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

Table 5.

Treatment emergent adverse events for all causalities (single dose)

System organ class Number of subjects (%) with adverse events [number of adverse events]
Placebo Dose of selisistat
Male (fasted) (n = 12) Male (fed) (n = 2) Female (fasted) (n = 2) Male 5 mg (fasted) (n = 6) Male 25 mg (fasted) (n = 6) Male 75 mg (fasted) (n = 6) Male 150 mg (fasted) (n = 6) Male 150 mg (fed) (n = 6) Male 300 mg (fasted) (n = 6) Female 300 mg (fasted) (n = 6) 600 mg (fasted) (n=6)
Nervous system disorders
Headache 2 (17%) [2] 1 (50%) [1] 1 (17%) [1] 1 (17%) [1] 2 (33%) [2] 1 (17%) [1] 5 (83%) [5] 1 (17%) [1]
Dizziness 1 (17%) [1]
Dizziness postural 1 (17%) [1]
Somnolence 1 (17%) [1]
Syncope 1 (17%) [1]
Total 2 (17%) [2] 1 (50%) [1] 1 (17%) [1] 2 (33%) [3] 2 (33%) [3] 1 (17%) [2] 5 (83%) [5] 1 (17%) [1]
Musculoskeletal and connective tissue disorders
Pain in extremity 1 (8%) [1] 1 (50%) [1] 1 (17%) [1]
Arthralgia 1 (17%) [1]
Total 1 (8%) [1] 1 (50%) [1] 1 (17%) [1] 1 (17%) [1]
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 1 (8%) [1] 1 (17%) [1]
Total 1 (8%) [1] 1 (17%) [1]
Skin and subcutaneous disorders
Dermatitis Acneiform 1 (8%) [1]
Rash 1 (17%) [1]
Total 1 (8%) [1] 1 (17%) [1]
Cardiac disorders
Palpitations 1 (17%) [1]
Total 1 (17%) [1]
General disorders and administration site conditions
Fatigue 1 (17%) [1]
Total 1 (17%) [1]
Infections and infestations
Nasopharyngitis 1 (17%) [1]
Total 1 (17%) [1]
Gastrointestinal disorders
Nausea 1 (17%) [1]
Total 1 (17%) [1]
Overall total 5 (42%) [5] 0 (0%) [0] 1 (50%) [1] 1 (17%) [1] 0 (0%) [0] 2 (33%) [5] 3 (50%) [5] 2 (33%) [4] 0 (0%) [0] 5 (83%) [7] 1 (17%) [1]

n = number of subjects studied.