Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 44370 TA Tablets in Healthy Male and Female Volunteers

Model scores of the 29,894 trials active now.

Model score 5% 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. 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: longadequatepriortime ofadministration or
  Phrases that lowered it: healthyvolunteersmalepharmacokineticsbmi
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Minimum age: 21 (lowers risk) · Who can join
• Design: parallel (raises risk) · Design
• Blinding: double (raises risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 181 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Responsible party: sponsor (lowers risk) · Design
• Keywords listed: 0 (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.

• Bioavailability of BI 44370 TA Drinking Solution or Tablets With and Without a High Fat Meal in Healthy Male and Female Volunteers NCT02215746 · started 2008 · scored riskier than 2% of active trials completed
• Effects of BI 44370 TA Orally Applied as Tablets on the Pharmacokinetics of Orally Administered Midazolam Solution in Healthy Volunteers NCT02217514 · started 2008 · scored riskier than 5% of active trials completed
• Investigation of Single Rising Doses of BI 685509 NCT02694354 · started 2016 · scored riskier than 16% of active trials completed
• Relative Bioavailability of BI 10773 Administered Twice Daily Compared BI 10773 Given Once Daily After Multiple Oral Doses in Healthy Male and Female Volunteers NCT02782624 · started 2009 · scored riskier than 1% of active trials completed
• Safety and Tolerability of BI 685509 in Healthy Subjects NCT03116906 · started 2017 · 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.