Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis

Model scores of the 29,894 trials active now.

Model score 15% 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 13% of the time (1,304 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 2014-09-30. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: coronaryrandomizationtherapyscoresurgery
  Phrases that lowered it: evaluate theto evaluatemaleinvestigatorscreening
• Phase: 2 (raises risk) · Design
• Sponsor's past trials: 1179 (raises risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 7.1% (lowers risk) · Drug's FDA history
• Sponsor's past termination rate: 7.8% (raises risk) · Sponsor's track record
• Number of arms: 3 (lowers risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 146 (lowers risk) · Sponsor's track record
• Blinding: quadruple (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports before start: 21407 (lowers risk) · Drug's FDA history
• Keywords listed: 1 (raises risk) · Design
• Drug's FAERS reports marked serious: 64.7% (raises risk) · Drug's FDA history
• Maximum age: 80 (raises risk) · Who can join
• 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 Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH NCT04378010 · started 2020 · scored riskier than 51% of active trials terminated
• Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH NCT06054815 · started 2023 · scored riskier than 20% of active trials completed
• Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis NCT01899859 · started 2013 · scored riskier than 93% of active trials completed
• The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis NCT04134091 · started 2019 · scored riskier than 39% of active trials completed
• Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL) NCT02633956 · started 2015 · scored riskier than 48% 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.