Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

Model scores of the 29,894 trials active now.

Model score 18% 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 11% of the time (493 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 2016-12-22. 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
• Sponsor's past termination rate: 10.3% (raises risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: the longterm safetywomen oflong termentry
  Phrases that lowered it: screeningstudy wasefficacysignificantor drug
• Design: single group (raises risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 14 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Collaborators: 1 (raises risk) · Design
• Disease area, metabolic: Yes (lowers risk) · Disease area
• Drug's FAERS reports before start: 1 (raises risk) · Drug's FDA history
• Maximum age: 75 (lowers risk) · Who can join
• Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
• Blinding: none (raises 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 Study of Long Term Safety Evaluation of Alirocumab NCT01954394 · started 2013 · scored riskier than 47% of active trials completed
• Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH) NCT02265952 · started 2015 · scored riskier than 13% of active trials completed
• Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) NCT01617655 · started 2012 · scored riskier than 27% of active trials completed
• Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia NCT01644474 · started 2012 · scored riskier than 39% of active trials completed
• Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term) NCT01507831 · started 2012 · scored riskier than 75% 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.