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Table 4 The most common treatment-related AEs*

From: NGX-4010, a capsaicin 8% patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: integrated analysis of two phase III, randomized, controlled trials

System organ class preferred term, n(%) NGX-4010 Control
Total 30 minutes 60 minutes Total 30 minutes 60 minutes
(n = 482) (n = 239) (n = 243) (n = 215) (n = 99) (n = 116)
Number of patients reporting ≥1 treatment-related AE 373 (77) 175 (73) 198 (81) 111 (52) 51 (52) 60 (52)
General disorders and administration-site conditions 369 (77) 173 (72) 196 (81) 108 (50) 51 (52) 57 (49)
 Application-site dryness 24 (5) 9 (4) 15 (6) 2 (1) 1 (1) 1 (1)
 Application-site erythema 177 (37) 80 (33) 97 (40) 58 (27) 24 (24) 34 (29)
 Application-site edema 10 (2) 2 (1) 8 (3) 2 (1) 0 2 (2)
 Application-site pain 312 (65) 152 (64) 160 (66) 67 (31) 36 (36) 31 (27)
 Application-site papules 20 (4) 9 (4) 11 (5) 1 (<1) 0 1 (1)
 Application-site paresthesia 10 (2) 7 (3) 3 (1) 3 (1) 1 (1) 2 (2)
 Application-site pruritus 38 (8) 18 (8) 20 (8) 4 (2) 1 (1) 3 (3)
 Application-site swelling 17 (4) 4 (2) 13 (5) 4 (2) 2 (2) 2 (2)
  1. AE adverse event.
  2. *Includes AEs experienced by ≥2% of patients in any of the total treatment groups.