Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers

Model scores of the 29,894 trials active now.

Model score 9% 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.

• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: safety tolerabilityof bitolerability andrisingbased
  Phrases that lowered it: mghealthytabletrelevantbmi
• Sponsor's past termination rate: 2.8% (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 169 (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Phase: 1 (lowers risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Minimum age: 21 (lowers risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Blinding: double (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past trials: 72 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Number of arms: 3 (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• 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.

• 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
• Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051. NCT01343719 · started 2011 · scored riskier than 7% of active trials completed
• Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 60732 in Healthy Male Volunteers NCT02244203 · started 2009 · scored riskier than 10% of active trials completed
• Metabolism and Pharmacokinetics of [14C]-BI 44370 BS Administered as an Oral Solution in Healthy Male Volunteers NCT02215772 · started 2008 · scored riskier than 6% of active trials completed
• This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood. NCT03483077 · started 2018 · scored riskier than 14% of active trials terminated

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.