A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage

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 2015-01-31. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: subjects withfunctionhepaticmild tothe subject
  Phrases that lowered it: volunteersthe pharmacokineticsopen labelhealthysingle dose
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Primary purpose: not given (lowers risk) · Design
• Phase: 1 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Maximum age: 74 (raises risk) · Who can join
• Has a data monitoring committee: not given (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 41 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: 2.8% (lowers risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 4 (lowers risk) · Design
• Sponsor's past termination rate: 7.4% (lowers risk) · Sponsor's track record
• Disease area, psychiatry: No (lowers risk) · Disease area
• Sponsor's past trials: 188 (lowers risk) · Sponsor's track record

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.

• Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function NCT05724693 · started 2023 · scored riskier than 4% of active trials completed
• A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants NCT01929876 · started 2013 · scored riskier than 1% of active trials completed
• Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects NCT01493869 · started 2011 · scored riskier than 4% of active trials completed
• Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function NCT04454424 · started 2020 · scored riskier than 11% of active trials completed
• A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment NCT05517525 · started 2022 · 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.