Safety and Tolerability of BI 409306 in Patients With Schizophrenia

Model scores of the 29,894 trials active now.

Model score 12% 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 7% of the time (289 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 2013-12-05. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 4.3% (lowers risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: dsmscoreschizophreniapatientsymptoms
  Phrases that lowered it: bipharmacokineticsmoderatedays14
• Has a data monitoring committee: not given (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 134 (lowers risk) · Sponsor's track record
• Phase: 1 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Number of arms: 4 (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 185 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, neurology: No (lowers risk) · Disease area
• Maximum age: 55 (raises risk) · Who can join
• Responsible party: sponsor (lowers risk) · Design
• Drug's FAERS reports with a death: no FAERS history (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 Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment. NCT02281773 · started 2014 · scored riskier than 28% of active trials completed
• This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year NCT03230097 · started 2017 · scored riskier than 27% of active trials terminated
• Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia NCT02832037 · started 2016 · scored riskier than 30% of active trials completed
• This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months NCT03351244 · started 2017 · scored riskier than 18% of active trials terminated
• A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia NCT05326347 · started 2022 · scored riskier than 20% 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.