Summary of AEs reported during the study
| N (%)* | Placebo (n=40) | Belimumab 10 mg/kg intravenous (n=53) |
| AEs by system organ class, any† | 33 (82.5) | 42 (79.2) |
| Infections and infestations | 28 (70.0) | 30 (56.6) |
| Gastrointestinal disorders | 16 (40.0) | 18 (34.0) |
| Musculoskeletal and connective tissue disorders | 13 (32.5) | 11 (20.8) |
| Nervous system disorders | 11 (27.5) | 12 (22.6) |
| Skin and subcutaneous tissue disorders | 9 (22.5) | 10 (18.9) |
| General disorders and administration site conditions | 9 (22.5) | 9 (17.0) |
| SAEs by system organ class and preferred term, any‡ | 14 (35.0) | 9 (17.0) |
| Infections and infestations | 5 (12.5) | 4 (7.5) |
| Herpes zoster | 1 (2.5) | 1 (1.9) |
| Abscess limb | 0 | 1 (1.9) |
| Epiglottitis | 1 (2.5) | 0 |
| Gastroenteritis | 0 | 1 (1.9) |
| Hepatitis A | 1 (2.5) | 0 |
| Influenza | 1 (2.5) | 0 |
| Pneumonia | 1 (2.5) | 0 |
| Vulvar abscess | 0 | 1 (1.9) |
| Renal and urinary disorders | 3 (7.5) | 2 (3.8) |
| Lupus nephritis | 2 (5.0) | 2 (3.8) |
| Glomerulonephritis | 1 (2.5) | 0 |
| Psychiatric disorders§ | 3 (7.5) | 0 |
| Major depression | 1 (2.5) | 0 |
| Suicidal ideation | 1 (2.5) | 0 |
| Suicide attempt | 1 (2.5) | 0 |
| Deaths¶ | 1 (2.5) | 0 |
| AEs of special interest | ||
| All malignancies | 0 | 0 |
| All post-infusion systemic reactions | 3 (7.5) | 4 (7.5) |
| Serious post-infusion systemic reactions | 0 | 0 |
| Systemic reactions hypersensitivity | 0 | 0 |
| All infections of special interest** | 3 (7.5) | 7 (13.2) |
| Serious infections of special interest | 1 (2.5) | 1 (1.9) |
| Depression/suicide††/self-injury | 4 (10) | 1 (1.9) |
| Depression | 2 (5) | 1 (1.9) |
| Serious depression | 1 (2.5) | 0 |
| Suicide††/self-injury | 3 (7.5) | 0 |
| Serious suicide/self-injury | 2 (5) | 0 |
†*Number of patients experiencing an event (a patient can experience ≥1 event); †AEs by system organ class that occurred in >20% of patients in either treatment group are listed;
‡SAEs by system organ class that occurred in >5% of patients in either treatment group are listed;
§Psychiatric disorders included: anger, anxiety, initial insomnia, insomnia, major depression, panic reaction, suicidal ideation, suicide attempt and trichotillomania;
¶Acute pancreatitis; considered unrelated to the study agent;
**Infections of special interest included: candida infection, herpes zoster and pulmonary tuberculosis;
††Includes suicide ideation and behaviour.
AE, adverse event; SAE, serious AE.