Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

Model scores of the 29,894 trials active now.

Model score 4% 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 2014-09-10. 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) (lowers risk) · Wording Phrases that raised it: safety tolerabilitytolerability andsubjectsand pharmacokineticsplacebo controlled
  Phrases that lowered it: tabletbioavailabilityhealthycrossoverpressure
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Design: crossover (lowers risk) · Design
• Sponsor's past termination rate: 5.5% (lowers risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 137 (lowers risk) · Sponsor's track record
• Maximum age: 45 (lowers risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Keywords listed: 0 (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• 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 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
• Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers NCT02696616 · started 2016 · scored riskier than 17% of active trials completed
• Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469 NCT01971502 · started 2013 · scored riskier than 4% of active trials completed
• A Study to Test How Well Healthy Men Tolerate BI 765250 When Given as an Infusion Into the Vein or as an Injection Under the Skin NCT05151653 · started 2022 · 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

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.