Comparison · NCT04816721-7d2cd5c6
Part 1: EDP-938 vs Part 1: Placebo: Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
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. Part 1: EDP-938 vs Part 1: Placebo: Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE). Trial comparisons, record NCT04816721-7d2cd5c6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04816721-7d2cd5c6
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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 | 0.389 | 0.248 | 0.551 | wilson | |
| Risk in group 2 | 0.563 | 0.332 | 0.769 | wilson | |
| Risk difference, group 1 minus group 2 | -0.174 | -0.424 | 0.109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.691 | 0.381 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 0.495 | 0.15 | 1.63 | log | |
| Number needed to treat, for one fewer participant with the outcome on Part 1: EDP-938 than on Part 1: Placebo | 5.76 | 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 | Part 1: EDP-938 | Participants who received oral doses of EDP-938 QD from Day 1 to Day 5 of the study. | 14 | 36 | OG000 |
| Group 2 | Part 1: Placebo | Participants who received oral doses of placebo matching EDP-938 QD from Day 1 to Day 5 of the study. | 9 | 16 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Part 1: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
- Description
TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.
- Time frame
- Day 1 to Day 28
- Population
Safety Population: Included all participants in Part 1 who received any dose (including partial doses) of any study drug. Per the protocol, analyses were planned to be grouped by EDP-938 and placebo, rather than by dose.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate EDP 938 Regimens in Children With RSV
- NCT number
- NCT04816721
- Phases
- PHASE2
- Conditions
- Respiratory Syncytial Virus (RSV)
- Interventions
- EDP-938, Placebo
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Results first posted
- 2025-07-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04816721?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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