Table 2:
Frequency of Alisertib Related Grade 3 or 4 Toxicity in All Cycles (n=500)
| CTCAE Class | Toxicity | Grade 3 n (%) | Grade 4 n (%) | Grade 5 n (%) |
|---|---|---|---|---|
| Hematologic | Anemia | 63 (12.6%) | 5 (1%) | |
| Febrile neutropenia | 18 (3.6%) | |||
| Lymphopenia | 47 (9.4%) | 14 (2.8%) | ||
| Neutropenia | 124 (24.8%) | 137 (27.4%) | ||
| Thrombocytopenia | 54 (10.8%) | 50 (10%) | ||
| Serum amylase increased | 1 (0.2%) | |||
| Leukopenia | 117 (23.4%) | 48 (9.6%) | ||
| Eye Disorders | Photophobia | 1 (0.2%) | ||
| Gastrointestinal | Diarrhea | 2 (0.4%) | ||
| Enterocolitis | 1 (0.2%) | |||
| Oral mucositis | 19 (3.8%) | |||
| Oral pain | 5 (1%) | |||
| Nausea | 2 (0.4%) | |||
| Vomiting | 2 (0.4%) | |||
| Investigations (Laboratory) | ALT increased | 17 (3.4%) | ||
| AST increased | 10 (2%) | |||
| Hyperbilirubinemia | 3 (0.6%) | |||
| GGT increased | 1 (0.2%) | |||
| INR increased | 1 (0.2%) | |||
| Infection | Infection | 1 (0.2%) | ||
| Pneumonia | 1 (0.2%) | |||
| Urinary tract infection | 1 (0.2%) | |||
| Metabolism/Nutrition | Anorexia | 1 (0.2%) | ||
| Dehydration | 6 (1.2%) | |||
| Hyperuricemia | 1 (0.2%) | |||
| Hypoalbuminemia | 1 (0.2%) | |||
| Hypocalcemia | 1 (0.2%) | |||
| Hypokalemia | 4 (0.8%) | 1 (0.2%) | ||
| Hyponatremia | 3 (0.6%) | |||
| Hypophosphatemia | 1 (0.2%) | |||
| Tumor lysis syndrome | 1 (0.2%) | |||
| Psychiatric | Depression | 1 (0.2%) | ||
| Neurological | Dizziness | 14 (2.8%) | ||
| Hypersomnia | 1 (0.2%) | |||
| Hepatobiliary | Hepatic hemorrhage | 1 (0.2%) | ||
| Respiratory | Respiratory failure | 1 (0.2%) | ||
| Skin/Dermatological | Palmar-plantar erythrodysesthesia | 2 (0.4%) |