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. 2021 Nov 1;12(8):810–832. doi: 10.6004/jadpro.2021.12.8.4

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).

a

Infusion-related reaction is a disorder characterized by adverse reaction to the infusion of pharmacological or biological substances.

b

Cytokine release syndrome is characterized by fever, tachypnea, headache, tachycardia, hypotension, rash, and/or hypoxia caused by the release of cytokines.

c

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.