Table 2.
Adverse events in double-blind and open-label part (safety population).
| Adverse events in double-blind part,a n (%) of patients | GTR (n = 353) | GA (n = 357) | PLC (n = 84) |
| Any adverse event | 180 (51.0) | 194 (54.3) | 47 (56.0) |
| Any severe adverse event | 14 (4.0) | 10 (2.8) | 0 |
| Any adverse event leading to discontinuation of study drug or trial participation | 12 (3.4) | 4 (1.1) | 2 (2.4) |
| Any serious adverse event | 12 (3.4) | 17 (4.8) | 2 (2.4) |
| Deaths | 0 | 0 | 0 |
| Most frequently reported adverse events | |||
| Injection site reaction | 58 (16.4) | 62 (17.4) | 6 (7.1) |
| Immediate post-injection reaction | 24 (6.8) | 18 (5.0) | 0 (0.0) |
| Headache | 16 (4.5) | 12 (3.4) | 7 (8.3) |
| Injection site swelling | 14 (4.0) | 12 (3.4) | 3 (3.6) |
| Nasopharyngitis | 13 (3.7) | 23 (6.4) | 6 (7.1) |
| Injection site pain | 11 (3.1) | 13 (3.6) | 1 (1.2) |
| Adverse events in open-label extension,b n (%) of patients | GTR/GTR (n = 324) | GA/GTR (n = 323) | PLC/GTR (n = 81) |
|---|---|---|---|
| Any adverse event | 108 (33.3) | 118 (36.5) | 35 (43.2) |
| Any severe adverse event | 1 (0.3) | 9 (2.8) | 2 (2.5) |
| Any adverse event leading to discontinuation of study drug or trial participation | 2 (0.6) | 1 (0.3) | 7 (8.6) |
| Adverse events in open-label extension,b n (%) of patients | GTR/GTR (n = 324) | GA/GTR (n = 323) | PLC/GTR (n = 81) |
| Any serious adverse event | 8 (2.5) | 11 (3.4) | 3 (3.7) |
| Deaths | 0 | 0 | 0 |
| Most frequently reported adverse events | |||
| Nasopharyngitis | 15 (4.6) | 16 (5.0) | 8 (9.9) |
| Headache | 9 (2.8) | 5 (1.5) | 2 (2.5) |
| Immediate post-injection reaction | 7 (2.2) | 3 (0.9) | 1 (1.2) |
| Back pain | 7 (2.2) | 3 (0.9) | 0 |
| Asthenia | 7 (2.2) | 2 (0.6) | 0 |
| Injection site reaction | 4 (1.2) | 3 (0.9) | 8 (9.9) |
GA: brand glatiramer acetate; GTR: generic glatiramer acetate; PLC: placebo.
a
The listed adverse events are those that were reported in ⩾2% of patients in the GTR or GA groups, or ⩾3 patients in the PLC group. The order is based on the incidence in the GTR group.
b
The listed adverse events are those that were reported in ⩾2% of patients in the GTR/GTR or GA/GTR groups, or ⩾3 patients in the PLC/GTR group. The order is based on the incidence in the GTR/GTR group.