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Comparison · NCT02993783-sae

Vedolizumab 300 mg vs Vedolizumab 600 mg: serious adverse events

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: serious adverse events. Trial comparisons, record NCT02993783-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02993783-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.750.4090.929wilson
Risk in group 210.7011wilson
Risk difference, group 1 minus group 2-0.25-0.5910.0984newcombe hybrid score
Risk ratio, group 1 over group 20.750.5031.12log
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer participant with a serious adverse event on Vedolizumab 300 mg than on Vedolizumab 600 mg4from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Vedolizumab 300 mgVedolizumab 300 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.68EG000
Group 2Vedolizumab 600 mgVedolizumab 600 mg, IV infusion, once on Days 1, 15, 43, 71 and 99.99EG001

Harm

What it counts
Total, serious adverse events
Time frame
From first dose of study drug to 18 weeks after the last dose of study drug (Up to approximately 32 weeks)

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

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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