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 @ 3:20 PM
Ignite Modification Date:
2025-12-25 @ 1:40 PM
NCT ID:
NCT04323592
Group ID:
EG000
Title:
Exposed to Methylprednisolone
Description:
SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose.
Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached.
Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description
standard care: usual standard of care:
* respiratory support
* empiric antibiotic therapy
* mechanical ventilation (invasive or noninvasive)
* pronation when possible
* other treatment which can be used are: antivirals, chloroquine, vitamins
Deaths Number Affected:
9
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
83
Other Number Affected:
23
Other Number At Risk:
83
Study:
NCT04323592
Results Section:
NCT04323592
Adverse Events Module:
NCT04323592