Table 2 Incidence of drug-related adverse events
Drug-related AE# (≥5%) | 600 mg bid (N = 14) | 800mg bid (N = 6) | Total (N = 20) | ||
|---|---|---|---|---|---|
Grade 1 | Grade2 | Grade 1 | Grade 2 | N (%) | |
Laboratory abnormality | Â | ||||
 Leukopenia | 2 | 1 | 0 | 0 | 3(15.0) |
 Neutropenia | 2 | 1 | 0 | 0 | 3(15.0) |
 LDH increased | 1 | 0 | 0 | 0 | 1(5.0) |
 Thrombocytopenia | 1 | 0 | 0 | 0 | 1(5.0) |
Skin and subcutaneous tissue disease | |||||
 Rash | 0 | 1 | 0 | 0 | 1(5.0) |
Gastrointestinal disorders | |||||
 Constipation | 0 | 0 | 1 | 0 | 1(5.0) |
 Diarrhea | 0 | 0 | 0 | 1 | 1(5.0) |
Serious Adverse Event (SAE)* | 600 mg bid | 800 mg bid | Outcome | ||
Gastrointestinal bleeding | 1 | 1 | Resolved/Death | ||
Dyspnea | 2 | 0 | Death | ||
Seroperitoneum | 1 | 0 | Unresolved | ||
Liver abscess | 1 | 0 | Unresolved | ||
Cardiac sudden death | 1 | 0 | Death | ||
Liver function damage aggravated | 0 | 1 | Death | ||