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 @ 1:21 PM
Ignite Modification Date: 2025-12-25 @ 12:26 PM
NCT ID: NCT00422695
Description: No interventional procedures were made
Frequency Threshold: 0
Time Frame: Adverse events were assessed during the examination. The patients were patients of records and were routinely examined in the clinic.
Study: NCT00422695
Study Brief: Pain and Sensory Changes Assessment in HIV+ Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HIV + Groups divided according to CD4 counts 105 HIV subjects None None 0 105 0 105 View
Healthy Controls HIV -free subjects 38 Healthy Controls None None 0 38 0 38 View
Serious Events(If Any):
Other Events(If Any):