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 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
NCT ID:
NCT04530604
Group ID:
EG000
Title:
Defibrotide
Description:
Defibrotide: All patients received 25 milligram/kilogram/day (mg/kg/day) of defibrotide, given in 4 divided doses (approximately every 6 hours), each dose infused over 2-hours intravenously (IV).
The planned duration of study therapy was 7 days (while in the hospital), with the following qualifications:
* Patients who responded to study therapy prior to day 7 (able to discontinue oxygen) discontinued study therapy at that earlier time point.
* Patients who did not respond to study therapy by day 7 of therapy, evidenced by \<20% reduction (or a worsening) of the amount of supplemental oxygen they were receiving, discontinued study therapy at day 7.
* Patients who had evidence of a partial pulmonary response by day 7 (\>20% reduction in supplemental oxygen requirement, but still requiring supplemental oxygen) could elect to continue to receive study drug through an additional 7 days of study (total 14-day therapy course).
Deaths Number Affected:
3
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
12
Other Number Affected:
9
Other Number At Risk:
12
Study:
NCT04530604
Results Section:
NCT04530604
Adverse Events Module:
NCT04530604