Table 2 Summary of treatment-emergent adverse events related to EB-101[a]
Related to Treatment | Severity Grade | Outcome | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Total, No. (%) | Definitely, No. (%) | Probably, No. (%) | Possibly, No. (%) | Grade 1: Mild, No. (%) | Grade 2: Moderate, No. (%) | Grade 3: Severe, No. (%) | Grade 4: Life-Threatening, No. (%) | Grade 5: Death, No. (%) | Resolved Without Treatment, No. (%) | Resolved With Treatment, (No. (%) | |
21 | 4 (19.0) | 12 (57.1) | 5 (23.8) | 18 (85.7) | 2 (9.5) | 1 (4.8) | 0 (0.0) | 0 (0.0) | 12 (57.1) | 9 (42.9) | |
Immediate postoperative skin pain at graft site | 4 (19.0) | – | 1 (8.3) | 3 (60.0) | 3 (16.7) | – | 1 (100.0) | – | – | – | 4 (44.4) |
Pruritus | 3 (14.3) | – | 3 (25.0) | – | 3 (16.7) | – | – | – | – | 3 (25.0) | – |
Immediate postoperative graft site infection within 10 days of treatment | 3 (14.3) | – | 2 (16.7) | 1 (20.0) | 2 (11.1) | 1 (50.0) | – | – | – | 2 (16.7) | 1 (11.1) |
Postoperative graft site infection 6 months after treatment | 1 (4.8) | – | – | 1 (20.0) | – | 1 (50.0) | – | – | – | – | 1 (11.1) |
Presence of tissue-bound anti-C7 antibodies at grafts | 8 (38.1) | 3 (75.0) | 5 (41.7) | – | 8 (44.4) | – | – | – | – | 5 (41.7) | 3 (33.3) |
Presence of circulating antibodies in serum | 2 (9.5) | 1 (25.0) | 1 (8.3) | – | 2 (11.1) | – | – | – | – | 2 (16.7) | – |