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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
NCT ID:
NCT02150967
Pre Assignment Details:
Subjects meeting inclusion/exclusion criteria were enrolled into the following cohorts:
Cohort 1 (FGFR2 fusions): Primary analysis population (N=108). Cohort 2 (Other FGFR alterations): N=25. Cohort 3 (FGFR2 fusions and prior FGFR inhibitor): N=10.
Note:
Primary efficacy outcome measures were prespecified only for Cohort 1. Cohorts 2 and 3 were added following PA 4 to support exploratory objectives only.
Cohorts 2 and 3 are not the primary analysis population.
Recruitment Details:
Participants with a diagnosis of advanced or metastatic cholangiocarcinoma were recruited to this open-label, single-arm global study across 20 centers (9 in the US, 5 in W. Europe, 6 in Asia) based on documented evidence of FGFR gene alteration. The first participant was treated on 23 July 2014. The data cutoff for the primary analysis (Cohort 1 only) was 01 March 2021.The data cutoff for the final analysis (Cohort 2 and 3 only) was 07 February 2022.
Study:
NCT02150967
Study Brief:
Results Section:
NCT02150967