| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability or incapacity, was a congenital anomaly or birth defect. | SAS included all participants who received at least one dose of study treatment, with participants analyzed according to the treatment actually received. | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
| | | Title | Denominators | Categories |
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| AEs | | | | SAEs | | |
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| Secondary | Time to Alleviation of Influenza Signs and Symptoms (TTAS) | TTAS was defined as the length of time taken from start of treatment to point at which all of following criteria were met & remained so for at least 21.5 hours:
- Score of 0 (no problem) or 1 (minor problem) for cough & nasal symptoms (Items 14 & 15 of Canadian Acute Respiratory Illness and Flu Scale [CARIFS]);
- A "yes" response to following question- "Since last assessment has participant been able to return to day care/school, or resume his/her normal daily activity in same way as performed prior to developing flu?";
- Return to afebrile state (tympanic temperature ≤ 37.2 degree Celsius [°C]). Median time was estimated using Kaplan-Meier (K-M) method.
| FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Participants who fulfilled the endpoint definition at baseline were excluded from the analysis. | Posted | | Median | 95% Confidence Interval | hours | | Up to Day 15 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir |
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| Secondary | Duration of Fever | Duration of fever was defined as the length of time from start of treatment to return to afebrile state (tympanic temperature ≤ 37.2°C) and remaining so for at least 21.5 hours. Participants who were afebrile at baseline (tympanic temperature ≤ 37.2 °C) or whose body temperature was not collected were excluded from the analysis. Median time was estimated using K-M method. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number participants who had fever at baseline. | Posted | | Median | 95% Confidence Interval | hours | | Up to Day 15 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Duration of Symptoms | Duration of symptoms was defined as the length of time from start of treatment to alleviation of all symptoms as defined by a score of 0 (no problem) or 1 (minor problem) and remaining so for at least 21.5 hours, for all 18 symptoms specified in the CARIFS questionnaire. Participants who withdrew prior to an event of interest or did not experience resolution of symptoms were censored at the last observation time point. Median time was estimated using K-M method. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. | Posted | | Median | 95% Confidence Interval | hours | | Up to Day 15 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Time to Return to Normal Health and Activity Based on the CARIFS Questionnaire | Time to return to normal health and activity was defined as time from start of treatment to normal health and activity. Normal health & activity was identified by a 'yes' response to the following question on the CARIFS: "Since the last assessment has the participant been able to return to day care/school, or resume his/her normal daily activity in the same way as performed prior to developing the flu?". Median time was estimated using K-M method. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Participants who fulfilled the endpoint definition at baseline (who had normal health & activity) were excluded from the analysis. | Posted | | Median | 95% Confidence Interval | hours | | Up to Day 15 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Number of Participants With Influenza-related Complications | Influenza-related complications included death, hospitalization, radiologically-confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, and myositis. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Percentage of Participants Requiring Antibiotics for Influenza-related Complications | Influenza-related complications included death, hospitalization, radiologically-confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, and myositis. Percentages have been rounded off. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. | Posted | | Number | | percentage of participants | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Time to Cessation of Viral Shedding by Virus Titer | Time to cessation of viral shedding by virus titer was defined as the time, in hours, between the initiation of study treatment and the first time when the influenza virus titer was below the lower limit of detection (LLoD) (0.75 log10 tissue culture infectious dose [TCID] 50/milliliters [mL]). Participants whose virus ribonucleic acid (RNA) did not reach the limit by the last observation timepoint were treated as censored at that timepoint. Median time was estimated using K-M method. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number of participants with post-baseline viral titer assessments. | Posted | | Median | 95% Confidence Interval | hours | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Time to Cessation of Viral Shedding by Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR) Using Samples From Respiratory Swabs | Time to cessation of viral shedding by RT-PCR was defined as the time between the initiation of study treatment and the first time when the virus RNA by RT-PCR qualitative result is below the LLoD (qualitative assessment). For the participants with multiple virus types, time to cessation of viral shedding by RT-PCR was defined as the time between the initiation of the study treatment and first time when the virus RNA by RT-PCR qualitative result is negative for all virus types. Participants whose virus RNA did not reach the limit by the last observation timepoint were censored at that timepoint. Median time was estimated using K-M method. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number of participants with with post-baseline RT-PCR results. | Posted | | Median | 95% Confidence Interval | hours | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 |
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| Secondary | Change From Baseline in Influenza Virus Titer Over Time Using Samples From Respiratory Swabs | Change from baseline in influenza virus titer (log10 TCID50/mL) on Days 2, 4, 6, 10, and 15 are presented. Influenza virus titer on specified time points was analysed with use of samples from respiratory swabs. If influenza virus titer was less than the lower limit of quantification (LLoQ), the virus titer was imputed as LLoQ - 0.001 (0.749 log10 TCID50/mL). Only participants with a positive virus titer on Day 1 were included in this analysis. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Mean | Standard Deviation | log10 TCID 50/mL | | Baseline, Days 2, 4, 6, 10, and 15 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | |
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| Secondary | Change From Baseline in Amount of Virus RNA (RT-PCR) at Each Timepoint Using Samples From Respiratory Swabs | If the amount of virus RNA was less than the LLoQ, the amount of virus RNA was imputed as LLoQ - 0.001 (2.79 log10 vp/mL for influenza A and 2.63 log10 vp/mL for influenza B). If a participant was infected with multiple virus types, the sum of those amounts of virus RNA was used for analysis. Participants positive for virus RNA by RT-PCR on Day 1 were included in this analysis. log10 vp/mL=log 10 virus particles per milliliter. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Mean | Standard Deviation | log10 vp/mL | | Baseline, Days 2, 4, 6, 10, and 15 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | |
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| Secondary | Percentage of Participants With Positive Influenza Virus Titer Over Time | Percentage of participants with positive influenza virus titer was defined as the percentage of participants whose influenza virus titer was not less than the LLoD (0.75 log10 TCID50/mL) or positive among those assessed for influenza virus titer on specified timepoints. Analyses were done with use of samples from respiratory swabs. Participants with a positive influenza virus titer on Day 1 were be included in this analysis. Percentages have been rounded off. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Number | | percentage of participants | | Baseline, Days 2, 4, 6, 10, and 15 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | |
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| Secondary | Percentage of Participants Positive by RT-PCR at Each Timepoint Using Samples From Respiratory Swabs | Percentage of participants with positive influenza virus titer was defined as the percentage of participants with a positive qualitative result among those assessed by RT-PCR on specified timepoints. Analyses were done with use of samples from respiratory swabs. Participants positive for virus RNA by RT-PCR on Day 1 were be included in this analysis. Percentages have been rounded off. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Number | | percentage of participants | | Baseline, Days 2, 4, 6, 10, and 15 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Area Under the Curve (AUC) in Virus Titer | AUC was calculated using the trapezoidal method. Participants with a positive virus titer on Day 1 were included in this analysis. The lower limit was defined as 0.75 log10 TCID50/mL for flu A and flu B. If a participant was infected with multiple virus types, the sum of those virus titers was used for analysis. log10 TCID50/mL*h=log10 TCID50 per milliliter-hours. Analyses were done with use of samples from respiratory swabs. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | log10 TCID 50/mL*h | | Up to Day 10 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | AUC in the Amount of Virus RNA (RT-PCR) Using Samples From Respiratory Swabs | AUC in virus RNA (RT-PCR) AUC was calculated using the trapezoidal method. Participants positive for virus RNA by RT-PCR on Day 1 were included in this analysis. If a participant was infected with multiple virus types, the sum of the amount of virus RNA was used for analysis. log10 vp/mL*h=log 10 virus particles per milliliter-hours. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | log10 vp/mL*h | | Up to Day 10 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Oseltamivir | Participants received oseltamivir, PO, BID for 5 days of the treatment period based on body weight: 30 mg for participants weighing ≤15 kg, 45 mg for participants weighing >15 kg to ≤23 kg, 60 mg for those weighing >23 kg to ≤40 kg, or 75 mg for those weighing >40 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Plasma Concentrations of S-033447 (Active Metabolite) | S-033447 is an active metabolite of baloxavir marboxil. | Pharmacokinetic analysis set (PKAS) included all participants with evaluable PK samples from the baloxavir marboxil arm. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Post-dose on Days 1, 2, 4, and 6 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) of S-033447 | S-033447 is an active metabolite of baloxavir marboxil. | PKAS included all participants with evaluable PK samples from the baloxavir marboxil arm. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified category. | Posted | | Mean | Standard Deviation | nanograms-hour per milliliter (ng*h/mL) | | Post-dose on Days 1, 2, 4, and 6 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Maximum Observed Concentration (Cmax) of S-033447 | S-033447 is an active metabolite of baloxavir marboxil. | PKAS included all participants with evaluable PK samples from the baloxavir marboxil arm. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified category. | Posted | | Mean | Standard Deviation | ng/mL | | Post-dose on Days 1, 2, 4, and 6 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Time of Maximum Observed Concentration (Tmax) of S-033447 | S-033447 is an active metabolite of baloxavir marboxil. | PKAS included all participants with evaluable PK samples from the baloxavir marboxil arm. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified category. | Posted | | Median | Full Range | hours | | Post-dose on Days 1, 2, 4, and 6 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Elimination Half-life (t1/2) of S-033447 | S-033447 is an active metabolite of baloxavir marboxil. | PKAS included all participants with evaluable PK samples from the baloxavir marboxil arm. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified category. | Posted | | Median | Full Range | hours | | Post-dose on Days 1, 2, 4, and 6 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Percentage of Participants With Polymorphic and Treatment-emergent Amino Acid Substitutions in the Polymerase Acidic (PA) Gene | Sanger sequencing of the influenza PA gene was performed to evaluate the incidence of polymorphic and treatment-emergent amino acid substitutions in baloxavir-treated participants with evaluable virus. | Evaluable participants included all participants randomized to baloxavir, exposed to study treatment, with pre-dose, and at least one post-dose sequences data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Influenza Type A/H1_2009 | Participants with influenza type A H1N1 2009 received a single dose of baloxavir marboxil, PO on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, and 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG001 | Influenza Type A/H3N2 | Participants with influenzatype A H3N2 received a single dose of baloxavir marboxil, PO on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, and 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. | | OG002 |
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| Secondary | Drug Susceptibility in Participants With Evaluable Virus | Drug susceptibility of the influenza virus, the 50% effective concentration (EC50) of baloxavir was measured by the ViroSpot™ assay using baseline swab samples for participants who received baloxavir marboxil. EC50 values were compared with EC50 values of reference strains and the respective ratio (EC50 / EC50 reference) was reported. The following influenza virus vaccines strains from the 2024/25 Northern hemisphere season were used as references: A/Wisconsin/67/2022 (H1N1) pdm09-like virus, A/Massachusetts/18/2022 (H3N2)-like virus and B/Austria/1359417/2021-like virus (B/Victoria/2/87 lineage). In the absence of established thresholds for baloxavir, reduced susceptibility was defined according to the WHO criteria for neurainidase inhibitor (NAI) as fold-changes in EC50 (EC50 / EC50 of reference) > 10 for influenza A and > 5 for influenza B viruses. | FASi included all randomized participants who received at least one dose of study treatment and had a laboratory confirmation of influenza infection (PCR result) from any swab sample collected at baseline or during the study, with participants analyzed according to the treatment assigned. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified category. | Posted | | Mean | Standard Deviation | ratio | | Up to Day 29 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. |
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| Secondary | Percentage of Participants With Responses to Palatability and Acceptability Questionnaire | A two-question palatability and acceptability questionnaire was used to record palatability and acceptability. Palatability of baloxavir marboxil was evaluated by response to the following question, "How was the taste of the medicine? Please pick the face that best matches how you/the child felt about the taste". The responses ranged from: like very much, like a little, not sure, dislike a little, or dislike very much. Acceptability of baloxavir marboxil was evaluated by response to the following question, "Would you/the child be happy to take the medicine again?" The responses ranged from: Yes, No, or Not sure. The questionnaire was completed as soon as possible after swallowing the baloxavir marboxil drug solution on Day 1. Percentages have been rounded off. | FAS included all randomized participants, with participants grouped according to the treatment assigned. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Number | | percentage of participants | | On Day 1 | | | | ID | Title | Description |
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| OG000 | Baloxavir Marboxil | Participants received a single dose of baloxavir marboxil, PO, on Day 1 of the treatment period based on body weight: 2 mg/kg for participants weighing <20 kg, 40 mg for those weighing ≥20 kg to <80 kg, or 80 mg for those weighing ≥80 kg. After treatment period, participants entered a follow-up period of 24 days. |
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