Trial · NCT02954354
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
NCT02954354, Phase 3, Completed, Shionogi; results first posted 2018-12-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza. Trials, record NCT02954354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02954354
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
- NCT number
- NCT02954354
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,436 participants, actual
- Lead sponsor
- Shionogi
- Conditions
- Influenza
- Interventions
- Baloxavir Marboxil, Placebo to Baloxavir Marboxil, Oseltamivir, Placebo to Oseltamivir
- First posted
- 2016-11-03
- Last updated
- 2019-05-08
- Results first posted
- 2018-12-14
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Alleviation of Symptoms in Participants Randomized to Baloxavir or Placebo | Initiation of study treatment up to Day 14 | Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all seven influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours. Time to alleviation of symptoms was analyzed using the Kaplan-Meier (KM) method; participants who did not experience alleviation of symptoms were censored at the last observation time point. |
| Primary | Time to Alleviation of Symptoms in Adults Randomized to Baloxavir or Oseltamivir | Initiation of study treatment up to Day 14 | Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all seven influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours. Time to alleviation of symptoms was analyzed using the Kaplan-Meier(KM) method; participants who did not experience alleviation of symptoms were censored at the last observation time point. |
| Secondary | Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods. Positive influenza virus titer was defined as virus titer not less than the lower limit of quantification (0.7 log₁₀ of the 50% tissue culture infective dose (TCID₅₀/mL) among those assessed for virus titer on Days 2, 3, 4, 5, 6 and 9. |
| Secondary | Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir | Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods. Positive influenza virus titer was defined as virus titer not less than the lower limit of quantification (0.7 log₁₀ of the 50% tissue culture infective dose (TCID₅₀/mL) among those assessed for virus titer on Days 2, 3, 4, 5, 6 and 9. |
| Secondary | Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Participants Randomized to Baloxavir or Placebo | Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible). The percentage of participants with detectable virus RNA (2.05 for flu A and 2.83 for flu B log₁₀ virus particles/mL) among those assessed measured by reverse transcription polymerase chain reaction (RT-PCR) on Days 2, 3, 4, 5, 6 and 9. |
| Secondary | Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir | Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Influenza virus RNA was quantified from nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible). The percentage of participants with detectable virus RNA (2.05 for flu A and 2.83 for flu B log₁₀ virus particles/mL) among those assessed measured by reverse transcription polymerase chain reaction (RT-PCR) on Days 2, 3, 4, 5, 6 and 9. |
| Secondary | Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods. If virus titer was less than the lower limit of quantification, the virus titer was imputed 0.7 (TCID₅₀/mL). |
| Secondary | Change From Baseline in Virus Titer at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods. If virus titer was less than the lower limit of quantification, the virus titer was imputed 0.7 (TCID₅₀/mL). |
| Secondary | Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to Baloxavir or Placebo | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible) were obtained for viral quantitation. Virus RNA is measured by reverse transcription polymerase chain reaction (RT-PCR). |
| Secondary | Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible) were obtained for viral quantitation. Virus RNA was measured by reverse transcription polymerase chain reaction (RT-PCR). |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Alleviation of Symptoms in Participants Randomized to Baloxavir or Placebo | Initiation of study treatment up to Day 14 | Participants in the intention-to-treat infection population assigned to baloxavir or placebo with available time to alleviation of symptoms data. | hours | MEDIAN |
| PRIMARY | Time to Alleviation of Symptoms in Adults Randomized to Baloxavir or Oseltamivir | Initiation of study treatment up to Day 14 | Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, and with available time to alleviation of symptoms data. | hours | MEDIAN |
| SECONDARY | Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with positive influenza virus titer on Day 1 and with available virus titer data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir | Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with positive influenza virus titer on Day 1 and with available virus titer data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Participants Randomized to Baloxavir or Placebo | Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with positive influenza virus RNA determined by RT-PCR on Day 1 and with available data at each time point were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir | Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with positive influenza virus RNA determined by RT-PCR on Day 1, and with available data at each time point were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with positive influenza virus titer on Day 1 and with available virus titer data at each time point. | log₁₀[TCID₅₀/mL] | MEAN |
| SECONDARY | Change From Baseline in Virus Titer at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with positive influenza virus titer on Day 1 and with available virus titer data at each time point. | log₁₀[TCID₅₀/mL] | MEAN |
| SECONDARY | Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to Baloxavir or Placebo | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with positive influenza virus titer on Day 1 and with available virus RNA data at each time point. | log₁₀ virus particles/mL | MEAN |
| SECONDARY | Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infection population ≥ 20 years of age and assigned to baloxavir or oseltamivir, with positive influenza virus titer on Day 1 and with available virus RNA data at each time point. | log₁₀ virus particles/mL | MEAN |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group366
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Alleviation of Symptoms in Participants Randomized to Baloxavir or Placebo | Baloxavir | 53.7 | 95% Confidence Interval 49.5 to 58.5 | hours | |
| Time to Alleviation of Symptoms in Participants Randomized to Baloxavir or Placebo | Placebo | 80.2 | 95% Confidence Interval 72.6 to 87.1 | hours | |
| Time to Alleviation of Symptoms in Adults Randomized to Baloxavir or Oseltamivir | Baloxavir | 53.5 | 95% Confidence Interval 48.0 to 58.5 | hours | |
| Time to Alleviation of Symptoms in Adults Randomized to Baloxavir or Oseltamivir | Oseltamivir | 53.8 | 95% Confidence Interval 50.2 to 56.4 | hours | |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Baloxavir | Day 2 | 47.6 | 95% Confidence Interval 42.7 to 52.5 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Placebo | Day 2 | 96.0 | 95% Confidence Interval 92.3 to 98.3 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Baloxavir | Day 3 | 21.7 | 95% Confidence Interval 17.8 to 26.0 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Placebo | Day 3 | 70.5 | 95% Confidence Interval 63.5 to 76.8 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Baloxavir | Day 4 | 16.7 | 95% Confidence Interval 10.3 to 24.8 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo | Placebo | Day 4 | 56.1 | 95% Confidence Interval 42.4 to 69.3 | percentage of participants |
1 to 10 of 366Source ClinicalTrials.gov
See all 366 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Baloxavir | 612 | |
| Overall Study | STARTED | Placebo | 310 | |
| Overall Study | STARTED | Oseltamivir | 514 | |
| Overall Study | Received Study Drug | Baloxavir | 610 | |
| Overall Study | Received Study Drug | Placebo | 309 | |
| Overall Study | Received Study Drug | Oseltamivir | 513 | |
| Overall Study | Intention to Treat Infected Population | Baloxavir | 456 | |
| Overall Study | Intention to Treat Infected Population | Placebo | 231 | |
| Overall Study | Intention to Treat Infected Population | Oseltamivir | 377 | |
| Overall Study | COMPLETED | Baloxavir | 578 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Baloxavir | 16 | 610 | |
| other | Bronchitis | Infections and infestations | Placebo | 17 | 309 | |
| other | Bronchitis | Infections and infestations | Oseltamivir | 18 | 513 | |
| other | Sinusitis | Infections and infestations | Baloxavir | 7 | 610 | |
| other | Sinusitis | Infections and infestations | Placebo | 8 | 309 | |
| other | Sinusitis | Infections and infestations | Oseltamivir | 5 | 513 | |
| other | Diarrhoea | Gastrointestinal disorders | Baloxavir | 18 | 610 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 14 | 309 | |
| other | Diarrhoea | Gastrointestinal disorders | Oseltamivir | 11 | 513 | |
| other | Nausea | Gastrointestinal disorders | Baloxavir | 8 | 610 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baloxavir | 0 | 610 |
| Total, all-cause mortality | Placebo | 0 | 309 |
| Total, all-cause mortality | Oseltamivir | 0 | 513 |
| Total, other adverse events | Baloxavir | 47 | 610 |
| Total, other adverse events | Placebo | 40 | 309 |
| Total, other adverse events | Oseltamivir | 45 | 513 |
| Total, serious adverse events | Baloxavir | 2 | 610 |
| Total, serious adverse events | Placebo | 0 | 309 |
| Total, serious adverse events | Oseltamivir | 0 | 513 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02954354
GET https://conductscience.org/api/trials/v1/NCT02954354/registered?page=2