Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (381 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 2014-02-28. 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: hearttherapyfailureventricularcardiac
  Phrases that lowered it: screeningplacebotypeareamale
• Accepts healthy volunteers: No (raises risk) · Who can join
• Minimum age: 21 (lowers risk) · Who can join
• Sponsor's past termination rate: 21.7% (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 10.8% (lowers risk) · Drug's FDA history
• Collaborators: 2 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: quadruple (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 62.6% (lowers risk) · Drug's FDA history
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Disease area, respiratory: Yes (raises risk) · Disease area
• Sponsor's past trials: 23 (lowers risk) · Sponsor's track record
• Drug's FAERS reports before start: 10369 (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.

• Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study) NCT00763867 · started 2008 · scored riskier than 84% of active trials completed
• Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2) NCT01970176 · started 2014 · scored riskier than 65% of active trials completed
• Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Diastolic Cardiomyopathy (Aim3) NCT02058095 · started 2014 · scored riskier than 64% of active trials completed
• Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) NCT03904693 · started 2019 · scored riskier than 54% of active trials completed
• Ranolazine in Diastolic Heart Failure NCT01163734 · started 2010 · scored riskier than 48% 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.