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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
NCT ID:
NCT00761267
Group ID:
EG002
Title:
Anidulafungin: Participants Aged 5 to <18 Years
Description:
Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.
Deaths Number Affected:
5
Deaths Number At Risk:
None
Serious Number Affected:
13
Serious Number At Risk:
30
Other Number Affected:
30
Other Number At Risk:
30
Study:
NCT00761267
Results Section:
NCT00761267
Adverse Events Module:
NCT00761267