Table 5.
Toxicity Criteria [20]
| Mild (Grade 1) | Moderate (Grade 2) | Severe or Medically Significant but Not Immediately Life-Threatening (Grade 3) | Life-Threatening Consequences (Grade 4) | |
|---|---|---|---|---|
| Liver Enzymes –either ALT, AST increase by factor | >ULN-3.0 x ULN | >3.0–5.0 x ULN | >5.0–20 x ULN | > 20 x ULN |
| Bilirubin | >ULN-1.5 x ULN | >1.5–3.0 x ULN | >3.0–10.0 x ULN | >10 x ULN |
|
Creatinine – mg/dL Normal baseline |
1.5 x ULN | >1.5–3.0 x ULN | >3.0–6.0 x ULN | > 6.0 x ULN |
|
Creatinine – mg/dL Elevated baseline |
1.5 x baseline | >1.5–3.0 x baseline | >3.0–6.0 x baseline | > 6.0 x baseline |
| Hemoglobin gm/dL | < LLN-10.0 | < 10.0 to 8.0 | < 8.0 | Life-threatening, urgent intervention indicated |
| WBC Decrease - cell/mm3 | LLN- 3000 | 2000 – 3000 | 1000 – 2000 | < 1000 |
| Platelets Decreased - cell/mm3 | LLN - 75,000 | 50,000 - < 75,000 | < 50,000–25,000 | < 25,000 |