Treatment-emergent AEs, SAEs and severe AEs in older adults and the overall populations
| At least one event, n (%)† | Pooled safety analysis population* | BASE | ||||||
| Older adults (N=63) | Overall (N=4170) | Older adults (N=156) | Overall (n=4003) | |||||
| PBO N=27 | BEL N=36 | PBO N=1355 | BEL N=2815 | PBO N=82 | BEL N=74 | PBO N=2001 | BEL N=2002 | |
| AEs‡ | 24 (88.9) | 28 (77.8) | 1184 (87.4) | 2440 (86.7) | – | – | – | – |
| Study drug-related | 8 (29.6) | 11 (30.6) | 463 (34.2) | 1019 (36.2) | – | – | – | – |
| Resulting in drug discontinuation | 1 (3.7) | 3 (8.3) | 109 (8.0) | 184 (6.5) | – | – | – | – |
| SAEs§ | 5 (18.5) | 10 (27.8) | 230 (17.0) | 421 (15.0) | 9 (11.0) | 6 (8.1) | 222 (11.1) | 220 (11.0) |
| Study drug-related | – | – | – | – | 2 (2.4) | 3 (4.1) | 56 (2.8) | 81 (4.0) |
| Resulting in drug discontinuation | – | – | – | – | 6 (7.3) | 4 (5.4) | 57 (2.8) | 60 (3.0) |
| SAEs by MedDRA system organ class¶ | ||||||||
| Cardiac disorders | 0 (0.0) | 1 (2.8) | 20 (1.5) | 28 (1.0) | 3 (3.7) | 1 (1.4) | 12 (0.6) | 16 (0.8) |
| Gastrointestinal disorders | 1 (3.7) | 1 (2.8) | 26 (1.9) | 45 (1.6) | 1 (1.2) | 2 (2.7) | 19 (0.9) | 18 (0.9) |
| General disorders and administration site conditions | 1 (3.7) | 1 (2.8) | 23 (1.7) | 34 (1.2) | 0 (0.0) | 0 (0.0) | 10 (0.5) | 5 (0.2) |
| Hepatobiliary disorders | 0 (0.0) | 1 (2.8) | 8 (0.6) | 18 (0.6) | 0 (0.0) | 0 (0.0) | 8 (0.4) | 5 (0.2) |
| Infections and infestations | 1 (3.7) | 2 (5.6) | 80 (5.9) | 151 (5.4) | 5 (6.1) | 2 (2.7) | 82 (4.1) | 75 (3.7) |
| Injury, poisoning and procedural complications | 1 (3.7) | 0 (0.0) | 13 (1.0) | 31 (1.1) | 0 (0.0) | 0 (0.0) | 8 (0.4) | 14 (0.7) |
| Musculoskeletal and connective tissue disorders | 0 (0.0) | 1 (2.8) | 28 (2.1) | 48 (1.7) | 1 (1.2) | 1 (1.4) | 24 (1.2) | 9 (0.4) |
| Nervous system disorders | 0 (0.0) | 4 (11.1) | 19 (1.4) | 42 (1.5) | 0 (0.0) | 0 (0.0) | 16 (0.8) | 14 (0.7) |
| Psychiatric disorders | 2 (7.4) | 0 (0.0) | 6 (0.4) | 16 (0.6) | 0 (0.0) | 1 (1.4) | 6 (0.3) | 20 (1.0) |
| Renal and urinary disorders | 0 (0.0) | 1 (2.8) | 30 (2.2) | 48 (1.7) | 0 (0.0) | 0 (0.0) | 16 (0.8) | 11 (0.5) |
| Respiratory, thoracic and mediastinal disorders | 1 (3.7) | 0 (0.0) | 19 (1.4) | 30 (1.1) | 0 (0.0) | 0 (0.0) | 19 (0.9) | 9 (0.4) |
| Vascular disorders | 0 (0.0) | 3 (8.3) | 16 (1.2) | 29 (1.0) | 0 (0.0) | 0 (0.0) | 4 (0.2) | 10 (0.5) |
| Severe AEs‡** | 7 (25.9) | 8 (22.2) | 209 (15.4) | 377 (13.4) | – | – | – | – |
| Severe SAEs§** | – | – | – | – | 7 (8.5) | 4 (5.4) | 101 (5.0) | 99 (4.9) |
*Pooled data from all studies except BASE.
†Patients only counted once per category.
‡Only data on SAEs and AESI were collected for BASE.
§SAE subcategory data were not summarised for the pooled safety analysis population.
¶Experienced by ≥1.5% of patients in any treatment group.
**Severe or life-threatening.
AE, adverse event; AESI, adverse event of special interest; BEL, belimumab; MedDRA, Medical Dictionary for Regulatory Activities; PBO, placebo; SAE, serious adverse event.