Table 2 All adverse events observed throughout the study period with gradings based on common terminology criteria for adverse events version 4
Adverse event | Overall– no. (%) | Causal link with study intervention | Grade I | Grade II | Grade III | ||
|---|---|---|---|---|---|---|---|
Not related | Unlikely | Probable | |||||
Headache | 34 (70.8%) | 34 (70.8%) | - | - | 28 (58.3%) | 6 (12.5%) | - |
Nausea | 27 (56.3%) | 27 (56.3%) | - | - | 27 (56.3%) | - | - |
Fever | 19 (39.6%) | 16 (33.3%) | 3 (6.3%) | - | 12 (25.0%) | 7 (14.6%) | - |
Fatigue | 8 (16.7%) | 8 (16.7%) | - | - | 7 (14.6%) | 1 (2.1%) | - |
Spasticity | 5 (10.4%) | 5 (10.4%) | - | - | 5 (10.4%) | - | - |