|  | Number of AE records | Number of patients |
---|---|---|---|
 |  | n | n |
Total AE | Â | 329 | 21 |
Type of AE | Infections and infestations | 59 | 18 |
 | Gastrointestinal disorders | 52 | 16 |
 | General disorders/administration site condition | 39 | 17 |
Intensity | Mild | 218 | 21 |
 | Moderate | 90 | 18 |
 | Severe | 17 | 7 |
Outcome | Resolved | 221 | 21 |
 | Additional therapy | 81 | 16 |
 | Hospitalization | 14 | 7 |
 | Premature termination | 8 | 5 |
Relationship to DSG | No | 156 | 20 |
 | Unlikely | 42 | 15 |
 | Possibly | 86 | 18 |
 | Probably | 37 | 13 |
 | Definitely | 6 | 4 |