Fig. 7

Exposure-Adjusted Event Rates for Adverse Events of Special Interest Through 5 Years. AE, adverse event; AESI, adverse event of special interest; CPK, creatine phosphokinase; DMARD, disease-modifying antirheumatic drug; GI, gastrointestinal; MACE, major adverse cardiovascular event; mono, monotherapy; MTX, methotrexate; NMSC, nonmelanoma skin cancer; PY, patient-years; QD, once daily; TB, tuberculosis; UPA, upadacitinib; VTE, venous thromboembolism. Treatment-emergent adverse event is defined as any adverse event with an onset date that is after the first dose of study drug, and no more than 30 days after the last dose of study drug. Data include patients receiving UPA or MTX monotherapy, censored at either time of rescue to UPA + MTX or with addition of background conventional synthetic DMARD. ^aPatients in the UPA 30 mg treatment group were later switched to the approved UPA 15 mg dose per protocol amendment. Upadacitinib 30 mg QD exposure was censored at the time of dose switch from 30 mg QD to 15 mg QD. ^bOpportunistic infections exclude herpes zoster and TB. ^cDefined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. ^dIncludes pulmonary embolism and deep vein thrombosis