Summary of treatment-emergent AEs (safety population)
| AEs, n (%) | Placebo (n=235) | Belimumab 10 mg/kg (n=470) |
| Any AE | 178 (75.7) | 352 (74.9) |
| Treatment-related AE* | 55 (23.4) | 136 (28.9) |
| SAE | 43 (18.3) | 58 (12.3) |
| Severe AE | 25 (10.6) | 39 (8.3) |
| SAE and/or severe AE | 47 (20.0) | 64 (13.6) |
| AE resulting in study agent discontinuation | 22 (9.4) | 29 (6.2) |
| Death | 1 (0.4) | 0 (0.0) |
| AEs by preferred term†, ‡ | ||
| Upper respiratory tract infection | 39 (16.6) | 65 (13.8) |
| Nasopharyngitis | 26 (11.1) | 56 (11.9) |
| Pyrexia | 21 (8.9) | 30 (6.4) |
| Viral upper respiratory tract infection | 15 (6.4) | 34 (7.2) |
| Cough | 16 (6.8) | 30 (6.4) |
| Diarrhoea | 14 (6.0) | 28 (6.0) |
| Herpes zoster | 12 (5.1) | 29 (6.2) |
| Headache | 16 (6.8) | 23 (4.9) |
| Urinary tract infection | 11 (4.7) | 21 (4.5) |
| Upper respiratory tract infection bacterial | 13 (5.5) | 16 (3.4) |
| Abdominal pain | 8 (3.4) | 17 (3.6) |
| Urinary tract infection bacterial | 2 (0.9) | 20 (4.3) |
| Abdominal pain upper | 6 (2.6) | 15 (3.2) |
| Dizziness | 7 (3.0) | 14 (3.0) |
| Nausea | 4 (1.7) | 17 (3.6) |
| Hypokalaemia | 8 (3.4) | 11 (2.3) |
| Oropharyngeal pain | 10 (4.3) | 7 (1.5) |
| Lupus nephritis | 7 (3.0) | 7 (1.5) |
| AESIs | ||
| Malignant neoplasms | 0 | 1 (0.2) |
| Post-infusion systemic reactions§ | 29 (12.3) | 61 (13.0) |
| Serious | 1 (0.4) | 0 |
| Infections of special interest | 20 (8.5) | 36 (7.7) |
| Depression¶ | 6 (2.6) | 9 (1.9) |
| Completed suicide** | 0 | 0 |
| Suicide attempts and ideation†† | 1 (0.4)‡‡ | 1 (0.2)§§ |
*Considered by the investigator to be at least possibly related to study agent.
†Patients were only counted once per MedDRA preferred term.
‡In ≥3% patients in either treatment group.
§Per anaphylactic reaction CMQ broad search.
¶Per MedDRA preferred term.
**As per GSK adjudication.
††Per standard MedDRA query.
‡‡This was recorded as a suicide attempt.
§§This was recorded as suicidal ideation.
AE, adverse event; AESI, adverse event of special interest; CMQ, customised MedDRA query; GSK, GlaxoSmithKline; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event.