Table 2.

Reasons for Treatment Discontinuation and Adverse Events Resulting in Dose Modification Over Time

	Year 1			Year 2			Year 3			Year 4
	AP CML	BP CML	ALL	AP CML	BP CML	ALL	AP CML	BP CML	ALL	AP CML	BP CML	ALL
Reason for treatment discontinuation,a n (%)	(n = 79)	(n = 64)	(n = 24)	(n = 38)	(n = 8)	(n = 1)	(n = 19)	(n = 3)	(n = 1)	(n = 17)	(n = 2)	(n = 1)
Any reason	41 (52)	56 (88)	23 (96)	19 (50)	5 (63)	0	2 (11)	1 (33)	0	3 (18)	0	0
AE	16 (20)	2 (3)	3 (13)	4 (11)	0	0	0	1 (33)	0	1 (6)	0	0
Disease progression	10 (13)	29 (45)	10 (42)	11 (29)	3 (38)	0	0	0	0	2 (12)	0	0
Death	5 (6)	6 (9)	2 (8)	0	0	0	0	0	0	0	0	0
Symptomatic deterioration	5 (6)	6 (9)	3 (13)	1 (3)	0	0	1 (5)	0	0	0	0	0
Unsatisfactory response	3 (4)	5 (8)	5 (21)	3 (8)	0	0	0	0	0	0	0	0
Subject request	1 (1)	3 (5)	0	0	0	0	0	0	0	0	0	0
Other	1 (1)	3 (5)	0	0	1 (13)	0	1 (5)	0	0	0	0	0
Investigator request	0	0	0	0	1 (13)	0	0	0	0	0	0	0
Lost to follow‐up	0	1 (2)	0	0	0	0	0	0	0	0	0	0
Protocol violation	0	1 (2)	0	0	0	0	0	0	0	0	0	0
AEs resulting in dose modification, n (%)
Discontinuationb
Thrombocytopenia	6 (8)	0	0	0	0	0	0	0	0	0	0	0
Pericardial effusion	1 (1)	0	0	0	0	0	0	0	0	2 (12)	0	0
ALT increased	2 (3)	0	0	1 (3)	0	0	0	0	0	0	0	0
Dose interruptionc
Thrombocytopenia	20 (25)	8 (13)	0	1 (3)	0	0	0	0	0	0	0	0
Neutropenia	11 (14)	6 (9)	1 (4)	0	0	0	0	0	0	0	0	0
Anemia	7 (9)	3 (5)	0	0	0	0	0	0	0	0	0	0
ALT increased	6 (8)	1 (2)	0	0	0	0	0	0	0	0	0	0
AST increased	5 (6)	0	0	0	0	0	0	0	0	0	0	0
Leukopenia	4 (5)	4 (6)	1 (4)	0	0	0	0	0	0	0	0	0
Vomiting	4 (5)	3 (5)	2 (8)	0	0	0	0	0	0	0	0	0
Diarrhea	3 (4)	2 (3)	1 (4)	0	0	0	1 (5)	0	0	0	0	0
Nausea	3 (4)	2 (3)	0	0	0	0	0	0	0	0	0	0
Pyrexia	3 (4)	1 (2)	1 (4)	0	0	0	0	0	0	0	0	0
Rash	4 (5)	2 (3)	1 (4)	0	0	0	0	0	0	1 (7)	0	0
Dose reductionc
Thrombocytopenia	14 (18)	5 (8)	0	0	0	0	0	0	0	0	0	0
Neutropenia	5 (6)	2 (3)	0	0	0	0	0	0	0	0	0	0
Anemia	3 (4)	1 (2)	0	1 (3)	0	0	0	0	0	0	0	0
Leukopenia	3 (4)	1 (2)	0	0	0	0	0	0	0	0	0	0
AST increased	3 (4)	0	0	0	0	0	0	0	0	0	0	0
Rash	3 (4)	0	1 (4)	0	0	0	0	0	0	0	0	0

^a1 year = 48 weeks.

^bIn ≥2 patients (any cohort).

^cIn ≥3 patients (any cohort).

AE, adverse event; ALL, acute lymphoblastic leukemia; ALT, alanine aminotransferase; AP, accelerated phase; AST, aspartate aminotransferase; BP, blast phase.