Table 3. Summary of Subjects with Treatment-Emergent Adverse Events with Incidence Greater Than 5% Among UV-4-Treated Subjects.
| Preferred Term* | Number of Subjects with TEAE > 5% Incidence (% of Subjects with TEAE > 5% Incidence) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| UV-4 Dose and Number in Cohort (N) | ||||||||||
| 3 mg (N = 6) | 10 mg (N = 6) | 30 mg (N = 6) | 90 mg (N = 6) | 180 mg (N = 6) | 360 mg (N = 6) | 720 mg (N = 6) | 1000 mg (N = 6) | All Doses (N = 48) | Placebo (N = 16) | |
| Respiratory rate increased | 3 (50.0) | 4 (66.7) | 1 (16.7) | 2 (33.3) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 14 (29.2) | 2 (12.5) |
| Proteinuria | 2 (33.3) | 1 (16.7) | 1 (16.7) | 0 | 0 | 2 (33.3) | 4 (66.7) | 0 | 10 (20.8) | 0 |
| Activated partial thromboplastin time prolonged | 0 | 3 (50.0) | 0 | 3 (50.0) | 1 (16.7) | 0 | 1 (16.7) | 1 (16.7) | 9 (18.8) | 1 (6.3) |
| Bradycardia | 1 (16.7) | 2 (33.3) | 2 (33.3) | 1 (16.7) | 2 (33.3) | 0 | 1 (16.7) | 0 | 9 (18.8) | 1 (6.3) |
| Hypocalcemia | 0 | 0 | 1 (16.7) | 0 | 2 (33.3) | 2 (33.3) | 3 (50.0) | 1 (16.7) | 9 (18.8) | 1 (6.3) |
| Blood urea increased | 0 | 1 (16.7) | 0 | 2 (33.3) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 7 (14.6) | 4 (25.0) |
| Nausea | 0 | 1 (16.7) | 0 | 0 | 3 (50.0) | 1 (16.7) | 1 (16.7) | 0 | 6 (12.5) | 0 |
| Haematuria | 0 | 0 | 0 | 1 (16.7) | 1 (16.7) | 0 | 2 (33.3) | 0 | 4 (8.3) | 1 (6.3) |
| Prothrombin time prolonged | 0 | 2 (33.3) | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 | 0 | 4 (8.3) | 0 |
| Headache | 1 (16.7) | 0 | 1 (16.7) | 0 | 1 (16.7) | 0 | 0 | 0 | 3 (6.3) | 1 (6.3) |
* Only preferred terms with > 5% incidence among subjects receiving UV-4, sorted by descending frequency. All dose groups were included.