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 |
AE adverse event
aOccurred in the same individual 14 days after the end of dosing following greater-than-usual physical activity by the individual