Safety Study of Afatinib for Brain Cancer

Model scores of the 29,894 trials active now.

Model score 26% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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 2021-08-31. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: brainradiationsafecancerto determine
  Phrases that lowered it: pharmacokineticand safetyefficacy andsafety ofthe efficacy
• Phase: 1 (lowers risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Responsible party: sponsor investigator (raises risk) · Design
• Disease area, cancer: Yes (raises risk) · Disease area
• Drug's FAERS reports with a death: 24.8% (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Disease area, neurology: Yes (raises risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Has a data monitoring committee: No (lowers risk) · Design
• Number of arms: 1 (raises risk) · Design
• Collaborators: 1 (raises risk) · Design
• Drug's FAERS reports before start: 2293 (raises risk) · Drug's FDA history
• Sponsor's past trials: 0 (raises risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 85.8% (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.

• Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC NCT03711422 · started 2018 · scored riskier than 57% of active trials terminated
• Cambridge Brain Mets Trial 1 NCT02768337 · started 2015 · scored riskier than 74% of active trials terminated
• Afatinib (BIBW 2992) QTcF Trial in Patients With Relapsed or Refractory Solid Tumours NCT00875433 · started 2009 · scored riskier than 69% of active trials completed
• A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations NCT01647711 · started 2012 · scored riskier than 37% of active trials completed
• Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas NCT02343406 · started 2015 · scored riskier than 81% 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.