Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-02-28. 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.

• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: and pharmacodynamicsplacebo controlledmultipletolerability pharmacokineticsblind placebo
  Phrases that lowered it: volunteershealthypharmacokineticsto investigateinvestigate the
• Phase: 1 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Sponsor's past termination rate: 5.4% (lowers risk) · Sponsor's track record
• Has a data monitoring committee: not given (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 135 (lowers risk) · Sponsor's track record
• Maximum age: 80 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Responsible party: sponsor (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 4 (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Disease area, psychiatry: No (lowers risk) · Disease area

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.

• Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181 NCT02044406 · started 2014 · scored riskier than 7% of active trials completed
• A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated NCT04537897 · started 2020 · scored riskier than 18% of active trials completed
• Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening) NCT02337283 · started 2015 · scored riskier than 20% of active trials completed
• First in Man Trial of BI 113608 NCT01540825 · started 2012 · scored riskier than 4% of active trials completed
• A Study to Test How Well Different Doses of BI 1584862 Are Tolerated by Healthy Men NCT06006598 · started 2023 · 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.