Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 7:50 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT05382104
Description: None
Frequency Threshold: 5
Time Frame: From start of study drug administration to follow-up (up to Day 18)
Study: NCT05382104
Study Brief: Maribavir Food-Effect Study in Healthy Adults Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A: Maribavir 400 mg Participants received maribavir single 400 mg tablet, under fasted conditions on Day 1 of Treatment Period 1, 2 and 3. 0 None 0 31 7 31 View
Treatment B: Maribavir 400 mg Participants received maribavir single 400 mg tablet, after low-fat/low-calorie meal on Day 1 of Treatment Period 1, 2 and 3. 0 None 0 30 9 30 View
Treatment C: Maribavir 400 mg Participants received maribavir single 400 mg tablet, after high-fat/high-calorie meal on Day 1 of Treatment Period 1, 2 and 3. 0 None 0 31 7 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View