Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

Model scores of the 29,894 trials active now.

Model score 23% 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 15% of the time (734 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 2018-02-07. 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: placebopfheartin subjectscardiac
  Phrases that lowered it: efficacygenotype20safetypresence
• Sponsor's past termination rate: 15.9% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past trials: 1319 (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Phase: 3 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Blinding: quadruple (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 3 (lowers risk) · Design
• Maximum age: 90 (lowers risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 220 (raises risk) · Sponsor's track record
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Drug's FAERS reports in the prior 12 months: 4 (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 100% (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.

• Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy NCT02791230 · started 2016 · scored riskier than 38% of active trials completed
• Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy NCT03860935 · started 2019 · scored riskier than 85% of active trials completed
• A Phase 3 Study of ALXN2060 in Japanese Participants With Symptomatic ATTR-CM NCT04622046 · started 2020 · scored riskier than 80% of active trials completed
• ENDEAVOUR: Phase 3 Multicenter Study of Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) NCT02319005 · started 2014 · scored riskier than 69% of active trials completed
• Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NTLA-2001 in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy (ATTRv-PN) and Patients With Transthyretin Amyloidosis-Related Cardiomyopathy (ATTR-CM) NCT04601051 · started 2020 · scored riskier than 44% 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.