Comparison · NCT04052425-sae
Ruxolitinib Cream 1.5% BID vs Vehicle Cream BID: 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. Ruxolitinib Cream 1.5% BID vs Vehicle Cream BID: serious adverse events. Trial comparisons, record NCT04052425-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04052425-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 | 0.0257 | 0.0131 | 0.0499 | wilson | |
| Risk in group 2 | 0.00917 | 0.00162 | 0.0501 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0165 | -0.0263 | 0.0419 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.8 | 0.355 | 22.2 | log | |
| Odds ratio, group 1 over group 2 | 2.85 | 0.353 | 23.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ruxolitinib Cream 1.5% BID than on Vehicle Cream BID | 60.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib cream during the Double-Blind Treatment Period and the Treatment-Extension Period. Participants applied ruxolitinib 1.5% cream BID for 24 weeks. Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period. | 8 | 311 | EG001 |
| Group 2 | Vehicle Cream BID | Participants applied matching vehicle cream twice a day (BID) for 24 weeks in the Double-Blind Period. | 1 | 109 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Source ClinicalTrials.gov
Trial
- Title
- Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
- NCT number
- NCT04052425
- Phases
- PHASE3
- Conditions
- Non-segmental Vitiligo
- Interventions
- Ruxolitinib cream, Vehicle
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2022-09-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04052425?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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