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 @ 7:37 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
NCT ID:
NCT00885703
Group ID:
EG006
Title:
Stage 2: Ampho B
Description:
Participants receive Amphotericin B followed by Fluconazole
Fluconazole: Step 1: \[For participants randomized to Fluconazole\] Induction dose of daily treatment of fluconazole given orally (adjusted according to weight).
Step 2: \[For participants randomized to Ampho B only\] If participant is intolerant to Ampho B, participant transitions to fluconazole dosage of 400-800mg daily given orally.
Step 3: If participant has a negative culture before week 10, participant transitions to consolidation therapy at dosage of 400mg daily given orally.
Step 4: At week 10, participant transitions to maintenance therapy at dosage of 200mg daily given orally.
Amphotericin B: Step 1: \[For participants randomized to Ampho B\] Ampho B given intravenously for approximately 2 weeks at a dosage of 0.7 to 1.0 mg/kg, dependent on a participant's weight
Deaths Number Affected:
4
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
24
Other Number Affected:
24
Other Number At Risk:
24
Study:
NCT00885703
Results Section:
NCT00885703
Adverse Events Module:
NCT00885703