A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects

Model scores of the 29,894 trials active now.

Model score 6% for any early termination, 1% 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 (233 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 2012-10-31. 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) (lowers risk) · Wording Phrases that raised it: subjects withhearttypestableacute
  Phrases that lowered it: healthyopen labelalcoholand safetydosing
• Sponsor's past termination rate: 10.4% (raises risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Drug's FAERS reports with a death: 100% (raises risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 58 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Maximum age: 79 (raises risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Sponsor's past trials: 135 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Disease area, psychiatry: 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.

• Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment NCT02508740 · started 2013 · scored riskier than 3% of active trials terminated
• Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419 NCT05412472 · started 2019 · scored riskier than 2% of active trials completed
• A Study of Epetraborole Tablets in Subjects With Degrees of Renal Function NCT05283746 · started 2022 · scored riskier than 2% of active trials completed
• A Study to Assess the Pharmacokinetics, Safety and Tolerability of Repeat Oral Doses of Darapladib (SB-480848) in Subjects With Severe Renal Impairment NCT01711723 · started 2012 · scored riskier than 37% of active trials completed
• A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy Volunteers NCT02199392 · started 2011 · scored riskier than 2% 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.