Table 2.
Incidence and severity of treatment-emergent adverse effects occurring at > 2% (safety population)
| TEAEs, N (%) | Cohort 1 (n = 21) | Cohort 2 (n = 34) | ||||||
|---|---|---|---|---|---|---|---|---|
| Total | Mild | Moderate | Severe | Total | Mild | Moderate | Severe | |
| Application site vesicles | 20 (95.2) | 18 (85.7) | 1 (4.8) | 1 (4.8) | 27 (79.4) | 16 (47.1) | 10 (29.4) | 1 (2.9) |
| Application site pain | 15 (71.4) | 11 (52.4) | 3 (14.3) | 1 (4.8) | 26 (76.5) | 17 (50.0) | 6 (17.6) | 3 (8.8) |
| Application site erythema | 13 (61.9) | 7 (33.3) | 5 (23.8) | 1 (4.8) | 19 (55.9) | 15 (44.1) | 4 (11.8) | 0 |
| Application site pruritis | 9 (42.9) | 9 (42.9) | 0 (0.0) | 0 (0.0) | 16 (47.1) | 16 (47.1) | 0 | 0 |
| Application site scab | 8 (38.1) | 6 (28.6) | 1 (4.8) | 1 (4.8) | 20 (58.8) | 17 (50.0) | 2 (5.9) | 0 |
| Application site dryness | 6 (28.6) | 6 (28.6) | 0 (0.0) | 0 (0.0) | 13 (38.2) | 12 (35.8) | 1 (2.9) | 0 |
| Application site edema | 4 (19.0) | 2 (9.5) | 2 (9.5) | 0 (0.0) | 6 (17.6) | 5 (14.7) | 0 | 1 (2.9) |
| Application site discoloration | 1 (4.8) | 1 (4.8) | 0 (0.0) | 0 (0.0) | 8(23.5) | 6 (17.6) | 1 (2.9) | 1 (2.9) |
| Application site exfoliation | 0 | 0 | 0 | 0 | 4 (11.8) | 3 (8.8) | 1 (2.9) | 0 |
| Application site erosion | 0 | 0 | 0 | 0 | 3 (8.8) | 0 | 2 (5.9) | 1 (2.9) |
| Papilloma viral infectiona | 0 | 0 | 0 | 0 | 3 (8.8) | 1 (2.9) | 2 (5.9) | 0 |
TEAEs Treatment-emergent adverse effects
aPapilloma viral infection is the MEDRA term used for ring warts