Comparison · NCT03969212-sae
Placebo: IPs vs Baloxavir Marboxil: IPs: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Placebo: IPs vs Baloxavir Marboxil: IPs: serious adverse events. Trial comparisons, record NCT03969212-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03969212-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00275 | 0.000756 | 0.00999 | wilson | |
| Risk in group 2 | 0.00138 | 0.000244 | 0.00779 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00137 | -0.00534 | 0.00869 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.99 | 0.181 | 21.9 | log | |
| Odds ratio, group 1 over group 2 | 1.99 | 0.18 | 22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Placebo: IPs than on Baloxavir Marboxil: IPs | 729 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Placebo: IPs | IPs were randomized in this arm to receive a single dose of matching placebo orally as a tablet or oral suspension based on their weight and age. | 2 | 726 | EG000 |
| Group 2 | Baloxavir Marboxil: IPs | IPs received a single dose of baloxavir marboxil orally based on their weight and age. | 1 | 723 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to Day 9 (IPs ≥12 years old) Baseline up to Day 21 (IPs <12 years old)
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
- NCT number
- NCT03969212
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- Baloxavir Marboxil, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2025-04-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03969212?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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