A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Model scores of the 29,894 trials active now.

Model score 12% 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 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 2019-07-17. 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: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports marked serious: 58.0% (lowers risk) · Drug's FDA history
• Sponsor's past termination rate: 10.5% (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: 2.6% (lowers risk) · Drug's FDA history
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: the subjectthe safetycompletedlong termopinion of
  Phrases that lowered it: visitand safetysafety ofto evaluateevaluate the
• Design: single group (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 22 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 2 (lowers risk) · Who can join
• Disease area, respiratory: Yes (raises risk) · Disease area
• Disease area, neurology: No (lowers risk) · Disease area
• Sponsor's past trials: 76 (lowers risk) · Sponsor's track record

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.

• Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor NCT02544451 · started 2015 · scored riskier than 24% of active trials completed
• A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis NCT01931839 · started 2013 · scored riskier than 17% of active trials completed
• Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation NCT04235140 · started 2020 · scored riskier than 20% of active trials completed
• Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation NCT01707290 · started 2013 · scored riskier than 15% of active trials completed
• A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation NCT02565914 · started 2015 · scored riskier than 16% 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.