Table 2.
Adverse events at least possibly related to therapy
| Event | Any Grade | Grade 1 | Grade 2 | Grade 3 |
|---|---|---|---|---|
| number of patients (%) | ||||
| Gastrointestinal | ||||
| Abdominal pain | 7 (46.6) | 6 (40) | 1 (6.6) | 0 |
| Nausea | 6 (40) | 6 (40) | 0 | 0 |
| Constipation | 4 (26.6) | 3 (20) | 1 (6.6) | 0 |
| Vomiting | 3 (20) | 2 (13.3) | 1 (6.6) | 0 |
| Abdominal distention | 2 (13.3) | 2 (13.3) | 0 | 0 |
| Flatulence | 2 (13.3) | 2 (13.3) | 0 | 0 |
| Diarrhea | 1 (6.6) | 1 (6.6) | 0 | 0 |
| Dysgeusia | 1 (6.6) | 1 (6.6) | 0 | 0 |
| Achalasia | 1 (6.6) | 0 | 0 | 1 (6.6) |
| Hepatic | ||||
| Alkaline phosphatase increased | 6 (40) | 4 (26.6) | 2 (13.3) | 0 |
| Bilirubin increased | 3 (20) | 1 (6.6) | 2 (13.3) | 0 |
| ALT increased | 2 (13.3) | 2 (13.3) | 0 | 0 |
| AST increased | 2 (13.3) | 2 (13.3) | 0 | 0 |
| Hematologic | ||||
| Platelet count decreased | 2 (13.3) | 1 (6.6) | 1 (6.6) | 0 |
| Neutrophil count decreased | 2 (13.3) | 0 | 2 (13.3) | 0 |
| White blood cells decreased | 2 (13.3) | 2 (13.3) | 0 | 0 |
| Lymphocyte count decreased | 1 (6.6) | 0 | 1 (6.6) | 0 |
| Pulmonary | ||||
| Cough | 1 (6.6) | 1 (6.6) | 0 | 0 |
| Constitutional | ||||
| Fatigue | 8 (53.3) | 7 (46.6) | 1 (6.6) | 0 |
| Rash | 2 (13.3) | 2 (13.3) | 0 | 0 |
| Pruritis | 2 (13.3) | 1 (6.6) | 1 (6.6) | 0 |
| Dizziness | 1 (6.6) | 1 (6.6) | 0 | 0 |
| Dry mouth | 1 (6.6) | 1 (6.6) | 0 | 0 |
| Dry skin | 1 (6.6) | 1 (6.6) | 0 | 0 |
| Edema | 1 (6.6) | 1 (6.6) | 0 | 0 |
| Weight loss | 1 (6.6) | 1 (6.6) | 0 | 0 |
| Neurological | ||||
| Headache | 2 (13.3) | 2 (13.3) | 0 | 0 |
| Renal | ||||
| Hypomagnesemia | 1 (6.6) | 1 (6.6) | 0 | 0 |
AEs were graded using the NIC Common Terminology for Adverse Events (Version 4.1)