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Table 2 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

From: A multicenter, open-label, randomized, proof-of-concept phase II clinical trial to assess the efficacy and safety of icatibant in patients infected with SARS-CoV-2 (COVID-19) and admitted to hospital units without invasive mechanical ventilation: study protocol (ICAT-COVID)


Magnitude of the adverse event

Grade 1

Mild adverse event. Asymptomatic or mild clinical symptoms or just an observation; intervention not indicated.

Grade 2

Moderate adverse event. Minimal, local or non-invasive intervention indicated.

Grade 3

Serious or medically significant adverse event, but not immediately life-threatening. Hospitalization or hospitalization prolongation indicated; important limitation of self-care.

Grade 4

Adverse event with risk of mortality or disability.

Grade 5

Death associated with an adverse event.