Table 2.

AEs of special interest during the TFR phase.

	Consolidation phase N = 86	First 48 weeks of TFR N = 86	Second 48 weeks of TFR N = 86	Third 48 weeks of TFR N = 86	Fourth 48 weeks of TFR N = 86	Fifth 48 weeks of TFR N = 86
Adverse event of special interest group	All grades, n (%)	All grades, n (%)	All grades, n (%)	All grades, n (%)	All grades, n (%)	All grades, n (%)
Total	27 (31.4)	41 (47.7)	19 (22.1)	6 (7.0)	13 (15.1)	9 (10.5)
Blood cholesterol increased	3 (3.5)	4 (4.7)	1 (1.2)	1 (1.2)	1 (1.2)	0
Blood glucose increased	0	1 (1.2)	2 (2.3)	1 (1.2)	1 (1.2)	1 (1.2)
Cardiac failure	0	1 (1.2)	0	0	0	0
Cardiovascular events	4 (4.7)	2 (2.3)	1 (1.2)	2 (2.3)	0	2 (2.3)
Ischemic cerebrovascular events	1 (1.2)	1 (1.2)	0	0	0	0
Ischemic heart disease	1 (1.2)	0	1 (1.2)	1 (1.2)	0	2 (2.3)
Peripheral arterial occlusive disease	1 (1.2)	1 (1.2)	0	1 (1.2)	0	0
Fluid retention	3 (3.5)	3 (3.5)	4 (4.7)	0	4 (4.7)	3 (3.5)
Edema and other fluid retentions	2 (2.3)	3 (3.5)	4 (4.7)	0	4 (4.7)	3 (3.5)
Severe	1 (1.2)	0	0	0	0	0
Hepatotoxicity	2 (2.3)	2 (2.3)	1 (1.2)	0	2 (2.3)	2 (2.3)
Drug-induced liver injury	0	1 (1.2)	1 (1.2)	0	0	0
Total transaminase activity and bilirubin elevations	2 (2.3)	1 (1.2)	0	0	2 (2.3)	2 (2.3)
Musculoskeletal pain	14 (16.3)	36 (41.9)	8 (9.3)	3 (3.5)	5 (5.8)	4 (4.7)
Myelosuppression (Thrombocytopenia)	1 (1.2)	0	0	0	0	0
Pancreatitis, lipase, and amylase elevations	1 (1.2)	0	0	0	0	0
Rash	5 (5.8)	0	2 (2.3)	0	2 (2.3)	0
Significant bleeding	0	0	1 (1.2)	0	0	0
Gastrointestinal hemorrhage	0	0	1 (1.2)	0	0	0
CNS hemorrhage	0	0	0	0	0	0

For patients remaining in TFR > 3.7 years.

AE, adverse event; CNS, central nervous system; TFR, treatment-free remission.