Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL

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 10% of the time (1,463 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-09-24. 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) (lowers risk) · Wording Phrases that raised it: surgeryundergoingsubjects withthe subjecttype
  Phrases that lowered it: the pharmacokineticssafety ofand safetyvisitaged
• Sponsor's past termination rate: 17.1% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Has a data monitoring committee: Yes (raises risk) · Design
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 6.2% (lowers risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 4 (lowers risk) · Design
• Drug's FAERS reports marked serious: 71.2% (lowers risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 9 (lowers risk) · Sponsor's track record
• Blinding: none (lowers risk) · Design
• Maximum age: 17 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 70 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Minimum age: 6 (lowers risk) · Who can join

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 in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL NCT03485014 · started 2018 · scored riskier than 4% of active trials completed
• PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery NCT02985762 · started 2016 · scored riskier than 40% of active trials completed
• Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers NCT04173611 · started 2020 · scored riskier than 7% of active trials terminated
• Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries NCT04518462 · started 2020 · scored riskier than 14% of active trials completed
• Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery NCT02713230 · started 2016 · scored riskier than 29% 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.