Table 4 Summary of SAEs (Safety set) (N = 240)
Parameter | SAE count | n (%) |
|---|---|---|
Any treatment-emergent SAE | 21 | 20 (8.3) |
Relationship to study drug | ||
No | 12 | 11 (4.6) |
Yes | 9 | 9 (3.8) |
Outcome | ||
Completely recovered | 10 | 9 (3.8) |
Condition still present and unchanged | 3 | 3 (1.3) |
Condition improving | 3 | 3 (1.3) |
Recovered with sequelae | 4 | 4 (1.7) |
Completely recovered, condition still present and unchanged | 1 | 1 (0.4) |
SAEs | ||
MS relapse | 4 | 4 (1.7) |
Hepatopathy | 2 | 2 (0.8) |
Epileptic seizure | 2 | 1 (0.4) |
Breast cancer | 1 | 1 (0.4) |
Bronchopneumonia | 1 | 1 (0.4) |
Cerebral infarction | 1 | 1 (0.4) |
Cerebrovascular accident | 1 | 1 (0.4) |
Disease progression | 1 | 1 (0.4) |
Gynecological infection | 1 | 1 (0.4) |
Herpes zoster | 1 | 1 (0.4) |
Humerus fracture | 1 | 1 (0.4) |
Insufficient treatment effect | 1 | 1 (0.4) |
Joint and muscle pain | 1 | 1 (0.4) |
Macular edema | 1 | 1 (0.4) |
Rebound of MS | 1 | 1 (0.4) |
Spastic bronchitis | 1 | 1 (0.4) |