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.