Table 2 Pooled CAMP-1 and CAMP-2 incidence and severity of TEAEs related to study drug (>1%)a
TEAEb incidence and severity | VP-102 (N = 311) | Vehicle (N = 216) | ||||
|---|---|---|---|---|---|---|
Mild | Moderate | Severe | Mild | Moderate | Severe | |
Vesicles | 187 (60.1) | 100 (32.2) | 11 (3.5) | 59 (27.3) | 4 (1.9) | 0 (0.0) |
Pruritus | 145 (46.6) | 23 (7.4) | 1 (0.3) | 62 (28.7) | 13 (6.0) | 0 (0.0) |
Pain | 127 (40.8) | 59 (19) | 7 (2.3) | 34 (15.7) | 2 (0.9) | 0 (0.0) |
Erythema | 73 (23.5) | 65 (20.9) | 1 (0.3) | 43 (19.9) | 15 (6.9) | 0 (0.0) |
Scab | 120 (38.6) | 27 (8.7) | 0 (0.0) | 44 (20.4) | 3 (1.4) | 0 (0.0) |
Discoloration | 87 (28.0) | 12 (3.9) | 1 (0.3) | 25 (11.5) | 2 (0.9) | 0 (0.0) |
Dryness | 58 (18.6) | 5 (1.6) | 0 (0.0) | 30 (13.9) | 1 (0.5) | 0 (0.0) |
Edema | 21 (6.8) | 8 (2.6) | 0 (0.0) | 7 (3.2) | 3 (1.4) | 0 (0.0) |
Scar | 7 (2.3) | 1 (0.3) | 0 (0.0) | 5 (2.3) | 0 (0.0) | 0 (0.0) |
Skin infection | 0 (0.0) | 1(.03) | 0 (0.0) | 0 (0.0) | 3 (1.4) | 0 (0.0) |