Table 3.

Severity of adverse events (AEs) according to CTCAE v. 3.0

Severity of AEs	Cohort 1	Cohort 2	Cohort 3	Cohort 4
	n (%)	n (%)	n (%)	n (%)
1	200 (60.2)	113 (56.8)	120 (47.6)	88 (55.7)
2	117 (35.2)	70 (35.2)	101 (40.1)	60 (38.0)
3	15 (4.5)	15 (7.5)	28 (11.1)	9 (5.7)
4	0	1 (0.5)	3 (1.2)	0
5	0	0	0	1 (0.6)

Chi-squared test between severity of adverse events (CTCAE v. 3.0 grade 1–2/>2) and fertile/postmenopausal women, p = 0.0005

Chi-squared test between severity of adverse events and fertile women/matched men and postmenopausal women/matched men, respectively, not significant

Percentages are computed from the number of adverse events that occurred in each patient cohort

CTCAE common technology criteria for adverse events