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 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
NCT ID:
NCT00891202
Group ID:
EG000
Title:
Eliglustat
Description:
PAP: Eliglustat tartrate capsule 50 mg orally on Day 1 followed by eliglustat tartrate 50 mg capsule BID from Day 2 to Week 4, then either eliglustat tartrate 50 mg capsule BID(participants with Genz-99067 trough plasma concentration\>=5 ng/mL) or eliglustat tartrate 100 mg capsule BID(participants with Genz-99067 trough plasma concentration\<5 ng/mL), up to Week 39. PK assessment at Week 2 used for dose adjustment after Week 4. LTTP: Participants of the eliglustat arm in PAP who completed PAP were included in LTTP \& received eliglustat tartrate capsule 50 mg BID orally from Day 1(post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 \& Week 47 were based on Genz-99067 trough plasma concentrations(if trough plasma concentration\<5 ng/mL: next higher dose administered;if\>=5 ng/mL: same dose continued) at Week 41 \& Week 45, respectively.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
20
Other Number Affected:
17
Other Number At Risk:
20
Study:
NCT00891202
Results Section:
NCT00891202
Adverse Events Module:
NCT00891202