Table 3.
Treatment-Related (including definite, possible, and probable) Adverse Events of All Grades and Grades 3 to 5 Occurring in More Than 10% of Patients in Any Arm
| Adverse Event | Total (n = 200) | Arm 1 (n = 22) | Arm 2 (n = 42) | Arm 3 (n = 75) | Arm 4 (n = 61) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All Grades | Grades 3-5 | All Grades | Grades 3-5 | All Grades | Grades 3-5 | All Grades | Grades 3-5 | All Grades | Grades 3-5 | |||||||||||
| No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | |
| Fatigue | 74 | 37.0 | 16 | 8.0 | 2 | 9.1 | 1 | 4.5 | 15 | 35.7 | 1 | 2.4 | 31 | 41.3 | 6 | 8.0 | 26 | 42.6 | 8 | 13.1 |
| Diarrhea | 73 | 36.5 | 13 | 6.5 | 8 | 36.4 | 2 | 9.1 | 24 | 57.1 | 7 | 16.7 | 26 | 34.7 | 2 | 2.7 | 15 | 24.6 | 2 | 3.3 |
| Rash | ||||||||||||||||||||
| Maculopapular | 70 | 35.0 | 9 | 4.5 | 3 | 13.6 | 0 | 0.0 | 14 | 33.3 | 1 | 2.4 | 29 | 38.7 | 7 | 9.3 | 24 | 39.3 | 1 | 1.6 |
| Acneiform | 61 | 30.5 | 6 | 3.0 | 11 | 50.0 | 1 | 4.5 | 18 | 42.9 | 1 | 2.4 | 29 | 38.7 | 4 | 5.3 | 3 | 4.9 | 0 | 0.0 |
| Nausea | 57 | 28.5 | 5 | 2.5 | 7 | 31.8 | 1 | 4.5 | 13 | 31.0 | 2 | 4.8 | 25 | 33.3 | 1 | 1.3 | 12 | 19.7 | 1 | 1.6 |
| Vomiting | 56 | 28.0 | 5 | 2.5 | 5 | 22.7 | 0 | 0.0 | 10 | 23.8 | 3 | 7.1 | 27 | 36.0 | 2 | 2.7 | 14 | 23.0 | 0 | 0.0 |
| Dry skin | 50 | 25.0 | 4 | 2.0 | 7 | 31.8 | 0 | 0.0 | 12 | 28.6 | 0 | 0.0 | 13 | 17.3 | 3 | 4.0 | 18 | 29.5 | 1 | 1.6 |
| Anorexia | 46 | 23.0 | 1 | 0.5 | 6 | 27.3 | 0 | 0.0 | 16 | 38.1 | 0 | 0.0 | 9 | 12.0 | 0 | 0.0 | 15 | 24.6 | 1 | 1.6 |
| Increased AST | 46 | 23.0 | 5 | 2.5 | 5 | 22.7 | 0 | 0.0 | 5 | 11.9 | 0 | 0.0 | 29 | 38.7 | 5 | 6.7 | 7 | 11.5 | 0 | 0.0 |
| Hyperglycemia | 41 | 20.5 | 3 | 1.5 | 2 | 9.1 | 0 | 0.0 | 11 | 26.2 | 1 | 2.4 | 24 | 32.0 | 2 | 2.7 | 4 | 6.6 | 0 | 0.0 |
| Oral mucositis | 40 | 20.0 | 6 | 3.0 | 3 | 13.6 | 1 | 4.5 | 13 | 31.0 | 3 | 7.1 | 14 | 18.7 | 1 | 1.3 | 10 | 16.4 | 1 | 1.6 |
| Increased alkaline phosphatase | 39 | 19.5 | 2 | 1.0 | 2 | 9.1 | 0 | 0.0 | 10 | 23.8 | 0 | 0.0 | 17 | 22.7 | 1 | 1.3 | 10 | 16.4 | 1 | 1.6 |
| Weight loss | 38 | 19.0 | 1 | 0.5 | 3 | 13.6 | 0 | 0.0 | 11 | 26.2 | 0 | 0.0 | 2 | 2.7 | 0 | 0.0 | 22 | 36.1 | 1 | 1.6 |
| Increased ALT | 32 | 16.0 | 4 | 2.0 | 0 | 0.0 | 0 | 0.0 | 5 | 11.9 | 0 | 0.0 | 22 | 29.3 | 4 | 5.3 | 5 | 8.2 | 0 | 0.0 |
| Pruritus | 22 | 11.0 | 1 | 0.5 | 1 | 4.5 | 0 | 0.0 | 4 | 9.5 | 0 | 0.0 | 8 | 10.7 | 1 | 1.3 | 9 | 14.8 | 0 | 0.0 |
| Other skin and subcutaneous tissue disorders, specify | 19 | 9.5 | 0 | 0.0 | 3 | 13.6 | 0 | 0.0 | 3 | 7.1 | 0 | 0.0 | 8 | 10.7 | 0 | 0.0 | 5 | 8.2 | 0 | 0.0 |
| Dyspnea | 18 | 9.0 | 4 | 2.0 | 1 | 4.5 | 0 | 0.0 | 2 | 4.8 | 1 | 2.4 | 8 | 10.7 | 1 | 1.3 | 7 | 11.5 | 2 | 3.3 |
| Palmar-plantar erythrodysesthesia syndrome | 17 | 8.5 | 5 | 2.5 | 1 | 4.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 1.3 | 0 | 0.0 | 15 | 24.6 | 5 | 8.2 |
| Dry mouth | 16 | 8.0 | 0 | 0.0 | 1 | 4.5 | 0 | 0.0 | 6 | 14.3 | 0 | 0.0 | 6 | 8.0 | 0 | 0.0 | 3 | 4.9 | 0 | 0.0 |
| Increased blood bilirubin | 13 | 6.5 | 1 | 0.5 | 5 | 22.7 | 0 | 0.0 | 2 | 4.8 | 0 | 0.0 | 1 | 1.3 | 0 | 0.0 | 5 | 8.2 | 1 | 1.6 |
| Hyponatremia | 13 | 6.5 | 3 | 1.5 | 1 | 4.5 | 0 | 0.0 | 3 | 7.1 | 1 | 2.4 | 0 | 0.0 | 0 | 0.0 | 9 | 14.8 | 2 | 3.3 |
| Alopecia | 13 | 6.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 2.4 | 0 | 0.0 | 5 | 6.7 | 0 | 0.0 | 7 | 11.5 | 0 | 0.0 |
| Hypertension | 13 | 6.5 | 3 | 1.5 | 0 | 0.0 | 0 | 0.0 | 1 | 2.4 | 0 | 0.0 | 2 | 2.7 | 0 | 0.0 | 10 | 16.4 | 3 | 4.9 |
| Anemia | 11 | 5.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 2 | 4.8 | 0 | 0.0 | 2 | 2.7 | 0 | 0.0 | 7 | 11.5 | 0 | 0.0 |
| Hypoalbuminemia | 10 | 5.0 | 0 | 0.0 | 1 | 4.5 | 0 | 0.0 | 1 | 2.4 | 0 | 0.0 | 1 | 1.3 | 0 | 0.0 | 7 | 11.5 | 0 | 0.0 |
| Dysgeusia | 9 | 4.5 | 0 | 0.0 | 1 | 4.5 | 0 | 0.0 | 5 | 11.9 | 0 | 0.0 | 3 | 4.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
| Increased creatinine | 9 | 4.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 5 | 11.9 | 0 | 0.0 | 2 | 2.7 | 0 | 0.0 | 2 | 3.3 | 0 | 0.0 |
| Hoarseness | 9 | 4.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 1.3 | 0 | 0.0 | 8 | 13.1 | 0 | 0.0 |
| Epistaxis | 8 | 4.0 | 0 | 0.0 | 3 | 13.6 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 1.3 | 0 | 0.0 | 4 | 6.6 | 0 | 0.0 |
| Hypophosphatemia | 8 | 4.0 | 1 | 0.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 8 | 13.1 | 1 | 1.6 |