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:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
NCT ID:
NCT02401256
Group ID:
EG000
Title:
CYP2B6
Description:
A cocktail of bupropion (100mg), montelukast (10mg) and rosuvastatin (5mg). These drugs will be administrated on 3 occasions (at the begging each inpatient visit of Phase 1, 2 and 4). The study has 4 phases: Phase 1 (control, baseline)Subjects received simultaneously a cocktail of a single dose of bupropion 100 mg (CYP2b6), montelukast 10 mg (CYP2C8) and rosuvastatin 5 mg (OATP1B1/BCRP) by mouth and their metabolism and pharmacokinetics determined. Phase 2 (inhibition)a single 600 mg oral dose of efavirenz is administered with the cocktail drugs listed above and their metabolism and pharmacokinetics determined Phase 3 (home treatment with efavirenz): Subjects is taken take efavirenz for approximately 17 days Phase 4 (induction): as in phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected in all phases. Blood draws is made in phase 3 for trough concentration measurements.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
70
Other Number Affected:
5
Other Number At Risk:
70
Study:
NCT02401256
Results Section:
NCT02401256
Adverse Events Module:
NCT02401256