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 @ 5:51 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
NCT ID:
NCT01927068
Group ID:
EG001
Title:
Global ISR Cohort 2
Description:
The goal of cohort 2 is to evaluate this patient population for treatment of in-stent restenotic lesions, which is different than the population in cohort 1.
All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).
Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB): Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Deaths Number Affected:
3
Deaths Number At Risk:
None
Serious Number Affected:
65
Serious Number At Risk:
122
Other Number Affected:
93
Other Number At Risk:
122
Study:
NCT01927068
Results Section:
NCT01927068
Adverse Events Module:
NCT01927068