An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Model scores of the 29,894 trials active now.

Model score 11% 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 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 2022-08-05. 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: placebodouble blindstagediagnosis ofrandomized double
  Phrases that lowered it: participantevaluate theparticipantsto evaluateopen label
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 7.0% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Sponsor's past termination rate: 10.3% (raises risk) · Sponsor's track record
• Sponsor's past trials: 911 (raises risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Blinding: triple (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 69 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 66.4% (lowers risk) · Drug's FDA history
• Drug's FAERS reports before start: 719807 (lowers risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Drugs with FDA adverse-event history: 14 (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Maximum age: 17 (raises risk) · Who can join
• Number of arms: 4 (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Keywords listed: 0 (lowers risk) · Design
• Collaborators: 1 (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 98726 (lowers risk) · Drug's FDA history

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.

• 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
• 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
• Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN) NCT02107898 · started 2014 · scored riskier than 11% of active trials completed
• Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) NCT03156621 · started 2017 · scored riskier than 14% of active trials completed
• Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy NCT02326220 · started 2015 · scored riskier than 13% 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.