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 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
NCT ID:
NCT04578535
Pre Assignment Details:
This study was conducted in 2 parts with a target dose level (TDL) of either 0.4 grams/kilograms (g/kg) (Part 1) or 1.0 g/kg (Part 2) through dose Ramp-Up or No Ramp-Up (direct administration of TDL). Each study part consisted of 3 TA (Part 1: TA 1 to 3 and Part 2: TA 4 to 6. TA 1 and 4 followed Schedule A (1/4 of the TDL to the full TDL) and TA 2 and 5 followed Schedule B (1/2 of TDL to full TDL) and TA 3 and 6 followed no ramp up (Schedule C).
Recruitment Details:
A total of 51 participants were enrolled in the study, 33 participants into the Ramp-Up dosing group (treatment arms \[TA\] 1, 2, 4, and 5) and 18 participants into the No Ramp-Up dosing group (TA 3 and TA 6).
Study:
NCT04578535
Study Brief:
Results Section:
NCT04578535