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.