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 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
NCT ID:
NCT03268603
Group ID:
EG000
Title:
Mesenchymal Stromal Cells
Description:
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules.
Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
Deaths Number Affected:
4
Deaths Number At Risk:
None
Serious Number Affected:
26
Serious Number At Risk:
57
Other Number Affected:
56
Other Number At Risk:
57
Study:
NCT03268603
Results Section:
NCT03268603
Adverse Events Module:
NCT03268603