Table 4. All adverse events for patients receiving continuous temozolomide (cTMZ) dosing and iniparib.
Adverse Event | Grade 1 No. (% of pts) |
Grade 2 No. (% of pts) |
Grade 3 No. (% of pts) |
Grade 4 | Total No. (% of pts) |
---|---|---|---|---|---|
ALT | 6 (30) | 6(30) | |||
Alkaline phosphatase | 1 (5) | 1 (5) | |||
Anemia | 9 (45) | 1 (5) | 1 (5) | 11 (55) | |
Anorexia | 2 (10) | 1 (5) | 3 (15) | ||
AST | 2 (10) | 2 (10) | |||
Blurred vision | 1 (5) | 1 (5) | |||
Constipation | 5 (25) | 2 (10) | 7 (35) | ||
Elevated serum creatinine | 1 (5) | 1 (5) | |||
Cushingoid | 1 (5) | 1 (5) | |||
Dehydration | 1 (5) | 1 (5) | |||
Diarrhea | 1 (5) | 1 (5) | |||
Dry skin | 1 (5) | 1 (5) | |||
Dysgeusia | 1 (5) | 1 (5) | |||
Edema limbs | 1 (5) | 1 (5) | |||
Erythema multiforme | 1 (5) | 1 (5) | |||
Fatigue | 6 (30) | 9 (45) | 15 (75) | ||
Flatulence | 1 (5) | 1 (5) | |||
Flushing | 2 (10) | 2 (10) | |||
GI complaints | 1 (5) | 1 (5) | |||
Hypoalbuminemia | 1 (5) | 1 (5) | |||
Injection site reaction | 1 (5) | 1 (5) | |||
Insomnia | 3 (15) | 3 (15) | |||
Intracranial haemorrhage | 1 (5) | 1 (5) | |||
motion decreased | 1 (5) | 1 (5) | |||
Mucositis oral | 1 (5) | 1 (5) | |||
Nausea | 7 (35) | 1 (5) | 1 (5) | 9 (45) | |
Nervous system | 1 (5) | 1 (5) | |||
Pain | 1 (5) | 1 (5) | |||
Pruritus | 1 (5) | 2 (10) | 3 (15) | ||
Rash maculo-papular | 1 (5) | 1 (5) | 2 (10) | ||
Urinary frequency | 1 (5) | 1 (5) | |||
Vomiting | 2 (10) | 2 (10) | |||
Weight loss | 1 (5) | 1 (5) | |||
Thromboembolic event | 1 (5) | 1 (5) | |||
Platelet decreased | 5 (25) | 1 (5) | 6 (30) | ||
White blood cell decreased | 7 (35) | 7 (35) | 4 (20) | 1 (5) | 19 (95) |
(Bold indicates met criteria for DLT)