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 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 1:07 PM
NCT ID:
NCT02012959
Group ID:
EG000
Title:
Treatment Phase A
Description:
During Treatment Phase A, participants received tolvaptan once daily on Days 1 and 2. If the serum sodium level did not increase at least 4 mEq/L by Day 2, treatment was extended one additional day (to Day 2a). On Day 2a, participants achieving an increase in serum sodium of ≥4 mEq/L were defined as responders, and participants not achieving a ≥4 mEq/L increase in serum sodium were defined as non-responders.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
9
Other Number Affected:
3
Other Number At Risk:
9
Study:
NCT02012959
Results Section:
NCT02012959
Adverse Events Module:
NCT02012959