Similar to the findings from the ER analysis from the original NDA, the ER analysis using PR-diarrhea assessed by PRO-CTCAE showed a trend of increasing probability of diarrhea (LWS ≥ 3) frequency with increasing steady state exposure (AUCs) (Fig. 2 B).
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Use of patient-reported outcomes (PRO) data to complement exposure-response analysis in early clinical cancer drug development.
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