TABLE III.
Non-Hematologic Adverse Events of Grade 3 and Higher for Patients With ALL at Clofarabine Dose of 52 mg/m2 AML Patients Treated at This Dose on the Dose-Finding Portion of the Study are Also Included
| Toxicity site | Toxicity type | CTCAE
|
|||||||
|---|---|---|---|---|---|---|---|---|---|
| ALL (n = 13)
|
AML (n = 7)
|
||||||||
| Induction, Cycle I
|
Induction, Cycle II
|
Induction, Cycle I
|
Induction, Cycle II
|
||||||
| N | % | N | % | N | % | N | % | ||
| Gastrointestinal | |||||||||
| Anorexia | 3 | 23% | 2 | 29% | 1 | 14% | 2 | 40% | |
| Diarrhea | 1 | 8% | 0 | 0% | 2 | 29% | 2 | 40% | |
| Nausea | 0 | 0% | 0 | 0% | 2 | 29% | 2 | 40% | |
| Infection | |||||||||
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection; ANC <1.0 × 109/L, fever ≥38.5 days) | 6 | 46% | 3 | 43% | 3 | 43% | 2 | 40% | |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 × 109/L) catheter-related | 2 | 15% | 0 | 0% | 1 | 14% | 0 | 0% | |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 × 109/L) skin (cellulites) | 1 | 8% | 0 | 0% | 1 | 14% | 0 | 0% | |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 × 109/L) blood | 2 | 15% | 2 | 29% | 4 | 57% | 2 | 40% | |
| Metabolic/laboratory | ALT, SGPT (serum glutamic pyruvic transaminase) | 5 | 38% | 1 | 14% | 0 | 0% | 0 | 0% |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | 4 | 31% | 1 | 14% | 0 | 0% | 0 | 0% | |
| Calcium, serum-high (hypercalcemia) | 1 | 8% | 2 | 29% | 0 | 0% | 0 | 0% | |
| GGT (gamma-glutamyl transpeptidase) | 2 | 15% | 0 | 0% | 0 | 0% | 0 | 0% | |
| Glucose, serum-high (hyperglycemia) | 1 | 8% | 2 | 29% | 2 | 29% | 1 | 20% | |
| Potassium, serum-low (hypokalemia) | 4 | 31% | 2 | 29% | 2 | 29% | 2 | 40% | |
| Pain | |||||||||
| Abdomen NOS | 2 | 15% | 0 | 0% | 1 | 14% | 1 | 20% | |
| Pulmonary/upper respiratory | |||||||||
| Dyspnea (shortness of breath) | 2 | 15% | 0 | 0% | 0 | 0% | 0 | 0% | |
| Hypoxia | 1 | 8% | 1 | 14% | 0 | 0% | 0 | 0% | |
| Total patients | 13 | 7 | 7 | 5 | |||||
| Patients with toxicity | 12 | 92% | 6 | 86% | 7 | 100% | 5 | 100% | |
| Patients without toxicity | 1 | 8% | 1 | 14% | 0 | 0% | 0 | 0% | |
CTCAE, Common Terminology Criteria for Adverse Events (version 3.0). Listed are toxicities occurring in more than one patient, and are listed regardless of relationship to study drug.