Number of Patients Treated With rhIL-12 at 500 ng/kg Intravenously With Grade 3 (severe) or Grade 4 (life-threatening) Adverse Experiences
| Adverse Experience . | Phase 2 . | Phase 1 . |
|---|---|---|
| . | (n = 17) (%) . | (n = 12) (%) . |
| Clinical | ||
| Fatigue | 6 (35) | 0 |
| Dyspnea | 5 (29) | 0 |
| Stomatitis | 4 (24) | 0 |
| Acidosis | 3 (18) | 0 |
| Gastrointestinal hemorrhage | 2 (12) | 2 (17) |
| Laboratory | ||
| Leukopenia | 11 (65) | 12 (100) |
| Hyperbilirubinemia | 8 (47) | 6 (50) |
| Elevated AST | 8 (47) | 2 (17) |
| Elevated ALT | 6 (35) | 1 (8) |
| Thrombocytopenia | 4 (24) | 0 |
| Elevated creatinine | 3 (18) | 0 |
| Elevated alkaline phosphatase | 2 (12) | 2 (17) |
| Adverse Experience . | Phase 2 . | Phase 1 . |
|---|---|---|
| . | (n = 17) (%) . | (n = 12) (%) . |
| Clinical | ||
| Fatigue | 6 (35) | 0 |
| Dyspnea | 5 (29) | 0 |
| Stomatitis | 4 (24) | 0 |
| Acidosis | 3 (18) | 0 |
| Gastrointestinal hemorrhage | 2 (12) | 2 (17) |
| Laboratory | ||
| Leukopenia | 11 (65) | 12 (100) |
| Hyperbilirubinemia | 8 (47) | 6 (50) |
| Elevated AST | 8 (47) | 2 (17) |
| Elevated ALT | 6 (35) | 1 (8) |
| Thrombocytopenia | 4 (24) | 0 |
| Elevated creatinine | 3 (18) | 0 |
| Elevated alkaline phosphatase | 2 (12) | 2 (17) |
Adverse experiences that occurred in greater than 15% of patients are listed.
Abbreviations: AST, aspartate aminotransferase; ALT, alanine aminotransferase.