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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT02318706
Pre Assignment Details:
Participants were randomized to DS-5565 (15, 20, or 30 mg) or placebo in the double-blind (DB) phase and open-label DS-5565 in the long-term (LT) phase. Patients who complete the DB phase may not enroll in the LT phase. DB phase determine significant difference vs placebo (\~750 target cases). LT phase confirm long-term safety (\~180 target cases).
Recruitment Details:
A total of 854 participants who met all inclusion and no exclusion criteria were enrolled; 834 were randomized to treatment in the double-blind phase. Twenty participants were excluded by the sponsor due to a serious Good Clinical Practice violation (inform consent form-related). A total of 214 participants enrolled in the open-label extension.
Study:
NCT02318706
Study Brief:
Results Section:
NCT02318706