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 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
NCT ID:
NCT04994535
Pre Assignment Details:
The ITT Population included all randomized participants; the mITT Population included all randomized participants with a baseline summary score ≥ 19 on the ANLFQ: Impacts questionnaire. The Safety Analysis Set included all participants who were treated with at least 1 dose of study drug.
Recruitment Details:
A total of 426 participants were enrolled and randomized into the study (ITT Population); 209 to BOTOX and 217 to placebo. A total of 208 participants were treated with BOTOX and 216 participants were treated with placebo (Safety Analysis Set). A total of 381 participants were included in the modified ITT (mITT) Population; 186 to BOTOX and 195 to placebo. A participant was considered to have completed the study if he/she had at least completed the treatment visit and the end of study visit.
Study:
NCT04994535
Study Brief:
Results Section:
NCT04994535