Number of patients with adverse events; patients could fulfil more than one category
Trial-phase | Open-label phase | ||
BoNT n=25 | Placebo n=23 | n=43 | |
Pain injection site, n (%) | 9 (36.0) | 2 (8.7) | 9 (20.9) |
Haematoma injection site, n (%) | 2 (8.0) | 2 (8.7) | 2 (4.7) |
Influenza-like symptoms, n (%) | 2 (8.0) | 4 (17.4) | 4 (9.3) |
Muscle weakness, n (%) | 6 (24.0) | 4 (17.4) | 12 (27.9) |
MRC scale, median (IQR) | 5 (5; 5) | 5 (5; 5) | 5 (5; 5) |
Worsening symptoms, n (%) | 5 (20.0) | 3 (13.0) | 3 (7.0) |
Other*, n (%) | 9 (36.0) | 10 (43.5) | 19 (44.2) |
*Other adverse events included musculoskeletal pain, planned surgery/medical intervention, muscle cramps, infection/inflammation, nausea, stomach ache, diarrhoea, chest pain, shortness of breath, dizziness, memory problems, transient confusion, globus feeling, skin abnormalities, headache and fatigue.
BoNT, botulinum neurotoxin.