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 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
NCT ID:
NCT00614666
Group ID:
EG000
Title:
A - First Dose Level (n=5)
Description:
nikkomycin Z 50 mg BID x 14 days
nikkomycin Z: Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.
* 50 mg BID (n=4) vs placebo capsule BID (n=1)
* 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2)
* 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2)
* 500 mg BID (n=4) vs Placebo capsule BID (n=1)
At least 4 subjects complete lower dose before randomization includes next higher dose.
Stage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
4
Other Number Affected:
3
Other Number At Risk:
4
Study:
NCT00614666
Results Section:
NCT00614666
Adverse Events Module:
NCT00614666