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

Journal of Patient-Reported Outcomes

Table 2 CR-diarrhea, PR-diarrhea and PK assessment schedules

Week	Pre-screening	Week, treatment period													Follow-up
Week	0	1	2	3	4–6	7–9	10–12	13–15	16–18	19–21	22–24	25–27	28–30	31–33	33+
Cycle*/Day		C1/D1	C1/D8	C1/D15	C2/D1	C3/D1	C4	C5/D1	C6/D1	C7	C8	C9	C10	C11
CTCAE	X	X	X	X	X	X	X	X	X	X		X		X	X
PRO-CTCAE		X^a	X	X	X, X, X	X, X, X	X, X, X	X, X, X	X, X, X	X	X	X	X	X	X
PK Plasma		Pre-dose (± 5 min) 1 h (± 5 min) 2 h (± 10 min) 4 h (± 10 min) 6 h (± 10 min) 8 h (± 10 min)			Pre-dose (± 5 min)	Pre-dose (± 5 min) 1 h (± 5 min) 2 h (± 10 min) 4 h (± 10 min) 6 h (± 10 min) 8h (± 10 min) 10 h (± 10 min) 12 h (± 1 h) 24 h (± 1 h)