Comparison · NCT00790933-0cc18982
Vedolizumab 300 mg (UC) vs Vedolizumab 300 mg (CD): Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings
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 (UC) vs Vedolizumab 300 mg (CD): Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings. Trial comparisons, record NCT00790933-0cc18982. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00790933-0cc18982
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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 | 0.00783 | 0.0038 | 0.0161 | wilson | |
| Risk in group 2 | 0.00519 | 0.00252 | 0.0107 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00264 | -0.00417 | 0.0113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.51 | 0.531 | 4.29 | log | |
| Odds ratio, group 1 over group 2 | 1.51 | 0.529 | 4.33 | log | |
| Number needed to treat, for one more participant with the outcome on Vedolizumab 300 mg (UC) than on Vedolizumab 300 mg (CD) | 379 | 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 (UC) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC). | 7 | 894 | OG000 |
| Group 2 | Vedolizumab 300 mg (CD) | Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease. | 7 | 1,349 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings
- Description
- A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs.
- Time frame
- From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
- Population
The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
Source ClinicalTrials.gov
Trial
- Title
- An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
- NCT number
- NCT00790933
- Phases
- PHASE3
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Interventions
- Vedolizumab
- Lead sponsor
- Takeda
- Results first posted
- 2019-03-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00790933?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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