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 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
NCT ID:
NCT01041027
Group ID:
EG000
Title:
Treatment (Paclitaxel, Carboplatin, Radiation Therapy)
Description:
CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21.
RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.
Paclitaxel: Given IV
Carboplatin: Given IV
Internal Radiation Therapy: Undergo HDR brachytherapy
External Beam Radiation Therapy: Undergo EBRT
Laboratory Biomarker Analysis: Correlative studies
Deaths Number Affected:
3
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
31
Other Number Affected:
5
Other Number At Risk:
31
Study:
NCT01041027
Results Section:
NCT01041027
Adverse Events Module:
NCT01041027