Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:24 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT05365750
Description: This was not a clinical trial but a nested case-control study. Following IRB approved procedures, we collected adverse events (AEs) and serious adverse events (SAE) related to study procedures (surveys, testing), related and un-related COVID-related hospitalizations (SAEs), and related and unrelated all-cause deaths (SAEs). Other unrelated AEs and SAEs were not collected as part of this study focused on COVID. AEs and SAEs and deaths are reported for case-control participants.
Frequency Threshold: 0
Time Frame: Through the completion of the study analytic period, an average of 6 months
Study: NCT05365750
Study Brief: COVID-19 Antibody and Reinfection Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Case Patients Nested Within the Cohort Case patients had a reinfection, defined as a positive SARS-CoV-2 RNA test ≥ 90 days after the first positive RNA. Case patients had serology completed between the infections. 0 None 0 80 0 80 View
Control Patients Nested Within the Cohort Control patients had a primary infection and serologic tests that were conducted between the primary infection and the index date. A control patient could be matched to more than one case patient if they had more than one eligible serologic test. Case patients were 1:20 matched to controls. 0 None 0 1034 0 1034 View
Serious Events(If Any):
Other Events(If Any):