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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:53 PM
NCT ID: NCT05818956
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: From start of study drug administration up to 7 days after the last dose (up to Day 20)
Study: NCT05818956
Study Brief: A Study of TAK-227 in Healthy Adults
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: TAK-227 50 mg TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition. 0 None 0 24 2 24 View
Treatment B: TAK-227 50 mg TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing. 0 None 0 24 0 24 View
Treatment C: TAK-227 50 mg TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing. 0 None 0 24 0 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View