Comparison · NCT04583280-sae
Rilematovir vs Placebo: 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. Rilematovir vs Placebo: serious adverse events. Trial comparisons, record NCT04583280-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04583280-sae
On this page
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 | 0.05 | 0.00888 | 0.236 | wilson | |
| Risk in group 2 | 0 | 0 | 0.324 | wilson | |
| Risk difference, group 1 minus group 2 | 0.05 | -0.277 | 0.236 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Rilematovir than on Placebo | 20 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rilematovir | Participants aged \>=28 days to \<3 months, \>=3 to \<6 months, and \>=6 months to \<=5 years received rilematovir 2.5 milligrams per kilogram (mg/kg), 3 mg/kg and 4.5 mg/kg respectively, as oral suspension BID from Days 1 to 7 (14 consecutive doses). | 1 | 20 | EG001 |
| Group 2 | Placebo | Participants aged greater than or equal to (\>=) 28 days to less than (\<) 3 months, \>=3 to \<6 months, and \>=6 months to less than or equal to (\<=) 5 years received placebo matching to rilematovir as oral suspension twice daily (BID) from Days 1 to 7 (14 consecutive doses). | 0 | 8 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Day 35
Source ClinicalTrials.gov
Trial
- Title
- A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
- NCT number
- NCT04583280
- Phases
- PHASE3
- Conditions
- Respiratory Tract Infections
- Interventions
- Rilematovir, Rilematovir X mg/kg, Placebo
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2023-04-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04583280?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04583280-sae