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. 2015 Feb 20;79(3):477–491. doi: 10.1111/bcp.12513

Table 6.

Treatment-emergent adverse events for all causalities (multiple dose)

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.