Incidence of Treatment-Emergent Adverse Events, SWOG Toxicity Grading System (n = 22)
| Adverse event* | Grade† | Total† | ||||
|---|---|---|---|---|---|---|
| 1, mild | 2, moderate | 3, severe | 4, life threatening | 5, lethal (fatal) | ||
| ↑ SGOT/SGPT‡ | 7 (31.8) | 9 (40.9) | 5 (22.7) | 0 (0.0) | 0 (0.0) | 21 (95.5) |
| ↑ ALP | 15 (68.2) | 2 (9.1) | 2 (9.1) | 0 (0.0) | 0 (0.0) | 19 (86.4) |
| ↑ LDH | 12 (54.5) | 2 (9.1) | 2 (9.1) | 0 (0.0) | 0 (0.0) | 16 (72.7) |
| ↑ Bilirubin | 0 (0.0) | 8 (36.4) | 2 (9.1) | 3 (13.6) | 0 (0.0) | 13 (59.1) |
| Abdominal pain | 5 (22.7) | 5 (22.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 10 (45.5) |
| ↓ Hemoglobin | 6 (27.3) | 2 (9.1) | 2 (9.1) | 0 (0.0) | 0 (0.0) | 10 (45.5) |
| ↓ White blood cells | 7 (31.8) | 2 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 9 (40.9) |
| M/F/L | 3 (13.6) | 5 (22.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 8 (36.4) |
| ↑ Creatinine | 5 (22.7) | 2 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 7 (31.8) |
| Nausea | 4 (18.2) | 2 (9.1) | 1 (4.5) | 0 (0.0) | 0 (0.0) | 7 (31.8) |
| Other pain§ | 4 (18.2) | 3 (13.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 7 (31.8) |
| Anorexia | 6 (27.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (27.3) |
| ↑ PT | 4 (18.2) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 0 (0.0) | 5 (22.7) |
| Fever, no infection | 1 (4.5) | 3 (13.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (18.2) |
| Gastrointestinal§ | 2 (9.1) | 1 (4.5) | 1 (4.5) | 0 (0.0) | 0 (0.0) | 4 (18.2) |
| ↓ Platelets | 4 (18.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (18.2) |
| Weight gain | 2 (9.1) | 2 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (18.2) |
| Anxiety/depression | 3 (13.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (13.6) |
| Constipation | 3 (13.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (13.6) |
| Diarrhea | 2 (9.1) | 1 (4.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (13.6) |
| Dyspnea | 0 (0.0) | 3 (13.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (13.6) |
| Edema | 1 (4.5) | 2 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (13.6) |
| Gastric ulcer | 0 (0.0) | 0 (0.0) | 2 (9.1) | 0 (0.0) | 1 (4.5) | 3 (13.6) |
| Insomnia | 3 (13.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (13.6) |
| Vomiting | 1 (4.5) | 2 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (13.6) |
| Cough | 1 (4.5) | 1 (4.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (9.1) |
| Hemorrhage | 0 (0.0) | 0 (0.0) | 2 (9.1) | 0 (0.0) | 0 (0.0) | 2 (9.1) |
| Infection | 1 (4.5) | 1 (4.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (9.1) |
| Other liver§ | 0 (0.0) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 1 (4.5) | 2 (9.1) |
| Pneumonia | 1 (4.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.5) | 2 (9.1) |
| Sweating | 2 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (9.1) |
↵* For each patient, highest severity of adverse event was counted once. Adverse events that were reported by at least 2 patients in total population are summarized.
↵† Values in parentheses are percentages.
↵‡ If patient's transaminase was above normal at baseline and patient experienced further increase during study, SWOG grading was not applied; rather, grade 1 toxicity (mild) was defined as 1%–50% increase from baseline, grade 2 toxicity (moderate) as 51%–200% increase from baseline, and grade 3 toxicity (severe) as >200% increase from baseline.
↵§ Other pain included pain in back (n = 1), epigastric (n = 1), chest (n = 1), legs (n = 1), shoulder (n = 1), stomach (n = 1), and toe (n = 1). Other gastrointestinal included abdominal discomfort (n = 1), early satiety (n = 1), heartburn (n = 1), and duodenal ulcer (n = 1). Other liver included hepatitis (n = 2).
SGOT = serum glutamic oxaloacetic transaminase; SGPT = serum glutamic pyruvic transaminase; ALP = alkaline phosphatase; LDH = lactic dehydrogenase; M/F/L = malaise/fatigue/lethargy; PT = prothrombin time; Hemorrhage = hemorrhage (clinical).