Table 2

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-related8 (29.6)11 (30.6)463 (34.2)1019 (36.2)
 Resulting in drug discontinuation1 (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-related2 (2.4)3 (4.1)56 (2.8)81 (4.0)
 Resulting in drug discontinuation6 (7.3)4 (5.4)57 (2.8)60 (3.0)
SAEs by MedDRA system organ class¶
 Cardiac disorders0 (0.0)1 (2.8)20 (1.5)28 (1.0)3 (3.7)1 (1.4)12 (0.6)16 (0.8)
 Gastrointestinal disorders1 (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 conditions1 (3.7)1 (2.8)23 (1.7)34 (1.2)0 (0.0)0 (0.0)10 (0.5)5 (0.2)
 Hepatobiliary disorders0 (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 infestations1 (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 complications1 (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 disorders0 (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 disorders0 (0.0)4 (11.1)19 (1.4)42 (1.5)0 (0.0)0 (0.0)16 (0.8)14 (0.7)
 Psychiatric disorders2 (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 disorders0 (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 disorders1 (3.7)0 (0.0)19 (1.4)30 (1.1)0 (0.0)0 (0.0)19 (0.9)9 (0.4)
 Vascular disorders0 (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.