Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 3% 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 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 2017-12-28. 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: tolerabilityfailureheartpatienthf
  Phrases that lowered it: open labelvisitpatients whommhgdrugs
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 13.5% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Drug's FAERS reports marked serious: 79.0% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 11.3% (lowers risk) · Drug's FDA history
• Keywords listed: 7 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past trials: 703 (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Maximum age: not given (lowers risk) · Who can join
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Responsible party: sponsor (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
• 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
• LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction NCT00887588 · started 2009 · scored riskier than 62% of active trials completed
• An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan. NCT03909295 · started 2019 · scored riskier than 38% of active trials terminated
• 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.