An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

Model scores of the 29,894 trials active now.

Model score 24% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (269 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 2019-01-29. 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: subject hassubject issubjects withsubject mustcriteria subject
  Phrases that lowered it: adultdrugalcoholsafetyat visit
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Design: single group (raises risk) · Design
• Sponsor's past termination rate: 8.6% (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers 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
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 151 (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Blinding: none (raises risk) · Design
• Number of arms: 1 (raises risk) · Design
• Drug's FAERS reports before start: 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 Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia NCT04109950 · started 2019 · scored riskier than 57% of active trials terminated
• An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication NCT05741528 · started 2023 · scored riskier than 24% of active trials completed
• Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2). NCT03370640 · started 2017 · scored riskier than 14% of active trials completed
• A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase NCT04825860 · started 2021 · scored riskier than 25% of active trials terminated
• A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia. NCT04115319 · started 2019 · scored riskier than 55% 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.