Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

Model scores of the 29,894 trials active now.

Model score 15% 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 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 2012-05-31. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 14.8% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 397 (raises risk) · Sponsor's track record
• Sponsor's past trials: 854 (raises risk) · Sponsor's track record
• Primary purpose: supportive care (lowers risk) · Design
• Drug's FAERS reports with a death: 24.4% (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: painsubject hasopioidcancersubject is
  Phrases that lowered it: moderateto severesubjectsperiodsafety
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Blinding: none (lowers risk) · Design
• Drug's FAERS reports in the prior 12 months: 7299 (lowers risk) · Drug's FDA history
• Drug's FAERS reports before start: 35088 (lowers risk) · Drug's FDA history

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
• Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain NCT01358526 · started 2011 · scored riskier than 37% 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
• OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients NCT02880475 · started 2014 · scored riskier than 4% of active trials completed
• A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects NCT02391571 · started 2015 · scored riskier than 17% 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.