Long-term Open-Label Safety Study to Evaluate EN3409

Model scores of the 29,894 trials active now.

Model score 11% 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 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 2014-11-30. 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.

• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: painacutechronicsubjects withto severe
  Phrases that lowered it: evaluate theto evaluateper dayscreeningvital signs
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports with a death: 12.3% (lowers risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 93.4% (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Maximum age: not given (lowers risk) · Who can join
• Drug's FAERS reports before start: 6239 (raises risk) · Drug's FDA history
• Keywords listed: 9 (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record

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.

• Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain NCT01298765 · started 2011 · scored riskier than 15% 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
• Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain NCT02367820 · started 2015 · scored riskier than 38% 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
• Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain NCT01428583 · started 2010 · scored riskier than 39% 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.