Table 3.

Absolute and relative criteria by organ systems to skip or discontinue IL-2

System	Relative criteria	Absolute criteria
Cardiac	Sinus tachycardia (120–130 beats per min)	Sustained (>1 hour) sinus tachycardia after correcting hypotension, fever, and tachycardia and stopping dopamine Development of clinically significant arrhythmia or cardiac event Hypotension refractory to fluid replacement
Gastrointestinal	Diarrhea 1000 mL/shift	Diarrhea 1000 mL/shift×2 Grade 3 CTCAE hepatic impairment criteria: AST/ALT>5–20×ULN if baseline was normal; >5–20×baseline if baseline was abnormal; bilirubin >3–10×ULN if baseline was normal; >3–10×baseline if baseline was abnormal
Hemorrhagic		Frank blood in the sputum, emesis, or stool
Musculoskeletal	Extremity tightness	Extremity paresthesias
Neurologic	Vivid dreams Emotional lability	Hallucination, disorientation, or mental status changes not rapidly reversible
Pulmonary	New resting shortness of breath Rales 1/3 up chest	New requirement of supplemental O2 by nasal cannula for saturation ≥92% Endotracheal intubation Moist rales halfway up chest Pleural effusion requiring tap or chest tube
Renal	sCR increase by 50% from baseline or absolute sCR of 2.5–2.9 mg/dL CO2<18 mEq/L	Urine output <4 mL/kg over 8 hours sCr≥3 mg/dL sCr increase by 100% from baseline or absolute sCr≥3 mg/dL Persistent acidosis despite replacement

ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; PRN, pro re nata (take as needed); sCr, serum creatinine; ULN, upper limit of normal.