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 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
NCT ID:
NCT03547635
Group ID:
EG001
Title:
A Marketed Comparator
Description:
A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
37
Other Number Affected:
5
Other Number At Risk:
37
Study:
NCT03547635
Results Section:
NCT03547635
Adverse Events Module:
NCT03547635