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Table 1 Summary of AEs through week 48 by demographic characteristics

From: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study

Parameter, n (%) Age subgroupsa Gender subgroups Race subgroups
≤ 50 years > 50 years Men Women Non-black/African American Black/African American
D/C/F/TAF Control D/C/F/TAF Control D/C/F/TAF Control D/C/F/TAF Control D/C/F/TAF Control D/C/F/TAF Control
n 507 252 256 126 623 313 140 65 597 293 155 82
Any AE 418 (82) 207 (82) 207 (81) 104 (83) 510 (82) 260 (83) 115 (82) 51 (79) 496 (83) 241 (82) 120 (77) 67 (82)
 Related 103 (20) 15 (6) 35 (14) 13 (10) 110 (18) 26 (8) 28 (20) 2 (3) 112 (19) 21 (7) 23 (15) 7 (9)
Serious AEs 20 (4) 9 (4) 15 (6) 9 (7) 31 (5) 14 (5) 4 (3) 4 (6) 31 (5) 13 (4) 4 (3) 5 (6)
 Related 0 0 1 (< 1)b 0 1 (< 1) 0 0 0 1 (< 1) 0 0 0
Grade 3–4 AEs 32 (6) 20 (8) 20 (8) 11 (9) 42 (7) 26 (8) 10 (7) 5 (8) 45 (8) 26 (9) 6 (4) 5 (6)
 Related 7 (1) 1 (< 1) 3 (1) 3 (2) 8 (1) 4 (1) 2 (1) 0 8 (1) 4 (1) 2 (1) 0
AEs leading to discontinuation 6 (1) 1 (< 1) 5 (2) 4 (3) 10 (2) 5 (2) 1 (1) 0 8 (1) 5 (2) 3 (2) 0
 Related 5 (1) 0 3 (1)c 3 (2) 7 (1) 3 (1) 1 (1) 0 7 (1) 3 (1) 1 (1) 0
  1. AE adverse event, D/C/F/TAF darunavir/cobicistat/emtricitabine/tenofovir alafenamide
  2. aRates of related AEs in the D/C/F/TAF and control arms, respectively, for patients ≤ 50 years without polypharmacy were: 0% (0/436) and 0% (0/206) with serious related AEs; 1% (6/436) and 1% (1/206) with grade 3–4 related AEs; 1% (5/436) and 0% (0/206) discontinued due to related AEs. Rates of related AEs in the D/C/F/TAF and control arms, respectively, for patients > 50 years with polypharmacy were: 0% (0/108) and 0% (0/50) with serious related AEs; 0% (0/108) and 2% (1/50) with grade 3–4 related AEs; 0% (0/108) and 2% (1/50) discontinued due to related AEs
  3. bThis patient had grade 3 pancreatitis; this AE led to discontinuation
  4. cEach patient had 1 study drug-related AE leading to discontinuation (pancreatitis, increase alanine aminotransferase, and urticaria)