Table 4 Intensity of adverse events reported as being related to the investigational product
AE intensity/type | One intake N = 161 | Two intakes N = 155 | ||||
|---|---|---|---|---|---|---|
Mild | Moderate | Severe | Mild | Moderate | Severe | |
Gastrointestinal | 1 | 4 | 0 | 2 | 1 | 0 |
Abdominal pain | 0 | 2 | 0 | 0 | 1 | 0 |
Duodenal ulcer | 0 | 1 | 0 | 0 | 0 | 0 |
Nausea | 1 | 1 | 0 | 2 | 0 | 0 |
Nervous system | 0 | 0 | 1 | 3 | 0 | 0 |
Dysgeusia | 0 | 0 | 0 | 1 | 0 | 0 |
Drowsiness | 0 | 0 | 0 | 2 | 0 | 0 |
Seizures | 0 | 0 | 1 | 0 | 0 | 0 |
Skin | 4 | 1 | 0 | 2 | 1 | 0 |
Pruritus | 3 | 0 | 0 | 0 | 1 | 0 |
Generalized pruritus | 1 | 1 | 0 | 2 | 0 | 0 |
Total | 5 | 5 | 1 | 7 | 2 | 0 |