Table 5.
Adverse events and serious adverse events.
| 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.