Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (493 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 2023-12-29. 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: termsubjectheartfailureaminotransferase
  Phrases that lowered it: evaluatevisitdrugstrialthe investigator
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 15.1% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 11.1% (lowers risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 65.1% (lowers risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Sponsor's past trials: 1224 (raises risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 158 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports before start: 159026 (lowers risk) · Drug's FDA history
• Maximum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 1 (lowers risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Collaborators: 0 (raises risk) · Design

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 Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study NCT06149104 · started 2023 · scored riskier than 25% of active trials completed
• Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure NCT02678312 · started 2016 · scored riskier than 69% of active trials completed
• Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age NCT01365481 · started 2011 · scored riskier than 30% of active trials completed
• Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction NCT02226120 · started 2014 · scored riskier than 39% of active trials completed
• Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload NCT03255226 · started 2018 · scored riskier than 10% 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.