Table 4.

Summary of Adverse Events and Adverse Drug Reactions Through Week 48

	D/C/F/TAF (N = 109)
Adverse Event	Overall	At Least Possibly Related
Any	92 (84)	36 (33)
Serious	10 (9)	0
Grade 1	30 (28)	27 (25)
Grade 2	48 (44)	7 (6)
Grade 3	13 (12)	2 (2)
Grade 4a	1 (<1)	0
Most common ADRs (≥2% of participants)	Any Grade	≥Grade 2
Diarrhea	13 (12)	2 (2)
Nausea	13 (12)	2 (2)
Rashb,c	5 (5)	4 (4)
Vomiting	4 (4)	0
Fatigue	3 (3)	0

Data are presented as no. (%).

Abbreviations: ADR, adverse drug reaction; D/C/F/TAF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide.

^aAbdominal injury (grade 4, not related) secondary to motor vehicle accident (grade 3, not related).

^bPooled preferred terms of allergic dermatitis, dermatitis, rash, macular rash, maculopapular rash, papular rash, and pruritic rash.

^cAll rash adverse events were grade 1 or 2, except for 1 that was grade 3.