Table 2. Most common treatment-related adverse events in ≥10% of patients (n = 47).
| Any dose (N = 47) | CC-223 30 mg (n = 23) |
CC-223 45 mg (n = 24) |
||
|---|---|---|---|---|
| Adverse event, n (%) | Any grade, n (%) | Grade 3,a n (%) | Any grade, n (%) | Any grade, n (%) |
| Gastrointestinal disorders | ||||
| Diarrhea | 36 (76.6) | 18 (38.3) | 17 (73.9) | 19 (79.2) |
| Stomatitis | 25 (53.2) | 5 (10.6) | 11 (47.8) | 14 (58.3) |
| Nausea | 18 (38.3) | 1 (2.1) | 6 (26.1) | 12 (50.0) |
| Vomiting | 7 (14.9) | 2 (4.3) | 2 (8.7) | 5 (20.8) |
| Dry mouth | 7 (14.9) | 0 | 2 (8.7) | 5 (20.8) |
| Abdominal pain | 5 (10.6) | 1 (2.1) | 2 (8.7) | 3 (12.5) |
| General disorders | ||||
| Fatigue | 31 (66.0) | 10 (21.3) | 17 (73.9) | 14 (58.3) |
| Asthenia | 11 (23.4) | 3 (6.4) | 7 (30.4) | 4 (16.7) |
| Malaise | 7 (14.9) | 0 | 3 (13.0) | 4 (16.7) |
| Mucosal inflammation | 6 (12.8) | 0 | 3 (13.0) | 3 (12.5) |
| Investigations | ||||
| Blood creatinine increased | 7 (14.9) | 1 (2.1) | 4 (17.4) | 3 (12.5) |
| AST increased | 5 (10.6) | 2 (4.3) | 3 (13.0) | 2 (8.3) |
| Metabolism and nutrition disorders | ||||
| Hyperglycemia | 13 (27.7) | 0 | 5 (21.7) | 8 (33.3) |
| Decreased appetite | 12 (25.5) | 1 (2.1) | 4 (17.4) | 8 (33.3) |
| Dehydration | 8 (17.0) | 1 (2.1) | 4 (17.4) | 4 (16.7) |
| Nervous system disorders | ||||
| Dysgeusia | 8 (17.0) | 0 | 3 (13.0) | 5 (20.8) |
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 19 (40.4) | 2 (4.3) | 7 (30.4) | 12 (50.0) |
| Rash | 18 (38.3) | 1 (2.1) | 6 (26.1) | 12 (50.0) |
| Maculopapular rash | 12 (25.5) | 3 (6.4) | 3 (13.0) | 9 (37.5) |
| Rash macular | 6 (12.8) | 1 (2.1) | 2 (8.7) | 4 (16.7) |
Adverse events were graded according to Common Terminology Criteria for Adverse Events version 4.0. AST, aspartate aminotransferase.
aTreatment-related adverse events were grade 3 only; no grade 4 or grade 5 were reported for these most common toxicities.