Comparison · NCT03440385-sae
Ozanimod vs Placebo: serious adverse events
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. Ozanimod vs Placebo: serious adverse events. Trial comparisons, record NCT03440385-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03440385-sae
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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 | 0.0594 | 0.0402 | 0.0869 | wilson | |
| Risk in group 2 | 0.0545 | 0.0307 | 0.0949 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00495 | -0.0398 | 0.0413 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.545 | 2.18 | log | |
| Odds ratio, group 1 over group 2 | 1.1 | 0.526 | 2.29 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ozanimod than on Placebo | 202 | 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 | Ozanimod | Participants with moderate to severe acute Crohn's disease were administered Ozanimod capsule orally. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) from Day 8 to Week 12. | 24 | 404 | EG000 |
| Group 2 | Placebo | Participants with moderate to severely active Crohn's disease were orally administered Placebo (daily) from Day 1 to Week 12. | 11 | 202 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All cause mortality, non serious adverse events and serious adverse events were collected from the first dose and up to approximately 31 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
- NCT number
- NCT03440385
- Phases
- PHASE3
- Conditions
- Crohn Disease
- Interventions
- Ozanimod, Placebo
- Lead sponsor
- Celgene
- Results first posted
- 2024-12-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03440385?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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