Table 3.
Reported Adverse Effects, Categorized and Graded According to CTCAE v3.0
Adverse Effect | Grade |
Total | Percentage of Grade 3-5 Adverse Effects | |||||
---|---|---|---|---|---|---|---|---|
0 | 1 | 2 | 3 | 4 | 5 | |||
Leukopenia | 2 | 4 | 20 | 19 | 1 | 0 | 46 | 43.4 |
Neutropenia | 1 | 3 | 3 | 19 | 20 | 0 | 46 | 84.7 |
Thrombocytopenia | 17 | 19 | 5 | 3 | 2 | 0 | 46 | 10.8 |
Anemia | 4 | 10 | 27 | 3 | 2 | 0 | 46 | 10.8 |
Hemolysis | 46 | 0 | 0 | 0 | 0 | 0 | 46 | 0 |
Other hematologic | 43 | 0 | 1 | 2 | 0 | 0 | 46 | 4.3 |
Allergy | 40 | 3 | 0 | 3 | 0 | 0 | 46 | 6.5 |
Auditory | 43 | 0 | 2 | 1 | 0 | 0 | 46 | 2.1 |
Cardiovascular | 39 | 3 | 2 | 1 | 1 | 0 | 46 | 4.3 |
Coagulation | 45 | 0 | 1 | 0 | 0 | 0 | 46 | 0 |
Constitutional | 33 | 8 | 4 | 1 | 0 | 0 | 46 | 2.1 |
Fatigue | 9 | 14 | 19 | 4 | 0 | 0 | 46 | 8.7 |
Alopecia | 8 | 7 | 31 | 0 | 0 | 0 | 46 | 0 |
Dermatologic | 36 | 8 | 2 | 0 | 0 | 0 | 46 | 0 |
Endocrine | 44 | 2 | 0 | 0 | 0 | 0 | 46 | 0 |
GI | 18 | 12 | 14 | 2 | 0 | 0 | 46 | 4.3 |
Nausea | 17 | 20 | 8 | 1 | 0 | 0 | 46 | 2.1 |
Vomiting | 35 | 7 | 3 | 1 | 0 | 0 | 46 | 2.1 |
Diarrhea | 35 | 8 | 2 | 1 | 0 | 0 | 46 | 2.1 |
Stomatitis | 45 | 1 | 0 | 0 | 0 | 0 | 46 | 0 |
Genitourinary/renal | 45 | 1 | 0 | 0 | 0 | 0 | 46 | 0 |
Hemorrhage | 43 | 1 | 2 | 0 | 0 | 0 | 46 | 0 |
Hepatic | 45 | 0 | 0 | 1 | 0 | 0 | 46 | 2.1 |
Infection/fever | 46 | 0 | 0 | 0 | 0 | 0 | 46 | 0 |
Febrile neutropenia | 45 | 0 | 0 | 1 | 0 | 0 | 46 | 2.1 |
Metabolic | 23 | 18 | 4 | 1 | 0 | 0 | 46 | 2.1 |
Creatinine | 44 | 2 | 0 | 0 | 0 | 0 | 46 | 0 |
Musculoskeletal | 41 | 2 | 2 | 1 | 0 | 0 | 46 | 2.1 |
Neurologic | 40 | 0 | 4 | 2 | 0 | 0 | 46 | 4.3 |
Neuromotor | 44 | 0 | 2 | 0 | 0 | 0 | 46 | 0 |
Sensory neuropathy | 14 | 15 | 12 | 5 | 0 | 0 | 46 | 10.8 |
Ocular/visual | 43 | 2 | 1 | 0 | 0 | 0 | 46 | 0 |
Pain | 35 | 3 | 6 | 0 | 2 | 0 | 46 | 4.3 |
Myalgia | 35 | 3 | 7 | 1 | 0 | 0 | 46 | 2.1 |
Arthralgia | 36 | 4 | 6 | 0 | 0 | 0 | 46 | 0 |
Pulmonary | 37 | 5 | 2 | 2 | 0 | 0 | 46 | 4.3 |
Abbreviation: CTCAE, Common Terminology Criteria for Adverse Events.