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Table 5 Toxicity Criteria [20]

From: A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID)

 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< 8.0Life-threatening, urgent intervention indicated
WBC Decrease - cell/mm3LLN- 30002000 – 30001000 – 2000< 1000
Platelets Decreased - cell/mm3LLN - 75,00050,000 - < 75,000< 50,000–25,000< 25,000