Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers

Model scores of the 29,894 trials active now.

Model score 6% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 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 2020-12-07. 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: ulndlserumplacebo controlledtolerability
  Phrases that lowered it: healthyvolunteerspharmacokineticsdrugpharmacokinetic
• Sponsor's past termination rate: 16.9% (raises risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 5.6% (lowers risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 67.5% (lowers risk) · Drug's FDA history
• Number of arms: 3 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 9 (lowers risk) · Sponsor's track record
• Sponsor's past trials: 77 (lowers 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.

• Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects NCT04158102 · started 2019 · scored riskier than 1% of active trials completed
• 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
• PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery NCT02985762 · started 2016 · scored riskier than 40% of active trials completed
• Efficacy, Safety, and Pharmacokinetics of Femoral Nerve Block With EXPAREL in Total Knee Arthroplasty NCT02713178 · started 2016 · scored riskier than 22% of active trials completed
• Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy NCT04002089 · started 2019 · scored riskier than 14% 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.