The Most Frequent TEAEs
The 5 evaluated TEAEs were: nausea, nasopharyngitis, upper respiratory
tract infection, headache, and hypertension.
The Analysis Set for
exposure-safety included pooled Phase 2 and Phase 3 subjects with RA who
received filgotinib and had evaluable PopPK-based exposure estimates
(AUC0-24) (N = 2678 for filgotinib and N = 2707 for
GS-829845). Data were not included in the analysis if they were
collected after subjects were rerandomized and were switched to a
different treatment group. As shown in Figure 4 (filgotinib) and Figure
5 (GS-829845), filgotinib or GS-829845 exposures
(AUC0-24) in subjects with RA were similar regardless of
the presence (black) or absence (gray) of the evaluated TEAEs up to Week
52.