Table 1_Real-world toxicity and discontinuation risk in ibrutinib therapy: a retrospective cohort study.docx

Neutropenia and hypertension were the most frequent severe toxicities. Dose modification occurred in 47 patients (82.5%), and permanent discontinuation occurred in 17 (29.8%). In reduced Firth penalized-likelihood models adjusted for starting-dose category, pre-existing ischemic heart disease was associated with permanent discontinuation (aOR 6.25, 95% profile-likelihood CI 1.29–39.19; p = 0.023), while creatinine clearance <60 mL/min was associated with Grade 3–5 toxicity (aOR 5.53, 95% profile-likelihood CI 1.26–38.46; p = 0.022).

A patient-level omnibus permutation test indicated a difference in adverse-event cluster distributions between the early (≤90 days) and late (>90 days) periods (p = 0.004), although an equal-window sensitivity analysis comparing days 0–90 with days 91–180 was not significant (p = 0.240).</p>Conclusion<p>Ibrutinib was associated with substantial toxicity and frequent treatment modification in routine clinical practice.

Pre-existing ischemic heart disease and impaired renal function emerged as exploratory markers of treatment vulnerability. The temporal findings support continued surveillance throughout therapy but do not establish a phase-specific monitoring strategy.</p>