Table 5.

Adverse events and serious adverse events.

Adverse EventsIA-BoNT/A GroupIA-placebo Groupp, BoNT/A vs Placebo
Total adverse events66730.76
Serious adverse effects*5110.47
No. patients with ≥ 1 serious adverse events390.16
Most common side effects
  Dry mouth43
  Accidental injury117
  Back pain34
  Upper respiratory symptoms/infection1010
  Difficulty swallowing04
  Scheduled procedure35
  Local side effects
    Pain in the study joint62
    Muscle weakness around the study joint or knee “giving out”42
Serious adverse effects
    Chest pain/new diagnosis of coronary artery disease03
    Supraventricular tachycardia01
    Decreased saturation01
    Subarachnoid hemorrhage10
    Atypical chest pain10
    Seafood allergy10
    Gouty arthritis01
    Cellulitis and septic arthritis01
    Deep vein thrombosis01
    Lethargy and decreased appetite01
  • * Defined as an event that was fatal, life-threatening, permanently disabling, or required hospitalization.