Comparison · NCT05369832-5eca5cbd
Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Treatment Emergent Adverse Event of Interest
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. Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Treatment Emergent Adverse Event of Interest. Trial comparisons, record NCT05369832-5eca5cbd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05369832-5eca5cbd
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 | 0.0707 | 0.0347 | 0.139 | wilson | |
| Risk in group 2 | 0.1 | 0.0396 | 0.231 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0293 | -0.165 | 0.0618 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.707 | 0.219 | 2.28 | log | |
| Odds ratio, group 1 over group 2 | 0.685 | 0.189 | 2.48 | log | |
| Number needed to treat, for one fewer participant with the outcome on Cohort 1: Ozanimod Advanced Therapy Naïve than on Cohort 2: Ozanimod Advanced Therapy Exposed | 34.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cohort 1: Ozanimod Advanced Therapy Naïve | Advanced therapy naïve participants received ozanimod 0.92 mg daily | 7 | 99 | OG000 |
| Group 2 | Cohort 2: Ozanimod Advanced Therapy Exposed | Advanced therapy exposed participants received ozanimod 0.92 mg daily | 4 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment Emergent Adverse Event of Interest
- Description
This endpoint reports the number of participants who experienced Adverse Events of Interest (AEIs) during the study. AEIs include bradycardia, heart conduction abnormalities (second-degree and higher atrioventricular block), macular edema, malignancy, serious or opportunistic infection, pulmonary effects, hepatic effects, posterior reversible encephalopathy syndrome, progressive multifocal leukoencephalopathy (PML), and events associated with orthostatic hypotension (e.g., dizziness, lightheadedness, syncope, seizure). The Sponsor may request additional information for nonserious AEIs.~A Treatment Emergent AEI is an AEI that starts after the first dose (or within 84 days after stopping), worsens relative to baseline in this period (or within 84 days after stopping), or has missing dates making the timing unclear.~Participants meeting any of these conditions are counted as having at least one AEI.
- Time frame
- From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days)
- Population
- Treated participants
Source ClinicalTrials.gov
Trial
- Title
- An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
- NCT number
- NCT05369832
- Phases
- PHASE4
- Conditions
- Colitis, Ulcerative
- Interventions
- Ozanimod
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2026-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05369832?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/NCT05369832-5eca5cbd