The Safety of Vardenafil in Patients Undergoing Cardiac Surgery

Model scores of the 29,894 trials active now.

Model score 10% for any early termination, 7% 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 (141 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 2011-10-31. 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.

• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cardiacthe purposepurpose ofpriorpast
  Phrases that lowered it: safety ofevaluate theto evaluateundergoingpatients
• Drug's FAERS reports with a death: 8.6% (lowers risk) · Drug's FDA history
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Responsible party: not given (raises risk) · Design
• Design: single group (raises risk) · Design
• Drug's FAERS reports marked serious: 72.4% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Has a data monitoring committee: No (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Number of arms: 1 (raises risk) · Design
• Drug's FAERS reports before start: 257 (raises 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 to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery NCT02136329 · started 2013 · scored riskier than 78% of active trials completed
• Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose NCT01543555 · started 2012 · scored riskier than 37% of active trials completed
• Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass NCT02025621 · started 2014 · scored riskier than 92% of active trials completed
• Dexmedetomidine and Outcomes of Cardiac Surgery (DOCS) NCT02237495 · started 2014 · scored riskier than 20% of active trials completed
• Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery NCT01352416 · started 2010 · scored riskier than 53% of active trials terminated

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.