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 @ 1:05 PM
Ignite Modification Date:
2025-12-25 @ 12:20 PM
NCT ID:
NCT02707861
Group ID:
EG000
Title:
Cohort 1
Description:
IV ibalizumab (combined with optimized background regimen):
800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial
OR
2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial
Administered for 48 weeks, or until ibalizumab becomes commercially available
ibalizumab: Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry
Optimized Background Regimen: An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Deaths Number Affected:
5
Deaths Number At Risk:
None
Serious Number Affected:
16
Serious Number At Risk:
41
Other Number Affected:
39
Other Number At Risk:
41
Study:
NCT02707861
Results Section:
NCT02707861
Adverse Events Module:
NCT02707861