Comparison · NCT04583280-0556b751
Rilematovir vs Placebo: Number of Participants With Post-baseline RSV-related Complications
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Rilematovir vs Placebo: Number of Participants With Post-baseline RSV-related Complications. Trial comparisons, record NCT04583280-0556b751. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04583280-0556b751
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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 | 0.158 | 0.0552 | 0.376 | wilson | |
| Risk in group 2 | 0.125 | 0.0224 | 0.471 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0329 | -0.328 | 0.274 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 0.154 | 10.4 | log | |
| Odds ratio, group 1 over group 2 | 1.31 | 0.115 | 14.9 | log | |
| Number needed to treat, for one more participant with the outcome on Rilematovir than on Placebo | 30.4 | 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). | 3 | 19 | OG001 |
| 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). | 1 | 8 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Post-baseline RSV-related Complications
- Description
RSV related complications included respiratory complications (respiratory failure, apnoeic attacks, bronchiolitis, bronchial obstruction, pneumonia and asthmatic crisis), infectious complications (otitis media, bacterial respiratory tract infections and sepsis), cardiovascular complications (arrhythmia, cardiogenic shock, hemodynamic instability, congestive cardiac failure), acid-base or electrolyte complications (metabolic acidosis, metabolic alkalosis, hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoglycemia and hyperglycemia). Participants were counted only once, regardless of the number of complications they actually experienced.
- Time frame
- Up to Day 35
- Population
- ITT-i analysis set included all randomized participants who received at least 1 dose of study intervention and had an RSV infection confirmed by central laboratory analysis.
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.
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