Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 3% 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 2019-04-12. 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) (raises risk) · Wording Phrases that raised it: ischemicheartcoronaryonsetdl
  Phrases that lowered it: participantsparticipanteffect ofvisitscreening
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 7.1% (lowers risk) · Drug's FDA history
• Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
• Sponsor's past trials: 802 (raises risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 62 (lowers risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports before start: 372178 (lowers risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 68.9% (lowers 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: 54483 (lowers risk) · Drug's FDA history
• 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.

• 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 heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) NCT01709500 · started 2012 · scored riskier than 22% 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
• Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients NCT04790513 · started 2021 · scored riskier than 23% 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.