Comparison · NCT05732454-5ef6ebd2
DB Period: Etrasimod 2 mg vs DB Period: Placebo: Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality)
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. DB Period: Etrasimod 2 mg vs DB Period: Placebo: Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality). Trial comparisons, record NCT05732454-5ef6ebd2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05732454-5ef6ebd2
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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 | 0.0667 | 0.0185 | 0.213 | wilson | |
| Risk in group 2 | 0.0357 | 0.00633 | 0.177 | wilson | |
| Risk difference, group 1 minus group 2 | 0.031 | -0.118 | 0.18 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.87 | 0.179 | 19.5 | log | |
| Odds ratio, group 1 over group 2 | 1.93 | 0.165 | 22.5 | log | |
| Number needed to treat, for one more participant with the outcome on DB Period: Etrasimod 2 mg than on DB Period: Placebo | 32.3 | 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 | DB Period: Etrasimod 2 mg | Participants who received etrasimod 2 mg orally once daily for 16 weeks in DB period of Part 1. | 2 | 30 | OG000 |
| Group 2 | DB Period: Placebo | Participants who received placebo matched to etrasimod orally once daily for 16 weeks in DB period of Part 1. | 1 | 28 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality)
- Description
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, Atrioventricular (AV) conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections \[including progressive multifocal leukoencephalopathy (PML)\], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and bilirubin elevation); posterior reversible encephalopathy syndrome (PRES) and malignancies.
- Time frame
- DB Period: From first dose of study drug up to 16 Weeks of treatment
- Population
- DB period: Safety analysis set included of all participants who were randomized and received at least 1 dose of study drug in DB period.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection
- NCT number
- NCT05732454
- Phases
- PHASE2, PHASE3
- Conditions
- Atopic Dermatitis, Atopic Dermatitis, Unspecified, Eczema, Eczema, Atopic
- Interventions
- etrasimod, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2025-05-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05732454?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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