Table 4.

Serious adverse events and critical safety end points in the APPLE trial^*

	Atorvastatin (n = 113)	Placebo (n = 108)
Death	1 (0.9)	0 (0.0)
Serious adverse events
All events	34 (30.1)	40 (37.0)
Infections	15 (13.3)	14 (13.0)
Musculoskeletal and connective tissue disorders	11 (9.7)	9 (8.3)
Psychiatric disorders	4 (3.5)	5 (4.6)
Nervous system disorders	1 (0.9)	6 (5.6)
Renal and urinary disorders	3 (2.7)	3 (2.8)
Gastrointestinal disorders	3 (2.7)	2 (1.9)
Skin and subcutaneous tissue disorders	2 (1.8)	3 (2.8)
Blood and lymphatic system disorders	2 (1.8)	2 (1.9)
General disorders and administration site conditions	1 (0.9)	2 (1.9)
Metabolism and nutrition disorders	1 (0.9)	2 (1.9)
Pregnancy, puerperium, and perinatal complications	3 (2.7)	0 (0.0)
Vascular disorders	1 (0.9)	2 (1.9)
Cardiac disorders	1 (0.9)	1 (0.9)
Congenital, familial, and genetic disorders	1 (0.9)	1 (0.9)
Hepatobiliary disorders	1 (0.9)	1 (0.9)
Immune system disorders	0 (0.0)	2 (1.9)
Neoplasms (benign, malignant, and unspecified, including cysts and polyps)	0 (0.0)	2 (1.9)
Respiratory, thoracic, and mediastinal disorders	2 (1.8)	0 (0.0)
CK elevation requiring investigation	1 (0.9)	0 (0.0)
Critical safety end points†
Muscle toxicity	29 (26.1)	33 (30.6)
Myositis	14 (12.5)	9 (8.3)
Rhabdomyolysis	0 (0.0)	0 (0.0)
CK >3 times the upper limit of normal	5 (4.5)	7 (6.5)
Myalgia	16 (14.3)	20 (18.5)
Muscle weakness	6 (5.4)	4 (3.7)
Liver toxicity	27 (24.1)	20 (18.7)
Neurotoxicity	27 (24.1)	32 (29.6)

^*There were no significant differences between the 2 groups. APPLE = Atherosclerosis Prevention in Pediatric Lupus Erythematosus.

^†Data on muscle toxicity were available for 111 patients in the atorvastatin group. Data on myositis, rhabdomyolysis, creatine kinase (CK) level, myalgia, muscle weakness, liver toxicity, and neurotoxicity were available for 112 patients in the atorvastatin group. Data on liver toxicity were available for 107 patients in the placebo group.