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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT02560558
Description: Adverse events were captured through active surveillance via open ended questions by the research coordinator at each study visit in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)
Frequency Threshold: 0
Time Frame: Up to 12 months post baseline
Study: NCT02560558
Study Brief: Bela 8 Week Dosing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belatacept 8-weekly Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. 0 None 9 81 23 81 View
Belatacept 4-weekly Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals. 2 None 10 82 27 82 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infectious Severe Adverse Events SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non Infectious severe Adverse Events SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infectious Adverse Events SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non melanoma skin cancer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View