Table 4. Adverse Events (AE).
| Subject number | AE No. | Preferred Term | CTCAE Grade | Frequency* | Relationship† |
| 101 | 1 | Fatigue | 1 | 2 | 1 |
| 102 | 1 | Fatigue | 1 | 2 | 1 |
| 2 | Constipation | 1 | 1 | 1 | |
| 103 | None | ||||
| 201 | 1 | Sialadenitis | 1 | 1 | 1 |
| 2 | Diarrhoea | 1 | 1 | 2 | |
| 3 | Back pain | 2 | 1 | 2 | |
| 4 | Blood pressure decreased | 1 | 1 | 2 | |
| 5 | Skin ulcer | 1 | 3 | 2 | |
| 6 | Skin ulcer | 1 | 3 | 2 | |
| 7 | Nasal congestion | 1 | 2 | 2 | |
| 8 | Gamma-glutamyltransferase increased | 2 | 3 | 2 | |
| 301 | 1 | Fatigue | 1 | 2 | 2 |
| 2 | Wheezing | 1 | 2 | 2 | |
| 302 | 1 | Fatigue | 1 | 2 | 1 |
| 2 | Hordeolum | 1 | 2 | 2 | |
| 401 | 1 | Erythema | 1 | 3 | 2 |
| 402 | 1 | Oedema peripheral | 1 | 3 | 2 |
| 2 | Erythema | 1 | 3 | 2 | |
| 3 | Erysipelas | 1 | 3 | 2 |
The AE experienced during the study are listed.
*Frequency: 1 = Intermittent, 2 = Continuous, 3 = Single Episode.
†
Relationship to Study Drug: 1 = Related, 2 = Not related.