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 @ 2:54 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT03244059
Description: Adverse event tabulated and classified based on severity.
Frequency Threshold: 0
Time Frame: 210 days or the end of treatment if withdrawn prior to 7 month completion
Study: NCT03244059
Study Brief: Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies
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 Subjects randomized to the experimental treatment arm will receive i.v. administrations of belimumab (10 mg/kg), consisting of three "loading" doses, two weeks apart, followed by five (5) more monthly infusions. The final assessment will be performed at month 8. Belimumab: Belimumab is an anti-BLyS (B-lymphocyte stimulating factor) agent administered by infusion. 0 None 4 10 4 10 View
Placebo These subjects will be treated with identically appearing placebo i.v. on the same schedule as the experimental arm subjects (i.e., three "loading" doses, two weeks apart, followed by five more monthly infusions. Again, the final assessment will be performed at month 7 (210+10 days after treatment start). Placebo: An identically appearing placebo infusion. 0 None 0 6 4 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SAE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
SAE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SAE SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Minor self limited SYSTEMATIC_ASSESSMENT Nervous system disorders None View
minor adverse event SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
minor adverse event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
minor adverse event SYSTEMATIC_ASSESSMENT Nervous system disorders None View
minor adverse event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
minor adverse event SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
minor adverse event SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
minor adverse event SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Minor self limited SYSTEMATIC_ASSESSMENT Nervous system disorders None View
minor adverse event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View