Placeboa | PF-06650833 dose group | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
IR 1 mg | IR 3 mg | IR 10 mg | IR 30 mg | IR 30 mg (fed) | IR 100 mg | IR 100 mgb | IR 300 mg | IR 1000 mg | IR 2000 mg (fed) | IR 6000 mg (fed) | MR 30 mg | MR 30 mg (fed) | MR 100 mg | MR 300 mg | ||
Subjects evaluable for AEs | 31 | 8 | 8 | 8 | 15 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 |
Subjects with AEs | 4 (0) | 1 (0) | 0 | 0 | 0 | 1 (1) | 1 (0) | 2 (1) | 0 | 2 (0) | 3 (1) | 2 (1) | 0 | 0 | 1 (0) | 2 (0) |
Number of AEs | 6 (0) | 1 (0) | 0 | 0 | 0 | 1 (1) | 1 (0) | 10 (7) | 0 | 3 (0) | 4 (1) | 2 (1) | 0 | 0 | 1 (0) | 4 (0) |
Number of subjects with AEs by system organ class and preferred term | ||||||||||||||||
Ear and labyrinth disorders | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vertigo | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Gastrointestinal disorders | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 1 (0) |
Abdominal discomfort | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) |
Abdominal distension | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 |
Abdominal pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diarrhea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) |
Dry mouth | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Enterocolitis | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Flatulence | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
General disorders and administration site conditions | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Fatigue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Pain | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Infections and infestations | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 |
Conjunctivitis | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Folliculitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 |
Upper respiratory tract infection | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 |
Injury, poisoning, and procedural complications | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 |
Fall | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 |
Metabolism and nutrition disorders | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Decreased appetite | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Musculoskeletal and connective tissue disorders | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 1 (0) |
Arthralgia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 |
Musculoskeletal stiffness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) |
Neck pain | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Nervous system disorders | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 1 (0) | 1 (1) | 2 (1) | 0 | 0 | 0 | 0 |
Dizziness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 |
Headache | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 1 (1) | 1 (1) | 0 | 0 | 0 | 0 |
Psychiatric disorders | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 |
Anxiety | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 |
Respiratory, thoracic, and mediastinal disorders | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Hypopnea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Skin and subcutaneous tissue disorders | 1 (0) | 0 | 0 | 0 | 0 | 1 (1) | 1 (0) | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) |
Acne | 0 | 0 | 0 | 0 | 0 | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dermatitis contact | 1 (0) | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Scab | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) |
Skin irritation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |