Safety of Polyphenon E in Multiple Sclerosis Pilot Study

Model scores of the 29,894 trials active now.

Model score 26% for any early termination, 7% 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 (201 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2010-11-30. 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) (raises risk) · Wording Phrases that raised it: mri000heartmslimit
  Phrases that lowered it: open labelparticipantssafetythe studystudy or
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Disease area, neurology: Yes (raises risk) · Disease area
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Responsible party: principal investigator (lowers risk) · Design
• Maximum age: 65 (lowers risk) · Who can join
• Number of arms: 1 (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Disease area, immunology: Yes (raises risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Collaborators: 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.

• Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II NCT01451723 · started 2011 · scored riskier than 89% of active trials terminated
• Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck NCT01116336 · started 2010 · scored riskier than 96% of active trials completed
• Sunphenon in Progressive Forms of Multiple Sclerosis NCT00799890 · started 2009 · scored riskier than 64% of active trials completed
• Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach NCT02008721 · started 2014 · scored riskier than 21% of active trials completed
• Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis NCT06083753 · started 2023 · scored riskier than 91% 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.