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 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
NCT ID:
NCT04428333
Pre Assignment Details:
One participant was incorrectly re-randomized into the study twice and was given a new participant ID. However, the participant was considered only once for the analyses. An additional participant was randomized after the data cut off for the primary posting and received only pembrolizumab. Therefore, this participant is included in safety analysis for the end of study posting.
Recruitment Details:
Recruitment in the study stopped following the review of unblinded interim safety and efficacy data by IDMC, after a pre-specified futility analysis of the 209229(NCT04128696) trial. A Dear investigator letter (DIL) was issued to stop screening \& randomization of more participants in both studies. Participants discontinued feladilimab/placebo, but treatment with pembrolizumab plus fluorouracil (5FU) platinum chemotherapy continued until disease progression, death or unacceptable toxicity.
Study:
NCT04428333
Study Brief:
Results Section:
NCT04428333