Exposure-safety Analysis
ER analyses for safety were pooled from all 5 studies and were performed separately for filgotinib and GS-829845 to characterize the individual safety profile of each analyte. Data were not included in the analysis if they were collected after subjects were rerandomized and were switched to a different treatment group. The evaluated safety endpoints included the 5 most frequent treatment-emergent adverse events (TEAEs) (nausea, nasopharyngitis, upper respiratory tract infection, headache, and hypertension) and Grade 3/4 laboratory abnormalities [glucose increase, lymphocyte decrease, phosphate decrease, lipase increase, and alanine transaminase (ALT) increase] that occurred in the filgotinib 200 mg once daily group based on Phase 2 and Phase 3 studies. Serious TEAEs and serious infections were also evaluated against the exposures. Exposures were compared based on the presence and absence of selected safety event.