A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery

Model scores of the 29,894 trials active now.

Model score 6% 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 13% of the time (1,304 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 2009-03-31. 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: Yes (lowers risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: patientgreater thanpainoxygenliver
  Phrases that lowered it: evaluatescheduledtabletstudysafety
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Has a data monitoring committee: not given (lowers risk) · Design
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 3 (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 14.2% (lowers risk) · Drug's FDA history
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Maximum age: 80 (raises risk) · Who can join
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports marked serious: 90.6% (raises risk) · Drug's FDA history
• Drug's FAERS reports before start: 288 (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.

• A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement NCT00612534 · started 2008 · scored riskier than 12% of active trials completed
• A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery NCT02542384 · started 2015 · scored riskier than 11% of active trials completed
• An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement NCT00859313 · started 2009 · scored riskier than 7% of active trials completed
• A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure NCT00894699 · started 2009 · scored riskier than 9% of active trials completed
• Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures NCT01819610 · started 2013 · scored riskier than 10% 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.