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Trial record 69 of 118 for:    oseltamivir

A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01033734
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Influenza
Intervention Drug: oseltamivir [Tamiflu]
Enrollment 8
Recruitment Details  
Pre-assignment Details A total of 2836 participants were prescreened, of which, 2828 failed evaluation. The most common reasons for screen failure included: negative influenza diagnosis, not meeting the age criterion, ability to tolerate/absorb oral medication, and an inability to comply with the study procedures.
Arm/Group Title Oseltamivir: Overall
Hide Arm/Group Description Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to (≤) 23 kilogram (kg) received 3 milligrams per kilogram (mg/kg); participants with body weight more than (>) 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 milligrams (mg). For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Oseltamivir: Overall
Hide Arm/Group Description Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight ≤23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
All-participants population included all participants who were enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
4.8  (3.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
2
  25.0%
Male
6
  75.0%
1.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1
Hide Description [Not Specified]
Time Frame Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 1 3 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour*nanogram/milliliter (h*ng/mL)
Oseltamivir 829
1460
(46.3%)
Oseltamivir Carboxylate 1700
4550
(61.1%)
2.Primary Outcome
Title AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2
Hide Description [Not Specified]
Time Frame Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 0 1 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
Oseltamivir 1070 1920
Oseltamivir Carboxylate 5970 6760
3.Primary Outcome
Title AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3
Hide Description [Not Specified]
Time Frame Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 1 0 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ng/mL
Oseltamivir 943
Oseltamivir Carboxylate 2000
4.Primary Outcome
Title AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4
Hide Description [Not Specified]
Time Frame Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 0 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ng/mL
Oseltamivir 2480
Oseltamivir Carboxylate 3800
5.Primary Outcome
Title AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5
Hide Description [Not Specified]
Time Frame Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 1 0 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hr*ng/mL
Oseltamivir 1010
Oseltamivir Carboxylate 2820
6.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1
Hide Description [Not Specified]
Time Frame Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 1 3 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
Oseltamivir 360
753
(36.9%)
Oseltamivir Carboxylate 311
499
(55.1%)
7.Primary Outcome
Title Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2
Hide Description [Not Specified]
Time Frame Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 0 1 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Oseltamivir 500 1270
Oseltamivir Carboxylate 663 725
8.Primary Outcome
Title Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3
Hide Description [Not Specified]
Time Frame Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 1 0 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Oseltamivir 404
Oseltamivir Carboxylate 237
9.Primary Outcome
Title Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4
Hide Description [Not Specified]
Time Frame Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 0 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Oseltamivir 915
Oseltamivir Carboxylate 549
10.Primary Outcome
Title Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5
Hide Description [Not Specified]
Time Frame Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 1 0 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Oseltamivir 403
Oseltamivir Carboxylate 408
11.Secondary Outcome
Title Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 1 3 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
Day 1: Oseltamivir (n = 1, 3, 0) 2.00
1.26
(41.7%)
NA [1] 
(NA%)
Day 1: Oseltamivir Carboxylate (n = 1, 3, 0) 4.00
4.61
(53.3%)
NA [1] 
(NA%)
Day 2: Oseltamivir (n = 0, 1, 1)
NA [1] 
(NA%)
2.00 [1] 
(NA%)
1.00
Day 2: Oseltamivir Carboxylate (n = 0, 1, 1)
NA [1] 
(NA%)
4.62 [1] 
(NA%)
6.00
Day 3: Oseltamivir (n = 1, 0, 0) 1.05
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 3: Oseltamivir Carboxylate (n = 1, 0, 0) 3.05
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 4: Oseltamivir (n = 0, 1, 0)
NA [1] 
(NA%)
2.50 [2] 
(NA%)
NA [1] 
(NA%)
Day 4: Oseltamivir Carboxylate (n = 0, 1, 0)
NA [1] 
(NA%)
8.05 [2] 
(NA%)
NA [1] 
(NA%)
Day 5: Oseltamivir (n = 1, 0, 0) 2.00
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 5: Oseltamivir Carboxylate (n = 1, 0, 0) 4.08
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Data not available as no participant was evaluable
[2]
Standard deviation not applicable as only 1 participant was evaluable
12.Secondary Outcome
Title Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 1 3 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1: Oseltamivir (n = 1, 3, 0) 4.40
2.41
(80.6%)
NA [1] 
(NA%)
Day 1: Oseltamivir Carboxylate (n = 1, 3, 0) 237
308
(74.4%)
NA [1] 
(NA%)
Day 2: Oseltamivir (n = 0, 2, 1)
NA [1] 
(NA%)
25.2
(1704911.2%)
4.76
Day 2: Oseltamivir Carboxylate (n = 0, 2, 1)
NA [1] 
(NA%)
319
(0.44%)
484
Day 3: Oseltamivir (n = 1, 0, 0) 2.60
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 3: Oseltamivir Carboxylate (n = 1, 0, 0) 149
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 4: Oseltamivir (n = 0, 1, 0)
NA [1] 
(NA%)
25.1 [2] 
(NA%)
NA [1] 
(NA%)
Day 4: Oseltamivir Carboxylate (n = 0, 1, 0)
NA [1] 
(NA%)
549 [2] 
(NA%)
NA [1] 
(NA%)
Day 5: Oseltamivir (n = 1, 0, 0) 15.1
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 5: Oseltamivir Carboxylate (n = 1, 0, 0) 339
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Data not available as no participant was evaluable.
[2]
Standard deviation not applicable as only 1 participant was evaluable.
13.Secondary Outcome
Title Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.
Arm/Group Title Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 1 3 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
Day 1: Oseltamivir (n = 1, 3, 0) 7.42
10.50
(23.4%)
NA [1] 
(NA%)
Day 1: Oseltamivir Carboxylate (n = 1, 3, 0) 7.42
11.98
(0.2%)
NA [1] 
(NA%)
Day 2: Oseltamivir (n = 0, 2, 1)
NA [1] 
(NA%)
3.50
(448.5%)
12.00
Day 2: Oseltamivir Carboxylate (n = 0, 2, 1)
NA [1] 
(NA%)
3.50
(448.47%)
12.00
Day 3: Oseltamivir (n = 1, 0, 0) 10.13
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 3: Oseltamivir Carboxylate (n = 1, 0, 0) 10.13
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 4: Oseltamivir (n = 0, 1, 0)
NA [1] 
(NA%)
8.05 [2] 
(NA%)
NA [1] 
(NA%)
Day 4: Oseltamivir Carboxylate (n = 0, 1, 0)
NA [1] 
(NA%)
8.05 [2] 
(NA%)
NA [1] 
(NA%)
Day 5: Oseltamivir (n = 1, 0, 0) 7.92
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 5: Oseltamivir Carboxylate (n = 1, 0, 0) 7.92
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Data not available as no participant was evaluable.
[2]
Standard deviation not applicable as only 1 participant was evaluable.
14.Secondary Outcome
Title Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available as no participant was evaluable for specified time-points.
Arm/Group Title Oseltamivir: Overall
Hide Arm/Group Description:
Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available as no participant was evaluable for specified time-points.
Arm/Group Title Oseltamivir: Overall
Hide Arm/Group Description:
Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate
Hide Description [Not Specified]
Time Frame Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected because of changes in planned analysis, due to early study termination.
Arm/Group Title Oseltamivir: Overall
Hide Arm/Group Description:
Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Participants With Greater Than or Equal to (>=) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values
Hide Description IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either >=5 times change in the NAI IC50 visit value from the Reference value at a visit, >=5 times change in the NAI IC50 Visit value from the Baseline value.
Time Frame Baseline, Day 1, 6 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.
Arm/Group Title Oseltamivir: Overall Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description:
Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Overall Number of Participants Analyzed 6 2 3 1
Measure Type: Number
Unit of Measure: Participants
Day 1 (n=6, 2, 3, 1) 1 0 1 0
Day 6 (n=1, 0, 1, 0) 1 NA [1]  1 NA [1] 
Day 30 (n=1, 1, 0, 0) 0 0 NA [1]  NA [1] 
[1]
Data not available as no participant was evaluable in this arm for specified time-point.
Time Frame Up to 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oseltamivir: Overall Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Hide Arm/Group Description Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses. Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
All-Cause Mortality
Oseltamivir: Overall Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oseltamivir: Overall Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/8 (25.00%)      1/2 (50.00%)      1/5 (20.00%)      0/1 (0.00%)    
General disorders         
Pyrexia * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Infections and infestations         
Sepsis * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Bronchospasm * 1  1/8 (12.50%)  1 1/2 (50.00%)  1 0/5 (0.00%)  0 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oseltamivir: Overall Oseltamivir: 6 to 12 Years Oseltamivir: 3 to 5 Years Oseltamivir: 1 to 2 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/8 (62.50%)      0/2 (0.00%)      4/5 (80.00%)      1/1 (100.00%)    
Cardiac disorders         
Left Ventricular Dysfunction * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
General disorders         
Catheter Site Erosion * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Device Expulsion * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Drug Withdrawal Syndrome * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 1/1 (100.00%)  1
Infusion Site Erythema * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Investigations         
Body Temperature Increased * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Rhinorrhoea * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders         
Ingrowing Nail * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Pain of Skin * 1  1/8 (12.50%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Low number of participants enrolled in the study at the time that the study was terminated limits conclusions that can be derived from the study data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01033734     History of Changes
Other Study ID Numbers: NP25139
First Submitted: December 15, 2009
First Posted: December 16, 2009
Results First Submitted: January 15, 2016
Results First Posted: August 24, 2016
Last Update Posted: August 24, 2016