A Safety and Tolerability Study of Denufosol in 2-4 Year Olds

Model scores of the 29,894 trials active now.

Model score 19% 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 (528 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 2010-10-31. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: to randomizationacutenewpediatricmedical condition
  Phrases that lowered it: evaluate theto evaluatenasalrespiratorymg
• Sponsor's past termination rate: 16.5% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Has a data monitoring committee: Yes (raises risk) · Design
• Phase: 2 (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 228 (raises risk) · Sponsor's track record
• Sponsor's past trials: 711 (raises risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Blinding: double (raises risk) · Design
• 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
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 2 (lowers risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Maximum age: 4 (raises risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Disease area, respiratory: Yes (raises risk) · Disease area

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.

• Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease NCT00625612 · started 2008 · scored riskier than 51% of active trials completed
• Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF NCT01840735 · started 2013 · scored riskier than 22% of active trials completed
• An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis NCT03229252 · started 2017 · scored riskier than 9% of active trials completed
• Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642) NCT00846781 · started 2009 · scored riskier than 51% of active trials terminated
• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor NCT02347657 · started 2015 · scored riskier than 7% 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.