Table 2.
Total and most frequent adverse events stratified by age
| AE, n (%) | Patients < 65 years (n = 575) | Patients ≥ 65 years (n = 372) |
|---|---|---|
| Any AE | 392 (68.2) | 250 (67.2) |
| Gastrointestinal AE | 54 (9.4) | 25 (6.7) |
| Cardiovascular AE | 19 (3.3) | 12 (3.2) |
| Application-site dermatitis | 50 (8.7) | 49 (13.2) |
| TEAEs reported in ≥3% of either age group | ||
| Headache | 110 (19.1) | 57 (15.3) |
| Arthralgia | 77 (13.4) | 55 (14.8) |
| Back pain | 64 (11.1) | 47 (12.6) |
| Nasopharyngitis | 46 (8.0) | 21 (5.6) |
| Upper respiratory tract infection | 43 (7.5) | 11 (3.0) |
| Pain in extremity | 33 (5.7) | 26 (7.0) |
| Pain | 27 (4.7) | 8 (2.2) |
| Influenza | 27 (4.7) | 7 (1.9) |
| Sinusitis | 26 (4.5) | 9 (2.4) |
| Toothache | 18 (3.1) | 4 (1.1) |
| Sinus congestion | 18 (3.1) | 1 (0.3) |
| Myalgia | 17 (3.0) | 9 (2.4) |
| Neck pain | 10 (1.7) | 13 (3.5) |
Abbreviations: AE, adverse event; TEAE, treatment-emergent adverse event.