Single-Dose Study of a New Formulation of BIIB061

Model scores of the 29,894 trials active now.

Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (544 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 2015-08-31. 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) (lowers risk) · Wording Phrases that raised it: tolerabilitydefinednewthe safetymonths after
  Phrases that lowered it: healthyvolunteersformulationthe pharmacokineticmale
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Sponsor's past termination rate: 17.3% (raises risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Minimum age: 20 (lowers risk) · Who can join
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 53 (lowers risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past trials: 179 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Blinding: none (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Maximum age: 55 (lowers risk) · Who can join
• Responsible party: sponsor (lowers 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.

• Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers NCT02228707 · started 2014 · scored riskier than 8% of active trials completed
• Single Ascending Doses of BIIB063 in Healthy Volunteers NCT02555085 · started 2015 · scored riskier than 3% of active trials terminated
• Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect NCT02071121 · started 2013 · scored riskier than 9% of active trials completed
• Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes NCT02833142 · started 2016 · scored riskier than 3% of active trials completed
• Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Participants NCT03454126 · started 2018 · scored riskier than 11% 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.