TABLE 7.
Incidence of drug-related AEs occurring in >1% of subjects
| Adverse event | No. (%) of subjects |
|||
|---|---|---|---|---|
| All subjects receiving DUR (n = 94) | All subjects receiving placebo (n = 30) | All subjects receiving DUR + SUL and IMI-CIL (n = 10) | All subjects receiving placebo + SUL and IMI-CIL (n = 2) | |
| Abdominal pain | 0 | 0 | 0 | 1 (50.0) |
| Catheter site phlebitis | 5 (5.3) | 0 | 0 | 0 |
| Dizziness | 4 (4.3) | 1 (3.3) | 0 | 0 |
| Dysgeusia | 2 (2.1) | 0 | 2 (20.0) | 0 |
| Headache | 10 (10.6) | 3 (10.0) | 2 (20.0) | 0 |
| Musculoskeletal stiffness | 1 (10.0) | 0 | ||
| Nasal congestion | 2 (2.1) | 0 | 0 | 0 |
| Nausea | 2 (2.1) | 1 (3.3) | 0 | 0 |
| Pain in extremity | 1 (1.1) | 1 (3.3) | 0 | 0 |
| Phlebitis | 2 (2.1) | 0 | 0 | 0 |
| Polydipsia | 0 | 0 | 1 (10.0) | 0 |
| Pruritus | 2 (2.1) | 1 (3.3) | 0 | 0 |
| Somnolence | 1 (1.1) | 1 (3.3) | 0 | 0 |
| Upper respiratory infection | 1 (1.1) | 1 (3.3) | 0 | 0 |
| Vulvovaginal candidiasis | 2 (2.1) | 0 | 1 (10.0) | 0 |