Comparison · NCT05369832-5839d455
Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation
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 Leading to Discontinuation. Trial comparisons, record NCT05369832-5839d455. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05369832-5839d455
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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 | 0.0505 | 0.0218 | 0.113 | wilson | |
| Risk in group 2 | 0.075 | 0.0258 | 0.199 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0245 | -0.151 | 0.0549 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.673 | 0.169 | 2.69 | log | |
| Odds ratio, group 1 over group 2 | 0.656 | 0.149 | 2.88 | 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 | 40.8 | 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 | 5 | 99 | OG000 |
| Group 2 | Cohort 2: Ozanimod Advanced Therapy Exposed | Advanced therapy exposed participants received ozanimod 0.92 mg daily | 3 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation
- Description
This endpoint measures the number of participants who experienced Treatment Emergent Adverse Events (TEAEs) that resulted in discontinuation of study treatment.~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 TEAE is an AE that: starts after the first dose (or within 84 days after stopping) and was not present before; or was preexisting but worsens after the first dose (or within 84 days after stopping); or has missing dates that prevent determining whether it occurred outside the treatment emergent period.
- 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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