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 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
NCT ID:
NCT01856920
Group ID:
EG001
Title:
Vaccine Subjects
Description:
6 months of surveillance followed by GI-6207 for 1 year
GI-6207 \[Recombinant Saccharomyces cerevisiae-CEA (610D)\]: GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
17
Other Number Affected:
17
Other Number At Risk:
17
Study:
NCT01856920
Results Section:
NCT01856920
Adverse Events Module:
NCT01856920