Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients

Model scores of the 29,894 trials active now.

Model score 9% 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 20% of the time (389 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 2017-07-17. 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: diagnosis ofacuteto determinecriteria diagnosis13
  Phrases that lowered it: evaluate theto evaluateefficacypharmacokineticsige
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Design: single group (raises risk) · Design
• Minimum age: 2 (lowers risk) · Who can join
• Has a data monitoring committee: No (lowers risk) · Design
• Maximum age: 13 (raises risk) · Who can join
• Primary purpose: treatment (raises 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
• Blinding: none (raises risk) · Design
• Number of arms: 1 (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Collaborators: 0 (raises risk) · Design
• Disease area, cardiovascular: Yes (raises risk) · Disease area

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.

• Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks NCT01188564 · started 2011 · scored riskier than 9% of active trials completed
• CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema NCT05819775 · started 2023 · scored riskier than 12% of active trials completed
• A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration NCT00851409 · started 2009 · scored riskier than 41% of active trials completed
• CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 NCT01095510 · started 2010 · scored riskier than 16% of active trials completed
• A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor NCT02247739 · started 2014 · scored riskier than 9% 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.