Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia

Model scores of the 29,894 trials active now.

Model score 13% 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 2017-12-06. 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: type diabetessubjectsdiabeticwith typesafety and
  Phrases that lowered it: combinationdlmgor equalequal to
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 10.2% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 7.9% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Drug's FAERS reports marked serious: 70.0% (lowers risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 76 (lowers risk) · Sponsor's track record
• Number of arms: 4 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: quadruple (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Sponsor's past trials: 402 (lowers risk) · Sponsor's track record
• Drug's FAERS reports in the prior 12 months: 32226 (lowers risk) · Drug's FDA history
• Drug's FAERS reports before start: 170439 (lowers risk) · Drug's FDA history
• Primary purpose: treatment (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.

• Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia NCT02739984 · started 2016 · scored riskier than 18% of active trials completed
• LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 NCT01763866 · started 2013 · scored riskier than 20% of active trials completed
• Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study NCT01516879 · started 2012 · scored riskier than 30% of active trials completed
• Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk NCT01953328 · started 2013 · scored riskier than 18% of active trials completed
• Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 NCT01763827 · started 2013 · scored riskier than 16% 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.