Table 3 All grade adverse events reported in ≥10% of patients or any reported grade 3 events (all relatedness), n = 50
AE description | Number (%) of AE by CTCAE grading | |||
|---|---|---|---|---|
Frequency | G1 | G2 | G3 | Total* |
Fatigue | 15 (30) | 10 (20) | 4 (8) | 29 (58) |
Nausea | 12 (24) | 5 (10) | 0 (0) | 17 (34) |
Hyperglycemia | 14 (28) | 1 (2) | 2 (4) | 17 (34) |
Anorexia | 12 (24) | 2 (4) | 1 (2) | 15 (30) |
QTc prolongation | 10 (20) | 3 (6) | 0 (0) | 13 (26) |
Alanine aminotransferase increased | 3 (6) | 2 (4) | 5 (10) | 10 (20) |
Anxiety | 5 (10) | 4 (8) | 0 (0) | 9 (18) |
Depression | 6 (12) | 3 (6) | 0 (0) | 9 (18) |
Diarrhea | 8 (16) | 1 (2) | 0 (0) | 9 (18) |
Aspartate aminotransferase increased | 3 (6) | 1 (2) | 4 (8) | 8 (16) |
Psychiatric disorders—other | 4 (8) | 3 (6) | 0 (0) | 7 (14) |
Gastrointestinal disorders—other | 5 (10) | 0 (0) | 1 (2) | 6 (12) |
Rash acneiform | 5 (10) | 0 (0) | 1 (2) | 6 (12) |
Constipation | 6 (12) | 0 (0) | 0 (0) | 6 (12) |
Cough | 5 (10) | 1 (2) | 0 (0) | 6 (12) |
Insomnia | 6 (12) | 0 (0) | 0 (0) | 6 (12) |
Pain | 1 (2) | 5 (10) | 0 (0) | 6 (12) |
Dyspnea | 2 (4) | 3 (6) | 0 (0) | 5 (10) |
Mucositis oral | 4 (8) | 1 (2) | 0 (0) | 5 (10) |
Rash maculo-papular | 0 (0) | 0 (0) | 2 (4) | 2 (4) |
Alkalosis | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
Dry skin | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
Hepatic failure | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
Hyponatremia | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
Nervous system disorders—other | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
Pain in extremity | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
Papulopustular rash | 0 (0) | 0 (0) | 1 (2) | 1 (2) |
Skin and subcutaneous tissue disorders—other | 0 (0) | 0 (0) | 1 (2) | 1 (2) |