92.7
|
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not calculated for 2 participants analyzed. Individual data are not reported due to privacy concerns
|
9.45 hours
Geometric Coefficient of Variation 53.3
|
SECONDARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol.
Oseltamivir carboxylate is active metabolite of oseltamivir.The apparent first-order elimination rate constant (Lambda Z) was determined by linear regression analysis of terminal data points. A minimum of 3 data points were used for lambda Z estimation. By reporting tool convention, if n\<3, no summary statistics were calculated
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Apparent First-order Elimination Rate Constant of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir, n= 33, 11, 4
|
0.338 1/hour
Geometric Coefficient of Variation 52.9
|
0.418 1/hour
Geometric Coefficient of Variation 41.5
|
0.349 1/hour
Geometric Coefficient of Variation 39.9
|
|
Apparent First-order Elimination Rate Constant of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate, n=17, 7, 2
|
0.0475 1/hour
Geometric Coefficient of Variation 110.6
|
NA 1/hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not calculated for 2 participants analyzed. Individual data are not reported due to privacy concerns
|
0.0735 1/hour
Geometric Coefficient of Variation 55.2
|
SECONDARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration
Oseltamivir carboxylate is active metabolite of oseltamivir. CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Total Plasma Clearance as a Function of Bioavailability and Apparent Plasma Clearance of the Metabolite as a Function of Bioavailability (CLm/F) of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir, n= 37, 17, 4
|
63000 mL/hour
Standard Deviation 63.7
|
50600 mL/hour
Standard Deviation 39.9
|
80500 mL/hour
Standard Deviation 42.8
|
|
Total Plasma Clearance as a Function of Bioavailability and Apparent Plasma Clearance of the Metabolite as a Function of Bioavailability (CLm/F) of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate, n=18,11, 2
|
2180 mL/hour
Standard Deviation 54.86
|
NA mL/hour
Standard Deviation NA
Total Plasma Clearance was not calculated for 2 participants analyzed. Individual data are not reported due to privacy concerns
|
3940 mL/hour
Standard Deviation 38.8
|
SECONDARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration.
Oseltamivir carboxylate is active metabolite of oseltamivir. V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
The Volume of Distribution as a Function of Bioavailability of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir, n= 37, 17, 4
|
183000 mL
Geometric Coefficient of Variation 87.9
|
121000 mL
Geometric Coefficient of Variation 69.8
|
234000 mL
Geometric Coefficient of Variation 66.2
|
|
The Volume of Distribution as a Function of Bioavailability of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate, n=18,11, 2
|
35400 mL
Geometric Coefficient of Variation 96.5
|
NA mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not calculated for 2 participants analyzed. Individual data are not reported due to privacy concerns
|
53700 mL
Geometric Coefficient of Variation 78.1
|
SECONDARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated patients with at least one blood sample evaluable for drug concentration level and who were adhered to the protocol
The last measurable plasma concentration of oseltamivir and oseltamivir carboxylate was the last quantifiable concentration of oseltamivir or oseltamivir carboxylate, respectively.
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Clast of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir
|
176 ng/mL
Geometric Coefficient of Variation 58.3
|
84.3 ng/mL
Geometric Coefficient of Variation 154.4
|
262 ng/mL
Geometric Coefficient of Variation 39.2
|
|
Clast of Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate
|
4410 ng/mL
Geometric Coefficient of Variation 34.0
|
3940 ng/mL
Geometric Coefficient of Variation 28.2
|
3800 ng/mL
Geometric Coefficient of Variation 50.1
|
SECONDARY outcome
Timeframe: 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1Population: Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol.
Oseltamivir carboxylate is an active metabolite of oseltamivir.
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Time of the Last Measurable Plasma Concentration for Oseltamivir and Oseltamivir Carboxylate
Oseltamivir
|
8.53 hours
Geometric Coefficient of Variation 32.9
|
6.94 hours
Geometric Coefficient of Variation 24.2
|
9.23 hours
Geometric Coefficient of Variation 30.1
|
|
Time of the Last Measurable Plasma Concentration for Oseltamivir and Oseltamivir Carboxylate
Oseltamivir carboxylate
|
10.64 hours
Geometric Coefficient of Variation 5.4
|
10.45 hours
Geometric Coefficient of Variation 5.3
|
10.11 hours
Geometric Coefficient of Variation 21.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Day 3 for who received two does on Day 1 or Day 4 for who received one dose on Day 1; Day 6, Day 11, Day 18, Day 30Population: Safety population included all treated participants with at least one post-baseline safety assessment
Neurological assessment was performed to assess the mental state of the participants through two scales: Infant face scale and Glasgow coma scale. Each scale consists of 3 subscales: eye opening (ranging 1 to 4), verbal response (ranging 1 to 5), and motor responses (ranging 1 to 6). The final score is the sum of these ranges and is scored between 3 and 15. 3 being the worst, and 15 the best. Change from baseline is change of final score post-baseline minus the final score at baseline.
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Number of Participants With Change From Baseline in Neurological Assessment Scores
With change in infant face scale measurement score
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Neurological Assessment Scores
With change in Glasgow coma scale assessment score
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 1, 3 or 4, 6, 11, 18, and 30Population: Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study
Median time to cessation of viral shedding was calculated for all patients with positive by culture / by polymerase chain reaction (PCR) at baseline using all data points between the start of the treatment and the 1st time point of negative culture without subsequent positive culture results. These time-to event analyses were only performed for the viral titre.
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Median Time to Cessation of Viral Shedding in Participants With Positive Culture at Baseline
|
113.0 hours
Interval 63.0 to 230.0
|
113.0 hours
Interval 110.0 to 116.0
|
228.5 hours
Interval 118.0 to 231.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day3/4, Day 6, Day 11, Day 18+/-2 days, Day 30+/-2 daysPopulation: Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study
The viral titer was measured by culture and reported in log10 (50% tissue culture infective dose \[TCID50\]). The viral load was analyzed by PCR and reported as log10 particles/mL. The number of patients positive for viral shedding by virus sub-type was measured on specified days from baseline to last visit on Day 30.
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=10 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=16 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=32 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Number of Participants With Virus Shedding by Virus Type
Day 6
|
4 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants With Virus Shedding by Virus Type
Baseline
|
10 Participants
|
14 Participants
|
32 Participants
|
|
Number of Participants With Virus Shedding by Virus Type
Day 3 or 4
|
5 Participants
|
14 Participants
|
20 Participants
|
|
Number of Participants With Virus Shedding by Virus Type
Day 11
|
9 Participants
|
16 Participants
|
32 Participants
|
|
Number of Participants With Virus Shedding by Virus Type
Day 18 +-2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Virus Shedding by Virus Type
Day 30 +-2
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1 to 11; Day 18; Day 30Population: Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study
This was performed for all participants who had fever at baseline. Fever is defined as body temperature \>37.0 degree Celsius. Rectal temperature is converted by subtracting 1 degree Celsius. Time to Resolution of Fever was defined as the time from the initiation of treatment to first time the afebrile state was reached and maintained for at least 21.5 hours, where afebrile state was defined as axillary temperature ≤ 37 degree Celsius.
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=17 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=4 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=37 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Time to Resolution of Fever in Participants With Fever at the Baseline
|
20.5 hours
Interval 12.0 to 36.0
|
24.0 hours
Interval 14.0 to 43.0
|
12.0 hours
Interval 9.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day3/4, Day 6, Day 11, Day 18+/-2 days, Day 30+/-2 daysPopulation: Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study
This was performed for all participants who had fever at baseline Fever is defined as body temperature \>37.0ºC. Rectal temperature is converted by subtracting 1 ºC. The rate of decline of body temperature was calculated as the slope of body temperature between the baseline temperature and the 1st temperature below 37°C. Participants with decline in body temperature were considered to have no fever; however, participants who did not show any decline in body temperature were considered to have persisting fever.
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=11 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=4 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=33 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Baseline, n=33, 11, 4, decline
|
55 percentage of participants
|
25 percentage of participants
|
36 percentage of participants
|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Baseline, n=33, 11, 4, no decline
|
45 percentage of participants
|
75 percentage of participants
|
64 percentage of participants
|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Day 4, n=33, 11, 4, decline
|
91 percentage of participants
|
100 percentage of participants
|
94 percentage of participants
|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Day 4, n=33, 11, 4, no decline
|
9 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Day 11, n=33, 11, 4, decline
|
100 percentage of participants
|
100 percentage of participants
|
97 percentage of participants
|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Day 11, n=33, 11, 4, no decline
|
0 percentage of participants
|
0 percentage of participants
|
3 percentage of participants
|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Day 18, n=16, 5, 1, decline
|
100 percentage of participants
|
100 percentage of participants
|
94 percentage of participants
|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Day 18, n=16, 5, 1, no decline
|
0 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Day 30, n=31, 9, 4, decline
|
89 percentage of participants
|
100 percentage of participants
|
97 percentage of participants
|
|
Percentage of Participants With Decline of Body Temperature to the Afebrile State
Day 30, n=31, 9, 4, no decline
|
11 percentage of participants
|
0 percentage of participants
|
3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 3 days after the last dose of oseltamivir (Approximately 14 days)Population: Safety population included all treated participants with at least one post-baseline safety assessment
An Adverse Event (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Secondary illnesses were influenza disease-related events, namely bronchitis, pneumonia, otitis media, and sinusitis that resolved without sequelae. Adverse events, serious adverse events, and secondary illness are reported for on-treatment period (from the first dose of oseltamivir upto 3 days after the last dose of oseltamivir \[Approximately 14 days\].
Outcome measures
| Measure |
Oseltamivir 2.5 mg/kg
n=20 Participants
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
|
Oseltamivir 2 mg/kg
n=5 Participants
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
Oseltamivir 3 mg/kg
n=40 Participants
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Secondary Illness
Participants with any AE
|
12 Participants
|
2 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Secondary Illness
Participants with any SAE
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Secondary Illness
Participants with secondary illness
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post baseline, Day 3, 4, 6, 11, 18+/- 2 days, 30+/-2 daysPopulation: Safety population included all treated participants with at least one post-baseline safety assessment. Due to the small numbers of participants and the extent of influenza induced variability, changes in vital sign patterns cannot be detected.
Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and heart rate were examined for any consistent within-patient post-baseline changes.
Outcome measures
Outcome data not reported
Adverse Events
Oseltamivir 3 mg
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Oseltamivir 2.5 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Oseltamivir 2 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oseltamivir 3 mg
n=40 participants at risk
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
|
Oseltamivir 2.5 mg
n=20 participants at risk
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/ twice a day for 5 days
|
Oseltamivir 2 mg
n=5 participants at risk
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
2.5%
1/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Infections and infestations
Cellulitis orbital
|
2.5%
1/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
Other adverse events
| Measure |
Oseltamivir 3 mg
n=40 participants at risk
Participants aged 91 to \<365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
|
Oseltamivir 2.5 mg
n=20 participants at risk
Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/ twice a day for 5 days
|
Oseltamivir 2 mg
n=5 participants at risk
Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
25.0%
10/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
55.0%
11/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
4/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Gastrointestinal disorders
Regurgitation
|
2.5%
1/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
30.0%
6/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
40.0%
2/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
General disorders
Pyrexia
|
7.5%
3/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
General disorders
Irritability
|
0.00%
0/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
10.0%
2/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
General disorders
Crepitations
|
0.00%
0/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
20.0%
1/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Infections and infestations
Rotavirus infection
|
2.5%
1/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Infections and infestations
Otitis media
|
0.00%
0/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Eye disorders
Conjunctivitis
|
5.0%
2/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
20.0%
1/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
20.0%
1/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/40 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
5.0%
1/20 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
0.00%
0/5 • Up to 3 days after the last dose of oseltamivir (Approximately 14 days)
SAEs and other AEs were collected in the safety population. Safety population included all treated participants with at least one post-baseline safety assessment. All AEs are reported for on-treatment period (from the first dose of oseltamivir up to 3 days after the last dose of oseltamivir \[Approximately 14 days\].
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
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