Table 5.
Adverse events
| No. (%) of patients | ||||
|---|---|---|---|---|
| R(n=211) | NR(n=118) | |||
| Any grade | ≥Grade 3 | Any grade | ≥Grade 3 | |
| Treatment-related adverse eventsb | 136(64.5%) | 37(17.5%) | 78(66.1%) | 22(18.6%) |
| Diarrhea | 41(19.4%) | 6(2.8%) | 8(6.8%) | 1(0.8%) |
| Vomiting | 39(18.5%) | 7(3.3%) | 17(14.4%) | 2(1.7%) |
| Fatigue | 38(18.0%) | 2(0.9%) | 21(17.8%) | 1(0.8%) |
| Neutropenia | 36(17.1%) | 4(1.9%) | 20(16.9%) | 4(3.4%) |
| Anorexia | 27(12.8%) | 3(1.4%) | 16(13.6%) | 2(1.7%) |
| Gastritis | 26(12.3%) | 3(1.4%) | 8(6.8%) | 1(0.8%) |
| Alopecia | 24(11.4%) | 0 | 15(12.7%) | 0 |
| Decreased white blood cells | 23(10.9%) | 3(1.4%) | 13(11.0%) | 6(5.1%) |
| Anemia | 18(8.5%) | 4(1.9%) | 12(10.2%) | 2(1.7%) |
| Decreased platelet count | 18(8.5%) | 2(0.9%) | 12(10.2%) | 3(2.5%) |
| Elevated liver enzymes | 11(5.2%) | 2(0.9%) | 2(1.7%) | 0 |
| Mucositis/stomatitis | 9(4.3%) | 1(0.5%) | 6(5.1%) | 0 |
| Fever | 8(3.8%) | 0 | 5(4.2%) | 0 |
| Arthritis/arthralgia/myalgia | 8(3.8%) | 0 | 3(2.5%) | 0 |
| Peripheral sensory neuropathy | 6(2.8%) | 0 | 0 | 0 |
| Increased blood creatinine | 5(2.4%) | 0 | 2(1.7%) | 0 |
| Hyponatremia | 5(2.4%) | 0 | 0 | 0 |
a. Adverse events were classified according to Medical Dictionary for Regulatory Activities and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Grading ranges from 1 through 5 (1, mild; 2, moderate; 3, severe; 4. life-threatening; and 5, death). b. Treatment-related adverse events occurring in 1% or more of patients in either group are listed. Events are shown in descending order of frequency in R group. c. The numbers represent the number of patients with an adverse event.