Table 15. GS-US-292-0104 and GS-US-292-0111. Common adverse events (all grades) in 5% of patients ≥ Elvitegravir, COBI, Elvitegravir, COBI, emtricitabine, tenofovir emtricitabine, tenofovir alafenamide (n=866) disoproxil fumarate (n=867) Diarrhoea 147 (17%) 164 (19%) Nausea 132 (15%) 151 (17%) Headache 124 (14%) 108 (13%) Upper 99 (11%) 109 (13%) respiratory tract infection 78 (9%) 80 (9%) Fatigue 71 (8%) 71 (8%) Cough 67 (8%) 60 (7%) Vomiting 62 (7%) 54 (6%) Arthralgia 61 (7%) 39 (5%) Back pain 60 (7%) 57 (7%) Insomnia 57 (7%) 48 (6%) Rash 55 (6%) 46 (5%) Pyrexia 45 (5%) 41 (5%) Dizziness 44 (5%) 37 (4%) Results for the other studies are described in Attachment 2 Deaths and SAEs Seven subjects died during the EVG/COBI/FTC/TAF Phase II and Phase III studies: 5 subjects in Studies GS-US-292-0104 and GS-US-292-0111, and 2 subjects in Study GSUS292-0109 None of the events that resulted in death were considered related to study drug by the investigator. Serious AEs were reported for a similar percentage of subjects in both treatment groups in the comparative Studies (GS-US-292-0104, GS-US-292-0111 and GS-US-292-0109) and < 10% in the EVG/COBI/FTC/TAF group in each study. No individual SAE occurred in 1% of subjects in either treatment group. ≥ Among virologically suppressed subjects in Study GS-US-292-0109, subjects who switched to EVG/COBI/FTC/TAF had a higher incidence of any AE considered by the investigator as
Table 15. GS-US-292-0104 and GS-US-292-0111. Common adverse events (all grades) in ≥ 5% of patients Elvitegravir, COBI, emtricitabine, tenofovir alafenamide (n=866) Elvitegravir, COBI, emtricitabine, tenofovir disoproxil fumarate (n=867) Diarrhoea 147 (17%) 164 (19%) Nausea 132 (15%) 151 (17%) Headache 124 (14%) 108 (13%) Upper respiratory tract infection 99 (11%) 109 (13%) 78 (9%) 80 (9%) Fatigue 71 (8%) 71 (8%) Cough 67 (8%) 60 (7%) Vomiting 62 (7%) 54 (6%) Arthralgia 61 (7%) 39 (5%) Back pain 60 (7%) 57 (7%) Insomnia 57 (7%) 48 (6%) Rash 55 (6%) 46 (5%) Pyrexia 45 (5%) 41 (5%) Dizziness 44 (5%) 37 (4%) Results for the other studies are described in Attachment 2 Deaths and SAEs Seven subjects died during the EVG/COBI/FTC/TAF Phase II and Phase III studies: 5 subjects in Studies GS-US-292-0104 and GS-US-292-0111, and 2 subjects in Study GSUS292-0109 None of the events that resulted in death were considered related to study drug by the investigator. Serious AEs were reported for a similar percentage of subjects in both treatment groups in the comparative Studies (GS-US-292-0104, GS-US-292-0111 and GS-US-292-0109) and < 10% in the EVG/COBI/FTC/TAF group in each study. No individual SAE occurred in ≥ 1% of subjects in either treatment group. Among virologically suppressed subjects in Study GS-US-292-0109, subjects who switched to EVG/COBI/FTC/TAF had a higher incidence of any AE considered by the investigator as
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