Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation

Model scores of the 29,894 trials active now.

Model score 2% for any early termination, 0% 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 2010-11-30. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: womendoublesmallbowelof childbearing
  Phrases that lowered it: single dosebioavailabilityhealthyopen labelvolunteers
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Design: crossover (lowers risk) · Design
• Phase: 2 (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 343 (raises risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor's past termination rate: 7.5% (lowers risk) · Sponsor's track record
• Sponsor's past trials: 876 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Blinding: none (lowers risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises 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.

• An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis NCT02189252 · started 2014 · scored riskier than 6% of active trials completed
• Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions NCT02359045 · started 2015 · scored riskier than 0% of active trials completed
• Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) NCT02859129 · started 2013 · scored riskier than 2% of active trials completed
• The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects NCT01486433 · started 2011 · scored riskier than 1% of active trials completed
• Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals NCT01431690 · started 2011 · scored riskier than 4% 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.