Table 2:

Complete response and freedom from high-grade recurrence in the efficacy population

	Carcinoma in situ cohort (n=103)	High-grade Ta or T1 cohort (n=48)	All patients (n=151)
Patients with complete response at month 3*	55 (53·4%; 43·3–63·3)	35 (72·9%; 58·2–84·7)	90 (59·6%; 51·3–67·5)
Duration of complete response† or high-grade recurrence-free survival‡, months	9·69 (9·17-NE)	12·35 (6·67-NE)	7·31 (5·68–11·93)
Patients who were free from high-grade recurrence
Month 6	42 (40·8%; 31·2–50·9)	30 (62·5%; 47·4–76·0)	72 (47·7%; 39·5–56·0)
Month 9	36 (35·0%; 25·8–45·0)	28 (58·3%; 43·2–72·4)	64 (42·4%; 34·4–50·7)
Month 12	25 (24·3%; 16·4–33·7)	21 (43·8%; 29·5–58·8)	46 (30·5%; 23·2–38·5)

Data are n (%; 95% CI) or median (95% CI). NE=not estimable.

^*Patients with a complete response included all patients who had both a complete response reported by the study investigator.

^†Patients in the carcinoma in situ cohort.

^‡Patients in the high-grade Ta or T1 cohort.