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. 2015 Dec 15;53(3):415–421. doi: 10.1002/mus.24776

Table 2.

Summary of AEs, AESIs, and serious AEs (safety evaluation set).

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.

a

By overall frequency and by preferred term.

b

Both participants had ischemia of the left lower limb that was not related to treatment.