Table 2.
Adverse Events | 12W-RDI ≥ 80% (n = 54) | 12W-RDI < 80% (n = 24) | ||
---|---|---|---|---|
All-Grade | ≥ Grade 3 | All-Grade | ≥ Grade 3 | |
Hematologic adverse events: | 45 (83%) | 12 (22%) | 20 (83%) | 7 (29%) |
Leukocytopenia | 21 (39%) | 2 (4%) | 11 (46%) | 1 (4%) |
Neutropenia | 25 (46%) | 4 (9%) | 11 (46%) | 3 (13%) |
Lymphocytopenia | 19 (35%) | 8 (15%) | 12 (50%) | 3 (13%) |
Anemia | 14 (26%) | 0 | 11 (46%) | 0 |
Thrombocytopenia | 19 (35%) | 0 | 11 (46%) | 0 |
Non-hematologic adverse events: | 54 (100%) | 12 (22%) | 24 (100%) | 11 (46%) |
Diarrhea | 31 (57%) | 0 | 10 (42%) | 0 |
Hypertension | 29 (54%) | 9 (17%) | 15 (63%) | 3 (13%) |
Nausea/anorexia | 28 (52%) | 0 | 17 (31%) | 0 |
Fatigue | 26 (48%) | 0 | 16 (67%) | 0 |
Hand-foot-syndrome | 20 (37%) | 0 | 8 (33%) | 0 |
Infection | 10 (19%) | 2 (4%) | 3 (13%) | 1 (4%) |
Pneumothorax | 7 (13%) | 2 (4%) | 0 | 0 |
Total bilirubin increase | 17 (31%) | 0 | 14 (58%) | 0 |
AST/ALT increase | 40 (74%) | 1 (2%) | 21 (88%) | 8 (33%) |
Serum creatinine increase | 9 (17%) | 0 | 7 (29%) | 1 (4%) |
Electrolytes disorder 1 | 25 (46%) | 0 | 14 (58%) | 2 (8%) |
Hypothyroidism | 30 (56%) | 0 | 10 (42%) | 0 |
Other adverse events 2 | 37 (69%) | 4 (7%) | 15 (63%) | 1 (4%) |
1 Electrolytes disorders included hypocalcinemia, hypercalcinemia, hyponatremia, hypokalemia, and hyperkalemia. The two patients with electrolytes disorders of Grade 3 or more observed in 12W-RDI <80% patients were both Grade 3 hypokalemia. 2 Other adverse events of Grade 3 or more observed in the 12W-RDI ≥80% patients were Grade 3 hyperglycemia, Grade 4 pulmonary embolism, Grade 3 ascites, and Grade 4 heart failure; that in the 12W-RDI <80% patient was Grade 3 mucositis.