Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 7.3% (lowers risk) · Drug's FDA history
• Phase: 3 (lowers risk) · Design
• Sponsor's past termination rate: 8.3% (raises risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 23 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 69.8% (lowers risk) · Drug's FDA history
• Blinding: quadruple (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: randomizationdiagnosisplacebo controlledcoronaryprior
  Phrases that lowered it: participantrosuvastatindailyatorvastatinclinical
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports before start: 224161 (lowers risk) · Drug's FDA history
• Drug's FAERS reports in the prior 12 months: 46319 (lowers risk) · Drug's FDA history
• Collaborators: 1 (raises risk) · Design
• Sponsor's past trials: 36 (lowers risk) · Sponsor's track record
• 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.

• Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) NCT03156621 · started 2017 · scored riskier than 14% of active trials completed
• Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE) NCT02476006 · started 2015 · scored riskier than 28% of active trials completed
• Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I) NCT01730040 · started 2012 · scored riskier than 46% of active trials completed
• Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia NCT01266876 · started 2011 · scored riskier than 16% of active trials completed
• Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) NCT01709513 · started 2012 · scored riskier than 33% 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.