Table 3.
TEAE, n (%) | Dose escalation (n = 25) | Dose expansion (n = 18) | ||
---|---|---|---|---|
All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
At least one TEAE | 25 (100) | 12 (48) | 18 (100) | 9 (50) |
Nausea | 12 (48) | 0 | 8 (44) | 1 (6) |
Diarrhea | 10 (40) | 0 | 6 (33) | 2 (11) |
Fatigue | 10 (40) | 3 (12) | 11 (61) | 2 (11) |
Anemiaa | 9 (36) | 1 (4) | 6 (33) | 0 |
Rash | 8 (32) | 0 | 2 (11) | 0 |
Decreased appetite | 7 (28) | 0 | 5 (28) | 0 |
Hyperglycemia | 7 (28) | 0 | 3 (17) | 0 |
Vomiting | 6 (24) | 0 | 6 (33) | 1 (6) |
Hypokalemia | 6 (24) | 1 (4) | 5 (28) | 1 (6) |
Hypoalbuminemia | 6 (24) | 0 | 2 (11) | 0 |
Hypomagnesemia | 6 (24) | 0 | 1 (6) | 0 |
Back pain | 6 (24) | 0 | 0 | 0 |
Hypocalcemia | 5 (20) | 0 | 1 (6) | 0 |
Increased alkaline phosphatase | 5 (20) | 0 | 0 | 0 |
Abdominal pain | 4 (16) | 1 (4) | 3 (17) | 0 |
Dehydration | 4 (16) | 1 (4) | 3 (17) | 1 (6) |
Dyspepsia | 4 (16) | 0 | 1 (6) | 0 |
Increased AST | 4 (16) | 0 | 0 | 0 |
Decreased weight | 3 (12) | 0 | 6 (33) | 0 |
Dyspnea | 3 (12) | 1 (4) | 4 (22) | 2 (11) |
Dysuria | 3 (12) | 0 | 2 (11) | 0 |
Hyponatremia | 3 (12) | 1 (4) | 1 (6) | 0 |
Constipation | 3 (12) | 0 | 1 (6) | 0 |
Stomatitis | 3 (12) | 0 | 1 (6) | 0 |
Disease progression | 3 (12) | 3 (12) | 1 (6) | 1 (6) |
Edema peripheral | 3 (12) | 1 (4) | 1 (6) | 1 (6) |
Dizziness | 3 (12) | 0 | 1 (6) | 1 (6) |
Pain in extremities | 3 (12) | 1 (4) | 0 | 0 |
Hypotension | 3 (12) | 1 (4) | 0 | 0 |
Headache | 2 (8) | 0 | 2 (11) | 0 |
Muscle spasms | 2 (8) | 0 | 2 (11) | 0 |
Musculoskeletal pain | 1 (4) | 0 | 3 (17) | 0 |
Prolonged activated partial thromboplastin time | 1 (4) | 1 (4) | 2 (11) | 1 (6) |
Asthenia | 1 (4) | 0 | 2 (11) | 0 |
Cough | 1 (4) | 0 | 2 (11) | 0 |
Decreased ejection fraction | 1 (4) | 0 | 2 (11) | 0 |
Flank pain | 1 (4) | 0 | 2 (11) | 1 (6) |
Exertional dyspnea | 0 | 0 | 5 (28) | 1 (6) |
Urinary tract infection | 0 | 0 | 4 (22) | 0 |
Lymphopenia | 0 | 0 | 2 (11) | 0 |
Pyrexia | 0 | 0 | 2 (11) | 0 |
Thrombocytopenia | 0 | 0 | 2 (11) | 0 |
Decreased potassium | 0 | 0 | 2 (11) | 0 |
AST aspartate aminotransferase, TEAE treatment-emergent adverse event
aIncludes grouped terms: anemia, hemoglobin decreased