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 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
NCT ID:
NCT02464969
Group ID:
EG000
Title:
Participants Receiving Apixaban
Description:
Participants between birth to \<18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;\<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;\<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;\<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;\<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;\< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;\<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;\<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter.
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
40
Serious Number At Risk:
152
Other Number Affected:
132
Other Number At Risk:
152
Study:
NCT02464969
Results Section:
NCT02464969
Adverse Events Module:
NCT02464969