There was a positive trend towards exposure-response for PFS [ 113 ].
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For larotrectinib, no relationship between exposure and toxicity was described in the approval report ( n = 66); in exposure-toxicity analyses for entrectinib there is a weak trend between higher exposure and frequency of serious AEs, although this was not significant after correction for gender in the analysis ( n = 263).
FMS-like Tyrosine Kinase 3 Receptor (FLT3) Inhibitors For midostaurin, lower exposure showed a trend towards increased risk of death in patients with acute myeloid leukemia in combination with daunorubicin and cytarabine, but this was not statistically significant, as described in the approval report ( n = 360) [ 101 ].