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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
NCT ID:
NCT02163694
Pre Assignment Details:
Subjects randomized to placebo were eligible to crossover to unblinded veliparib monotherapy. After Protocol Amendment 5, investigators and subjects were unblinded to treatment assignment, subjects randomized to placebo discontinued from the study, subjects discontinuing therapy prior to progression no longer remained on study, and no new subjects initiated crossover unblinded veliparib monotherapy treatment.
Recruitment Details:
A total of 513 subjects enrolled in the study (N=174 to the placebo + C/P arm, and N=339 to the veliparib + C/P arm). Two subjects form each arm (N= 4) were determined not to have a suspected deleterious or deleterious mutation in BRCA1/2 and were excluded from the ITT population \[ITT Population (N=509); Placebo + C/P arm (N=172), and Veliparib + C/P arm (N=337)\]. Of the 4 subjects, 3 subjects received treatment and later discontinued due to disease progression.
Study:
NCT02163694
Study Brief:
Results Section:
NCT02163694