Table 4.
Any TEAEs related to study treatment reported by ≥ 2 subjects.
| Dose group | Control (N=12) | Low (N=46) | Intermediate (N=6) | High (N=6) | Non-tolerated (N=18) | Overall (N=88) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fimaporfin dose | 0 μg | 0.75–7.5 μg | 12.5 μg | 17.5 μg | 25–50 μg | 0–50 μg | ||||||
| Preferred Term | Mild | Moderate | Mild | Moderate | Mild | Moderate | Mild | Moderate | Mild | Moderate | Mild | Moderate |
| Any related TEAE | 4 (33%) [4] | – | 6 (13%) [7] | – | 1 (17%) [1] | – | 5 (83%) [13] | – | 9 (50%) [23] | 4 (22%) [5] | 25 (28%) [48] | 4 (5%) [5] |
| Local TEAE | 3 (25%) [3] | – | 5 (11%) [6] | – | 1 (17%) [1] | – | 5 (83%) [12] | – | 6 (33%) [8] | 3 (17%) [4] | 20 (23%) [30] | 3 (3%) [4] |
| IS vesicles | — | – | 2 (4%) [2] | – | – | – | 3 (50%) [7] | – | 2 (11%) [2] | – | 7 (8.%) [11] | – |
| IS pruritus | 3 (25%) [3] | – | 2 (4%) [2] | – | – | – | – | – | 2 (11%) [4] | – | 7 (8.%) [9] | – |
| IS pain | – | – | – | – | 1 (17%) [1] | – | 1 (17%) [1] | – | 1 (6%) [1] | 1 (6%) [1] | 3 (3%) [3] | 1 (1%) [1] |
| IS ulcer | – | – | – | – | – | – | – | – | 1 (6%) [1] | 2 (11%) [3] | 1 (1%) [1] | 2 (2%) [3] |
| IS reaction | – | – | 1 (2%) [2] | – | – | – | 1 (17%) [1] | – | – | – | 2 (2%) [3] | – |
| IS erythema | – | – | — | – | – | – | 2 (33%) [2] | – | – | – | 2 (2%) [2] | – |
| IS scab | – | – | — | – | – | – | 1 (17%) [1] | – | – | – | 1 (1%) [1] | – |
| Systemic TEAE | 1 (8%) [1] | – | 1 (2%) [1] | – | – | – | 1 (17%) [1] | – | 8 (44%) [15] | 1 (6%) [1] | 11 (13%) [18] | 1 (1%) [1] |
| Headache | 1 (8%) [1] | – | – | – | – | – | – | – | 3 (17%) [3] | – | 4 (5%) [4] | – |
| Procedural site reaction | – | – | – | – | – | – | 1 (17%) [1] | – | – | 1 (6%) [1] | 1 (1%) [1] | 1 (1%) [1] |
AEs considered to be local symptoms were anywhere the MedDRA Preferred Term contained the term Injection site (IS)’. For Related to Study Treatment this counts all TEAEs that have been recorded as having a suspected relationship to study treatment with and/or without red light. N, Number of subjects studied; (), Percentage of subjects with adverse events; [], Number of adverse events. Events were coded using MedDRA (Version 19.0).