TABLE 2.
Adverse event summary
| Characteristic | Phase IA |
Phase IB (1.5 g) | ||
|---|---|---|---|---|
| Cohort 1 (1.0 g) | Cohort 2 (1.5 g) | Cohort 3 (2.0 g) | ||
| No. of participants | 9 | 9 | 9 | 9 |
| No. of participants with SAEs | 0 | 0 | 0 | 0 |
| No. of participants with unexpected events | 0 | 0 | 0 | 0 |
| No. (%) of clinical events | 4 | 7 | 20 | 5 |
| Grade 1 | 4 (100) | 3 (43) | 17 (85) | 5 (100) |
| Grade 2 | 0 | 4 (57) | 3 (15) | 0 |
| Grade 3 | 0 | 0 | 0 | 0 |
| Grade 4 | 0 | 0 | 0 | 0 |
| No. (%) of laboratory events | 8 | 5 | 11 | 6 |
| Grade 1 | 2 (25) | 4 (80) | 8 (73) | 6 (100) |
| Grade 2 | 6 (75) | 1 (20) | 2 (18) | 0 |
| Grade 3 | 0 | 0 | 1 (9) | 0 |
| Grade 4 | 0 | 0 | 0 | 0 |