Data Sheet 1_Treatment context is associated with thrombocytopenia report phenotypes in lung cancer: an active-comparator analysis of FAERS and JADER.docx

Relative to C1, adjusted odds ratios (ORs) for immune-like versus marrow-like phenotype were 0.111 (95% CI, 0.069–0.173) in C2 and 0.014 (0.006–0.029) in C3; C3 was exploratory because only eight reports were immune-like. In 2,835 broad cohort reports, adjusted immune-like composition was 13.0% (95% bootstrap interval, 11.0%–15.1%) in C1 and 4.7% (3.4%–6.2%) in C2. Treatment date and stricter phenotype analyses were directionally consistent.

JADER reproduced the C2 versus C1 direction but showed calibration shift; treatment-variable ablation reduced cross-database discrimination. Reviewers agreed on 111/120 reports (92.5%; 95% CI, 87.5%–96.7%; Cohen’s κ, 0.897; Gwet’s AC1, 0.901). In the locked 927-report frame, design-weighted final categories were 23.4% immune probable, 37.3% immune possible, 13.6% indeterminate, and 25.8% non-immune probable.

Among 100 determinate reports, weighted AUROC was 0.892 (0.827–0.948), PR-AUC 0.956 (0.922–0.982), and calibration-in-the-large intercept 2.054 (1.707–2.432), indicating underprediction.</p>Conclusion<p>Coding-defined thrombocytopenia report composition differed across treatment contexts. Blinded review supported reproducible structured category assignment and score-based report ordering, while calibration shift and treatment-variable ablation defined important limits.

Findings support pharmacovigilance case prioritization and hypothesis generation, not clinical diagnosis, incidence estimation, patient-level etiologic attribution, or causal inference.</p>