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 @ 1:48 PM
Ignite Modification Date:
2025-12-25 @ 12:41 PM
NCT ID:
NCT00572195
Group ID:
EG000
Title:
Evaluation Group (Stimulation ON)
Description:
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
RNS® System: The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.
Deaths Number Affected:
9
Deaths Number At Risk:
None
Serious Number Affected:
177
Serious Number At Risk:
230
Other Number Affected:
228
Other Number At Risk:
230
Study:
NCT00572195
Results Section:
NCT00572195
Adverse Events Module:
NCT00572195