BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis

Model scores of the 29,894 trials active now.

Model score 25% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 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 2016-01-31. 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) (raises risk) · Wording Phrases that raised it: progressionrandomizationsclerosisprogressiveuncontrolled
  Phrases that lowered it: to investigateparticipantseffect ofthe effectmultiple
• Sponsor's past termination rate: 16.9% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Drug's FAERS reports marked serious: 15.5% (lowers risk) · Drug's FDA history
• Phase: 3 (lowers risk) · Design
• Blinding: triple (raises risk) · Design
• Drug's FAERS reports with a death: 0.7% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 51 (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Disease area, neurology: Yes (raises risk) · Disease area
• Drug's FAERS reports in the prior 12 months: 15845 (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Sponsor's past trials: 178 (lowers risk) · Sponsor's track record
• Collaborators: 0 (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.

• BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis NCT01156311 · started 2010 · scored riskier than 96% of active trials completed
• BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) NCT00835770 · started 2009 · scored riskier than 99% of active trials completed
• Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012 NCT02579681 · started 2014 · scored riskier than 84% of active trials completed
• An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) NCT01838668 · started 2013 · scored riskier than 74% of active trials completed
• Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants NCT03870763 · started 2019 · scored riskier than 63% of active trials terminated

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.