Table 8. CTCAE Grading for Infusion-Related Reactions, Cytokine Release Syndrome, and Anaphylaxis.
CTCAE term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
---|---|---|---|---|---|
Infusion-related reactiona | Mild transient reaction; infusion interruption not indicated; intervention not indicated | Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (e.g., antihistamines, NSAIDS, narcotics, IV fluids); prophylactic medications indicated for ≤ 24 hr | Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae | Life-threatening consequences; urgent intervention indicated | Death |
Cytokine release syndromeb | Fever with or without constitutional symptoms | Hypotension responding to fluids; hypoxia responding to < 40% O2 | Hypotension managed with one pressor; hypoxia requiring ≥ 40% O2 | Life-threatening consequences; urgent intervention indicated | Death |
Anaphylaxisc | Symptomatic bronchospasm, with or without urticaria; parenteral intervention indicated; allergy-related edema/angioedema; hypotension | Life-threatening consequences; urgent intervention indicated | Death |
Note. CTCAE = Common Terminology Criteria for Adverse Events; NSAID = nonsteroidal anti-inflammatory drug. Information from National Institutes of Health (2017).
Infusion-related reaction is a disorder characterized by adverse reaction to the infusion of pharmacological or biological substances.
Cytokine release syndrome is characterized by fever, tachypnea, headache, tachycardia, hypotension, rash, and/or hypoxia caused by the release of cytokines.
Anaphylaxis is characterized by an acute inflammatory reaction resulting from the release of histamine and histamine-like substances from mast cells, causing a hypersensitivity immune response. Clinically, it presents with breathing difficulty, dizziness, hypotension, cyanosis, and loss of consciousness, and may lead to death.