Table 4.

Summary of AEs by treatment phase

	Induction phase (n = 42)	Consolidation phase (n = 42)	Follow-up phase (n = 42)	Overall (N = 42)
Patients with any AE, n (%)	42 (100.0)	28 (66.7)	12 (28.6)	42 (100.0)
Grade 3-4 AE, n (%)	28 (66.7)	14 (33.3)	7 (16.7)	32 (76.2)
Neutropenia	19 (45.2)	4 (9.5)	1 (2.4)
Febrile neutropenia	5 (11.9)	1 (2.4)	0 (0.0)
Anemia	3 (7.1)	0 (0.0)	1 (2.4)
Leukopenia	2 (4.8)	0 (0.0)	0 (0.0)
Fatigue	2 (4.8)	0 (0.0)	0 (0.0)
Lipase increased	2 (4.8)	3 (7.1)	0 (0.0)
Syncope	1 (2.4)	2 (4.8)	0 (0.0)
AE leading to any study treatment discontinuation, n (%)	6 (14.3)	9 (21.4)	0 (0.0)	15 (35.7)
SAE, n (%)	11 (26.2)	5 (11.9)	5 (11.9)	18 (42.9)