Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (528 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 2017-09-30. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: in subjectssubjecttransplantationmultiplesubjects with
  Phrases that lowered it: open labelvisitthe pharmacokineticsscreeningevaluate the
• Accepts healthy volunteers: No (raises risk) · Who can join
• Drug's FAERS reports marked serious: 51.7% (lowers risk) · Drug's FDA history
• Sponsor's past termination rate: 11.6% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 2.6% (lowers risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Disease area, respiratory: Yes (raises risk) · Disease area
• Sponsor's past trials: 69 (lowers risk) · Sponsor's track record
• Minimum age: 2 (lowers risk) · Who can join
• Disease area, neurology: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 10 (lowers risk) · Sponsor's track record
• Number of arms: 1 (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.

• Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation NCT01897233 · started 2013 · scored riskier than 8% of active trials completed
• Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del NCT03601637 · started 2018 · scored riskier than 16% of active trials completed
• Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation NCT01225211 · started 2010 · scored riskier than 13% of active trials completed
• A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation NCT02514473 · started 2015 · scored riskier than 9% of active trials completed
• Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease NCT02390219 · 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.