Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-25 @ 4:29 PM
NCT ID:
NCT01285557
Pre Assignment Details:
Randomization was stratified by the histologic subtype (adenocarcinoma, diffuse type or signet ring cell adenocarcinoma); extent of metastasis (1 versus more than 1 metastatic site); Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1) and region (North America, Western Europe, Eastern Europe, Rest of world). Cut-off dates for all clinical data collection was 07 March 2014 and for overall survival analysis was 15 August 2014.
Recruitment Details:
A total of 690 participants were screened from 14 April 2011 to 25 February 2014, of which 361 participants enrolled in the study. The data cut-off date for all clinical data except overall survival was 07 Mar 2014 and for overall survival was 15 Aug 2014. The participants were randomized using interactive Voice/Web randomization system(2:1 ratio) to receive S-1/cisplatin or 5-Fluorouracil (5-FU)/cisplatin. A total of 329 participants failed screening due to failure to meet inclusion criteria.
Study:
NCT01285557
Study Brief:
Results Section:
NCT01285557