Table 7 Incidence of adverse events and adverse drug reactions.
Item | Control | NBIW | ||
|---|---|---|---|---|
Adverse events | Symptoms | Nausea | 1 | 0 |
Malaise | 2 | 0 | ||
Headache | 1 | 0 | ||
Skin reddening | 1 | 0 | ||
Nasal discharge | 1 | 0 | ||
Abdominal pain | 1 | 0 | ||
Abdominal pain, diarrhea (loose stool) | 0 | 1 | ||
Weight loss | 0 | 1 | ||
Increase in creatine kinase | 0 | 1 | ||
Severity | Mild | 4 | 3 | |
Moderate | 0 | 0 | ||
Severe | 0 | 0 | ||
Incidence | Number of patients | 4 | 3 | |
Number of events | 7 | 3 | ||
Adverse drug reactions | Symptoms | – | – | – |
Severity | Mild | 0 | 0 | |
Moderate | 0 | 0 | ||
Severe | 0 | 0 | ||
Incidence | Number of patients | 0 | 0 | |
Number of events | 0 | 0 | ||
