Supplementary Table 1. Definition of abnormal level (items measured at individual study centers).
| Laboratory test | Standard reference range |
|---|---|
| WBC [/µL] | < 3000/µL, ≥2-fold increase from week 0 |
| RBC [104/µL] | 550 × 104/µL, < the lower limit of the reference range |
| Hemoglobin [g/dL] | > 2 g/dL increase above the upper limit of the reference range |
| Hematocrit [g/dL] | Change of ≥ − 10% or + 10% from week 0 |
| Platelet count§ [104/µL] | < 7.5 × 104/µL |
| Leukocyte percent (basophils)§ [%] | — |
| Leukocyte percent (eosinophils)§ [%] | — |
| Leukocyte percent (neutrophils)§ [%] | < 1500/µL |
| Leukocyte percent (lymphocytes)§ [%] | < 800/µL, > 4000 µL |
| Leukocyte percent (monocytes)§ [%] | — |
| Total protein [g/dL] | > 1 g/dL decrease from week 0 |
| Albumin [g/dL] | <3 g/dL |
| Total bilirubin [g/dL] | > 1.5-fold the upper limit of the reference range |
| AST (GOT) [IU/L] | > 3.0-fold the upper limit of the reference range |
| ALT (GPT) [IU/L] | > 3.0-fold the upper limit of the reference range |
| ALP [IU/L] | > 2.5-fold the upper limit of the reference range |
| LDH [IU/L] | > the upper limit of the reference range |
| Cholinesterase [IU/L] | > the upper limit of the reference range |
| gamma-GTP [IU/L] | > the upper limit of the reference range |
| Uric acid [mg/dL] | > the upper limit of the reference range |
| BUN [mg/dL] | — |
| Creatinine [mg/dL] | > 1.5-fold the upper limit of the reference range |
| Na [mEq/L] | < the lower limit or > the upper limit of the reference range |
| Cl [mEq/L] | — |
| K [nEq/L] | > 5.5 mEq, <the lower limit of the reference range |
| Ca [mg/dL] | > 11.5 mg/dL, < 8.0 mg/dL |
| P [mg/dL] | < 2.5 mg/dL |
| Blood glucose [mg/dL] | > 160 mg/dL, < 55 mg/dL |
| CPK [IU/L] | > 2.5-fold the upper limit of the reference range |
| Qualitative urine (glucose) | ≥ ±, + (−is normal) |
| Qualitative urine (protein) | ≥ 2+ |
| Qualitative urine (urobilinogen) | ≥ + |
| Specific gravity | — |
| pH | — |
| Qualitative (occult blood) | ≥ ±, + (−is normal) |
The reference range was based on the definition at each study center.
§
To be investigated only if abnormalities are noted in WBC.
WBC, white blood cell; RBC, red blood cell; AST (GOT), aspartate aminotransferase; ALT (GPT), alanine aminotransferase; ALP, alkaline phosphatase; LDH, lactate dehydrogenase; GTP, guanosine 5′-triphosphate; BUN, blood urea nitrogen; CPK, creatine phosphokinase