Adverse Events | IA-BoNT/A Group | IA-placebo Group | p, BoNT/A vs Placebo |
---|---|---|---|
Total adverse events | 66 | 73 | 0.76 |
Serious adverse effects* | 5 | 11 | 0.47 |
No. patients with ≥ 1 serious adverse events | 3 | 9 | 0.16 |
Most common side effects | |||
Dry mouth | 4 | 3 | |
Accidental injury | 11 | 7 | |
Back pain | 3 | 4 | |
Upper respiratory symptoms/infection | 10 | 10 | |
Difficulty swallowing | 0 | 4 | |
Headache | 3 | 2 | |
Nausea | 2 | 1 | |
Scheduled procedure | 3 | 5 | |
Local side effects | |||
Pain in the study joint | 6 | 2 | |
Muscle weakness around the study joint or knee “giving out” | 4 | 2 | |
Serious adverse effects | |||
Cardiac | |||
Chest pain/new diagnosis of coronary artery disease | 0 | 3 | |
Supraventricular tachycardia | 0 | 1 | |
Pulmonary | |||
Decreased saturation | 0 | 1 | |
Pneumonia | 0 | 1 | |
Other | |||
Subarachnoid hemorrhage | 1 | 0 | |
Atypical chest pain | 1 | 0 | |
Seafood allergy | 1 | 0 | |
Depression | 2 | 0 | |
Gouty arthritis | 0 | 1 | |
Influenza | 0 | 1 | |
Cellulitis and septic arthritis | 0 | 1 | |
Deep vein thrombosis | 0 | 1 | |
Lethargy and decreased appetite | 0 | 1 |
↵* Defined as an event that was fatal, life-threatening, permanently disabling, or required hospitalization.