Table 2.

Adverse events by treatment regimen

Doublet TAG-AZA (n = 19)	n (%)
Event term	Grade 2	Grade 3	Grade 4	Grade 5	Total, grade 2+
ALT increased	6 (31.6)	4 (21.1)			10 (52.6)
CLS	7 (36.8)	2 (10.5)			9 (47.3)
Febrile neutropenia		7 (36.8)			7 (36.8)
Neutrophil count decreased	1 (5.3)		5 (26.3)		6 (31.6)
Platelet count decreased	1 (5.3)	2 (10.5)	3 (15.8)		6 (31.6)
White blood cell decreased	1 (5.3)	2 (10.5)	3 (15.8)		6 (31.6)
Hypotension	4 (21.1)	2 (10.5)			6 (31.6)
Blood bilirubin increased		4 (21.1)			4 (21.1)
Lung infection	1 (5.3)		2 (10.5)		3 (15.8)
Anemia	1 (5.3)	2 (10.5)			3 (15.8)
Hypophosphatemia	1 (5.3)	2 (10.5)			3 (15.8)
Back pain	1 (5.3)	2 (10.5)			3 (15.8)
Infections and infestations - other		2 (10.5)			2 (10.5)
Lymphocyte count decreased		2 (10.5)			2 (10.5)
Hypocalcemia		2 (10.5)			2 (10.5)
Hypoxia		2 (10.5)			2 (10.5)

Triplet TAG-AZA-VEN (n = 37)
Event term	Grade 2	Grade 3	Grade 4	Grade 5	Total, grade 2+
Platelet count decreased	2 (5.4)	2 (5.4)	17 (45.9)		21 (56.8)
White blood cell decreased		1 (2.7)	17 (45.9)		18 (48.6)
Neutrophil count decreased			14 (37.8)		14 (37.8)
Anemia	1 (2.7)	10 (27)	1 (2.7)		12 (32.4)
Febrile neutropenia	1 (2.7)	9 (24.3)	1 (2.7)		11 (29.7)
Infections and infestations - other	2 (5.4)	6 (16.2)			8 (21.7)
CLS	5 (13.5)	1 (2.7)	1 (2.7)		7 (18.9)
Lymphocyte count decreased			5 (13.5)		5 (13.5)
Tumor lysis syndrome	1 (2.7)	4 (10.8)			5 (13.5)
Sepsis		1 (2.7)	1 (2.7)	2 (5.4)	4 (10.8)

Displayed are any terms that occurred as grade 3 or higher in 10% or more of patients in either the doublet or triplet regimens, with the incidence of grade 2 to 5 events shown for each term. Additionally, all CLS events are shown. CTCAE v4.0 does not define any CLS as grade 1; the lowest possible is grade 2. AEs in this table are listed regardless of attribution as treatment-related or not treatment-related. Grade 5 events of disease progression are not included.

CTCAE, Common Terminology Criteria for Adverse Events.