Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

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 7% of the time (289 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2016-11-30. 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 withtype diabetesto administrationin subjectsdisease
  Phrases that lowered it: kgdrugsubject whobloodmale
• Sponsor's past termination rate: 2.0% (lowers risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 25 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• 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
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Sponsor's past trials: 99 (lowers risk) · Sponsor's track record
• Blinding: none (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• 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.

• A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215 NCT02571816 · started 2015 · scored riskier than 3% of active trials completed
• DZD9008 PK Study in Hepatic Impairment Subjects NCT06084104 · started 2023 · scored riskier than 4% of active trials completed
• Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients NCT01887301 · started 2013 · scored riskier than 4% of active trials completed
• A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function NCT04482270 · started 2020 · scored riskier than 3% of active trials completed
• A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function NCT06390410 · started 2024 · scored riskier than 3% 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.