Event, n (%) | Capsaicin 8% patch (30 min) + SOC (n = 156) | Capsaicin 8% patch (60 min) + SOC (n = 157) | SOC (n = 155) |
---|---|---|---|
PRAEs | 105 (67.3) | 109 (69.4) | 75 (48.4) |
Mild PRAEs | 83 (53.2) | 89 (56.7) | 55 (35.5) |
Moderate PRAEs | 50 (32.1) | 54 (34.4) | 34 (21.9) |
Severe PRAEs | 19 (12.2) | 12 (7.6) | 10 (6.5) |
PRAEs identified as general disorders or administration site conditions | 54 (34.6) | 53 (33.8) | 10 (6.5) |
Application site pain | 44 (28.2) | 46 (29.3) | 0 (0) |
Mild | 23 (14.7) | 28 (17.8) | 0 (0) |
Moderate | 19 (12.2) | 16 (10.2) | 0 (0) |
Severe | 2 (1.3) | 2 (1.3) | 0 (0) |
Application site erythema | 12 (7.7) | 14 (8.9) | 0 (0) |
Mild | 12 (7.7) | 13 (8.3) | 0 (0) |
Moderate | 0 (0) | 1 (0.6) | 0 (0) |
Severe | 0 (0) | 0 (0) | 0 (0) |
PRAEs leading to permanent discontinuation | 7 (4.5) | 8 (5.1) | 3 (1.9) |
TEAEs | 104 (66.7) | 106 (67.5) | N/A |
Application site reactions | 60 (38.5) | 69 (43.9) | |
TEAEs most commonly reported (>5% of each group) | N/A | ||
Application site pain | 44 (28.2) | 46 (29.3) | |
Burning sensation | 14 (9.0) | 15 (9.6) | |
Application site erythema | 12 (7.7) | 14 (8.9) | |
Pain in extremity | 6 (3.8) | 13 (8.3) | |
TEAEs leading to permanent discontinuation | 7 (4.5) | 8 (5.1) | N/A |
Drug-relateda TEAEs | 62 (39.7) | 71 (45.2) | N/A |
Drug-relateda TEAEs leading to permanent discontinuation | 0 (0) | 4 (2.5) | N/A |
Muscle spasmsb | 0 (0) | 1 (0.6) | |
Rectal adenocarcinomac | 0 (0) | 1 (0.6) | |
Neuralgiad | 0 (0) | 1 (0.6) | |
Plantar psoriasise | 0 (0) | 1 (0.6) | |
Severe TEAEs | 19 (12.2) | 12 (7.6) | N/A |
Drug-relateda severe TEAEs | 4 (2.6) | 3 (1.9) | N/A |
Application site pain | 2 (1.3) | 2 (1.3) | |
Rectal adenocarcinomac | 0 (0) | 1 (0.6) | |
Burning sensation | 1 (0.6) | 0 (0) | |
Hypoaesthesia | 1 (0.6) | 0 (0) | |
Serious TEAEs | 20 (12.8) | 13 (8.3) | N/A |
Drug-relateda serious TEAEs | 0 (0) | 2 (1.3) | N/A |
Angina pectorisf | 0 (0) | 1 (0.6) | |
Accelerated hypertensiong | 0 (0) | 1 (0.6) | |
Rectal adenocarcinomac | 0 (0) | 1 (0.6) | |
Deaths | 1 (0.6) | 1 (0.6) | 2 (1.3) |