Table 4.
AEs with >15 % incidence by maximum toxicity grade (ITT population)
| Adverse events | Number of subjects (%) | |||
|---|---|---|---|---|
| Lapatinib + nab-paclitaxel (n = 60) | ||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Diarrhea (n = 54) | 38 | 30 | 20 | 2 |
| Fatigue (n = 41) | 40 | 18 | 8 | 2 |
| Nausea (n = 39) | 38 | 23 | 2 | 2 |
| Rash (n = 29) | 25 | 18 | 5 | 0 |
| Alopecia (n = 24) | 15 | 25 | 0 | 0 |
| Vomiting (n = 23) | 25 | 8 | 5 | 0 |
| Anemia (n = 22) | 17 | 18 | 2 | 0 |
| Neutropenia (n = 22) | 5 | 10 | 22 | 0 |
| Neuropathy peripheral (n = 21) | 20 | 12 | 3 | 0 |
| Edema peripheral (n = 16) | 15 | 12 | 0 | 0 |
| Cough (n = 15) | 20 | 5 | 0 | 0 |
| Dyspnea (n = 15) | 15 | 5 | 5 | 0 |
| Decreased appetite (n = 15) | 10 | 13 | 2 | 0 |
| Constipation (n = 13) | 20 | 2 | 0 | 0 |
| Epistaxis (n = 13) | 22 | 0 | 0 | 0 |
| Nail disorder (n = 13) | 13 | 8 | 0 | 0 |
| Dehydration (n = 12) | 0 | 13 | 7 | 0 |
| Weight decreased (n = 11) | 10 | 7 | 2 | 0 |
| Pyrexia (n = 11) | 15 | 3 | 0 | 0 |
| Insomnia (n = 11) | 15 | 3 | 0 | 0 |
| Dyspepsia (n = 10) | 15 | 2 | 0 | 0 |
| Pain in extremity (n = 10) | 12 | 5 | 0 | 0 |
| Dysgeusia (n = 10) | 13 | 3 | 0 | 0 |
AE adverse event, ITT intent-to-treat