Table 6.
Number of subjects (%) with adverse events [number of adverse events] | ||||||
---|---|---|---|---|---|---|
System organ class | Placebo | Dose of selisistat | ||||
Male (n = 6) | Female (n = 6) | Male 100 mg once daily (n = 6) | Male 300 mg once daily (n = 6) | Male 100 mg twice daily (n = 6) | Female 100 mg twice daily (n = 6) | |
Gastrointestinal disorders | ||||||
Diarrhoea | 1 (50%) [1] | 1 (17%) [1] | 1 (17%) [1] | |||
Abdominal pain upper | 1 (50%) [1] | 1 (17%) [1] | ||||
Constipation | 1 (50%) [1] | 1 (17%) [1] | ||||
Nausea | 1 (50%) [1] | 1 (17%) [1] | ||||
Flatulence | 1 (17%) [1] | |||||
Abdominal distension | 1 (17%) [1] | |||||
Total | 2 (100%) [4] | 1 (17%) [1] | 1 (17%) [1] | 3 (50%) [5] | ||
Nervous system disorders | ||||||
Headache | 1 (17%) [2] | 1 (17%) [1] | ||||
Dizziness | 1 (17%) [1] | |||||
Total | 1 (17%) [2] | 1 (17%) [1] | 1 (17%) [1] | |||
Musculoskeletal and connective tissue disorders | ||||||
Neck pain | 1 (17%) [1] | |||||
Back pain | 1 (17%) [1] | 1 (17%) [1] | ||||
Total | 1 (17%) [1] | 1 (17%) [1] | 1 (17%) [1] | |||
Skin and subcutaneous tissue disorders | ||||||
Rash | 1 (17%) [1] | 1 (17%) [1] | 1 (17%) [1] | |||
Total | 1 (17%) [1] | 1 (17%) [1] | 1 (17%) [1] | |||
Ear and labyrinth disorders | ||||||
Hearing impaired | 1 (17%) [1] | |||||
Total | 1 (17%) [1] | |||||
Infections and infestations | ||||||
Nasopharyngitis | 1 (17%) [1] | 1 (17%) [1] | ||||
Total | 1 (17%) [1] | 1 (17%) [1] | ||||
Injury, poisoning and procedural complications | ||||||
Arthropod bite | 1 (17%) [1] | |||||
Total | 1 (17%) [1] | |||||
Metabolism and nutrition disorders | ||||||
Decreased appetite | 1 (17%) [1] | |||||
Total | 1 (17%) [1] | |||||
Renal and urinary disorders | ||||||
Micturition urgency | 1 (17%) [1] | |||||
Total | 1 (17%) [1] | |||||
Respiratory, thoracic and mediastinal disorders | ||||||
Epistaxis | 1 (17%) [1] | |||||
Total | 1 (17%) [1] | |||||
General disorders and administration site conditions | ||||||
Fatigue | 1 (17%) [1] | |||||
Total | 1 (17%) [1] | |||||
Overall total | 3 (50%) [6] | 2 (100%) [6] | 2 (33%) [2] | 2 (33%) [4] | 3 (50%) [3] | 6 (100%) [8] |
n = number of subjects studied.