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: 2025-12-25 @ 1:05 AM
Ignite Modification Date: 2025-12-25 @ 11:17 PM
NCT ID: NCT01025193
Description: None
Frequency Threshold: 5
Time Frame: adverse events were collected for up to 12 months during which patients received belimumab therapy and for 8 weeks after the last dose of belimumab therapy.
Study: NCT01025193
Study Brief: Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belimumab Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the patient waiting for kidney transplant's blood. This use was considered investigational (not approved by the Food and Drug Administration). Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant. None None 3 8 6 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Ablation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
fluid overload SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hives SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
non-cardiac related chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Shakiness SYSTEMATIC_ASSESSMENT General disorders None View
anemia (low red blood cell count) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
fluid overload SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
infection cold symptoms SYSTEMATIC_ASSESSMENT Infections and infestations None View
partial parathyroidectomy SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Rash left antecubitus from adhesive tape SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertensive episode SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View