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 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
NCT ID:
NCT01372202
Group ID:
EG000
Title:
Arm A
Description:
Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).
Deaths Number Affected:
7
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
13
Other Number Affected:
4
Other Number At Risk:
13
Study:
NCT01372202
Results Section:
NCT01372202
Adverse Events Module:
NCT01372202