Table 5.
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.