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Comparison · NCT02196324-sae

Serlopitant 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. Serlopitant vs Placebo: serious adverse events. Trial comparisons, record NCT02196324-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02196324-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.04690.01610.129wilson
Risk in group 20.03170.008750.109wilson
Risk difference, group 1 minus group 20.0151-0.06760.1newcombe hybrid score
Risk ratio, group 1 over group 21.480.2558.54log
Odds ratio, group 1 over group 21.50.2429.3log
Number needed to harm, for one more participant with a serious adverse event on Serlopitant than on Placebo66.1from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1SerlopitantRandomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.364EG001
Group 2PlaceboRandomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.263EG000

Harm

What it counts
Total, serious adverse events
Time frame
From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10).

Source ClinicalTrials.gov

Trial

Title
A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)
NCT number
NCT02196324
Phases
PHASE2
Conditions
Prurigo Nodularis
Interventions
serlopitant, Placebo
Lead sponsor
Vyne Therapeutics Inc.
Results first posted
2021-02-02

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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