Pooled Safety Analysis of IncobotulinumtoxinA

Studies were obtained from the integrated clinical database containing data from all Merz-sponsored clinical trials of incobotulinumtoxinA (Supplementary Figure S1). The studies included were those that were placebo-controlled or were repeat-dose studies of incobotulinumtoxinA in adults with cervical dystonia, blepharospasm, upper limb spasticity, lower limb spasticity, sialorrhea, or essential tremor of the upper limb (Table 1).
Single-dose and repeat-dose data were considered separately, although individual studies contributed to either or both analyses, depending on their design. Single-dose data were defined as those obtained from a study with a single treatment of incobotulinumtoxinA in a placebo-controlled setting or studies in which the first injection session of a repeat-dose study was placebo-controlled. Repeat-dose data were defined as those from studies in which subjects were intended to receive repeated treatments with incobotulinumtoxinA over ≥2 cycles; however, subjects who, for any reason, received only one incobotulinumtoxinA treatment in a repeat-dose study were also included in the safety analyses. Only subjects who received treatment with incobotulinumtoxinA were included in the repeat-dose analysis (i.e., subjects who received a placebo only were excluded).