Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 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 2018-02-28. 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: subjectmripainctto determine
  Phrases that lowered it: efficacythe trialsafetysubjects whoclinical
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports with a death: 22.1% (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Primary purpose: supportive care (lowers risk) · Design
• Number of arms: 2 (raises risk) · Design
• Maximum age: 75 (lowers risk) · Who can join
• Drug's FAERS reports before start: 9761 (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 85.9% (raises 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.

• Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration NCT01709747 · started 2013 · scored riskier than 43% of active trials completed
• Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain NCT04466410 · started 2021 · scored riskier than 25% of active trials terminated
• Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients NCT02321319 · started 2017 · scored riskier than 18% of active trials terminated
• 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

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.