Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

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 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 2014-06-30. 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.

• Minimum age: 20 (lowers risk) · Who can join
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 9.1% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: type diabetesequal toin combinationcombination withplacebo
  Phrases that lowered it: evaluatecardiovascularhypertensionsubjectsthe effect
• Drug's FAERS reports with a death: 8.6% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: triple (raises risk) · Design
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 90 (lowers risk) · Sponsor's track record
• Number of arms: 8 (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports in the prior 12 months: 14493 (lowers risk) · Drug's FDA history
• Drug's FAERS reports before start: 103044 (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 309 (raises risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 70.4% (lowers risk) · Drug's FDA history
• Disease area, neurology: No (lowers risk) · Disease area

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.

• A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects NCT01652703 · started 2012 · scored riskier than 38% 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
• Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4 NCT02634580 · started 2016 · scored riskier than 13% of active trials completed
• Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia NCT02662569 · started 2016 · scored riskier than 30% of active trials completed
• Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study NCT01516879 · started 2012 · scored riskier than 30% 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.