Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
NCT ID:
NCT02047318
Group ID:
EG007
Title:
LUM001 MRX Treatment
Description:
Participants received LUM001 (also known as Maralixibat or MRX) as an oral solution once daily based on participant's weight. Participants who received placebo in the predecessor study LUM001-302 had their dose escalated from 14, 35, 70, and 140 microgram per kilogram per day (mcg/kg/day) for 4-week dose escalation period. Participants who received maralixibat during study LUM001-302, underwent a mock dose escalation and remained on the dose received at the end of study LUM001-302. During 8-weeks of dose optimization period, drug was adjusted in titrated manner up to 280 mcg/kg/day or highest tolerated dose and dosing was continued to complete the stable dosing and safety monitoring periods for up to 136 weeks of cumulative MRX exposure in this study at this dose level. In the long-term extension, participants could receive BID dosing up to 560 mcg/kg/day for the remainder of the study for up to 336 weeks of cumulative MRX exposure in this study. This reporting group includes all doses of MRX.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
19
Other Number Affected:
18
Other Number At Risk:
19
Study:
NCT02047318
Results Section:
NCT02047318
Adverse Events Module:
NCT02047318