Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration

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 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 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: painopioidchronicivsubject has
  Phrases that lowered it: safety ofsubjects whoto evaluateevaluate thethe trial
• Phase: 3 (lowers risk) · Design
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports with a death: 22.2% (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 1 (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports in the prior 12 months: 2293 (lowers risk) · Drug's FDA history
• Drug's FAERS reports before start: 10490 (raises risk) · Drug's FDA history
• 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.

• Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration NCT01709721 · started 2013 · scored riskier than 58% of active trials completed
• 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
• Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets NCT01922739 · started 2013 · scored riskier than 70% of active trials completed
• 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
• 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

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.