Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease

Model scores of the 29,894 trials active now.

Model score 24% 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 14% of the time (493 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 2019-10-23. 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: long termterm safetythe longextensionheart
  Phrases that lowered it: participantparticipantsevaluate theto evaluatehealth
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 18 (lowers risk) · Sponsor's track record
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Collaborators: 0 (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
• Sponsor type: industry (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.

• Open-Label Phase 3 Long-Term Safety Study of Migalastat NCT01458119 · started 2011 · scored riskier than 60% of active trials terminated
• Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease NCT04049760 · started 2019 · scored riskier than 51% of active trials completed
• Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease NCT01196871 · started 2011 · scored riskier than 24% of active trials completed
• Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years) NCT03500094 · started 2018 · scored riskier than 16% of active trials completed
• Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease NCT00925301 · started 2009 · scored riskier than 35% 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.