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 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
NCT ID:
NCT03979820
Group ID:
EG006
Title:
Phenelzine + Tyramine
Description:
Participants received from Day 8 up to Day 19 concomitant medication of 1 film-coated tablets of 15 mg of phenelzine sulfate (Nardil®) administered twice daily from Day 8 up to Day 18 (daily dosage: 30 mg) and once daily on Day 19 (daily dosage: 15 mg) orally with 240 ml of water and escalating doses of tyramine (tyramine steady state challenge) until TYR30 was reached. The planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg given once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. Treatment with phenelzine sulfate was stopped as soon as the individual subject attained TYR30 on treatment.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
14
Other Number Affected:
14
Other Number At Risk:
14
Study:
NCT03979820
Results Section:
NCT03979820
Adverse Events Module:
NCT03979820