Table V.

Summary of TEAEs by cycle.

Category	Cycle 1 (N* = 88)			Cycle 2 (N = 81)			Cycle 3 (N = 77)			Cycle 4 (N = 68)
	n*	(%)	n′*	n	(%)	n′	n	(%)	n′	n	(%)	n′
Cycles with at least one
TEAE	51	(58.0)	125	44	(54.3)	74	29	(37.7)	58	22	(32.4)	44
Non-related TEAE	48	(54.5)	116	42	(51.9)	72	29	(37.7)	58	22	(32.4)	41
Drug-related TEAE†	5	(5.7)	9	2	(2.5)	2	0	(0.0)	0	3	(4.4)	3
Patients who died in the cycle	1	(1.1)		0	(0.0)		1	(1.3)		0	(0.0)
Cycles with at least one
Severe TEAE	8	(9.1)	16	6	(7.4)	7	4	(5.2)	6	1	(1.5)	2
Severe drug-related TEAE†	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0
Non-serious TEAE	50	(56.8)	111	43	(53.1)	71	29	(37.7)	51	22	(32.4)	42
Serious TEAE	9	(10.2)	14	2	(2.5)	3	5	(6.5)	7	2	(2.9)	2
Serious drug-related TEAE†	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0
TEAE leading to study discontinuation	2	(2.3)	4	0	(0.0)	0	3	(3.9)	5	0	(0.0)	0
Drug-related TEAE leading to study discontinuation†	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0	0	(0.0)	0
Serious TEAE leading to study discontinuation	2	(2.3)	2	0	(0.0)	0	2	(2.6)	2	0	(0.0)	0

TEAE, treatment-emergent adverse event.

*N, number of cycles; n, number of cycles with at least one event in the category; n′, number of events in the category. It should be noted that a patient could have had findings in more than one category, in a given cycle, and that for each cycle (1, 2, 3 and 4), N and n are also equal to the number of patients in that cycle and to the number of patients with data available in that cycle, respectively.

^†TEAEs which the investigator considered to have a possible, probable, definite, unassessable or missing (if any) relationship to study medication.