TABLE II.
Non-Hematologic Adverse Events of Grade 3 and Higher for Patients With ALL and AML Treated at Clofarabine Dose of 40 mg/m2
| Toxicity site | Toxicity type | CTCAE
|
|||||||
|---|---|---|---|---|---|---|---|---|---|
| ALL (n = 8)
|
AML (n = 2)
|
||||||||
| Induction, Cycle I
|
Induction, Cycle II
|
Induction, Cycle I
|
Induction, Cycle II
|
||||||
| N | % | N | % | N | % | N | % | ||
| Gastrointestinal | |||||||||
| Anorexia | 1 | 13% | 0 | 0% | 1 | 50% | 0 | 0% | |
| Diarrhea | 2 | 25% | 0 | 0% | 0 | 0% | 0 | 0% | |
| Infection | |||||||||
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection; ANC <1.0 × 109/L, fever ≥38.5 days) | 5 | 63% | 1 | 25% | 1 | 50% | 0 | 0% | |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 × 109/L) lung (pneumonia) | 2 | 25% | 0 | 0% | 2 | 100% | 0 | 0% | |
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 × 109/L) blood | 2 | 25% | 1 | 25% | 1 | 50% | 0 | 0% | |
| Infection, other | 0 | 0% | 0 | 0% | 0 | 0% | 1 | 100% | |
| Metabolic/laboratory | |||||||||
| ALT, SGPT (serum glutamic pyruvic transaminase) | 2 | 25% | 0 | 0% | 1 | 50% | 0 | 0% | |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | 3 | 38% | 0 | 0% | 0 | 0% | 0 | 0% | |
| Potassium, serum-low (hypokalemia) | 3 | 38% | 0 | 0% | 1 | 50% | 0 | 0% | |
| Pain | |||||||||
| Abdomen NOS | 3 | 38% | 0 | 0% | 0 | 0% | 0 | 0% | |
| Head/headache | 2 | 25% | 0 | 0% | 0 | 0% | 0 | 0% | |
| Pulmonary/upper respiratory | |||||||||
| Hypoxia | 2 | 25% | 1 | 25% | 0 | 0% | 0 | 0% | |
| Pneumonitis/pulmonary infiltrates | 2 | 25% | 0 | 0% | 1 | 50% | 0 | 0% | |
| Total patients | 8 | 4 | 2 | 1 | |||||
| Patients with toxicity | 7 | 88% | 2 | 50% | 2 | 100% | 1 | 100% | |
| Patients without toxicity | 1 | 13% | 2 | 50% | 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.