Table 2.

Summary of Grade 3, 4, or 5 Adverse Events.

Adverse Event	Midostaurin Group (N = 355)	Placebo Group (N = 354)	P Value*
	no. of patients (%)
Hematologic
Thrombocytopenia	346 (97)	342 (97)	0.52
Neutropenia	338 (95)	339 (96)	0.86
Anemia	329 (93)	311 (88)	0.03
Leukopenia	93 (26)	105 (30)	0.32
Lymphopenia	68 (19)	78 (22)	0.35
Other blood or bone marrow event	1 (<1)	4 (1)	0.22
Bone marrow hypocellularity	0	1 (<1)	0.50
Nonhematologic
Febrile neutropenia	290 (82)	292 (82)	0.84
Infection	186 (52)	178 (50)	0.60
Lymphopenia	68 (19)	78 (22)	0.35
Diarrhea	56 (16)	54 (15)	0.92
Hypokalemia	49 (14)	60 (17)	0.25
Pain	47 (13)	44 (12)	0.82
Increased alanine aminotransferase	45 (13)	33 (9)	0.19
Rash or desquamation	50 (14)	27 (8)	0.008
Fatigue	32 (9)	37 (10)	0.53
Pneumonitis or pulmonary infiltrates	28 (8)	29 (8)	0.89
Nausea	20 (6)	34 (10)	0.05
Hyponatremia	31 (9)	23 (6)	0.32
Hyperbilirubinemia	25 (7)	28 (8)	0.67
Mucositis or stomatitis	22 (6)	28 (8)	0.38
Hypophosphatemia	19 (5)	29 (8)	0.14
Hypocalcemia	24 (7)	21 (6)	0.76

^*P values are two-sided and were calculated with the use of Fisher's exact test.