Comparison · NCT04068792-sae
JNJ-53718678 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
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ConductScience Library. JNJ-53718678 vs Placebo: serious adverse events. Trial comparisons, record NCT04068792-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04068792-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 | 0.0909 | 0.0162 | 0.377 | wilson | |
| Risk in group 2 | 0.0909 | 0.0162 | 0.377 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.296 | 0.296 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0712 | 14.1 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.0546 | 18.3 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | JNJ-53718678 | As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days | 1 | 11 | EG001 |
| Group 2 | Placebo | As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days. | 1 | 11 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Day 31
Source ClinicalTrials.gov
Trial
- Title
- A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
- NCT number
- NCT04068792
- Phases
- PHASE2
- Conditions
- Respiratory Syncytial Viruses
- Interventions
- RSV Mobile Application, Placebo, JNJ-53718678 2.5 mg/kg, JNJ-53718678 3 mg/kg, JNJ-53718678 4.5 mg/kg
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2022-06-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04068792?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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