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 @ 10:43 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
NCT ID:
NCT04936035
Pre Assignment Details:
As pre-specified in SAP, data collected for the participant flow after '6-Month Placebo-controlled DB Period' (i.e., Months 6 to 12 DB period + DB Extension Period) was to be reported together as 'Post-6-Month DB Period' per treatment sequence (Pbo/Zil \& Zil/Zil). Before Protocol Amendment 6 (PA6), participants completing 12 months in this study could join a separate open-label extension (OLE) study. With PA6, the OLE study was canceled. Hence, the 24-month extension treatment was also ended.
Recruitment Details:
Total of 86 clinical sites across North America \& 25 sites in Europe enrolled 394 participants. 16 participants from Ukraine were unable to continue participation due to geopolitical instability. Due to challenges in data collection \& cleaning, these participants were excluded from all analysis sets. Hence, results are presented for 378 randomized participants. Study has 2 periods: 6-Month Placebo-controlled Double-blind (DB) Period \& Post-6-Month DB Period \[DB (Months 6 to 12)+DB Extension\].
Study:
NCT04936035
Study Brief:
Results Section:
NCT04936035