Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 12:14 PM
Ignite Modification Date:
2025-12-25 @ 12:01 PM
NCT ID:
NCT04213261
Group ID:
EG000
Title:
FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts
Description:
Intra-subject randomized (paired wounds in each subject receive experimental treatment, FCX-007, or remain untreated). Up to three target wound pairs will be identified for each subject. Following pairing, target wounds will be randomly assigned as the treatment wound (FCX-007 is administered) or control wound. Subjects will receive intradermal injections of FCX-007 in each specified treatment wound in two or more treatment sessions. The first treatment session occurs at Day 1 and the second at Week 12/Month 3. Additional treatment sessions may occur at Week 24/Month 6 and Week 36/Month 9 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated.
FCX-007 (dabocemagene autoficel; see below for FCX-007 description): FCX-007 is comprised of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
6
Other Number Affected:
2
Other Number At Risk:
6
Study:
NCT04213261
Results Section:
NCT04213261
Adverse Events Module:
NCT04213261