Table 4.
Adverse events according to MedDRA preferred term and by severity
| Na | (%)a | Ea | |
|---|---|---|---|
| Exposed subjects | 12 | ||
| Total | 9 | 75 | 43 |
| Mild | 9 | 75 | 33 |
| Abdominal pain upper | 2 | 17 | 2 |
| Abdominal tenderness | 1 | 8 | 1 |
| Back pain | 1 | 8 | 1 |
| Chest discomfort | 1 | 8 | 1 |
| Constipation | 2 | 17 | 2 |
| Cystitis | 1 | 8 | 1 |
| Dizziness | 2 | 17 | 3 |
| Dry mouth | 1 | 8 | 1 |
| Dysgeusia | 1 | 8 | 1 |
| Feeling cold | 1 | 8 | 1 |
| Flushing | 1 | 8 | 1 |
| Headache | 1 | 8 | 1 |
| Hordeolum | 1 | 8 | 1 |
| Injection site irritation | 2 | 17 | 2 |
| Injection site pain | 1 | 8 | 1 |
| Nasopharyngitis | 1 | 8 | 1 |
| Nausea | 3 | 25 | 3 |
| Sensory disturbance | 1 | 8 | 1 |
| Rash | 1 | 8 | 2 |
| Sensation of foreign body | 1 | 8 | 1 |
| Tachycardia | 3 | 25 | 4 |
| Moderate | 3 | 25 | 8 |
| Abdominal discomfort | 1 | 8 | 1 |
| Crohn’s diseaseb | 1 | 8 | 1 |
| Dizziness | 1 | 8 | 1 |
| Flushing | 1 | 8 | 2 |
| Nausea | 2 | 17 | 2 |
| Sensory disturbance | 1 | 8 | 1 |
| Severe | 1 | 8 | 2 |
| Abdominal pain upper | 1 | 8 | 1 |
| Flushing | 1 | 8 | 1 |
Notes:
a
N: Number of subjects with event, % = percentage of exposed with event, E = number of events;
b
The lower level term was “Crohn’s disease aggravated”.