Table 3.
Treatment-Emergent Adverse Events.a
| Adverse Event | AM-101 (n = 201), No. (%) | Placebo (n = 135), No. (%) | Total (N = 336), No. (%) |
|---|---|---|---|
| Any adverse event | 90 (45) | 46 (34) | 136 (41) |
| Adverse events, treatment related | 14 (7) | 6 (4) | 20 (6) |
| Mild | 11 (5) | 4 (3) | 15 (4) |
| Moderate | 3 (1) | 2 (1) | 5 (1) |
| Severe | 0 (0) | 0 (0) | 0 (0) |
| Adverse events, procedure related | 34 (17) | 22 (16) | 56 (17) |
| Mild | 26 (13) | 21 (16) | 47 (14) |
| Moderate | 6 (3) | 1 (1) | 7 (2) |
| Severe | 2 (1) | 0 (0) | 2 (1) |
| All severe adverse events (including unrelated cases) | 3 (1) | 1 (1) | 4 (1) |
| Serious adverse events | 5 (2) | 1 (1) | 6 (2) |
| Adverse events leading to | |||
| Study drug withdrawal/interruption | 5 (2) | 3 (2) | 8 (2) |
| Premature study termination | 1 (0) | 1 (1) | 2 (1) |
a
Frequencies and percentages of patients with adverse events; occurrence of an adverse event in the same patient was counted only once.