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 @ 4:57 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
NCT ID:
NCT04132050
Group ID:
EG001
Title:
Placebe Group (Period I)
Description:
R788 placebo will be administered orally for 24 weeks. On Day 1, 100 mg of the investigational product will be administered. The dose of 100 mg of the study drug will be administered and this must be the only administration of the study drug on Day 1, irrespective of the time of administration. The investigational product will be administered twice daily beginning on the next day (=100 mg bid). If the platelet count at Week 4 or later is below 50000/μL and the investigational product has been well tolerated, the dose of investigational product will be increased from 100 mg bid to 150 mg bid at the discretion of the investigator. The dose during Period I will be adjusted in accordance with the platelet count and tolerance to the investigational product.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
12
Other Number Affected:
7
Other Number At Risk:
12
Study:
NCT04132050
Results Section:
NCT04132050
Adverse Events Module:
NCT04132050