Table 1 Treatment-emergent adverse events by system organ class
Treatment-emergent AE, n (%) | CC-99677 10 mg (n = 5) | CC-99677 30 mg (n = 6) | CC-99677 60 mg (n = 6) | CC-99677 120 mg (n = 6) | CC-99677 150 mg (n = 5) | Placebo (n = 9) |
|---|---|---|---|---|---|---|
Subjects with ≥ 1 treatment-emergent AE | 3 (60.0) | 4 (66.7) | 1 (16.7) | 3 (50.0) | 2 (40.0) | 7 (77.8) |
Nervous system disorders | 2 (40.0) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 0 | 1 (11.1) |
 Headache | 2 (40.0) | 0 | 1 (16.7) | 1 (16.7) | 0 | 1 (11.1) |
 Dizziness | 1 (20.0) | 1 (16.7) | 0 | 0 | 0 | 0 |
Gastrointestinal disorders | 2 (40.0) | 2 (33.3) | 0 | 1 (16.7) | 0 | 2 (22.2) |
 Nausea | 2 (40.0) | 0 | 0 | 0 | 0 | 0 |
 Constipation | 0 | 0 | 0 | 0 | 0 | 2 (22.2) |
 Diarrhea | 0 | 0 | 0 | 1 (16.7) | 0 | 0 |
 Abdominal pain | 0 | 0 | 0 | 1 (16.7) | 0 | 0 |
 Chapped lips | 0 | 1 (16.7) | 0 | 0 | 0 | 0 |
 Dyspepsia | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
 Rectal hemorrhage | 0 | 1 (16.7) | 0 | 0 | 0 | 0 |
Musculoskeletal and connective tissue disorders | 0 | 2 (33.3) | 0 | 1 (16.7) | 0 | 2 (22.2) |
 Back pain | 0 | 0 | 0 | 0 | 0 | 1 (11.1) |
 Myalgia | 0 | 2 (33.3) | 0 | 0 | 0 | 1 (11.1) |
 Musculoskeletal pain | 0 | 0 | 0 | 1 (16.7) | 0 | 0 |
Infections and infestations | 1 (20.0) | 1 (16.7) | 0 | 0 | 0 | 1 (11.1) |
 Nasopharyngitis | 0 | 1 (16.7) | 0 | 0 | 0 | 1 (11.1) |
 Rash pustular | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
General disorders and administration site conditions | 2 (40.0) | 0 | 0 | 0 | 0 | 2 (22.2) |
 Vessel puncture site pain | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
 Catheter site related reaction | 0 | 0 | 0 | 0 | 0 | 1 (11.1) |
 Sensation of foreign body | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
 Vessel puncture site reaction | 0 | 0 | 0 | 0 | 0 | 1 (11.1) |
Respiratory, thoracic, and mediastinal disorders | 1 (20.0) | 0 | 0 | 1 (16.7) | 0 | 0 |
 Oropharyngeal pain | 1 (20.0) | 0 | 0 | 1 (16.7) | 0 | 0 |
Injury, poisoning, and procedural complications | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
 Muscle strain | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
Investigations | 0 | 0 | 0 | 1 (16.7) | 1 (20.0) | 0 |
 Alanine aminotransferase increased | 0 | 0 | 0 | 1 (16.7) | 0 | 0 |
 Aspartate aminotransferase increased | 0 | 0 | 0 | 0 | 1 (20.0)a | 0 |
 Blood creatine phosphokinase increased | 0 | 0 | 0 | 0 | 1 (20.0)a | 0 |
Vascular disorders | 0 | 0 | 0 | 0 | 1 (20.0) | 1 (11.1) |
 Flushing | 0 | 0 | 0 | 0 | 1 (20.0) | 0 |
 Hot flush | 0 | 0 | 0 | 0 | 0 | 1 (11.1) |
Ear and labyrinth disorders | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
 Ear pain | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
Psychiatric disorders | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
 Insomnia | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
Reproductive system and breast disorders | 0 | 0 | 0 | 0 | 1 (20.0) | 0 |
 Dysmenorrhea | 0 | 0 | 0 | 0 | 1 (20.0) | 0 |