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:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
NCT ID:
NCT02021318
Group ID:
EG001
Title:
Darbepoetin Alfa
Description:
Participants received initial dose of darbepoetin alfa based upon the weight \[either 0.45 μg/kg of body weight, as a single subcutaneous or IV injection once weekly or 0.75 μg/kg of body weight, as a single subcutaneous injection once every 2 weeks\] as per EU SmPC along with IV iron supplementation according to the standard of care. Dose-adjustment was performed based upon regular measurement of Hb levels until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which darbepoetin alfa dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL. Participants received darbepoetin alfa for up to a maximum of 104 weeks.
Deaths Number Affected:
37
Deaths Number At Risk:
None
Serious Number Affected:
181
Serious Number At Risk:
293
Other Number Affected:
203
Other Number At Risk:
293
Study:
NCT02021318
Results Section:
NCT02021318
Adverse Events Module:
NCT02021318