Table 3.
10 μg (N=5) Subjects (%) Events | 30 μg (N=4) Subjects (%) Events | 100 μg (N=4) Subjects (%) Events | 300 μg (N=4) Subjects (%) Events | 1 mg (N=5) Subjects (%) Events | |
---|---|---|---|---|---|
At least one TEAE | 5 (100.0%) 7 | 1 (25.0%) 2 | 3 (75.0%) 5 | 2 (50.0%) 2 | 4 (80.0%) 19 |
At least one Severe TEAE | 0 (0.0%) 0 | 0 (0.0%) 0 | 0 (0.0%) 0 | 0 (0.0%) 0 | 1 (20.0%) 3 |
At least one Drug-Related AE[1] | 3 (60.0%) 4 | 0 (0.0%) 0 | 1 (25.0%) 1 | 1 (25.0%) 1 | 4 (80.0%) 16 |
At least one TESAE | 0 (0.0%) 0 | 0 (0.0%) 0 | 0 (0.0%) 0 | 0 (0.0%) 0 | 1 (20.0%) 1 |
Drug-related is defined as unlikely, possibly, probably or definitely related to study drug.