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 | |||||
| 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 | ||
#No grade 3/4 drug-related AEs were observed
*All SAE were judged by the investigators as drug-unrelated
Abbreviation: LDH: lactate dehydrogenase