A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

Model scores of the 29,894 trials active now.

Model score 8% 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 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 2013-08-31. 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: mg dltherapyuncontrolledacutemg day
  Phrases that lowered it: pharmacokineticsinteractiondrugsafetyatorvastatin
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: quadruple (lowers risk) · Design
• Drug's FAERS reports with a death: 8.5% (lowers risk) · Drug's FDA history
• Maximum age: 80 (lowers risk) · Who can join
• Drug's FAERS reports marked serious: 70.6% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 17099 (raises risk) · Drug's FDA history
• Sponsor's past trials: 4 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Number of arms: 2 (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record

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 of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance NCT01751984 · started 2012 · scored riskier than 12% of active trials completed
• A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg NCT02659397 · started 2015 · scored riskier than 11% of active trials completed
• Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia NCT00741715 · started 2008 · scored riskier than 7% of active trials terminated
• Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy NCT02072161 · started 2014 · scored riskier than 13% of active trials completed
• Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension NCT02178098 · started 2014 · scored riskier than 8% 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.