Safety assessments
pulmonary embolism, TB, death, RA, stroke, VTEs, Toxicity, deaths, gastrointestinal perforations, Cancer
PULMONARY EMBOLISM, THROMBOEMBOLIC EVENT, MYOCARDIAL INFARCTION, DEEP VEIN THROMBOSIS (DVT), ADVERSE EVENT, STROKE, ADVERSE EVENT, GASTROINTESTINAL PERFORATION, EVENTS, CANCER
Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.1. The severity of AEs was assessed based on Outcome Measures in Rheumatology (OMERACT) criteria. Grades 3 and 4 laboratory abnormalities were also determined by OMERACT criteria, except for creatine phosphokinase (CPK) and serum creatinine, which were based on the National Cancer Institute’s Common Toxicity Criteria v4.03. AEs of special interest (AESIs) were selected due to their higher prevalence among RA populations, as a customary concern for immunomodulators, or because they were labeled/emerging risks with advanced RA therapies, including JAKis. A treatment-emergent adverse event (TEAE) was defined as an AE with onset on or after the first dose of upadacitinib 15 mg QD, and no more than 30 days after the last dose of upadacitinib 15 mg QD. TEAEs were used in the analysis, unless specified otherwise. Laboratory data presented were evaluated until at least week 84.An independent Cardiovascular Adjudication Committee blindly adjudicated all deaths and potential cardiovascular (CV) events, including potential arterial and venous thromboembolic events (VTEs). Major adverse CV events (MACE) included CV death, non-fatal myocardial infarction, and non-fatal stroke. VTEs included deep vein thrombosis (DVT) and pulmonary embolism (PE). Active/latent TB events and potential gastrointestinal perforations were assessed by the sponsor.