Table 2.
Number of subjects (%) | IncobotulinumtoxinA (n = 210) | Placebo (n = 107) |
---|---|---|
Any AE | 47 (22.4) | 18 (16.8) |
Any AE related to treatment | 8 (3.8) | 2 (1.9) |
Any AESIa | 7 (3.3) | 3 (2.8) |
Dry mouth | 4 (1.9) | 1 (0.9) |
Muscular weakness | 1 (0.5) | 1 (0.9) |
Urinary retention | 1 (0.5) | 1 (0.9) |
Blurred vision | 1 (0.5) | 0 |
Bradycardia | 1 (0.5) | 0 |
Constipation | 1 (0.5) | 0 |
Diplopia | 1 (0.5) | 0 |
Hypoglossal nerve paresis | 0 | 1 (0.9) |
Any AESI related to treatment | 4 (1.9) | 2 (1.9) |
Any serious AEa | 7 (3.3) | 2 (1.9) |
Peripheral ischemiab | 2 (1.0) | 0 |
Biliary colic | 1 (0.5) | 0 |
Bladder calculus | 0 | 1 (0.9) |
Epilepsy | 1 (0.5) | 0 |
Pancreatic enlargement | 1 (0.5) | 0 |
Pneumonia | 1 (0.5) | 0 |
Renal cancer | 0 | 1 (0.9) |
Urinary tract infection | 1 (0.5) | 0 |
Urosepsis | 1 (0.5) | 0 |
Any serious AE related to treatment | 0 | 0 |
Any fatal AE | 0 | 0 |
AE, adverse event; AESI, adverse event of special interest.
By overall frequency and by preferred term.
Both participants had ischemia of the left lower limb that was not related to treatment.