Comparison · NCT04567628-0e5721fe
TDM Cohort vs Historical Cohort: Number of Participants Categorized Based on Dose Escalation
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. TDM Cohort vs Historical Cohort: Number of Participants Categorized Based on Dose Escalation. Trial comparisons, record NCT04567628-0e5721fe. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04567628-0e5721fe
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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 | 0.397 | 0.352 | 0.443 | wilson | |
| Risk in group 2 | 0.179 | 0.168 | 0.19 | wilson | |
| Risk difference, group 1 minus group 2 | 0.218 | 0.172 | 0.266 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.22 | 1.94 | 2.53 | log | |
| Odds ratio, group 1 over group 2 | 3.02 | 2.46 | 3.7 | log | |
| Number needed to treat, for one more participant with the outcome on TDM Cohort than on Historical Cohort | 4.59 | 3.77 | 5.83 | 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 | TDM Cohort | Participants diagnosed with IBD (UC or CD) within Takeda Canada PSP group who received treatment with vedolizumab 300 mg, infusion, intravenously, at Weeks 0, 2, and 6, and every 8 weeks thereafter as per product Health Canada Product Monograph, or every 4 or 6 weeks thereafter as per standard clinical practice between the year 2015 to 2020 along with the biomarker testing and TDM at pre-specified intervals during their treatment were observed retrospectively. | 173 | 436 | OG000 |
| Group 2 | Historical Cohort | Participants diagnosed with IBD (UC or CD) within Takeda Canada PSP group who received treatment with vedolizumab 300 mg, infusion, intravenously, at Weeks 0, 2, and 6, and every 8 weeks thereafter as per product Health Canada Product Monograph, or every 4 or 6 weeks thereafter as per standard clinical practice between the year 2015 to 2020 but did not undergo biomarker testing or TDM during their treatment were observed retrospectively. | 852 | 4,758 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Categorized Based on Dose Escalation
- Description
- Dose escalation was defined as a change from doses every 8 weeks to every 4 weeks.
- Time frame
- Baseline (Week 0) up to Week 30 (after first dose of vedolizumab)
- Population
- Analyzed participants included all participants who were not screen failures, met all the inclusion criteria and had enough information about response to the biological treatment.
Source ClinicalTrials.gov
Trial
- Title
- Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
- NCT number
- NCT04567628
- Phases
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Interventions
- No Intervention
- Lead sponsor
- Takeda
- Results first posted
- 2024-03-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04567628?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.govNone 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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