Table 6.
Treatment-emergent serious adverse events by body system (>1% in any group) for 24-week to 30-week randomized comparator-controlled trials14–21
| System | Incidence, n (%) (preferred terms)
|
||||
|---|---|---|---|---|---|
| Pooled exenatide QW (n=1,934) |
Pooled exenatide BID (n=606) |
Pooled non-GLP-1RA comparators (n=1,338) |
Exenatide QW (n=461) |
Liraglutide QD (n=450) |
|
| Cardiac disorders | 8 (0.4%) | 4 (0.7%) | 9 (0.7%) | 1 (0.2%) | 2 (0.4%) |
| Gastrointestinal disorders | 9 (0.5%) | 2 (0.3%) | 8 (0.6%) | 3 (0.7%) | 2 (0.4%) |
| General disorders and administration site conditions | 1 (<0.1%) | 2 (0.3%) | 7 (0.5%) | 0 (0.0%) | 1 (0.2%) |
| Hepatobiliary disorders | 5 (0.3%) | 2 (0.3%) | 6 (0.4%) | 2 (0.4%) | 0 (0.0%) |
| Infections and infestations | 12 (0.6%) | 2 (0.3%) | 12 (0.9%) | 2 (0.4%) | 0 (0.0%) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 5 (0.3%) | 0 (0.0%) | 4 (0.3%) | 2 (0.4%) | 0 (0.0%) |
| Nervous system disorders | 6 (0.3%) | 1 (0.2%) | 6 (0.4%) | 0 (0.0%) | 1 (0.2%) |
Abbreviations: BID, twice daily; GLP-1RA, glucagon-like peptide-1 receptor agonist; QD, once daily; QW, once weekly.