Table 1.
Frequency of common AEs in all patients exposed to GA40 during the OLE a .
| ES (n = 943, PY = 4169.7) |
DS (n = 419, PY = 1549.2) |
All (N = 1362, PY = 5718.8) |
|
| Total patients with serious AEs, n (%) | 117 (12) | 36 (9) | 153 (11) |
| Total patients with any AEs, n (%) | 777 (82) | 322 (77) | 1099 (81) |
| Influenza, n (%) | 68 (7) | 25 (6) | 93 (7) |
| Bronchitis, n (%) | 51 (5) | 20 (5) | 71 (5) |
| Nasopharyngitis, n (%) | 167 (18) | 56 (13) | 223 (16) |
| Upper respiratory tract infections, n (%) | 98 (10) | 32 (8) | 130 (10) |
| Urinary tract infection, n (%) | 105 (11) | 36 (9) | 141 (10) |
| Back pain, n (%) | 99 (10) | 33 (8) | 132 (10) |
| Headache, n (%) | 132 (14) | 39 (9) | 171 (13) |
| Total patients with injection-site reactions, n (%) | 378 (40) | 162 (39) | 540 (40) |
| Injection-site erythema, n (%) | 252 (27) | 116 (28) | 368 (27) |
| Injection-site pain, n (%) | 115 (12) | 55 (13) | 170 (12) |
| Injection-site pruritus, n (%) | 68 (7) | 23 (5) | 91 (7) |
| Injection-site swelling, n (%) | 50 (5) | 24 (6) | 74 (5) |
| Injection-site atrophy, n (%) | 20 (2) | 10 (2) | 30 (2) |
AE: adverse event; DS: delayed start; ES: early start; GA40: glatiramer acetate 40 mg/mL subcutaneous injection administered three times weekly; OLE: open-label extension; PY: patient-years.
a
Individual AEs reported here (Medical Dictionary for Regulatory Activities preferred term) are those occurring in >5% of patients exposed to GA40 at any time during the OLE, with the exception of injection-site atrophy. Injection-site atrophy (categorical term) includes injection-site atrophy, injection-site lipoatrophy, and injection-site lipodystrophy acquired.