Table 3.

Adverse events in low complement/anti-dsDNA-positive subgroup

AE	Placebo (n=287)	Belimumab 1 mg/kg (n=284)	Belimumab 10 mg/kg (n=305)
≥1 AE, %	92	92	93
≥1 Serious AE, %	15	21	20
≥1 Serious infection, %	7	8	5
≥1 Severe AE, %*	14	16	17
≥1 Serious and/or severe AE, %	20	25	26
≥1 AE resulting in discontinuation, %	9	7	8
Deaths, n (%)†	1 (<1)	2 (<1)	3 (<1)

^*Severe refers to grades 3 (severe: causing inability to perform usual activities) and 4 (life-threatening: potentially life-threatening or disabling, with significant medical intervention required).

^†The primary causes of death were: unknown with placebo; unknown and sepsis with belimumab 1 mg/kg; and cardiac arrest, acute infective diarrhoea and respiratory insufficiency with belimumab 10 mg/kg.

AE, adverse event.