Comparison · NCT03546816-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 NCT03546816-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03546816-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 | 0.0432 | 0.0199 | 0.091 | wilson | |
| Risk in group 2 | 0.0213 | 0.00726 | 0.0607 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0219 | -0.0239 | 0.0717 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.03 | 0.518 | 7.95 | log | |
| Odds ratio, group 1 over group 2 | 2.08 | 0.509 | 8.47 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Serlopitant 5 mg than on Placebo | 45.7 | 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 subjects received serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day. | 6 | 139 | EG000 |
| Group 2 | Placebo | Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day. | 3 | 141 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 35 days (+3 days) after Week 10 or Early Treatment Discontinuation
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
- NCT03546816
- Phases
- PHASE3
- Conditions
- Pruritus, Prurigo Nodularis
- Interventions
- 5mg Serlopitant Tablets, Placebo Tablets
- Lead sponsor
- Vyne Therapeutics Inc.
- Results first posted
- 2020-09-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03546816?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/NCT03546816-sae