Comparison · NCT02993783-daf424a4
Vedolizumab 300 mg vs Vedolizumab 600 mg: Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Vedolizumab 300 mg vs Vedolizumab 600 mg: Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28. Trial comparisons, record NCT02993783-daf424a4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02993783-daf424a4
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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 | 0.375 | 0.137 | 0.694 | wilson | |
| Risk in group 2 | 0.444 | 0.189 | 0.733 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0694 | -0.444 | 0.34 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.844 | 0.266 | 2.68 | log | |
| Odds ratio, group 1 over group 2 | 0.75 | 0.107 | 5.24 | log | |
| Number needed to treat, for one fewer participant with the outcome on Vedolizumab 300 mg than on Vedolizumab 600 mg | 14.4 | 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 | Vedolizumab 300 mg | Vedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99. | 3 | 8 | OG000 |
| Group 2 | Vedolizumab 600 mg | Vedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99. | 4 | 9 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28
- Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
- Time frame
- From first dose up to Day 28
- Population
- SAS included all participants who received any amount of the study drug.
Source ClinicalTrials.gov
Trial
- Title
A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
- NCT number
- NCT02993783
- Phases
- PHASE2
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Interventions
- Vedolizumab
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Results first posted
- 2019-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02993783?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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