Non-Serious Adverse Events | Causal Relationship | ||||||
Unlikely | Very Likely | Not Assessable | Unrelated | Possible | Likely | ||
Intensity | Mild | 9 | 1 | 1 | 171 | 6 | 4 |
Moderate | 1 | 0 | 0 | 70 | 1 | 0 | |
Severe | 1 | 0 | 0 | 9 | 1 | 0 | |
Subtotal | 11 | 1 | 1 | 250 | 8 | 4 | |
Serious adverse events | Unlikely | Very Likely | Not Assessable | Unrelated | Possible | Likely | |
Intensity | Moderate | 0 | 0 | 0 | 2 | 0 | 0 |
Severe | 0 | 0 | 0 | 7 | 0 | 0 | |
Serious, life-threatening | 0 | 0 | 0 | 3 | 0 | 0 | |
Death | 0 | 0 | 0 | 3 | 0 | 0 | |
Subtotal | 0 | 0 | 0 | 15 | 0 | 0 |