Comparison · NCT05369832-9cb75d3b
Cohort 1: Ozanimod Advanced Therapy Naïve vs Cohort 2: Ozanimod Advanced Therapy Exposed: Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
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 Serious Adverse Events (TESAEs). Trial comparisons, record NCT05369832-9cb75d3b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05369832-9cb75d3b
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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 | 0.0707 | 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 Serious Adverse Events (TESAEs)
- Description
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, is a congenital anomaly/birth defect, requires in-patient hospitalization or causes prolongation of existing hospitalization, or results in persistent/significant disability/incapacity.~Treatment Emergent Serious Adverse Event (TE SAE) is a SAE 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 TESAE.
- 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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