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:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
NCT ID:
NCT01697358
Group ID:
EG001
Title:
OMM Alone
Description:
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
7
Serious Number At Risk:
108
Other Number Affected:
11
Other Number At Risk:
108
Study:
NCT01697358
Results Section:
NCT01697358
Adverse Events Module:
NCT01697358