Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

Model scores of the 29,894 trials active now.

Model score 4% 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 6% of the time (816 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 2013-05-31. 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 withtolerabilitypatients withmatchedin subjects
  Phrases that lowered it: healthyrelevantthe pharmacokineticspharmacokineticbetween 18
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Sponsor's past termination rate: 12.3% (raises risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 119 (lowers risk) · Sponsor's track record
• Primary purpose: basic science (lowers risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Sponsor's past trials: 664 (raises risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 3 (lowers risk) · Design
• Disease area, psychiatry: No (lowers risk) · Disease area
• Collaborators: 1 (raises risk) · Design
• 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.

• Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment NCT01762462 · started 2012 · scored riskier than 6% of active trials completed
• A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants NCT05409911 · started 2022 · scored riskier than 5% of active trials completed
• Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects NCT01860326 · started 2011 · scored riskier than 4% of active trials completed
• To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects NCT02063230 · started 2014 · scored riskier than 4% of active trials completed
• Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment NCT01763190 · started 2012 · scored riskier than 9% 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.