Table 2.
Frequency and incidence of treatment-emergent adverse events (incidence ⩾ 2%), immediate post-injection reactions (incidence ⩾ 2%), and injection-site reactions (incidence ⩾ 5%).
| TEAE MedDRA preferred term | GA (N and PY) | |
|---|---|---|
| N = 232, PY = 3088.2 | ||
| Events, n | Participants, n (%) | |
| Participants with at least one TEAE leading to study discontinuation | 101 | 38 (16.4) |
| Injection-site erythema | 8 | 8 (3.4) |
| Injection-site pain | 7 | 6 (2.6) |
| Injection-site swelling | 5 | 5 (2.2) |
| Pregnancy | 8 | 5 (2.2) |
| Participants with at least one serious TEAE | 329 | 87 (37.5) |
| Urinary tract infection | 11 | 9 (3.9) |
| Chest pain | 10 | 7 (3.0) |
| Dehydration | 9 | 7 (3.0) |
| Uterine leiomyoma | 7 | 6 (2.6) |
| Back pain | 6 | 5 (2.2) |
| Depression | 10 | 5 (2.2) |
| IPIR combination of categories | N = 232, PY = 2845.9 | |
| Cases, n | Participants, n (%) | |
| Participants with ⩾ 1 IPIR | 174 | 55 (23.7) |
| Chest pain, vasodilatation (flushing) | 23 | 16 (6.9) |
| Chest pain, dyspnea, vasodilatation (flushing) | 20 | 14 (6.0) |
| Dyspnea, vasodilatation (flushing) | 18 | 13 (5.6) |
| Chest pain, dyspnea | 9 | 7 (3.0) |
| Palpitations, vasodilatation (flushing) | 9 | 7 (3.0) |
| ISR MedDRA preferred term | N = 232, PY = 2845.9 | |
| Events, n | Participants, n (%) | |
| Participants with ⩾ 1 ISR | 2059 | 202 (87.1) |
| Erythema | 352 | 152 (65.5) |
| Pain | 315 | 133 (57.3) |
| Mass | 370 | 81 (34.9) |
| Pruritis | 265 | 75 (32.3) |
| Swelling | 202 | 69 (29.7) |
| Hemorrhage | 73 | 30 (12.9) |
| Induration | 77 | 45 (19.4) |
| Urticaria | 76 | 37 (15.9) |
| Reaction | 28 | 19 (8.2) |
| Inflammation | 23 | 14 (6.0) |
| Warmth | 23 | 21 (9.1) |
| Bruising | 68 | 34 (14.7) |
GA: glatiramer acetate; PY: patient-years of study; TEAE: treatment-emergent adverse event; MedDRA: Medical Dictionary for Regulatory Activities; IPIR: immediate post-injection reaction; ISR: injection-site reaction. TEAEs leading to study discontinuation were those classified in “action taken with the study treatment” attribute as “drug withdrawn.” IPIRs were defined as at least two or more symptoms occurring immediately after injection that include the following symptoms: vasodilatation (flushing), chest pain, palpitations, anxiety, dyspnea, constriction of the throat (laryngospasm), and urticaria.