Table 3 Treatment-related adverse event occurring during the first cycle according to treatment arm and CTCAE category.
Standard-arm (n = 78) < grade 3 | ≥ grade 3 | ATRA-Arm (n = 66) < grade 3 | ≥ grade 3 | |
---|---|---|---|---|
Cardiac Arrhythmia, no | 1 | 0 | 0 | 1 |
Cardiac general, no | 1 | 1 | 6 | 1 |
coagulation, no | 1 | 0 | 1 | 0 |
Constitutional Symptoms, no | 28 | 3 | 24 | 2 |
Dermatology/skin, no | 9 | 0 | 7 | 1 |
Endocrine, no | 0 | 0 | 1 | 0 |
Gastrointestinal, no | 48 | 4 | 42 | 6 |
Hemorrhage/bleeding, no | 9 | 1 | 10 | 2 |
Hepatobiliary/pancreas, no | 2 | 0 | 0 | 0 |
infection, no | 15 | 25 | 13 | 27 |
Lymphatics, no | 2 | 0 | 6 | 0 |
Metabolic/laboratory, No | 22 | 5 | 26 | 7 |
Neurology, no | 9 | 0 | 5 | 1 |
Ocular/visual, no | 0 | 0 | 2 | 0 |
pain, no | 11 | 2 | 16 | 2 |
Pulmonary/upper respiratory, no | 0 | 0 | 8 | 5 |
Renal/genitourinary, no | 6 | 5 | 6 | 3 |
Syndromes, no | 1 | 1 | 0 | 0 |
Vascular, no | 1 | 0 | 1 | 1 |