Table 1.
Severity scales used to categorize laboratory parameters and solicited reactions
| Mild | Moderate | Severe | |
|---|---|---|---|
| Pain | Easily tolerated | Sufficiently discomforting to interfere with normal behavior or activities | Incapacitating, unable to perform usual activities, may have and/or require medical care or absenteeism |
| Erythema or edema | < 2.5 cm | ≥ 2.5 to < 5 cm | ≥ 5 cm |
| Fever | ≥ 37.5°C to 38°C oral | ≥ 38.1°C to 39.0°C oral | ≥ 39.1°C oral |
| Headache, malaise, myalgia, or asthenia | Noticeable but does not interfere with daily activities | Interferes with daily activities | Prevents daily activities |
| Hb decrease (female; g/dL) | ≥ 9.4 to ≤ 10.9 | ≥ 8.4 to < 9.4 | < 8.4 |
| Hb decrease (male; g/dL) | ≥ 11.3 to ≤ 12.8 | ≥ 10.3 to < 11.3 | < 10.3 |
| WBC decrease (cells/mm3) | < LLN to ≥ 3,000 | < 3,000 to ≥ 2,000 | < 2,000 |
| Lymphocytes decrease (cells/mm3) | < LLN to ≥ 700 | < 700 to ≥ 500 | < 500 |
| Neutrophils decrease (cells/mm3) | < LLN to ≥ 1,500 | < 1,500 to ≥ 1,000 | < 1,000 |
| Platelets decrease (cells/mm3) | < LLN to ≥ 100,000 | < 100,000 to ≥ 75,000 | < 75,000 |
| ALT (increase by factor) | > ULN to < 2.5 × ULN | ≥ 2.5 to < 4.0 × ULN | ≥ 4.0 × ULN |
| AST (increase by factor) | > ULN to < 2.5 × ULN | ≥ 2.5 to < 4.0 × ULN | ≥ 4.0 × ULN |
| Serum creatinine (increase by factor) | > ULN to < 1.5 × ULN | ≥ 1.5 to < 2.0 × ULN | ≥ 2.0 × ULN |
| CPK (increase by factor) | > ULN to < 2.5 × ULN | ≥ 2.5 to < 4.0 × ULN | ≥ 4.0 × ULN |
| Bilirubin total (increase by factor) | > ULN to < 1.5 × ULN | ≥ 1.5 to < 2.0 × ULN | ≥ 2.0 × ULN |
ULN = upper limit of normal; LLN = lower limit of normal.