Open Label Study of Long Term Safety Evaluation of Alirocumab

Model scores of the 29,894 trials active now.

Model score 16% 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 9% of the time (803 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 2017-06-30. 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: No (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: long termthe longterm safetycompletedextension
  Phrases that lowered it: efficacysafety ofparticipantsto evaluateparticipant
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Sponsor's past trials: 735 (raises risk) · Sponsor's track record
• Sponsor's past termination rate: 11.7% (raises risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports before start: 1 (raises risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 100% (lowers risk) · Drug's FDA history
• Disease area, neurology: No (lowers risk) · Disease area
• Keywords listed: 0 (lowers risk) · Design
• Collaborators: 1 (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 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) NCT01576484 · started 2012 · scored riskier than 59% of active trials completed
• An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia NCT03510884 · started 2018 · scored riskier than 18% of active trials completed
• An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia NCT02890992 · started 2016 · scored riskier than 24% 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
• An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia NCT03510715 · started 2018 · scored riskier than 19% 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.