Table 3.

Treatment-emergent AEs of clinical interest grade ≥3: incidence rates in cycles 1 and 2

	Blinatumomab, N = 267		SOC, N = 109
	Cycle 1, n = 267	Cycle 2, n = 151	Cycle 1, n = 109	Cycle 2, n = 28
Any AE	202 (76)	56 (37)	98 (90)	20 (71)
Cytokine release syndrome	11 (4)	1 (1)	0	0
Cytokine release syndrome	8 (3)	1 (1)	0	0
Hematophagic histiocytosis	3 (1)	0	0	0
Cytokine storm	0	0	0	0
Tumor lysis syndrome	8 (3)	0	1 (1)	0
Acute pancreatitis	1 (<1)	0	0	1 (4)
Neurologic events	19 (7)	4 (3)	9 (8)	1 (4)
Headache	1 (<1)	0	3 (3)	0
Insomnia	1 (<1)	0	0	0
Tremor	1 (<1)	0	0	0
Dizziness	1 (<1)	0	0	0
Somnolence	3 (1)	0	0	0
Seizure	2 (1)	0	3 (3)	0
Gastrointestinal disorders	11 (4)	3 (2)	12 (11)	3 (11)
Diarrhea	2 (1)	1 (1)	1 (1)	0
Nausea	0	0	3 (3)	0
Constipation	0	0	0	0
Vomiting	0	0	0	1 (4)
Stomatitis	0	2 (1)	2 (2)	0
Abdominal pain	3 (1)	0	2 (2)	1 (4)
Dyspepsia	0	0	0	0
Infections	61 (23)	17 (11)	52 (48)	8 (29)
Cytopenias	118 (44)	24 (16)	74 (68)	17 (61)
Febrile neutropenia	52 (19)	5 (3)	36 (33)	9 (32)
Neutropenia	28 (10)	14 (9)	28 (26)	7 (25)
Thrombocytopenia	37 (14)	0	29 (27)	9 (32)
Decreased platelets	10 (4)	1 (1)	11 (10)	3 (11)
Decreased white blood cells	10 (4)	2 (1)	5 (5)	1 (4)
Decreased neutrophils	7 (3)	1 (1)	9 (8)	5 (18)
Leukopenia	8 (3)	2 (1)	4 (4)	1 (4)
Decreased lymphocytes	2 (1)	0	4 (4)	0
Lymphopenia	1 (<1)	0	0	0
Elevated liver enzymes	32 (12)	2 (1)	14 (13)	3 (11)
Progressive multifocal leukoencephalopathy	1 (<1)	0	0	0
Decreased immunoglobulins	0	3 (2)	0	0
Other AEs of interest
Pyrexia	15 (6)	2 (1)	4 (4)	1 (4)
Anemia	51 (19)	1 (1)	37 (34)	9 (32)

Values are n (%).