Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Model scores of the 29,894 trials active now.

Model score 27% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (1,304 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 2017-07-14. 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: ulniipatientbowelsurgery
  Phrases that lowered it: maleperiodthe studyrelevantscreening
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 16.3% (lowers risk) · Drug's FDA history
• Blinding: triple (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 2 (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Sponsor's past trials: 2 (raises risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports before start: 32794 (lowers risk) · Drug's FDA history
• Maximum age: 80 (lowers risk) · Who can join
• Drug's FAERS reports in the prior 12 months: 11107 (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 SYN-010 in IBS-C NCT03763175 · started 2018 · scored riskier than 66% of active trials terminated
• TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial NCT03555188 · started 2018 · scored riskier than 24% of active trials completed
• A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome NCT03721107 · started 2018 · scored riskier than 14% of active trials completed
• Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With IBS-D NCT03099785 · started 2017 · scored riskier than 18% of active trials completed
• 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) NCT02107196 · started 2014 · scored riskier than 15% 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.