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 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
NCT ID:
NCT01925950
Group ID:
EG000
Title:
Placebo
Description:
Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.
Part 1: 2 mg of placebo 4 times per day for up to 16 weeks.
Part 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:
Weeks 17-24: 2 mg placebo 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg placebo 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg placebo daily, up to 16 weeks.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
1
Other Number Affected:
0
Other Number At Risk:
1
Study:
NCT01925950
Results Section:
NCT01925950
Adverse Events Module:
NCT01925950