Table 3.
Overall summary of AEs in the (a) MP and (b) OLEX periods
| (a) MP (n, %) | Treatment group | |||||
|---|---|---|---|---|---|---|
| High-dose | Low-dose | Total | ||||
| IncobotulinumtoxinA (N = 44) | Placebo (N = 22) | IncobotulinumtoxinA (N = 23) | Placebo (N = 11) | IncobotulinumtoxinA (N = 67) | Placebo (N = 33) | |
| AE | 22 (50.0) | 8 (36.4) | 10 (43.5) | 4 (36.4) | 32 (47.8) | 12 (36.4) |
| AE related to treatment | 3 (6.8) | 0 | 2 (8.7) | 0 | 5 (7.5) | 0 |
| Serious AEs | 1 (2.3) | 0 | 1 (4.3) | 1 (9.1) | 2 (3.0) | 1 (3.0) |
| Serious AEs related to treatment | 0 | 0 | 0 | 0 | 0 | 0 |
| AE of special interest | 2 (4.5) | 0 | 1 (4.3) | 0 | 3 (4.5) | 0 |
| AE of special interest related to treatment | 2 (4.5) | 0 | 0 | 0 | 2 (3.0) | 0 |
| AE leading to discontinuation | 1 (2.3) | 2 (9.1) | 0 | 0 | 1 (1.5) | 2 (6.1) |
| AE leading to discontinuation related to treatment | 0 | 0 | 0 | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
| (b) OLEX (n, %) | Cycle 2 (N = 100) | Cycle 3 (N = 91) | Cycle 4 (N = 82) | Total (N = 100) |
|---|---|---|---|---|
| AE | 36 (36.0) | 30 (33.0) | 21 (25.6) | 65 (65.0) |
| AE related to treatment | 3 (3.0) | 0 | 3 (3.7) | 6 (6.0) |
| Serious AEs | 1 (1.0) | 3 (3.3) | 0 | 4 (4.0) |
| Serious AEs related to treatment | 0 | 0 | 0 | 0 |
| AE of special interest | 2 (2.0) | 2 (2.2) | 0 | 4 (4.0) |
| AE of special interest related to treatment | 2 (2.0) | 0 | 0 | 2 (2.0) |
| AE leading to discontinuation | 1 (1.0) | 1 (1.1) | 0 | 2 (2.0) |
| AE leading to discontinuation related to treatment | 0 | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 | 0 |
AE adverse event, MP main period, n number of subjects, OLEX open-label extension