Outcome | TCZ (N, %) | SAR (N, %) |
---|---|---|
Congenital anomaly | 0 (0.00) | 1 (0.01) |
Death | 30 (0.17) | 30 (0.37) |
Disability | 1 (0.01) | 1 (0.01) |
Hospitalization-initial or prolonged | 27 (0.15) | 37 (0.45) |
Life-threatening | 6 (0.03) | 29 (0.35) |
Other serious/important medical events | 137 (0.78) | 54 (0.66) |
Required intervention to prevent permanent impairment/damage | 2 (0.01) | 0 (0.00) |