Table 3.
All Adverse Events Observed in ≥ 10% of Patients
| Adverse Event | No. | % | Grade |
|||
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | |||
| GI | ||||||
| Diarrhea | 22 | 76 | 15 | 7 | 0 | 0 |
| Nausea | 17 | 59 | 11 | 6 | 0 | 0 |
| Vomiting | 9 | 31 | 8 | 0 | 1 | 0 |
| Decreased appetite | 6 | 21 | 5 | 1 | 0 | 0 |
| Dyspepsia | 4 | 14 | 3 | 1 | 0 | 0 |
| Abdominal pain | 4 | 14 | 4 | 0 | 0 | 0 |
| General | ||||||
| Fatigue | 10 | 35 | 4 | 5 | 0 | 1 |
| Peripheral edema | 6 | 21 | 4 | 2 | 0 | 0 |
| Insomnia | 5 | 17 | 2 | 3 | 0 | 0 |
| Pyrexia | 4 | 14 | 2 | 2 | 0 | 0 |
| Dizziness | 4 | 14 | 2 | 2 | 0 | 0 |
| Headache | 4 | 14 | 4 | 0 | 0 | 0 |
| Hypertension | 3 | 10 | 1 | 2 | 0 | 0 |
| Blood | ||||||
| Thrombocytopenia | 8 | 28 | 0 | 0 | 3 | 5 |
| Neutropenia | 8 | 28 | 0 | 0 | 1 | 7 |
| Epistaxis | 5 | 17 | 4 | 1 | 0 | 0 |
| Contusion | 4 | 14 | 3 | 1 | 0 | 0 |
| Respiratory | ||||||
| Cough | 9 | 31 | 6 | 3 | 0 | 0 |
| Upper RTI | 7 | 24 | 2 | 5 | 0 | 0 |
| Sinusitis | 6 | 21 | 2 | 4 | 0 | 0 |
| Lower RTI | 4 | 14 | 0 | 1 | 3 | 0 |
| Pneumonia | 4 | 14 | 0 | 1 | 2 | 1 |
| Productive cough | 4 | 14 | 4 | 0 | 0 | 0 |
| Nasopharyngitis | 4 | 14 | 4 | 0 | 0 | 0 |
| Dyspnea | 3 | 13 | 2 | 1 | 0 | 0 |
| Pain | ||||||
| Arthralgia | 4 | 14 | 2 | 2 | 0 | 0 |
| Oropharyngeal | 3 | 10 | 2 | 1 | 0 | 0 |
| Extremity | 3 | 10 | 0 | 3 | 0 | 0 |
| Skin | ||||||
| Basal cell carcinoma | 4 | 14 | 0 | 3 | 1 | 0 |
| Skin lesion | 4 | 14 | 1 | 2 | 1 | 0 |
| Dry skin | 3 | 10 | 3 | 0 | 0 | 0 |
| Rash | 3 | 10 | 1 | 2 | 0 | 0 |
| Squamous cell carcinoma | 3 | 10 | 0 | 1 | 2 | 0 |
| Infections and other | ||||||
| Herpes simplex | 4 | 14 | 2 | 2 | 0 | 0 |
| Urinary tract | 4 | 14 | 0 | 4 | 0 | 0 |
| Viral | 4 | 14 | 4 | 0 | 0 | 0 |
| Influenza-like illness | 3 | 10 | 2 | 1 | 0 | 0 |
| Stomatitis | 3 | 10 | 1 | 2 | 0 | 0 |
Abbreviation: RTI, respiratory tract infection.