An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (280 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 2009-02-28. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: chronicacutenonpriorsubjects
  Phrases that lowered it: solidmentalsubjects whoto evaluateevaluate the
• Design: crossover (lowers risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Primary purpose: diagnostic (lowers risk) · Design
• Collaborators: 3 (lowers risk) · Design
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 9.3% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Responsible party: not given (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 2 (raises risk) · Design
• Blinding: none (raises risk) · Design
• Drug's FAERS reports marked serious: 74.3% (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 Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI) NCT00676702 · started 2008 · scored riskier than 6% of active trials completed
• Viokase 16, Viokase16 Plus Nexium and Nexium Alone NCT01142128 · started 2009 · scored riskier than 13% of active trials terminated
• A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) NCT00788593 · started 2008 · scored riskier than 18% of active trials completed
• Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis NCT00630279 · started 2008 · scored riskier than 35% of active trials terminated
• A Phase IIa Study With Escalating Dose of MS1819-SD NCT03481803 · started 2017 · scored riskier than 35% 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.