Bilastine Updosing - Characterization of Underlying Mechanisms

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 13% of the time (1,012 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 2011-12-31. 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.

• Design: crossover (lowers risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: placebochronicto assessassess thedouble blind
  Phrases that lowered it: 20and safetysafety ofdaythe efficacy
• Sponsor's past termination rate: 7.7% (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Phase: 2/3 (raises risk) · Design
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 55 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Disease area, dermatology: Yes (raises risk) · Disease area
• Blinding: double (raises risk) · Design
• Sponsor's past trials: 52 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Collaborators: 1 (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 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.

• Bilastine Updosing in Chronic Spontaneous Urticaria NCT02213367 · started 2014 · scored riskier than 49% of active trials completed
• Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients NCT04439955 · started 2020 · scored riskier than 78% of active trials completed
• A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines NCT03580369 · started 2018 · scored riskier than 29% of active trials completed
• Study to Assess Efficacy, Safety and Mechanism of Rupatadine in Cold Urticaria NCT01605487 · started 2012 · scored riskier than 22% of active trials completed
• A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. NCT03580356 · started 2018 · scored riskier than 18% 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.