Table 3. All adverse events for patients receiving monthly temozolomide (mTMZ) dosing and iniparib.
| Adverse Event | Grade 1 No. (% of pts) |
Grade 2 No. (% of pts) |
Grade 3 No. (% of pts) |
Grade 4 No. (% of pts) |
Total No. (% of pts) |
|---|---|---|---|---|---|
| ALT | 2 (9) | 1 (4) | 3 (13) | ||
| Alkaline phosphatase | 1 (4) | 1 (4) | |||
| Allergic reaction | 1 (4) | 1 (4) | |||
| Anemia | 12 (52) | 1 (4) | 13 (57) | ||
| Anorexia | 2 (9) | 2 (9) | |||
| Arthralgia | 1 (4) | 1 (4) | |||
| AST | 3 (13) | 3 (13) | |||
| Blood bilirubin increased | 1 (4) | 1 (4) | |||
| Chills | 1 (4) | 1 (4) | |||
| Confusion | 1 (4) | 1 (4) | |||
| Constipation | 8 (35) | 1 (4) | 9 (39) | ||
| Elevated serum creatinine | 1 (4) | 1 (4) | |||
| Depression | 1 (4) | 1 (4) | |||
| Diarrhea | 1 (4) | 1 (4) | |||
| Dizziness | 5 (22) | 5 (22) | |||
| Dry skin | 1 (4) | 1 (4) | |||
| Fatigue | 10 (43) | 4 (17) | 1 (4) | 15 (65) | |
| Headache | 2 (9) | 2 (9) | |||
| Hyperglycemia | 4 (17) | 4 (17) | |||
| Hyperkalemia | 1 (4) | 1 (4) | |||
| Hypertension | 1 (4) | 1 (4) | |||
| Hypoalbuminemia | 2 (9) | 2 (9) | |||
| Hypocalcemia | 3 (13) | 3 (13) | |||
| Hypokalemia | 1 (4) | 1 (4) | |||
| Injection site reaction | 1 (4) | 2 (9) | 3 (13) | ||
| Nausea | 9 (39) | 9 (39) | |||
| Neutrophil count decreased | 1 (4) | 1 (4) | |||
| Pain | 1 (4) | 1 (0.8) | 2 (9) | ||
| Platelet decreased | 11 (48) | 3 (13) | 1 (4) | 15 (65) | |
| Pruritus | 1 (4) | 1 (4) | |||
| Purpura | 1 (4) | 1 (4) | |||
| Rash maculo-papular | 2 (9) | 3 (13) | 1 (4) | 6 (26) | |
| Urticaria | 1 (4) | 1 (4) | |||
| Venous injury | 1 (4) | 1 (4) | |||
| Vomiting | 4 (17) | 4 (17) | |||
| White blood cell count decreased | 8 (35) | 3 (13) | 2 (8) | 13 (56) |
(Bold indicates met criteria for DLT)