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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT01934504
Description: None
Frequency Threshold: 5
Time Frame: Subjects in Tolerant AAV, Non-Tolerant AAV, Healthy Controls were followed though Week 26. Subjects in Discontinuation group were followed until 8 weeks after discontinuing immunosuppression meds anytime between Week 0 and 52, for a max time of 60 weeks
Study: NCT01934504
Study Brief: Defining Immune Tolerance in ANCA-associated Vasculitis (AAV)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tolerant AAV Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26. None None 0 6 0 6 View
Non-Tolerant AAV Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26. None None 0 3 0 3 View
Healthy Controls Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26. None None 0 16 0 16 View
AAV Discontinuing Immunosuppression Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener's Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects' primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication. None None 0 8 0 8 View
Serious Events(If Any):
Other Events(If Any):