Table 1 Tocilizumab-associated adverse events

Serious and/or medically significant infections

Opportunistic infections

Infections treated with intravenous (IV) anti-infectives

Myocardial infarction (MI)/ acute coronary syndrome (ACS)

All MI/ACS events

Gastrointestinal perforations

Gastrointestinal perforation includes related fistulae and related intra-abdominal abscesses

Malignancies

All malignancies

Anaphylaxis/hypersensitivity reactions

Anaphylaxis as per Sampson’s criteria [26]

Hypersensitivity based on investigators’ medical judgment

Demyelinating disorders

All demyelinating disorders

Stroke

Includes stroke and transient ischemic attack (TIA) events

Serious and/or medically significant bleeding events

Bleeding requiring transfusion

Bleeding with hospital visit for evaluation (including emergency department for outpatient clinic)

Serious and/or medically significant hepatic events

Event with hepatic clinical diagnosis

Meets hepatic laboratory criteria for Hy’s Law^a

Hepatic laboratory abnormality resulting in TCZ withdrawal (i.e., permanent discontinuation of TCZ therapy)