Comparison · NCT01536535-sae
Mild UC vs Moderate to Severe UC: 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. Mild UC vs Moderate to Severe UC: serious adverse events. Trial comparisons, record NCT01536535-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01536535-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 | 0.118 | 0.0785 | 0.174 | wilson | |
| Risk in group 2 | 0.316 | 0.262 | 0.376 | wilson | |
| Risk difference, group 1 minus group 2 | -0.198 | -0.27 | -0.12 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.373 | 0.24 | 0.58 | log | |
| Odds ratio, group 1 over group 2 | 0.29 | 0.171 | 0.491 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Mild UC than on Moderate to Severe UC | 5.05 | 3.71 | 8.32 | from the risk difference interval |
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 | Mild UC | Mild = Initiated on 5-Aminosalicylates (ASA) or on oral CS with PUCAI \< 45 | 21 | 178 | EG000 |
| Group 2 | Moderate to Severe UC | Moderate/Severe = Initiated on IV CS or oral CS with PUCAI ≥45 | 79 | 250 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from Baseline through to the 52 week visit.
Source ClinicalTrials.gov
Trial
- Title
- Predicting Response to Standardized Pediatric Colitis Therapy
- NCT number
- NCT01536535
- Phases
- PHASE4
- Conditions
- Ulcerative Colitis
- Interventions
- Mesalazine, IV Corticosteroid, Oral Corticosteroids, Additional Therapies, Colectomy
- Lead sponsor
- Connecticut Children's Medical Center
- Results first posted
- 2019-08-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01536535?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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