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 @ 10:40 PM
Ignite Modification Date: 2025-12-25 @ 8:11 PM
NCT ID: NCT00122135
Description: No patient reported an adverse event at the time of the study (immediately before/after physician - patient encounter. Nobody reported any adverse events later to study personnel.
Frequency Threshold: 0
Time Frame: There was only a one-time physician-patient encounter for this minimum risk study and any adverse event would have been reported immediately on the day of the encounter. There was no systematic assessment for AE.
Study: NCT00122135
Study Brief: A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients With VI Clinic encounter w/physician \& patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter Clinic encounter w/physician \& patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed. None None 0 60 0 60 View
Patients Without VI Clinic encounter w/physician \& patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter Clinic encounter w/physician \& patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed. None None 0 60 0 60 View
Serious Events(If Any):
Other Events(If Any):