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 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
NCT ID:
NCT03754803
Pre Assignment Details:
A total of 376 participants were enrolled in the Full Analysis Set, of which 10 were excluded for various reasons, including protocol violations and participant withdrawal. The remaining 366 participants were included in the Effectiveness Analysis Set.
Recruitment Details:
Under EU privacy laws, participants who withdraw consent can choose whether their data up to withdrawal may be used or must be deleted. Safety data (e.g., ADRs, SAEs) are exempt and must be retained. This resulted in a higher number of participants analyzed for the Safety Analysis Set (N = 368) compared to Effectiveness Analysis Set (N = 366).
Study:
NCT03754803
Study Brief:
Results Section:
NCT03754803