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 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
NCT ID:
NCT00387127
Group ID:
EG000
Title:
Chemoradiotherapy + Placebo, Followed by Placebo
Description:
Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional \[2D\] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy \[IMRT\]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m\^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
18
Serious Number At Risk:
31
Other Number Affected:
31
Other Number At Risk:
31
Study:
NCT00387127
Results Section:
NCT00387127
Adverse Events Module:
NCT00387127