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 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 1:28 PM
NCT ID:
NCT04294459
Pre Assignment Details:
Study was planned to be conducted in 2 parts: Phase 1 (safety run-in) and Phase 2 (efficacy). Sponsor decided to terminate the study for non-safety reasons on 02 May 2022. Based on available clinical data at time of interim analysis, it was determined that enrollment of remaining participants was unlikely to have any significant impact on study results and hence trial was stopped. Participant flow, baseline, outcome measures and safety data were presented for combined Phase 1 and 2 population.
Recruitment Details:
Study was conducted at 6 active sites in 2 countries. A total of 23 participants were enrolled between 18 Jun 2020 and 02 Nov 2021 and received isatuximab monotherapy.
Study:
NCT04294459
Study Brief:
Results Section:
NCT04294459