Table 4 The most common treatment-related AEs*
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) |