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 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:47 PM
NCT ID:
NCT01888003
Group ID:
EG000
Title:
Anemia Treatment Group (AMG)
Description:
Patients diagnosed preoperatively as being anemic (defined as a Hgb \< 13.0 g/dL and MCV \< 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.
Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb \< 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days, -7 days before their planned surgery, and if indicated, based on labs, testing on the day of their surgery
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
5
Other Number Affected:
0
Other Number At Risk:
5
Study:
NCT01888003
Results Section:
NCT01888003
Adverse Events Module:
NCT01888003