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 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
NCT ID:
NCT01072656
Group ID:
EG001
Title:
Sham Stimulation (Phase V)
Description:
IPG is set to ON but the voltage is set to 0V.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
9
Other Number Affected:
9
Other Number At Risk:
9
Study:
NCT01072656
Results Section:
NCT01072656
Adverse Events Module:
NCT01072656