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 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
NCT ID:
NCT01423851
Pre Assignment Details:
The screening period was from Day -14 to Day 0 for Phase I and Phase II. Informed consent form (ICF) was signed prior to screening procedures. All the study assessments were performed as per the schedule of assessment.
Recruitment Details:
Subjects who met all the inclusion and none of the exclusion criteria were enrolled at 09 sites in the USA. The conduct of this study started on 02 June 2011 (the first patient screened) and the last patient last visit was on 22 April 2020.
A total of 48 and 29 patients were enrolled during Phase 1 and Phase 2 of the study respectively.
Participants could be reduced or escalated to the noted dose at physician discretion.
Study:
NCT01423851
Study Brief:
Results Section:
NCT01423851