Patients, events/patients (%a) | LA (n = 263) | CWE (n = 248) | EE (n = 157) |
---|---|---|---|
Most common AEs by preferred term | |||
Dyspnea | 5/4 (1.5) | 4/3 (1.2) | 1/1 (0.6) |
Syncope | 2/2 (0.8) | 2/2 (0.8) | 0/0 (0.0) |
Injection site reaction | 2/2 (0.8) | 8/8 (3.2) | 0/0 (0.0) |
Injection site pain | 2/2 (0.8) | 14/10 (4.0) | 0/0 (0.0) |
Injection site induration | 1/1 (0.4) | 5/5 (2.0) | 0/0 (0.0) |
Fatigue | 1/1 (0.4) | 3/3 (1.2) | 0/0 (0.0) |
Arthralgia | 1/1 (0.4) | 3/3 (1.2) | 0/0 (0.0) |
Rash | 0/0 (0.0) | 2/2 (0.8) | 2/2 (1.3) |
Anxiety | 0/0 (0.0) | 1/1 (0.4) | 1/1 (0.6) |
Most common AE classified by system organ class | |||
General disorders and administration site conditions | 16/13 (4.9) | 55/32 (12.9) | 5/4 (2.6) |
Nervous system disorders | 10/10 (3.8) | 9/8 (3.2) | 0/0 (0.0) |
Respiratory, thoracic, and mediastinal disorders | 7/6 (2.3) | 4/3 (1.2) | 0/0 (0.0) |
Severity of AE, events/patients | |||
Mild | 19/12 (4.6) | 40/28 (11.3) | 0/0 (0.0) |
Moderate | 22/12 (4.6) | 62/38 (15.3) | 5/5 (3.2) |
Severe | 13/6 (2.3) | 14/9 (3.6) | 5/3 (1.9) |
Data unavailable | 4/2 (0.8) | 7/5 (2.0) | 2/2 (1.3) |
Patient-reported assessment of AEs after glatiramer acetate treatmentb | |||
Improved with glatiramer acetate | 209 (80.4) | 162 (66.1) | 58 (38.4) |
Same with glatiramer acetate | 41 (15.8) | 62 (25.3) | 87 (57.6) |
Worse with glatiramer acetate | 10 (3.9) | 21 (8.6) | 6 (4.0) |
Data unavailable | 3 | 3 | 6 |