A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00545532
Collaborator
(none)
228
208
2
110.9
1.1
0
Study Details
Study Description
Brief Summary
This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza
Actual Study Start Date
:
Feb 4, 2008
Actual Primary Completion Date
:
May 2, 2017
Actual Study Completion Date
:
May 2, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Conventional dose Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. |
Drug: oseltamivir
Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days
Other Names:
Other: placebo
Placebo matched to oseltamivir po twice daily for 10 days
|
| Experimental: Double dose Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
Drug: oseltamivir
Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days
Other Names:
Other: placebo
Placebo matched to oseltamivir po twice daily for 10 days
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Adverse Events [Baseline up to Day 40]
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
- Percentage of Participants Who Developed Viral Resistance to Oseltamivir [Baseline up to Day 40]
Resistance was defined as the presence of oseltamivir resistance mutations in viruses isolated from nasopharyngeal swab samples, identified by sequencing of the neuraminidase (NA) and hemagglutinin (HA) genes (genotypic resistance) and/or determination of the oseltamivir concentration at which the response is reduced by half (IC50) in an NA inhibition assay (phenotypic resistance). Reported are post-baseline phenotypic and genotypic resistance in adults >/= 18 years and children and adolescents <18 years in the modified Intent-to-Treat infected (mITTi) population.
- Percentage of Participants With Tissue Rejection or Graft Versus Host Disease (GVHD) [Baseline up to Day 40]
The percentage of transplant patients in the safety population who experienced tissue rejection and/or GvHD is reported.
Secondary Outcome Measures
- Time to Resolution (TTR) of All Clinical Influenza Symptoms [Baseline up to Day 40]
TTR of all clinical influenza symptoms was defined as the time from treatment initiation to the start of the 24-hour period in which all 7 influenza symptoms had scores </= 1 (mild) and remained </=1 for at least 21.5 hours. . Reported are TTRs in adults >/= 18 years, adults and adolescents >/= 13 years and children <13 years in the mITTi population.
- Total Symptom Score Area Under the Efficacy Curve (AUE) [Baseline up to Day 40]
The overall extent and severity of illness was quantified by the AUE of the total symptom scores over the duration of illness, i.e., from the start of treatment to the time symptoms first alleviated. Total symptom scores were calculated from the sum of seven individual symptom scores with each individual symptom scored from 0 (healthy) to 3 (worst sickness) and a maximum total symptom score of 21. The AUE of these average scores was then calculated for each participant using the trapezoidal rule (the trapezoidal rule calculates the area under any curve by adding up all trapezoids under such a curve). A larger area indicates more severe disease. In this study participants were treated for 10 days. If a participant had scored 21 on every visit then AUE would have been 21 score x 10 days x 24 hours/day =5040 score x hours units, which is the highest possible score. The lowest possible score is 0. Reported are results for adults >/= 18 years in the mITTi population.
- Time to Resolution of Fever [Baseline up to Day 40]
Fever was defined as temperature >/= 37.8 degrees Celsius at any time point during the study. TTR of fever was determined in Adults >/= 18 years, Adults and adolescents >/= 13 years and Children < 13 years of the mITTi population.
- Change From Baseline in Viral Load Assessed by Culture [Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.]
Nasopharyngeal swab samples were cultured in Madin-Darby Canine Kidney cells. Culture supernatants were harvested after 2 weeks, or after a full-blown cytopathic effect was observed. Presence of infectious viruses in the cell culture supernatants (viral titer), expressed as log10 50% Tissue Culture Infectious Dose/milliliter (TCID50/mL), was determined by hemagglutination assay using turkey erythrocytes for H1 and B viruses or by detection of the virus nucleoprotein (NP) using ELISA for H3 viruses. A value of < 0.5 log10 TCID50/mL was interpreted as negative. Data are reported for adults >/= 18 years and adolescents and children < 18 years.
- Percentage of Participants With Viral Shedding Assessed by Culture Over Time [Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.]
Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the percentage of participants with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
- Time to Cessation of Viral Shedding by Cell Culture [Baseline up to Day 40]
Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
- Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR) [Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.]
Nasopharyngeal swab samples were tested for influenza A and B RNA using semi-quantitative RT-PCR specific for influenza A and B matrix gene, respectively, after viral RNA isolation. Cycle threshold (Ct) value was determined for each sample. Conversion of Ct values into viral load, expressed as log10 virus particles/mL (vp/mL), was obtained using external standard curves ran in parallel in all RT-PCR experiments. A value of < 2.6 log10 vp/mL for Flu A strains and < 3.0 log10 vp/mL for Flu B strains was interpreted as a negative result. Data are reported for adults >/= 18 years and adolescents and children < 18 years.
- Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time [Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40.]
Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the percentage of subjects with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
- Time to Cessation of Viral Shedding by RT-PCR [Baseline up to Day 40]
Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years.
- Percentage of Participants With Persistent Viral Shedding [Baseline to Day 11 (EOT)]
Persistent shedding was defined as a viral load reduction <1 log10 vp/mL at end of treatment compared with baseline. Reported is the percentage of participants with persistent viral shedding at end of treatment in adults >/= 18 years and adolescents and children < 18 years.
- Percentage of Participants Who Developed Secondary Illness [Baseline up to Day 40]
Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with at least one event in adults >/= 18 years and adolescents and children < 18 years.
- Percentage of Participants Who Initiated Antibiotic Treatment [Baseline up to Day 40]
Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with secondary illness, who initiated antibiotic treatment, in adults >/= 18 years and adolescents and children < 18 years.
- Percentage of Participants Hospitalized [Baseline up to Day 40]
Reported is the percentage of participants, who required hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.
- Duration of Hospitalization [Baseline up to Day 40]
Reported is the duration of hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years.
- Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir Cmax data for adults >/= 18 years.
- Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir Ctrough data for adults >/= 18 years.
- Pharmacokinetics : Area Under the Concentration-Time Curve From 0 to 12 Hours (AUC0-12) at Steady State of Oseltamivir in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose]
AUC0-12 was reported at steady state as nanograms per hour per milliliter. (ng*hr/mL). Reported here are oseltamivir AUC0-12 data for adults >/= 18 years.
- Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir tmax data for adults >/= 18 years.
- Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir ke data for adults >/= 18 years.
- Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir CL/F data for adults >/= 18 years.
- Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir Vc/F data for adults >/= 18 years.
- Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate Cmax data for adults >/= 18 years.
- Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate Ctrough data for adults >/= 18 years.
- Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate AUC0-12 data for adults >/= 18 years.
- Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate tmax data for adults >/= 18 years.
- Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oxeltamivir carboxylate ke data for adults >/= 18 years.
- Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate CL/F data for adults >/= 18 years.
- Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate Vc/F data for adults >/= 18 years.
- Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose]
AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose]
AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir carboxylate AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate tmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
- Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children [Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose]
Reported here are oseltamivir carboxylate Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
-
Immunocompromised participants with primary or secondary immunodeficiency
-
Symptoms suggestive of influenza-like illness
-
Use of an effective contraceptive, as specified by protocol; women of childbearing potential cannot be pregnant or breastfeeding
Exclusion Criteria:
-
Influenza vaccination with live attenuated vaccine in the 2 weeks prior to randomization
-
Antiviral treatment for influenza in 2 weeks prior to randomization
-
Severe hepatic impairment
-
Any current renal replacement therapy
-
Any gastrointestinal disorders which may interfere with the absorption of oseltamivir
-
Participation in a study with an investigational drug from 4 weeks prior to study start until study end
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uni of Alabama At Birmingham; Division of Nephrology | Birmingham | Alabama | United States | 35233 |
| 2 | University of Alabama at Birmingham; Pediatric Nephrology | Birmingham | Alabama | United States | 35233 |
| 3 | Pacific Oaks Medical Group | Beverly Hills | California | United States | 90211 |
| 4 | Providence Clinical Research | Burbank | California | United States | 91505 |
| 5 | AIDS Research Alliance | Los Angeles | California | United States | 90015 |
| 6 | UCLA Medical center Medicine/Nephrology | Los Angeles | California | United States | 90095 |
| 7 | University of California Davis Health System | Sacramento | California | United States | 95817 |
| 8 | CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi | San Francisco | California | United States | 94115 |
| 9 | University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan | Aurora | Colorado | United States | 80045 |
| 10 | New England Research Associates | Trumbull | Connecticut | United States | 06611 |
| 11 | Christiana Care Health System | Newark | Delaware | United States | 19713 |
| 12 | Omega Research Consultants | Orlando | Florida | United States | 32810 |
| 13 | All Children'S Hospital; Pediatric Blood & Marrow Transplant Program | Saint Petersburg | Florida | United States | 33701 |
| 14 | Kendall South Medical Center Inc. | South Miami | Florida | United States | 33143 |
| 15 | Vita Research Solutions, Inc | Tamarac | Florida | United States | 33319 |
| 16 | University of South Florida | Tampa | Florida | United States | 33612 |
| 17 | Piedmont Hospital; Transplant Services | Atlanta | Georgia | United States | 30309 |
| 18 | EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center | Atlanta | Georgia | United States | 30322 |
| 19 | Medical College of Georgia; Medicine/ Nephrology | Augusta | Georgia | United States | 30912 |
| 20 | Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine | Chicago | Illinois | United States | 60611 |
| 21 | Rush Uni Medical Center; Medicine/ Section of Infectious Diseases | Chicago | Illinois | United States | 60612 |
| 22 | University of Chicago; Infectious Disease | Chicago | Illinois | United States | 60655 |
| 23 | Tulane University Medical Center | New Orleans | Louisiana | United States | 70112 |
| 24 | University of Maryland School of Medicine | Baltimore | Maryland | United States | 21201 |
| 25 | Brigham & Women'S Hospital | Boston | Massachusetts | United States | 02115 |
| 26 | Western New England Renal & Transplant Associates, P.C. | Springfield | Massachusetts | United States | 01107 |
| 27 | Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease | Ann Arbor | Michigan | United States | 48109-0378 |
| 28 | Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building | Detroit | Michigan | United States | 48201 |
| 29 | Henry Ford Health System; Gastroenterology | Detroit | Michigan | United States | 48202-2689 |
| 30 | Wayne State University School of Medicine | Detroit | Michigan | United States | 48210 |
| 31 | Beals Institute PC | Lansing | Michigan | United States | 48917 |
| 32 | Washington University; Wash Uni. Sch. Of Med | Saint Louis | Missouri | United States | 63110 |
| 33 | Our Lady of Lourdes Medical Center; Transplant Dept | Camden | New Jersey | United States | 08103 |
| 34 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 35 | Long Island Jewish/North Shore Hospital | New Hyde Park | New York | United States | 11042 |
| 36 | Mount Sinai Medical Center; Division of Liver Diseases | New York | New York | United States | 10029 |
| 37 | DJL Clinical Research PLLC | Charlotte | North Carolina | United States | 28210 |
| 38 | Novant Health Pulmonary and Critical Care | Matthews | North Carolina | United States | 28105 |
| 39 | Duke University Health Systems | Raleigh | North Carolina | United States | 27609 |
| 40 | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157 |
| 41 | Uni of Cincinnati Medical Center; Nephrology & Hypertension | Cincinnati | Ohio | United States | 45267 |
| 42 | Cleveland Clinic Foundation; Infectious Disease | Cleveland | Ohio | United States | 44195 |
| 43 | Toledo Hospital | Toledo | Ohio | United States | 43606 |
| 44 | Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center | Oklahoma City | Oklahoma | United States | 73112-4481 |
| 45 | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 46 | Drexel University; College of Medicine | Philadelphia | Pennsylvania | United States | 19102 |
| 47 | Uni of Pennsylvania; Infectious Diseases | Philadelphia | Pennsylvania | United States | 19104 |
| 48 | University of Pennsylvania Health System | Philadelphia | Pennsylvania | United States | 19104 |
| 49 | Children'S Hospital of Pittsburgh; Infectious Disease | Pittsburgh | Pennsylvania | United States | 15213 |
| 50 | Medical University of South Carolina; Pediatric Cardiology | Charleston | South Carolina | United States | 29425 |
| 51 | Children'S Medical Center of Dallas | Dallas | Texas | United States | 75235 |
| 52 | Baylor University Medical Center Transplant Administration | Dallas | Texas | United States | 75246 |
| 53 | UT Southwestern Medical Center; Pediatrics Dept. | Dallas | Texas | United States | 75390 |
| 54 | Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation | Dallas | Texas | United States | TX 75246 |
| 55 | The Methodist Hospital | Houston | Texas | United States | 77005 |
| 56 | M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health | Houston | Texas | United States | 77030 |
| 57 | Texas Tech University Health Sciences Center; Department of Urology | Lubbock | Texas | United States | 79430 |
| 58 | University of Texas Health Science Center Transplant center | San Antonio | Texas | United States | 78229 |
| 59 | Scott and White Division of Nephrology Dept of Medicine | Temple | Texas | United States | 76508 |
| 60 | University of Utah Health Science Center Gastroenterology | Salt Lake City | Utah | United States | 84132 |
| 61 | Hospital General de Agudos Juan Antonio Fernandez; infectologÃa | Buenos Aires | Argentina | 1202 | |
| 62 | Instituto Medico Platense | Buenos Aires | Argentina | ||
| 63 | Instituto Medico Especializado Alexander Fleming | Ciudad Autonoma Buenos Aires | Argentina | 1426 | |
| 64 | Hospital General de Agudos Dr. Ignacio Pirovano | Ciudad Autonoma Buenos Aires | Argentina | 1430 | |
| 65 | Hospital Italiano de La Plata | La Plata | Argentina | 1725 | |
| 66 | Hospital de Niños Dr. Orlando Alassia | Santa Fe | Argentina | S3000CII | |
| 67 | Onze Lieve Vrouwziekenhuis Aalst | Aalst | Belgium | 9300 | |
| 68 | UZ Brussel | Brussel | Belgium | 1090 | |
| 69 | Institut Jules Bordet | Bruxelles | Belgium | 1000 | |
| 70 | Hospital Erasme; Neurologie | Bruxelles | Belgium | 1070 | |
| 71 | Fiocruz - Fundação Oswaldo Cruz | Rio de Janeiro | RJ | Brazil | 21040-360 |
| 72 | Hospital Alemao Oswaldo Cruz; Oncologia | Sao Paulo | SP | Brazil | 01323-020 |
| 73 | Iop - Graacc - Unifesp | Sao Paulo | SP | Brazil | 04023-062 |
| 74 | Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos | Sao Paulo | SP | Brazil | 04038-002 |
| 75 | Hospital das Clinicas - FMUSP | Sao Paulo | SP | Brazil | 05403-000 |
| 76 | UMHA - Sv. Georgi; Clinic of Nephrology & Haemodialysis | Plovdiv | Bulgaria | 4002 | |
| 77 | UMHAT Sv. Georgi, EAD; Clinic of Infectious Diseases | Plovdiv | Bulgaria | 4002 | |
| 78 | Mhat Alexandrovska Ead ; Clinic of Nephrology & Transplantation, Uni Hospital | Sofia | Bulgaria | 1431 | |
| 79 | Specialized Hospital for children with oncohaematologica Diseases; Dept. Of Transplantations | Sofia | Bulgaria | 1527 | |
| 80 | Uni of Manitoba; Faculty of Medicine | Winnipeg | Manitoba | Canada | R3E 6518 |
| 81 | St Paul'S | Saskatoon | Saskatchewan | Canada | S7M 0Z9 |
| 82 | Hospital Luis Calvo Mackenna; Unidad de Investigacion | Santiago | Chile | 7500539 | |
| 83 | Hospital Dr. Sotero del Rio | Santiago | Chile | 8207257 | |
| 84 | Centro de Investigaciones Clinicas Viña del Mar | Viña Del Mar Valparaiso | Chile | 2520000 | |
| 85 | Infectologos Asociados | Barranquilla | Colombia | ||
| 86 | Simedics Ips | Bogota | Colombia | ||
| 87 | Centro de Investigaciones Clinicas S.A.S | Cali | Colombia | ||
| 88 | Fundacion Cardiovascular de Colombia - Instituto del Corazón | Floridablanca | Colombia | ||
| 89 | Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika | Brno | Czechia | 625 00 | |
| 90 | Fakultni Nemocnice; Hemato-Oncology | Plzen | Czechia | 300 00 | |
| 91 | Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF | Praha 5 | Czechia | 150 06 | |
| 92 | The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf | Praha | Czechia | 12820 | |
| 93 | KASMED, s.r.o.; Alergologie a klinicka imunologie | Tabor | Czechia | 390 01 | |
| 94 | Revmatologicka Ambulance-Terezin | Terezin | Czechia | 411 55 | |
| 95 | Revmatologicka ambulance | Zlin | Czechia | 760 01 | |
| 96 | West Tallinn Central Hospital; Nephrology | Tallinn | Estonia | 10617 | |
| 97 | North Estonia medical Centre; Hematology | Tallinn | Estonia | 13419 | |
| 98 | Tartu Uni Clinics; Clinic of Surgery & Internal Medicine Dept of Nephrology | Tartu | Estonia | 51014 | |
| 99 | Tartu Uni Hospital; Hematology - Oncology Clinic | Tartu | Estonia | 51014 | |
| 100 | Tartu University Hospital; Department of Infectious Diseases | Tartu | Estonia | 51014 | |
| 101 | Centre Hospitalier de la Croix Rousse | Lyon | France | 69317 | |
| 102 | Hopital Robert Debre; Pediatric Hematology Dept | Paris | France | 75019 | |
| 103 | Hopital Saint Louis; Service de Nephrologie - Transplantation | Paris | France | 75475 | |
| 104 | Hopital Europeen Georges Pompidou; Service de Nephrologie | Paris | France | 75908 | |
| 105 | Hopital Rangueil; Nephrologie | Toulouse | France | 31059 | |
| 106 | CHRU Bretonneau | Tours | France | 37044 | |
| 107 | Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie | Aachen | Germany | 52057 | |
| 108 | Charite - Campus Virchow Klinikum; Abteilung fuer Chirurgie | Berlin | Germany | 13353 | |
| 109 | Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung | Essen | Germany | 45122 | |
| 110 | Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany | 20246 | |
| 111 | UNI-Klinikum Heidelberg Chirurgische Klinik | Heidelberg | Germany | 69120 | |
| 112 | Ludwig-Maximilian-Universitaetsklinik; Med. Poliklinik/Infektiologie | Muenchen | Germany | 80336 | |
| 113 | Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV | Muenchen | Germany | 80336 | |
| 114 | Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie | Muenster | Germany | 48149 | |
| 115 | Clinica Familiar Luis Angel Garcia | Ciudad de Guatemala | Guatemala | 01001 | |
| 116 | CERICAP | Ciudad de Guatemala | Guatemala | 01009 | |
| 117 | Centro de Investigaciones Pediatricas | Guatemala City | Guatemala | 1015 | |
| 118 | Hospital Roosevelt Guatemala; Clinica de Infecciosas | Guatemala City | Guatemala | ||
| 119 | Unidad Nacional de Oncologia Pediatrica | Guatemala | Guatemala | ||
| 120 | Fov.Onk.Egyesitett Szt. Istvan es Szt Laszlo Korh.-Rend.Int. | Budapest | Hungary | 1096 | |
| 121 | Debreceni Egyetem, Orvos- és Egészségtudományi Centrum; | Debrecen | Hungary | 4032 | |
| 122 | Petz Aladar Megyei Korhaz; Hematologia | Gyor | Hungary | 9024 | |
| 123 | Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza | Gyula | Hungary | 5700 | |
| 124 | Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek | Gyula | Hungary | 5703 | |
| 125 | Pecsi Tudomanyegyetem | Pecs | Hungary | 7624 | |
| 126 | University of Szeged; Transplantation Department | Szeged | Hungary | 6720 | |
| 127 | Fejer Megyei Szent Gyorgy Korhaz | Szekesfehervar | Hungary | 8000 | |
| 128 | Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int. | Szolnok | Hungary | 5000 | |
| 129 | Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt. | Veszprem | Hungary | 8200 | |
| 130 | Rambam Health Care Campus; Hematology | Haifa | Israel | 31096 | |
| 131 | Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept. | Jerusalem | Israel | 91120 | |
| 132 | Rabin MC- Belinson campus | Petach Tikva | Israel | 49100 | |
| 133 | Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation | Petach Tikva | Israel | 49100 | |
| 134 | Rabin Medical Center; Liver Inst. | Petach Tikva | Israel | 49100 | |
| 135 | Chaim Sheba Medical Center; Hematology BMT & CBB | Ramat Gan | Israel | 52662 | |
| 136 | Sourasky MC; Transplant Unit | Tel Aviv | Israel | 64239 | |
| 137 | Chaim Sheba MC; Pediatric Hematology Oncology | Tel Hashomer | Israel | 52621 | |
| 138 | Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali | Parma | Emilia-Romagna | Italy | 43100 |
| 139 | POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo | Roma | Lazio | Italy | 00168 |
| 140 | I.N.M.I. L. Spallanzani IRCCS | Roma | Lazio | Italy | RM 00149 |
| 141 | ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive | Brescia | Lombardia | Italy | 25126 |
| 142 | ASST DI MONZA; Divisione Malattie Infettive | Monza | Lombardia | Italy | 20052 |
| 143 | Fondazione IRCCS Policlinico San Matteo | Pavia | Lombardia | Italy | 27100 |
| 144 | Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi | Milano | Molise | Italy | 20122 |
| 145 | Latvia Transplantation Center P. Stradina Hospital; Transplantation | Riga | Latvia | LV-1002 | |
| 146 | Children's Clinical University Hospital | Riga | Latvia | LV-1004 | |
| 147 | Kaunas Clinics Public Institution; Clinic of Nephrology | Kaunas | Lithuania | 50009 | |
| 148 | Klaipeda University Hospital; Public Institution | Klaipeda | Lithuania | 92288 | |
| 149 | Siauliai Republican Hospital Public Institution | Siauliai | Lithuania | 76231 | |
| 150 | Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center | Vilnius | Lithuania | 08661 | |
| 151 | Vilnius University Hospital Santariskiu Clinic | Vilnius | Lithuania | 08661 | |
| 152 | Republican Tuberculosis and Infectious Diseases University H | Vilnius | Lithuania | 8117 | |
| 153 | Phylaxis Clinical Research S de RL de CV | Cuautitlan Izcalli | Mexico | 54769 | |
| 154 | Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; InfectologÃa piso 7 | Guadalajara | Mexico | 44280 | |
| 155 | Centro de Investigacion ClÃnica GRAMEL S.C | Mexico | Mexico | 03720 | |
| 156 | Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia | Mexico | Mexico | 14000 | |
| 157 | INER- Instituto Nacional de Enfermedades Respiratorias"Ismae | Mexico | Mexico | 14080 | |
| 158 | Hospital Universitario de Monterrey; Infectologia | Monterrey | Mexico | 64040 | |
| 159 | Hospital de Especialidades del Centro Medico Puerta de Hierr | Zapopan | Mexico | 45116 | |
| 160 | Wojewodzki Szp.Specjalistyczny im.K.Dluskiego w Bialymstoku | Bialystok | Poland | 15-540 | |
| 161 | NZOZ Vitamed | Bydgoszcz | Poland | 85-079 | |
| 162 | Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | 80-214 | |
| 163 | SPZOZ Szpital Uniw W Krakowie | Krakow | Poland | 31-501 | |
| 164 | SPZOZ Uniwersytecki Szp Klin; nr1 im.N.Barlickiego UM | Lodz | Poland | 90-153 | |
| 165 | SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie | Szczecin | Poland | 70-111 | |
| 166 | Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology | Warszawa | Poland | 02-006 | |
| 167 | Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego | Warszawa | Poland | 04-730 | |
| 168 | SP Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw | Poland | 50-367 | |
| 169 | ALL-MED Specjalistyczna Opieka Medyczna | Wroclaw | Poland | 50-445 | |
| 170 | Institutul de Urologie Si Transplant Renal Fundeni | Bucharest | Romania | 022328 | |
| 171 | Josha Research | Bloemfontein | South Africa | 9301 | |
| 172 | Londisizwe Research Centre | Durban | South Africa | 4001 | |
| 173 | Sebastian Peter | Durban | South Africa | 4001 | |
| 174 | Dr V Naidoo Private Practice | Durban | South Africa | 4092 | |
| 175 | Govind U | Durban | South Africa | 4096 | |
| 176 | Soweto CTC - Dr Phoshoko site | Johannesburg | South Africa | 1818 | |
| 177 | Soweto CTC - Dr Mushwana site | Johannesburg | South Africa | 1983 | |
| 178 | Newtown Clinical Research | Johannesburg | South Africa | 2113 | |
| 179 | Mzansi Ethical Research Centre | Middelburg | South Africa | 1055 | |
| 180 | Be Part Yoluntu Centre | Paarl | South Africa | 7626 | |
| 181 | Global Clinical Trials Port Elizabeth | Port Elizabeth | South Africa | 6020 | |
| 182 | Kalafong Hospital; Pathology | Pretoria | South Africa | 0002 | |
| 183 | Emmed Research | Pretoria | South Africa | 0084 | |
| 184 | Synexus Clinical Research Centres SA Stanza Bopape | Pretoria | South Africa | 0112 | |
| 185 | Soweto Clinical Trial Centre | Soweto | South Africa | 1818 | |
| 186 | Tygerberg Hospital Pediatrics and Child Health | Tygerberg; Cape Town | South Africa | 7505 | |
| 187 | Welkom Clinical Trial Centre | Welkom | South Africa | 9460 | |
| 188 | Hospital Universitari de Bellvitge; Servicio de Nefrologia | Hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 189 | Hospital Clinico Universitario de Santiago | Santiago de Compostela | LA Coruña | Spain | 15706 |
| 190 | Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas | Barcelona | Spain | 08035 | |
| 191 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
| 192 | Hospital ClÃnic i Provincial; Servicio de HematologÃa y OncologÃa | Barcelona | Spain | 08036 | |
| 193 | Hospital General Universitario Gregorio Marañon | Madrid | Spain | 28007 | |
| 194 | Hospital Infantil Universitario Nino Jesus | Madrid | Spain | 28009 | |
| 195 | Hospital Clinico San Carlos; Servicio de Nefrologia | Madrid | Spain | 28040 | |
| 196 | Hospital Universitario ClÃnico San Carlos; Servicio de Enfermedades Infecciosas | Madrid | Spain | 28040 | |
| 197 | Hospital Universitario 12 de Octubre; HIV Unit | Madrid | Spain | 28041 | |
| 198 | Hospital Universitario 12 de Octubre; Servicio de Pediatria | Madrid | Spain | 28041 | |
| 199 | Hospital Universitario La Paz; HepatologÃa y Trasplantes | Madrid | Spain | 28046 | |
| 200 | Hospital Universitario la Paz; Servicio de Enfermedades Infecciosas - HIV unit | Madrid | Spain | 28046 | |
| 201 | Universitätsspital Zürich; Klinik für Nephrologie | Zürich | Switzerland | 8091 | |
| 202 | Ukrainian Pediatric Specialized Hospital of Ministry of Health of Ukraine Dept of BMT | Kiev | Ukraine | 01135 | |
| 203 | Institute of Nephrology AMS; Dept of Nephrology & dialysis | Kiev | Ukraine | 04050 | |
| 204 | Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed | Lugnansk | Ukraine | 91045 | |
| 205 | Zaporozhye State Medical University; Dept of Transplantology | Zaporozhye | Ukraine | 69600 | |
| 206 | University Hospitals Bristol NHS Foundation Trust | Bristol | United Kingdom | BS2 8BJ | |
| 207 | Manchester Royal Infirmary; Renal Transplant Unit | Manchester | United Kingdom | M13 9WL | |
| 208 | Nottingham City Hospital; Transplant Unit | Nottingham | United Kingdom | NG5 1PB |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545532
Other Study ID Numbers:
- NV20234
- 2006-002468-24
First Posted:
Oct 17, 2007
Last Update Posted:
Jul 12, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Participant flow is provided for the safety analysis population, which was the primary analysis population for evaluation of safety. Safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization. Participants were reported under the actual treatment received. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Period Title: Overall Study | ||
| STARTED | 105 | 110 |
| COMPLETED | 99 | 100 |
| NOT COMPLETED | 6 | 10 |
Baseline Characteristics
| Arm/Group Title | Conventional Dose | Double Dose | Total |
|---|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. | Total of all reporting groups |
| Overall Participants | 105 | 110 | 215 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
43.0
(15.5)
|
43.9
(16.5)
|
43.5
(16.0)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
57
54.3%
|
62
56.4%
|
119
55.3%
|
| Male |
48
45.7%
|
48
43.6%
|
96
44.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
15
14.3%
|
21
19.1%
|
36
16.7%
|
| Not Hispanic or Latino |
90
85.7%
|
89
80.9%
|
179
83.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
6
5.7%
|
3
2.7%
|
9
4.2%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
27
25.7%
|
33
30%
|
60
27.9%
|
| White |
72
68.6%
|
72
65.5%
|
144
67%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
2
1.8%
|
2
0.9%
|
Outcome Measures
| Title | Percentage of Participants With Adverse Events |
|---|---|
| Description | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 105 | 110 |
| On Treatment |
40.0
38.1%
|
47.3
43%
|
| Off Treatment |
25.7
24.5%
|
29.1
26.5%
|
| Title | Percentage of Participants Who Developed Viral Resistance to Oseltamivir |
|---|---|
| Description | Resistance was defined as the presence of oseltamivir resistance mutations in viruses isolated from nasopharyngeal swab samples, identified by sequencing of the neuraminidase (NA) and hemagglutinin (HA) genes (genotypic resistance) and/or determination of the oseltamivir concentration at which the response is reduced by half (IC50) in an NA inhibition assay (phenotypic resistance). Reported are post-baseline phenotypic and genotypic resistance in adults >/= 18 years and children and adolescents <18 years in the modified Intent-to-Treat infected (mITTi) population. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 81 | 86 |
| Post-BL Phenotypic Resist, >/= 18 years |
8.2
7.8%
|
1.3
1.2%
|
| Post-BL Genotypic Resist, >/= 18 years |
9.6
9.1%
|
2.6
2.4%
|
| Post-BL Phenotypic Resist, < 18 years |
25.0
23.8%
|
0
0%
|
| Post-BL Genotypic Resist, < 18 years |
25.0
23.8%
|
12.5
11.4%
|
| Title | Percentage of Participants With Tissue Rejection or Graft Versus Host Disease (GVHD) |
|---|---|
| Description | The percentage of transplant patients in the safety population who experienced tissue rejection and/or GvHD is reported. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 105 | 110 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
| Title | Time to Resolution (TTR) of All Clinical Influenza Symptoms |
|---|---|
| Description | TTR of all clinical influenza symptoms was defined as the time from treatment initiation to the start of the 24-hour period in which all 7 influenza symptoms had scores </= 1 (mild) and remained </=1 for at least 21.5 hours. . Reported are TTRs in adults >/= 18 years, adults and adolescents >/= 13 years and children <13 years in the mITTi population. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline, and for whom data were available. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 82 | 86 |
| Adults >/= 18 years |
103.3
|
103.6
|
| Adults and adolescents >/= 13 years |
103.4
|
107.2
|
| Children < 13 years |
32.1
|
115.9
|
| Title | Total Symptom Score Area Under the Efficacy Curve (AUE) |
|---|---|
| Description | The overall extent and severity of illness was quantified by the AUE of the total symptom scores over the duration of illness, i.e., from the start of treatment to the time symptoms first alleviated. Total symptom scores were calculated from the sum of seven individual symptom scores with each individual symptom scored from 0 (healthy) to 3 (worst sickness) and a maximum total symptom score of 21. The AUE of these average scores was then calculated for each participant using the trapezoidal rule (the trapezoidal rule calculates the area under any curve by adding up all trapezoids under such a curve). A larger area indicates more severe disease. In this study participants were treated for 10 days. If a participant had scored 21 on every visit then AUE would have been 21 score x 10 days x 24 hours/day =5040 score x hours units, which is the highest possible score. The lowest possible score is 0. Reported are results for adults >/= 18 years in the mITTi population. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 59 | 67 |
| Median (Full Range) [score * hour] |
774.7
|
811.5
|
| Title | Time to Resolution of Fever |
|---|---|
| Description | Fever was defined as temperature >/= 37.8 degrees Celsius at any time point during the study. TTR of fever was determined in Adults >/= 18 years, Adults and adolescents >/= 13 years and Children < 13 years of the mITTi population. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 38 | 35 |
| Adults >/= 18 years |
11.0
|
0.5
|
| Adults and adolescents >/= 13 years |
11.0
|
0.5
|
| Children < 13 years |
NA
|
26.0
|
| Title | Change From Baseline in Viral Load Assessed by Culture |
|---|---|
| Description | Nasopharyngeal swab samples were cultured in Madin-Darby Canine Kidney cells. Culture supernatants were harvested after 2 weeks, or after a full-blown cytopathic effect was observed. Presence of infectious viruses in the cell culture supernatants (viral titer), expressed as log10 50% Tissue Culture Infectious Dose/milliliter (TCID50/mL), was determined by hemagglutination assay using turkey erythrocytes for H1 and B viruses or by detection of the virus nucleoprotein (NP) using ELISA for H3 viruses. A value of < 0.5 log10 TCID50/mL was interpreted as negative. Data are reported for adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40. |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 81 | 86 |
| >/= 18 years, Baseline (BL) |
3.38
|
3.75
|
| >/= 18 years, Change from BL on Day 2/3 |
-1.50
|
-1.50
|
| >/= 18 years, Change from BL on Day 6 |
-2.50
|
-3.00
|
| >/= 18 years, Change from BL on Day 8 |
-2.75
|
-3.25
|
| >/= 18 years, Change from BL on Day 11 |
-2.88
|
-3.25
|
| >/= 18 years, Change from BL on Day 15 |
-3.00
|
-3.25
|
| >/= 18 years, Change from BL on Day 40 |
-3.00
|
-3.25
|
| < 18 years, BL |
3.13
|
4.00
|
| < 18 years, Change from BL on Day 2/3 |
-1.00
|
-2.00
|
| < 18 years, Change from BL on Day 6 |
-2.00
|
-3.50
|
| < 18 years, Change from BL on Day 8 |
-2.50
|
-3.50
|
| < 18 years, Change from BL on Day 11 |
-2.50
|
-3.50
|
| < 18 years, Change from BL on Day 15 |
-2.50
|
-3.50
|
| < 18 years, Change from BL on Day 40 |
-2.50
|
-3.50
|
| Title | Percentage of Participants With Viral Shedding Assessed by Culture Over Time |
|---|---|
| Description | Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the percentage of participants with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40. |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 81 | 86 |
| >/= 18 years, Baseline |
91.4
87%
|
84.2
76.5%
|
| >/= 18 years, Day 2/3 |
67.2
64%
|
58.9
53.5%
|
| >/= 18 years, Day 6 |
15.4
14.7%
|
18.3
16.6%
|
| >/= 18 years, Day 8 |
3.2
3%
|
4.8
4.4%
|
| >/= 18 years, Day 11 |
1.5
1.4%
|
4.2
3.8%
|
| >/= 18 years, Day 15 |
7.9
7.5%
|
1.5
1.4%
|
| >/= 18 years, Day 40 |
0.0
0%
|
0.0
0%
|
| < 18 years, Baseline |
100.0
95.2%
|
100.0
90.9%
|
| < 18 years, Day 2/3 |
71.4
68%
|
75.0
68.2%
|
| < 18 years, Day 6 |
42.9
40.9%
|
0.0
0%
|
| < 18 years, Day 8 |
0.0
0%
|
0.0
0%
|
| < 18 years, Day 11 |
14.3
13.6%
|
0.0
0%
|
| < 18 years, Day 15 |
28.6
27.2%
|
0.0
0%
|
| < 18 years, Day 40 |
0.0
0%
|
0.0
0%
|
| Title | Time to Cessation of Viral Shedding by Cell Culture |
|---|---|
| Description | Viral shedding was determined through measurement of the viral titer after viral culture in Madin-Darby Canine Kidney cells by hemagglutination assay (for Flu A/H1N1 and Flu B) and NP-ELISA (for Flu A/H3N2) and expressed in log10 TCID50/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 81 | 86 |
| >/= 18 years |
105.0
|
105.4
|
| < 18 years |
150.3
|
94.9
|
| Title | Change From Baseline in Viral Load Assessed by Reverse Transcription Polymerase Chain Reaction (RT-PCR) |
|---|---|
| Description | Nasopharyngeal swab samples were tested for influenza A and B RNA using semi-quantitative RT-PCR specific for influenza A and B matrix gene, respectively, after viral RNA isolation. Cycle threshold (Ct) value was determined for each sample. Conversion of Ct values into viral load, expressed as log10 virus particles/mL (vp/mL), was obtained using external standard curves ran in parallel in all RT-PCR experiments. A value of < 2.6 log10 vp/mL for Flu A strains and < 3.0 log10 vp/mL for Flu B strains was interpreted as a negative result. Data are reported for adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40. |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 81 | 86 |
| >/= 18 years, Baseline (BL) |
6.47
|
6.52
|
| >/= 18 years, Change from BL on Day 2/3 |
-1.20
|
-1.35
|
| >/= 18 years, Change from BL on Day 6 |
-2.36
|
-2.34
|
| >/= 18 years, Change from BL on Day 8 |
-2.66
|
-2.62
|
| >/= 18 years, Change from BL on Day 11 |
-3.51
|
-2.96
|
| >/= 18 years, Change from BL on Day 15 |
-3.63
|
-2.60
|
| >/= 18 years, Change from BL on Day 40 |
-4.80
|
-7.71
|
| < 18 years, BL |
5.88
|
5.96
|
| < 18 years, Change from BL on Day 2/3 |
-0.66
|
-0.71
|
| < 18 years, Change from BL on Day 6 |
-1.97
|
-1.73
|
| < 18 years, Change from BL on Day 8 |
1.56
|
-2.26
|
| < 18 years, Change from BL on Day 11 |
-0.89
|
-2.41
|
| < 18 years, Change from BL on Day 15 |
1.26
|
| Title | Percentage of Participants With Viral Shedding Assessed by RT-PCR Over Time |
|---|---|
| Description | Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the percentage of subjects with viral shedding over time in adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline (Day 1), Day 2/3, Day 6, Day 8, Day 11 end of treatment (EOT), follow-up (FU) Day 15 and FU Day 40. |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 81 | 86 |
| >/= 18 years, Baseline |
100.0
95.2%
|
97.4
88.5%
|
| >/= 18 years, Day 2/3 |
92.8
88.4%
|
88.0
80%
|
| >/= 18 years, Day 6 |
56.7
54%
|
49.3
44.8%
|
| >/= 18 years, Day 8 |
41.5
39.5%
|
23.4
21.3%
|
| >/= 18 years, Day 11 |
25.4
24.2%
|
21.9
19.9%
|
| >/= 18 years, Day 15 |
10.6
10.1%
|
9.0
8.2%
|
| >/= 18 years, Day 40 |
1.5
1.4%
|
1.5
1.4%
|
| < 18 years, Baseline |
100.0
95.2%
|
100.0
90.9%
|
| < 18 years, Day 2/3 |
85.7
81.6%
|
75.0
68.2%
|
| < 18 years, Day 6 |
85.7
81.6%
|
57.1
51.9%
|
| < 18 years, Day 8 |
20.0
19%
|
42.9
39%
|
| < 18 years, Day 11 |
28.6
27.2%
|
14.3
13%
|
| < 18 years, Day 15 |
42.9
40.9%
|
0.0
0%
|
| < 18 years, Day 40 |
0.0
0%
|
0.0
0%
|
| Title | Time to Cessation of Viral Shedding by RT-PCR |
|---|---|
| Description | Viral shedding was determined by direct viral load measurement from nasopharyngeal swabs by RT-PCR assay and expressed in log10 vp/mL. Reported is the time to cessation of viral shedding over time in adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 81 | 86 |
| >/= 18 years |
178.0
|
154.1
|
| < 18 years |
181.0
|
180.5
|
| Title | Percentage of Participants With Persistent Viral Shedding |
|---|---|
| Description | Persistent shedding was defined as a viral load reduction <1 log10 vp/mL at end of treatment compared with baseline. Reported is the percentage of participants with persistent viral shedding at end of treatment in adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline to Day 11 (EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 81 | 86 |
| Number [percentage of participants] |
1.2
1.1%
|
4.7
4.3%
|
| Title | Percentage of Participants Who Developed Secondary Illness |
|---|---|
| Description | Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with at least one event in adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITTi population: all participants randomized to a particular treatment, regardless of whether they received that treatment or not, who received at least one dose of study drug and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 81 | 86 |
| >/=18 years |
8.2
7.8%
|
5.1
4.6%
|
| < 18 years |
12.5
11.9%
|
0.0
0%
|
| Title | Percentage of Participants Who Initiated Antibiotic Treatment |
|---|---|
| Description | Secondary illness included bronchitis, pneumonia, acute sinusitis, sinusitis, lower respiratory infection or otitis media. Reported is the percentage of participants with secondary illness, who initiated antibiotic treatment, in adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 105 | 110 |
| >/= 18 years |
8.2
7.8%
|
5.0
4.5%
|
| < 18 years |
14.3
13.6%
|
0.0
0%
|
| Title | Percentage of Participants Hospitalized |
|---|---|
| Description | Reported is the percentage of participants, who required hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITTi population included all participants randomized and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 83 | 86 |
| >/= 18 years |
6.8
6.5%
|
7.7
7%
|
| < 18 years |
11.1
10.6%
|
0.0
0%
|
| Title | Duration of Hospitalization |
|---|---|
| Description | Reported is the duration of hospitalization at any time between treatment initiation and the end of the study period, in adults >/= 18 years and adolescents and children < 18 years. |
| Time Frame | Baseline up to Day 40 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITTi population included all participants randomized and with central laboratory confirmation of influenza infection, excluding participants infected with oseltamivir-resistant influenza at baseline. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 83 | 86 |
| >/= 18 years |
7.0
|
6.50
|
| < 18 years |
5.0
|
NA
|
| Title | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Oseltamivir in Adults |
|---|---|
| Description | Reported here are oseltamivir Cmax data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The pharmacokinetic evaluable patient (PKEP) population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [nanograms per milliliter (ng/mL)] |
65.5
(26.8)
|
149
(80.7)
|
| Title | Pharmacokinetics: Trough Plasma Concentration (Ctrough) of Oseltamivir in Adults |
|---|---|
| Description | Reported here are oseltamivir Ctrough data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [ng/mL] |
2.33
(0.641)
|
6.98
(5.1)
|
| Title | Pharmacokinetics : Area Under the Concentration-Time Curve From 0 to 12 Hours (AUC0-12) at Steady State of Oseltamivir in Adults |
|---|---|
| Description | AUC0-12 was reported at steady state as nanograms per hour per milliliter. (ng*hr/mL). Reported here are oseltamivir AUC0-12 data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [ng*hr/mL] |
197
(49.7)
|
501
(320)
|
| Title | Pharmacokinetics: Time to Maximum Concentration (Tmax) of Oseltamivir in Adults |
|---|---|
| Description | Reported here are oseltamivir tmax data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [hour] |
1.08
(0.484)
|
1.08
(0.504)
|
| Title | Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adults |
|---|---|
| Description | Reported here are oseltamivir ke data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [1/hr] |
5.15
(0.497)
|
4.79
(1.25)
|
| Title | Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adults |
|---|---|
| Description | Reported here are oseltamivir CL/F data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [liter/hour (L/hr)] |
402
(96.0)
|
367
(126)
|
| Title | Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adults |
|---|---|
| Description | Reported here are oseltamivir Vc/F data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [liter (L)] |
77.5
(13.6)
|
75.4
(17.5)
|
| Title | Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adults |
|---|---|
| Description | Reported here are oseltamivir carboxylate Cmax data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [ng/mL] |
655
(276)
|
1420
(574)
|
| Title | Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adults |
|---|---|
| Description | Reported here are oseltamivir carboxylate Ctrough data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [ng/mL] |
363
(167)
|
831
(358)
|
| Title | Pharmacokinetics : AUC0-12 at Steady State of Oseltamivir Carboxylate in Adults |
|---|---|
| Description | Reported here are oseltamivir carboxylate AUC0-12 data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all particiants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [ng*hr/mL] |
6240
(2710)
|
13800
(5670)
|
| Title | Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adults |
|---|---|
| Description | Reported here are oseltamivir carboxylate tmax data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [hour] |
3.83
(1.08)
|
3.96
(0.841)
|
| Title | Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adults |
|---|---|
| Description | Reported here are oxeltamivir carboxylate ke data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [1/hr] |
1.67
(0.681)
|
1.61
(0.915)
|
| Title | Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir Carboxylate in Adults |
|---|---|
| Description | Reported here are oseltamivir carboxylate CL/F data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [L/hr] |
14.0
(5.72)
|
13.5
(7.66)
|
| Title | Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adults |
|---|---|
| Description | Reported here are oseltamivir carboxylate Vc/F data for adults >/= 18 years. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Conventional Dose | Double Dose |
|---|---|---|
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. |
| Measure Participants | 9 | 13 |
| Mean (Standard Deviation) [liter (L)] |
8.39
(0.00)
|
8.39
(0.00)
|
| Title | Pharmacokinetics: Cmax of Oseltamivir in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adolescents (>/=13 years old) over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
61.9
|
| Conventional Dose: 75 mg |
45.9
|
| Double Dose: 90 mg |
107
|
| Double Dose: 150 mg |
86.6
|
| Title | Pharmacokinetics: Ctrough of Oseltamivir in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
2.84
|
| Conventional Dose: 75 mg |
3.37
|
| Double Dose: 90 mg |
6.65
|
| Double Dose: 150 mg |
3.88
|
| Title | Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir in Adolescents and Children |
|---|---|
| Description | AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all subjects in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
229
|
| Conventional Dose: 75 mg |
171
|
| Double Dose: 90 mg |
425
|
| Double Dose: 150 mg |
339
|
| Title | Pharmacokinetics: Tmax of Oseltamivir in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
1
|
| Conventional Dose: 75 mg |
1
|
| Double Dose: 90 mg |
1
|
| Double Dose: 150 mg |
1.25
|
| Title | Pharmacokinetics: Cmax of Oseltamivir Carboxylate in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir carboxylate Cmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
363
|
| Conventional Dose: 75 mg |
848
|
| Double Dose: 90 mg |
770
|
| Double Dose: 150 mg |
906
|
| Title | Pharmacokinetics: Ctrough of Oseltamivir Carboxylate in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir carboxylate Ctrough data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
215
|
| Conventional Dose: 75 mg |
459
|
| Double Dose: 90 mg |
445
|
| Double Dose: 150 mg |
464
|
| Title | Pharmacokinetics: AUC0-12 at Steady State of Oseltamivir Carboxylate in Adolescents and Children |
|---|---|
| Description | AUC0-12 will be reported at steady state as ng*hr/mL. Reported here are oseltamivir carboxylate AUC0-12 data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
3550
|
| Conventional Dose: 75 mg |
8010
|
| Double Dose: 90 mg |
7460
|
| Double Dose: 150 mg |
8420
|
| Title | Pharmacokinetics: Tmax of Oseltamivir Carboxylate in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir carboxylate tmax data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
3.75
|
| Conventional Dose: 75 mg |
4
|
| Double Dose: 90 mg |
4
|
| Double Dose: 150 mg |
4
|
| Title | Pharmacokinetics: Elimination Constant (ke) of Oseltamivir in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
4.22
|
| Conventional Dose: 75 mg |
4.56
|
| Double Dose: 90 mg |
3.40
|
| Double Dose: 150 mg |
5.74
|
| Title | Pharmacokinetics: Apparent Clearance (CL/F) of Oseltamivir in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
263
|
| Conventional Dose: 75 mg |
439
|
| Double Dose: 90 mg |
212
|
| Double Dose: 150 mg |
442
|
| Title | Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
62.3
|
| Conventional Dose: 75 mg |
96.4
|
| Double Dose: 90 mg |
62.3
|
| Double Dose: 150 mg |
76.9
|
| Title | Pharmacokinetics: Elimination Constant (ke) of Oseltamivir Carboxylate in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir carboxylate ke data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
2.01
|
| Conventional Dose: 75 mg |
1.12
|
| Double Dose: 90 mg |
1.44
|
| Double Dose: 150 mg |
2.12
|
| Title | Pharmacokinetics: Apparent Clearance (CL/F), of Oseltamivir Carboxylate in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir carboxylate CL/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
16.9
|
| Conventional Dose: 75 mg |
9.36
|
| Double Dose: 90 mg |
12.1
|
| Double Dose: 150 mg |
17.8
|
| Title | Pharmacokinetics: Apparent Volume of Distribution (Vc/F) of Oseltamivir Carboxylate in Adolescents and Children |
|---|---|
| Description | Reported here are oseltamivir carboxylate Vc/F data for adolescents and children < 18 years. Individual data are provided as participants received different drug doses. Drug dose is indicated in the row title for each participant. |
| Time Frame | Pre-dose (30 minutes), 1.5, 4, 8 hours postdose on Day 6 or any day after the 11th dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PKEP population comprised all participants in the ITT population who had at least one valid post-dose drug concentration measurement at a scheduled visit time point. |
| Arm/Group Title | Adolescents and Children With Pharmacokinetic Evaluation |
|---|---|
| Arm/Group Description | This analysis set comprises participants < 18 years from both arms in the study who underwent pharmacokinetic evaluation. Immunocompromised participants in the Conventional dose arm received oseltamivir syrup at doses ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. Participants in the Double dose arm received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily over 10 days. |
| Measure Participants | 4 |
| Conventional Dose: 60 mg |
8.39
|
| Conventional Dose: 75 mg |
8.39
|
| Double Dose: 90 mg |
8.39
|
| Double Dose: 150 mg |
8.39
|
Adverse Events
| Time Frame | Baseline up to Day 40 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The safety population included all participants who received at least one treatment with study medication. | |||
| Arm/Group Title | Conventional Dose | Double Dose | ||
| Arm/Group Description | Immunocompromised participants received oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days. | Immunocompromised participants received oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days. | ||
All Cause Mortality |
||||
| Conventional Dose | Double Dose | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/105 (0%) | 1/110 (0.9%) | ||
Serious Adverse Events |
||||
| Conventional Dose | Double Dose | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/105 (7.6%) | 10/110 (9.1%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 1/105 (1%) | 1/110 (0.9%) | ||
| Anaemia | 1/105 (1%) | 0/110 (0%) | ||
| Thrombocytopenia | 0/105 (0%) | 1/110 (0.9%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 0/105 (0%) | 1/110 (0.9%) | ||
| General disorders | ||||
| Asthenia | 0/105 (0%) | 1/110 (0.9%) | ||
| Pyrexia | 0/105 (0%) | 1/110 (0.9%) | ||
| Infections and infestations | ||||
| Pneumonia | 2/105 (1.9%) | 1/110 (0.9%) | ||
| Bronchopulmonary aspergillosis | 0/105 (0%) | 2/110 (1.8%) | ||
| Lower respiratory tract infection | 0/105 (0%) | 1/110 (0.9%) | ||
| Oral herpes | 1/105 (1%) | 0/110 (0%) | ||
| Pulmonary tuberculosis | 0/105 (0%) | 1/110 (0.9%) | ||
| Pyelonephritis | 1/105 (1%) | 0/110 (0%) | ||
| Sepsis | 0/105 (0%) | 1/110 (0.9%) | ||
| Septic shock | 1/105 (1%) | 0/110 (0%) | ||
| Sinusitis | 0/105 (0%) | 1/110 (0.9%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Leukaemia recurrent | 0/105 (0%) | 1/110 (0.9%) | ||
| Metastases to meninges | 1/105 (1%) | 0/110 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Conventional Dose | Double Dose | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 23/105 (21.9%) | 35/110 (31.8%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 10/105 (9.5%) | 11/110 (10%) | ||
| Nausea | 10/105 (9.5%) | 14/110 (12.7%) | ||
| Vomiting | 10/105 (9.5%) | 12/110 (10.9%) | ||
| Nervous system disorders | ||||
| Headache | 5/105 (4.8%) | 12/110 (10.9%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800 821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545532
Other Study ID Numbers:
- NV20234
- 2006-002468-24
First Posted:
Oct 17, 2007
Last Update Posted:
Jul 12, 2018
Last Verified:
Jun 1, 2018