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 @ 11:46 AM
Ignite Modification Date: 2025-12-26 @ 10:19 AM
NCT ID: NCT02988661
Description: The intervention is a well-established education self-management program, consequently, adverse events were not expected to occur from participating in the study and were not collected. Nevertheless, information on all-cause mortality was collected beginning at the baseline assessment and continued through the 18-month assessment.
Frequency Threshold: 0
Time Frame: Information concerning mortality was collected beginning at the baseline assessment and continued through the 18-month assessment.
Study: NCT02988661
Study Brief: Women Empowered to Live With Lupus 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
Chronic Disease Self-management Program (CDSMP) A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort. 2 None 0 0 0 0 View
Usual Care African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts. 18 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):