Safety Tolerability and Pharmacokinetic of BI 409306

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 2011-08-05. 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: administrationtolerabilitylongstudy issurgery
  Phrases that lowered it: healthyvolunteersbioavailabilitymalebmi
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Sponsor's past termination rate: 4.2% (lowers risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Minimum age: 21 (lowers risk) · Who can join
• Trials the sponsor started in the prior 2 years: 181 (lowers risk) · Sponsor's track record
• 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
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past trials: 95 (lowers risk) · Sponsor's track record
• Maximum age: 50 (lowers risk) · Who can join
• Number of arms: 12 (lowers risk) · Design
• Blinding: double (raises risk) · Design
• Disease area, neurology: 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 and Pharmacodynamics of Multiple Rising Doses NCT01505894 · started 2012 · scored riskier than 11% of active trials completed
• Assessment of Exposure of BI 409306 in Cerebrospinal Fluid (CSF) Relative to Plasma as Well as to Evaluation of the Effect of Different Doses of BI 409306 on the cGMP (Cyclic Guanosine Monophosphate) Levels in CSF in Healthy Male Volunteers NCT01493570 · started 2011 · scored riskier than 4% of active trials completed
• This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study) NCT03934203 · started 2019 · scored riskier than 4% of active trials completed
• Safety and Tolerability of BI 685509 in Healthy Subjects NCT03116906 · started 2017 · scored riskier than 15% 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

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.