Table 2.
Body system/category | Adverse event | No. patients (%) |
|
Grade 3 | Grade 4 | ||
Hematologic | Anemia | 2 (2) | 0 (0) |
Leukopenia | 41 (49) | 8 (10) | |
Lymphopenia | 11 (13) | 5 (6) | |
Neutropenia | 24 (29) | 5 (6) | |
Thrombocytopenia | 9 (11) | 0 (0) | |
Hemorrhage | Hemoptysis | 1 (1) | 0 (0) |
Hepatic | Elevated ALT | 2 (2) | 1 (1) |
Elevated AST | 3 (4) | 1 (1) | |
Elevated bilirubin | 1 (1) | 0 (0) | |
Hypoalbuminemia | 4 (5) | 0 (0) | |
Infection | Febrile neutropenia | 3 (4) | 1 (1) |
Infection | 4 (5) | 0 (0) | |
Metabolic/laboratory | Hyperglycemia | 8 (10) | 0 (0) |
Hyperkalemia | 1 (1) | 0 (0) | |
Hypocalcemia | 7 (8) | 3 (4) | |
Hypokalemia | 15 (18) | 4 (5) | |
Hypomagnesemia | 8 (10) | 2 (2) | |
Hyponatremia | 2 (2) | 0 (0) | |
Hypophosphatemia | 2 (2) | 0 (0) | |
Elevated ALK phosphatase | 1 (1) | 0 (0) | |
Neurologic | Depression | 1 (1) | 0 (0) |
Neurosensory | 1 (1) | 0 (0) | |
Syncope | 2 (2) | 0 (0) | |
Pain | Pain, abdominal | 8 (10) | 1 (1) |
Pain, back | 1 (1) | 0 (0) | |
Pain, gingivitis | 1 (1) | 0 (0) | |
Renal/genitourinary | Polyuria | 1 (1) | 0 (0) |
Cardiovascular | QTc interval prolongation | 1 (1) | 0 (0) |
Hypertension | 1 (1) | 0 (0) | |
Hypotension | 3 (4) | 0 (0) | |
Sinus bradycardia | 1 (1) | 0 (0) | |
Thrombosis | 2 (2) | 1 (1) | |
Coagulation | Elevated PTT | 1 (1) | 0 (0) |
Elevated prothrombin time | 2 (2) | 0 (0) | |
Constitutional symptoms | Fatigue | 14 (17) | 0 (0) |
Weight loss | 6 (7) | 0 (0) | |
Dermatologic/skin | Alopecia | 1 (1) | 0 (0) |
Rash/desquamation | 3 (4) | 0 (0) | |
RXN, hand/foot syndrome | 9 (11) | 0 (0) | |
Pruritus | 1 (1) | 0 (0) | |
Skin irritation | 1 (1) | 0 (0) | |
Gastrointestinal | Anorexia | 22 (26) | 1 (1) |
Dehydration | 18 (21) | 2 (2) | |
Diarrhea | 16 (19) | 4 (5) | |
Dysphagia | 2 (2) | 0 (0) | |
Hemorrhoids | 1 (1) | 0 (0) | |
Nausea | 25 (30) | 0 (0) | |
Mucositis | 19 (23) | 1 (1) | |
Vomiting | 13 (15) | 2 (2) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ALK, alkaline; QTc, Q-T corrected; PTT, partial thromboplastin time; RXN, reaction.