An Open-label Extension Study To Evaluate Safety Of PF-06252616 In Boys With Duchenne Muscular Dystrophy

Model scores of the 29,894 trials active now.

Model score 42% 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 19% of the time (731 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 2018-11-22. 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) (raises risk) · Wording Phrases that raised it: subjectslong termterm safetythe longextension
  Phrases that lowered it: safety ofmalepharmacokineticsrangepharmacokinetic
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 16.1% (raises risk) · Sponsor's track record
• Sponsor's past trials: 1616 (raises risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• 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
• Trials the sponsor started in the prior 2 years: 155 (lowers risk) · Sponsor's track record
• Maximum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Design: not given (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Collaborators: 0 (raises risk) · Design
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Keywords listed: 1 (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history

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.

• A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 in Duchenne Muscular Dystrophy NCT02310763 · started 2014 · scored riskier than 73% of active trials terminated
• Phase IIb Study of PRO045 in Subjects With Duchenne Muscular Dystrophy NCT01826474 · started 2013 · scored riskier than 42% of active trials terminated
• Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy NCT01540409 · started 2012 · scored riskier than 98% of active trials completed
• Phase I/II Study of PRO044 in Duchenne Muscular Dystrophy (DMD) NCT01037309 · started 2009 · scored riskier than 76% of active trials completed
• An Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability Deflazacort NCT02295748 · started 2014 · scored riskier than 40% 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.