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Table 1 Adequate organ function laboratory values

From: PRIMMO study protocol: a phase II study combining PD-1 blockade, radiation and immunomodulation to tackle cervical and uterine cancer

System Laboratory Value
Hematological
 Absolute leukocyte count ≥2500 /mcL
 Absolute lymphocyte count (ALC) ≥500 /mcL
 Absolute neutrophil count (ANC) ≥1500 /mcL
 Platelets ≥100,000 / mcL
 Hemoglobin ≥9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
Renal
 Serum creatinine ≤1.5 X upper limit of normal (ULN)
 OR OR
 Measured or calculateda creatinine clearance
(GFR can also be used in place of creatinine or CrCl)
≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Hepatic
 Serum total bilirubin ≤ 1.5 X ULN
 OR OR
 Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
 AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR
≤ 5 X ULN for subjects with liver metastases
 Albumin > 2.5 mg/dL
Coagulation
 International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapyas long as PT or PTT is within therapeutic range of intended use of anticoagulants
 Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy
as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  1. aCreatinine clearance should be calculated per institutional standard