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)

Model scores of the 29,894 trials active now.

Model score 11% 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 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 2015-11-16. 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: pressuremultiplesubjectstolerabilitygreater than
  Phrases that lowered it: volunteershealthypharmacokinetics ofmaleadministration
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Design: single group (raises risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Phase: 1 (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 133 (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Blinding: double (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Number of arms: 7 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past termination rate: 5.2% (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Responsible party: sponsor (lowers risk) · Design

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, and Pharmacokinetics of Single Doses BI 425809 NCT02068690 · started 2014 · scored riskier than 3% 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
• 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
• A Study in Healthy Men to Test How Different Doses of BI 1595043 Are Tolerated NCT04439838 · started 2020 · scored riskier than 18% of active trials completed
• Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers NCT02852824 · started 2016 · scored riskier than 28% 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.