Exposure–safety analysis
neutropenia, diarrhea, rash, nausea,, Cancer
ADVERSE EVENT, NEUTROPENIA, THROMBOCYTOPENIA, EVENTS, CANCER
In the exposure‐response analysis of key safety outcomes, the risks of eight prespecified AEs selected for their clinical relevance were investigated (diarrhea, nausea, vomiting, rash, elevated alanine aminotransferase [ALT], elevated aspartate aminotransferase [AST], thrombocytopenia, and neutropenia). AEs were captured as ordered events graded on a 5‐point scale (0–4), with 0 representing no AE and 4 representing the most severe grade of AE. AEs were based on the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), using the scale applicable at the time of each study. No Grade 5 AEs were observed in any of the studies. Only the first occurrence of the highest‐grade AE within the first year of bosutinib treatment was included in the analysis. The analysis did not account for patients who dropped out. For each of the eight prespecified AEs, bosutinib 