Table 3. Treatment related toxicity.
Cumulative toxicology analysis | Number of patients |
---|---|
Clinical toxicities | |
Treatment-related mortality | 0 |
Non-specific abdominal pain (mild, grade 1) | 2 |
Fatigue | |
Total | 8 |
Grade 1 | 4 |
Grade 2 | 1 |
Grade 3 | 3 |
Laboratory toxicities | |
Hyperbilirubinemia | |
Total | 3 |
Grade 1 | 1 |
Grade 2 | 0 |
Grade 3Ψ | 2 |
Grade ≥4 | 0 |
Transaminitis (AST/ALT) | |
Total | 5 |
Grade 1 | 2 |
Grade 2 | 1 |
Grade 3 | 2 |
Grade ≥4 | 0 |
Elevated alkaline phosphatase | |
Total | 3 |
Grade 1* | 1 |
Grade 2* | 2 |
Grade ≥3 | 0 |
Hematological toxicity (RBC, WBC, Platelets) | |
Grade 1 | 2 |
Renal toxicity | |
Total | 0 |
*, all cases with elevated level of alkaline phosphatase were observed with gemcitabine at 1,000 mg/m2; Ψ, grade 3 elevated level of bilirubin was seen with gemcitabine at 800 mg/m2.