An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan.

Model scores of the 29,894 trials active now.

Model score 14% 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 10% of the time (1,463 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 2019-11-19. 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: heartfractionejectionpatientfailure
  Phrases that lowered it: japaneseopen labelinvestigatorjudgedpatients who
• Sponsor's past termination rate: 15.1% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 11.1% (lowers risk) · Drug's FDA history
• Sponsor's past trials: 1225 (raises risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 65.1% (lowers risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 157 (lowers risk) · Sponsor's track record
• Minimum age: 50 (lowers risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports before start: 159026 (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 in the prior 12 months: 38372 (lowers risk) · Drug's FDA history
• Blinding: none (lowers 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.

• This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure NCT01035255 · started 2009 · scored riskier than 59% of active trials terminated
• Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction NCT02468232 · started 2015 · scored riskier than 39% 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
• Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure NCT00913653 · started 2009 · scored riskier than 48% of active trials completed
• Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction NCT01920711 · started 2014 · scored riskier than 50% 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.