Table 5.

Incidence of Newly Occurring Serious AEs, any Causality Over Time^a

	Year 1			Year 2			Year 3			Year 4
	AP CML (n = 79)	BP CML (n = 64)	ALL (n = 24)	AP CML (n = 34)	BP CML (n = 5)	ALL (n = 1)	AP CML (n = 19)	BP CML (n = 3)	ALL (n = 1)	AP CML (n = 15)	BP CML (n = 2)	ALL (n = 1)
Any AE,b n (%)	36 (46)	37 (58)	18 (75)	10 (29)	1 (20)	0	3 (16)	1 (33)	0	5 (33)	0	0
Thrombocytopenia	6 (8)	1 (2)	3 (13)	0	0	0	0	0	0	0	0	0
General physical health deterioration	1 (1)	3 (5)	2 (8)	0	0	0	0	0	0	0	0	0
Anemia	5 (6)	1 (2)	0	0	0	0	0	0	0	0	0	0
Febrile neutropenia	1 (1)	4 (6)	4 (17)	0	0	0	0	0	0	0	0	0
Leukocytosis	1 (1)	2 (3)	2 (8)	0	0	0	0	0	0	0	0	0
Nausea	0	5 (8)	1 (4)	0	0	0	0	0	0	0	0	0
Vomiting	0	4 (6)	1 (4)	0	0	0	0	0	0	0	0	0
Disease progression	5 (6)	3 (5)	1 (4)	0	0	0	0	0	0	0	0	0
Pyrexia	4 (5)	6 (9)	1 (4)	0	0	0	0	0	0	0	0	0
Pneumonia	6 (8)	5 (8)	3 (13)	3 (9)	0	0	0	0	0	0	0	0
Headache	4 (5)	2 (3)	2 (8)	0	0	0	0	0	0	0	0	0
Pleural effusion	3 (4)	2 (3)	1 (4)	0	0	0	1 (5)	0	0	1 (7)	0	0
Respiratory failure	1 (1)	2 (3)	2 (8)	0	0	0	0	0	0	0	0	0

^aNewly occurring serious AEs refers to those not experienced by the same patient in previous years for patients on‐treatment during that specific year (1 year = 365.25 days).

^bIn ≥5 patients in the safety population (n = 167) in year 1, or in ≥2 patients in years 2, 3, or 4.

AE, adverse event; AP, accelerated phase; CML, chronic myeloid leukemia; BP, blast phase; ALL, acute lymphoblastic leukemia.