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:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT02919306
Group ID:
EG000
Title:
Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine
Description:
Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
17
Other Number Affected:
15
Other Number At Risk:
17
Study:
NCT02919306
Results Section:
NCT02919306
Adverse Events Module:
NCT02919306