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. 2021 Jul 11;39(6):1604–1612. doi: 10.1007/s10637-021-01145-y

Table 3.

All-cause TEAEs occurring in ≥ 10% of patients in the safety population in either study portion

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