Comparison · NCT03677401-sae
Serlopitant 5 mg 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. Serlopitant 5 mg vs Placebo: serious adverse events. Trial comparisons, record NCT03677401-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03677401-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 | 0.034 | 0.0146 | 0.0771 | wilson | |
| Risk in group 2 | 0.0135 | 0.00371 | 0.0479 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0205 | -0.019 | 0.0647 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.52 | 0.496 | 12.8 | log | |
| Odds ratio, group 1 over group 2 | 2.57 | 0.491 | 13.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Serlopitant 5 mg than on Placebo | 48.8 | 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 | Serlopitant 5 mg | Randomized participants received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period. | 5 | 147 | EG001 |
| Group 2 | Placebo | Randomized participants received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period. | 2 | 148 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for participants who discontinued study drug early.
Source ClinicalTrials.gov
Trial
- Title
- Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
- NCT number
- NCT03677401
- Phases
- PHASE3
- Conditions
- Pruritus, Prurigo Nodularis
- Interventions
- 5mg Serlopitant Tablets, Placebo Tablets
- Lead sponsor
- Vyne Therapeutics Inc.
- Results first posted
- 2020-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03677401?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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