Comparison · NCT05369832-f0f0eed7
Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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 Events (TEAEs). Trial comparisons, record NCT05369832-f0f0eed7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05369832-f0f0eed7
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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 | 0.616 | 0.518 | 0.706 | wilson | |
| Risk in group 2 | 0.55 | 0.398 | 0.693 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0662 | -0.107 | 0.242 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.813 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 1.31 | 0.625 | 2.76 | log | |
| Number needed to treat, for one more participant with the outcome on Cohort 1: Ozanimod Advanced Therapy Naïve than on Cohort 2: Ozanimod Advanced Therapy Exposed | 15.1 | 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 | 61 | 99 | OG000 |
| Group 2 | Cohort 2: Ozanimod Advanced Therapy Exposed | Advanced therapy exposed participants received ozanimod 0.92 mg daily | 22 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- Description
An Adverse Event (AE) is any new medical problem or worsening of a preexisting condition in a study participant who receives the study treatment. It does not have to be caused by the treatment. An AE can be any unfavorable and unintended sign (such as an abnormal lab finding), symptom, or disease that happens around the time the study treatment is used, whether or not it is related to the treatment.~A Treatment Emergent Adverse Event (TEAE) is an AE that meets any of the following:~* Starts after the first dose of the study treatment (or within 84 days after stopping it) and was not present before; or~* Was already present before treatment but gets worse after the first dose (or within 84 days after stopping it); or~* Has missing onset and end dates, making it unclear whether it occurred outside the treatment-emergent period.~Participants meeting any of these conditions are counted as having at least one TEAE.
- 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.
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