A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Model scores of the 29,894 trials active now.

Model score 28% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (528 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 2019-05-02. 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: chroniclong termextensionterm safetythe long
  Phrases that lowered it: patients whomgto evaluateevaluate thedaily
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 14.4% (raises risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Sponsor's past trials: 891 (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Design: single group (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Disease area, dermatology: Yes (raises risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 195 (lowers risk) · Sponsor's track record
• Disease area, respiratory: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Collaborators: 0 (raises risk) · Design
• Keywords listed: 8 (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Number of arms: 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.

• Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU NCT02477332 · started 2015 · scored riskier than 90% of active trials completed
• An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU NCT04109313 · started 2019 · scored riskier than 87% of active trials completed
• Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab NCT04210843 · started 2020 · scored riskier than 59% of active trials terminated
• Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU) NCT03437278 · started 2018 · scored riskier than 51% of active trials completed
• A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study NCT03693625 · started 2018 · scored riskier than 35% 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.