AE category | Physician-reported AEs included in the analysis |
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SIEs | Infections for which the patient was hospitalized and/or received intravenous antibiotics, which were categorized as follows: joint/bursa, cellulitis/skin, sinusitis, diverticulitis, sepsis, pneumonia, bronchitis, gastroenteritis, meningitis/encephalitis, urinary tract infection, upper respiratory infection, active tuberculosis (latent tuberculosis infection was not included), and other infections |
SIE microorganism | Opportunistic infections: coccidioidomycosis, Cryptococcus, herpes zoster, histoplasmosis, John Cunningham virus, Listeria, Pneumocystis, active tuberculosis (latent tuberculosis infection was not included), and other opportunistic infections. Nonopportunistic infections: methicillin-resistant Staphylococcus aureus (MRSA), bacterial infection other than MRSA, and other nonopportunistic infections |
Malignancies | Nonmelanoma skin cancer, melanoma skin cancer, lymphoma, breast cancer, lung cancer, and other cancers |
CVEs | Myocardial infarction, transient ischemic attack, stroke, congestive heart failure with hospitalization, cardiac revascularization procedure, ventricular arrhythmia, cardiac arrest, acute coronary syndrome, unstable angina, hypertension with hospitalization, peripheral arterial thromboembolic event, urgent peripheral arterial revascularization, peripheral ischemia or gangrene (necrosis), and other CVEs |