A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of CHF6297 in Healthy Subjects and Patients With COPD

Model scores of the 29,894 trials active now.

Model score 6% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (45 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 2019-03-31. 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.

• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: safety tolerabilityascendingthe safetytolerability andtolerability pharmacokinetics
  Phrases that lowered it: healthyeffectmalediseasescrossover
• Sponsor's past termination rate: 2.8% (lowers risk) · Sponsor's track record
• Phase: 1/2 (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
• Blinding: quadruple (lowers risk) · Design
• Design: not given (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 72 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Number of arms: 2 (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Maximum age: 75 (raises risk) · Who can join

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.

• Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients NCT01730404 · started 2012 · scored riskier than 6% of active trials completed
• A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366 NCT03378648 · started 2017 · scored riskier than 5% of active trials completed
• A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001 NCT02386761 · started 2014 · scored riskier than 7% of active trials completed
• Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects With Moderate, Severe COPD NCT03004417 · started 2016 · scored riskier than 4% of active trials completed
• A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD NCT02986321 · started 2016 · scored riskier than 8% 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.