An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (213 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-01-18. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: randomizationevidencechronicdiagnosis ofprior
  Phrases that lowered it: and safetyefficacy andsafety ofevaluate theto evaluate
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 13.4% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports marked serious: 33.9% (lowers risk) · Drug's FDA history
• Drug's FAERS reports with a death: 2.7% (lowers risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 90 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Maximum age: 85 (lowers risk) · Who can join
• Drug's FAERS reports before start: 54301 (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Blinding: double (raises risk) · Design
• Sponsor's past trials: 328 (lowers risk) · Sponsor's track record
• Number of arms: 2 (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 50675 (lowers risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis NCT02611830 · started 2015 · scored riskier than 43% of active trials completed
• Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis NCT00783718 · started 2009 · scored riskier than 58% of active trials completed
• Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) NCT03138655 · started 2017 · scored riskier than 65% of active trials completed
• A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC) NCT04779307 · started 2021 · scored riskier than 38% of active trials completed
• ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis NCT03093259 · started 2017 · scored riskier than 29% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.