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 @ 5:18 PM
NCT ID:
NCT01004003
Group ID:
EG000
Title:
Phase 1 Group 1, 100mg Nintedanib Bid
Description:
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
6
Other Number Affected:
6
Other Number At Risk:
6
Study:
NCT01004003
Results Section:
NCT01004003
Adverse Events Module:
NCT01004003