Trial · NCT02949011
Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
NCT02949011, Phase 3, Completed, Shionogi; results first posted 2019-11-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications. Trials, record NCT02949011. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02949011
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
- NCT number
- NCT02949011
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,184 participants, actual
- Lead sponsor
- Shionogi
- Conditions
- Influenza
- Interventions
- Baloxavir Marboxil, Placebo to Baloxavir Marboxil, Oseltamivir, Placebo to Oseltamivir
- First posted
- 2016-10-31
- Last updated
- 2019-11-19
- Other registries' IDs
- eudract:2016-002688-32
- Results first posted
- 2019-11-06
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Improvement of Influenza Symptoms | From Day 1 pretreatment up to Day 14 | Participants assessed the severity of 7 influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness/chills, muscle/joint pain, and fatigue) on a 4-point scale (0 = no symptoms, 1= mild, 2 = moderate, and 3 = severe). Time to improvement of symptoms was defined as the time from the start of treatment to the time when all influenza symptoms were alleviated, maintained, or improved, as defined below, for a duration of at least 21.5 hours: * Preexisting symptoms (cough, fatigue, or muscle/joint pain that existed prior to influenza) that were worse at baseline must have improved at least 1 point from baseline * Preexisting symptoms not worse at baseline must have maintained baseline severity * New symptoms must have alleviated, defined as a symptom score of none (0) or mild (1). Time to improvement of symptoms was analyzed using Kaplan-Meier (KM) methods; participants who did not experience improvement of symptom s were censored at the last observation. |
| Secondary | Percentage of Participants With Positive Influenza Virus Titer at Each Time Point | 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) using 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 | 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) measured by reverse transcription polymerase chain reaction (RT-PCR) among those assessed on Days 2, 3, 4, 5, 6 and 9. |
| Secondary | Change From Baseline in Virus Titer at Each Time Point | 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 | 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). |
| Secondary | Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer | Day 1 to Day 9 | This endpoint was defined as AUC of change from Baseline in virus titer from Day 1 to Day 9. AUC was calculated using the trapezoidal method. |
| Secondary | Area Under the Curve (AUC) Adjusted by Baseline in Viral RNA | Day 1 to Day 9 | This endpoint was defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 9. The AUC was calculated using the trapezoidal method. |
| Secondary | Time to Cessation of Viral Shedding Determined by Virus Titer | Day 1 to Day 9 | Time to cessation of viral shedding by virus titer was defined as the time between the initiation of the study treatment and first time when the virus titer was below the limit of detection (0.7 log₁₀\[TCID₅₀/mL\]). The median and 95% confidence interval (CI) for time to cessation of viral shedding determined by virus titer was analyzed using the Kaplan-Meier (KM) method; participants whose virus titer had not reached cessation by the last observation time point were treated as censored at that time point. |
| Secondary | Time to Cessation of Viral Shedding Determined by Virus RNA | Day 1 to Day 9 | 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 was below the limit of detection measured by RT-PCR. Time to cessation of viral shedding by RT-PCR was analyzed using the KM method; participants whose virus RNA had not reached cessation by the last observation time point were treated as censored at that time point. |
| Secondary | Percentage of Participants Whose Symptoms Were Improved at Each Time Point | 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216 hours after the initial dose of study treatment | Participants assessed the severity of 7 influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (0 = no symptoms, 1= mild, 2 = moderate, and 3 = severe). Improvement of symptoms was defined as all influenza symptoms alleviated, maintained, or improved, as defined below, for a duration of at least 21.5 hours: * Preexisting symptoms (cough, fatigue, or muscle/joint pain that existed prior to influenza) judged to be worse at baseline must have improved at least 1 point from baseline severity * Preexisting symptoms judged not to be worse at baseline must have maintained baseline severity * New symptoms at baseline must have alleviated, defined as a symptom score of none (0) or mild (1). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Improvement of Influenza Symptoms | From Day 1 pretreatment up to Day 14 | Participants in the intention-to-treat infected population with available time to improvement of symptoms data. | hours | MEDIAN |
| SECONDARY | Percentage of Participants With Positive Influenza Virus Titer at Each Time Point | Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infected population with a 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 | Days 2, 3, 4 (optional), 5, 6 (optional), and 9. | Participants in the intention-to-treat infected population with positive influenza virus RNA determined by RT-PCR on Day 1 and with available data at each time point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Virus Titer at Each Time Point | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infected population 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 | Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9 | Participants in the intention-to-treat infected population with positive RT-PCR on Day 1 and with available virus RNA data at each time point. | log₁₀ virus particles/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer | Day 1 to Day 9 | Participants in the intention-to-treat infected population with a positive virus titer on Day 1 and available sample on Day 9. | log₁₀[TCID₅₀/mL]*hours | MEAN |
| SECONDARY | Area Under the Curve (AUC) Adjusted by Baseline in Viral RNA | Day 1 to Day 9 | Participants in the intention-to-treat infected population with a positive virus RNA determined by RT-PCR at baseline and available sample on Day 9. | log₁₀ virus particles/mL*hours | MEAN |
| SECONDARY | Time to Cessation of Viral Shedding Determined by Virus Titer | Day 1 to Day 9 | Participants in the intention-to-treat infected population with a positive virus titer on Day 1 whose time to cessation of viral shedding by virus titer was not missing. | hours | MEDIAN |
| SECONDARY | Time to Cessation of Viral Shedding Determined by Virus RNA | Day 1 to Day 9 | Participants in the intention-to-treat infected population with positive influenza virus RNA determined by RT-PCR on Day 1 whose time to cessation of viral shedding by RT-PCR. | hours | MEDIAN |
| SECONDARY | Percentage of Participants Whose Symptoms Were Improved at Each Time Point | 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216 hours after the initial dose of study treatment | Participants in the intention-to-treat infected population with available symptoms data at each time point. | percentage of participants | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group258
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Improvement of Influenza Symptoms | Baloxavir Marboxil | 73.2 | 95% Confidence Interval 67.2 to 85.1 | hours | |
| Time to Improvement of Influenza Symptoms | Placebo | 102.3 | 95% Confidence Interval 92.7 to 113.1 | hours | |
| Time to Improvement of Influenza Symptoms | Oseltamivir | 81.0 | 95% Confidence Interval 69.4 to 91.5 | hours | |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point | Baloxavir Marboxil | Day 2 | 58.6 | 95% Confidence Interval 53.2 to 63.9 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point | Placebo | Day 2 | 86.9 | 95% Confidence Interval 82.9 to 90.3 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point | Oseltamivir | Day 2 | 86.9 | 95% Confidence Interval 82.9 to 90.3 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point | Baloxavir Marboxil | Day 3 | 31.7 | 95% Confidence Interval 26.7 to 36.9 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point | Placebo | Day 3 | 72.7 | 95% Confidence Interval 67.6 to 77.4 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point | Oseltamivir | Day 3 | 60.0 | 95% Confidence Interval 54.6 to 65.2 | percentage of participants |
| Percentage of Participants With Positive Influenza Virus Titer at Each Time Point | Baloxavir Marboxil | Day 4 | 18.5 | 95% Confidence Interval 12.2 to 26.2 | percentage of participants |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 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 Marboxil | 730 | |
| Overall Study | STARTED | Placebo | 729 | |
| Overall Study | STARTED | Oseltamivir | 725 | |
| Overall Study | Received Study Drug | Baloxavir Marboxil | 728 | |
| Overall Study | Received Study Drug | Placebo | 728 | |
| Overall Study | Received Study Drug | Oseltamivir | 722 | |
| Overall Study | Intention to Treat Infected Population | Baloxavir Marboxil | 388 | |
| Overall Study | Intention to Treat Infected Population | Placebo | 386 | |
| Overall Study | Intention to Treat Infected Population | Oseltamivir | 389 | |
| Overall Study | COMPLETED | Baloxavir Marboxil | 697 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events93
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 Marboxil | 21 | 730 | |
| other | Bronchitis | Infections and infestations | Placebo | 33 | 727 | |
| other | Bronchitis | Infections and infestations | Oseltamivir | 30 | 721 | |
| other | Sinusitis | Infections and infestations | Baloxavir Marboxil | 14 | 730 | |
| other | Sinusitis | Infections and infestations | Placebo | 21 | 727 | |
| other | Sinusitis | Infections and infestations | Oseltamivir | 22 | 721 | |
| other | Diarrhoea | Gastrointestinal disorders | Baloxavir Marboxil | 20 | 730 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 21 | 727 | |
| other | Diarrhoea | Gastrointestinal disorders | Oseltamivir | 23 | 721 | |
| other | Nausea | Gastrointestinal disorders | Baloxavir Marboxil | 20 | 730 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baloxavir Marboxil | 1 | 730 |
| Total, all-cause mortality | Placebo | 0 | 727 |
| Total, all-cause mortality | Oseltamivir | 1 | 721 |
| Total, other adverse events | Baloxavir Marboxil | 70 | 730 |
| Total, other adverse events | Placebo | 92 | 727 |
| Total, other adverse events | Oseltamivir | 90 | 721 |
| Total, serious adverse events | Baloxavir Marboxil | 5 | 730 |
| Total, serious adverse events | Placebo | 9 | 727 |
| Total, serious adverse events | Oseltamivir | 8 | 721 |
Source ClinicalTrials.gov
Papers2
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/NCT02949011
GET https://conductscience.org/api/trials/v1/NCT02949011/registered?page=2