Table 4.

Summary of long-term safety

Long-term safety		3th year	4th year	5th year	>6th year
New AE with RX> 24 mos	Total No of pts on RX	60	53	50	41
All grades	Patients, n (%)	10 (17)	6 (11)	5 (10)	10 (24)
	Events, n	13	14	10	18
Grade 1 – 2	Patients, n (%)	6 (60)	2 (33)	4 (80)	9 (90)
	Events, n (%)	9 (69)	10 (71)	9 (90)	17 (94)
Grade 3	Patients, n (%)	4 (40)	4 (67)	1 (20)	1 (10)
	Events, n (%)	4 (31)	4 (29)	1 (10)	1 (6)
Grade 4	Patients, n (%)		1 (17)	2 (40)	1 (10)
	Events, n (%)		1 (7)	2 (20)	1 (6)
Deaths on Study	Patients, n (%)				1 (6)

^*Grade 4 toxicities occurred only in patients with ET.