Open Label Study of Long Term Evaluation Against LDL-C Trial

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (493 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 2018-06-20. 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: amgsafestudycondition30 days
  Phrases that lowered it: longexposureproductsefficacyproduct
• Phase: 2 (raises risk) · Design
• Sponsor's past termination rate: 5.4% (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 78 (lowers risk) · Sponsor's track record
• Sponsor's past trials: 223 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Blinding: none (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 2 (raises risk) · Design
• Maximum age: 75 (raises risk) · Who can join
• Collaborators: 0 (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 Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia NCT01854918 · started 2013 · scored riskier than 49% of active trials completed
• Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab NCT02304484 · started 2014 · scored riskier than 87% of active trials completed
• Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension NCT02867813 · started 2016 · scored riskier than 35% of active trials completed
• Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries NCT03080935 · started 2017 · scored riskier than 18% of active trials terminated
• Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin NCT01133522 · started 2010 · scored riskier than 41% 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.