Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients

Model scores of the 29,894 trials active now.

Model score 8% 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 12% of the time (118 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 2015-11-30. 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: mutationlungpatientskeywomen
  Phrases that lowered it: healthykgindexbody massinclusive
• Sponsor's past termination rate: 13.2% (raises risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 286 (raises risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Phase: 1/2 (raises risk) · Design
• Blinding: triple (raises risk) · Design
• Number of arms: 20 (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past trials: 410 (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• 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.

• 28 Day Repeat Dose in Cystic Fibrosis Patients NCT00903201 · started 2009 · scored riskier than 27% of active trials completed
• A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis NCT02951195 · started 2016 · scored riskier than 12% of active trials completed
• Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis NCT03140527 · started 2017 · scored riskier than 6% of active trials completed
• A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF) NCT02953314 · started 2016 · scored riskier than 11% of active trials completed
• A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis NCT03029455 · started 2016 · scored riskier than 6% 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.