Table 2. Incidence of all treatment-emergent adverse events by subject treatment group.
Treatment | Placebo | SRT2104 | SRT2104 | |||
0.5 g/day | 2.0 g/day | |||||
(n = 8) | (n = 8) | (n = 9) | ||||
Number of subjects experiencing any adverse event | 8 | (100%) | 8 | (100%) | 9 | (100%) |
Nervous system disorders | ||||||
Headache | 2 | (25%) | 5 | (63%) | 1 | (11%) |
Lethargy | 1 | (13%) | 1 | (13%) | 0 | |
Dizziness | 0 | 0 | 1 | (11%) | ||
Migraine | 0 | 1 | (13%) | 0 | ||
Syncope vasovagal | 0 | 0 | 1 | (11%) | ||
Gastrointestinal disorders | ||||||
Diarrhoea | 3 | (38%) | 1 | (13%) | 2 | (22%) |
Nausea | 2 | (25%) | 1 | (13%) | 0 | |
Abdominal distension | 1 | (13%) | 1 | (13%) | 0 | |
Abdominal pain lower | 0 | 1 | (13%) | 0 | ||
Constipation | 0 | 0 | 1 | (11%) | ||
Vomiting | 0 | 1 | (13%) | 0 | ||
Infections | ||||||
Nasopharyngitis | 0 | 1 | (13%) | 4 | (44%) | |
Lower respiratory tract infection | 0 | 0 | 1 | (11%) | ||
General disorders | ||||||
Application site haematoma | 2 | (25%) | 1 | (13%) | 1 | (11%) |
Fatigue | 1 | (13%) | 0 | 0 | ||
Mass | 1 | (13%) | 0 | 0 | ||
Tenderness | 1 | (13%) | 0 | 0 | ||
Injury and procedural complications | ||||||
Thermal burn | 1 | (13%) | 0 | 1 | (11%) | |
Limb injury | 0 | 0 | 1 | (11%) | ||
Procedural pain | 0 | 1 | (13%) | 0 | ||
Fall | 1 | (13%) | 0 | 0 | ||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 0 | 1 | (13%) | 0 | ||
Back pain | 0 | 1 | (13%) | 0 | ||
Sensation of heaviness | 0 | 1 | (13%) | 0 | ||
Joint stiffness | 1 | (13%) | 0 | 0 | ||
Muscle spasms | 1 | (13%) | 0 | 0 | ||
Muscular weakness | 1 | (13%) | 0 | 0 | ||
Blood and urine | ||||||
Blood creatinine increased | 0 | 1 | (13%) | 0 | ||
Urine output increased | 0 | 1 | (13%) | 0 | ||
Psychiatric disorders | ||||||
Insomnia | 0 | 1 | (13%) | 0 | ||
Sleep disorder | 0 | 1 | (13%) | 0 | ||
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 0 | 0 | 1 | (11%) | ||
Dysphonia | 0 | 0 | 1 | (11%) | ||
Epistaxis | 1 | (13%) | 0 | 0 | ||
Skin and subcutaneous tissue disorders | ||||||
Rash | 1 | (13%) | 1 | (13%) | 0 | |
Erythema | 0 | 1 | (13%) | 0 | ||
Cardiac disorders | ||||||
Palpitations | 0 | 1 | (13%) | 0 | ||
Eye disorders | ||||||
Dry eye | 1 | (13%) | 0 | 0 | ||
Eye pain | 1 | (13%) | 0 | 0 | ||
Metabolism and Nutrition Disorders | ||||||
Decreased Appetite | 1 | (13%) | 1 | (13%) | 0 |