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) | – |
[a] Includes adverse events considered "definitely", "probably", and "possibly" related to grafting that occurred after the date of treatment. Adverse events characterized using the National Cancer Institute’s Common Terminology Criteria for Adverse Events version 4.0