Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets

Model scores of the 29,894 trials active now.

Model score 20% 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 10% of the time (1,463 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 2014-08-31. 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) (raises risk) · Wording Phrases that raised it: extensionpainopioidcompletedterm safety
  Phrases that lowered it: visitsafety oftabletsto evaluatedeviation from
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 12.7% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 29 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Design: single group (raises risk) · Design
• Drug's FAERS reports with a death: 22.3% (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports before start: 16903 (lowers risk) · Drug's FDA history
• Sponsor's past trials: 79 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 73.5% (lowers risk) · Drug's FDA history
• Number of arms: 1 (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Maximum age: 80 (raises risk) · Who can join
• Blinding: none (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.

• Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time NCT01223365 · started 2010 · scored riskier than 56% of active trials completed
• Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time NCT01240863 · started 2010 · scored riskier than 62% of active trials completed
• Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain NCT01789970 · started 2013 · scored riskier than 27% of active trials completed
• Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period. NCT01400139 · started 2011 · scored riskier than 56% of active trials completed
• A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet NCT01769677 · started 2013 · scored riskier than 2% 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.