Table 3.
Adverse Events (safety population)
Adverse Event | Grade 1 to 2 |
Grade 3 to 4 |
||
---|---|---|---|---|
No. | % | No. | % | |
Diarrhea | 54 | 81 | 2 | 3 |
Fatigue | 53 | 79 | 4 | 6 |
Peripheral neuropathy | 53 | 79 | 2 | 3 |
Alopecia | 48 | 72 | 0 | |
AST elevation | 42 | 63 | 2 | 3 |
ALT elevation | 37 | 55 | 2 | 3 |
Dry skin | 35 | 52 | 1 | 1.5 |
Mucositis | 37 | 55 | 0 | |
Acneiform rash | 37 | 55 | 0 | |
Nausea | 33 | 49 | 1 | 1.5 |
Arthralgia | 36 | 54 | 0 | |
Hot flashes | 33 | 49 | 0 | |
Dyspepsia | 26 | 43 | 0 | |
Xerophthalmia | 28 | 42 | 0 | |
Palmar-plantar erythrodysesthesia syndrome | 25 | 37 | 2 | 3 |
Anorexia | 23 | 34 | 0 | |
Cough | 35 | 52 | 0 | |
Peripheral edema | 26 | 39 | 0 | |
Epistaxis | 25 | 37 | 0 | |
Epiphora | 24 | 36 | 0 | |
Dyspnea | 22 | 33 | 0 |
NOTE. Safety population includes all patients who received at least one dose of study drug. Adverse events of all grades shown have a frequency of 25% or higher.