Comparison · NCT03532932-sae
UC Participants vs CD Participants: 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. UC Participants vs CD Participants: serious adverse events. Trial comparisons, record NCT03532932-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03532932-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 | 0.12 | 0.103 | 0.14 | wilson | |
| Risk in group 2 | 0.122 | 0.0999 | 0.149 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00201 | -0.0337 | 0.0277 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.984 | 0.765 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 0.981 | 0.737 | 1.31 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on UC Participants than on CD Participants | 498 | 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 | UC Participants | Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. | 146 | 1,214 | EG000 |
| Group 2 | CD Participants | Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. | 84 | 687 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 12 months after enrollment into the study
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
- NCT number
- NCT03532932
- Phases
- Conditions
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
- Interventions
- Lead sponsor
- Takeda
- Results first posted
- 2024-03-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03532932?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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