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Journal of Patient-Reported Outcomes
Fig. 3 | Journal of Patient-Reported Outcomes

Fig. 3

From: Use of patient-reported outcomes (PRO) data to complement exposure–response analysis in early clinical cancer drug development

Fig. 3

A Time to event analysis of ER for CR-diarrhea. B Time to event analysis of ER for PR-diarrhea. Cumulative probability of time-to event for A CR-diarrhea or B PR-diarrhea after the first dose of study drug by Kaplan–Meier analysis in the 120-patient subgroup. Patients were grouped by AUCs median for Kaplan–Meier analysis of time-to-event cumulative probability. The occurrence of any grade CR-diarrhea (CTCAE) or PR-diarrhea (LWS ≥ 3) (frequent or almost constant) was considered an event, and patients with no event were censored and hatch-marked (+) in the plot. Log rank testing did not reveal a robust difference between AUCs median groups from CR-diarrhea (CTCAE) (p = 0.6). Log rank testing revealed that the AUCs-upper-median group showed a trend of higher PR-diarrhea (LWS ≥ 3) probability at early stages of treatment, compared to the AUCs-lower-median group (p = 0.08)

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