Table 3.

TEAE and Laboratory Abnormalities in the Double-Blind Treatment Period

	450 mg Q4W
	Tafolecimab (n = 205)	Placebo (n = 98)
Adverse events
Any TEAE	85 (41.5)	53 (54.1)
TESAE	5 (2.4)	4 (4.1)
Leading to treatment discontinuation	1 (0.5)	1 (1.0)
Deaths	0	0
Adverse events >1% of patients receiving tafolecimab
Urinary tract infection	12 (5.9)	4 (4.1)
Hyperuricemia	7 (3.4)	4 (4.1)
Upper respiratory tract infection	6 (2.9)	3 (3.1)
Toothache	6 (2.9)	1 (1.0)
Weight decreased	5 (2.4)	2 (2.0)
Arthralgia	5 (2.4)	0
Hepatic function abnormal	3 (1.5)	2 (2.0)
Protein urine present	3 (1.5)	1 (1.0)
Blood uric acid increased	3 (1.5)	0
Adverse events of special interest	6 (2.9)	5 (5.1)
Hypersensitivitya	2 (1.0)	1 (1.0)
Injection site reactionb	2 (1.0)	1 (1.0)
Alanine aminotransferase increasedc	0	0
Liver damaged	0	0
Muscle eventse	2 (1.0)	3 (3.1)
Laboratory results
n	204	98
AST >3× ULN (any post-baseline value)	0	0
Creatine kinase >3 × ULN (any post-baseline value)	0	2 (2.0)
Total bilirubin >2 × ULN (any post-baseline value)	1 (0.5)	0

Values are n (%).

ALT = alanine aminotransferase; AST = aspartate aminotransferase; DILI = drug-induced liver injury; Q4W = every 4 weeks; TEAE = treatment-emergent adverse events; ULN = upper limit of normal.

^aAcute onset within minutes to hours: cutaneous and/or mucosal symptoms (angioedema, urticaria, eczema), respiratory symptoms (dyspnea, wheezing, bronchospasm), hypotension (SBP <90 mm Hg or >30% decrease from baseline),

^bSymptoms such as swelling, flushing, ecchymosis, pruritus, induration, pain at the injection site.

^cALT 3 × ULN if baseline was normal; ALT >2 × baseline if baseline >ULN.

^dRefer to the 2015 Chinese Society of Hepatology guideline for the basic conditions and severity grading of DILI.

^eMuscle pain, muscle aches, muscle stiffness, muscle tenderness, muscle cramps, muscle weakness, or flulike symptoms.