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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
NCT ID:
NCT01055067
Pre Assignment Details:
Based on the Simon 2-stage design, 21 participants were enrolled (Stage 1). If \<2 had either a complete response (CR) or partial response (PR), then the study was terminated. If ≥2 had either CR or PR, then enrollment was extended to 41 participants. After Stage 2 with 41 participants, treatment was effective if ≥5 had CR or PR after 4 cycles.
Recruitment Details:
A total of 27 participants who met all inclusion and no exclusion criteria were enrolled and treated at 7 clinic sites in the United States, 2 in France, and 2 in the United Kingdom. Of the 27 enrolled, 21 were included in Stage 1 in which the interim futility analysis was performed per the Simon 2-stage design.
Study:
NCT01055067
Study Brief:
Results Section:
NCT01055067