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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT01228903
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01228903
Study Brief: Uric Acid and the Endothelium in CKD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. Placebo: Placebo tablets with no active ingredient None None 0 41 9 41 View
Allopurinol Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels. None None 1 39 4 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GI discomfort None Gastrointestinal disorders None View
rash None Skin and subcutaneous tissue disorders None View
Abnormal Liver Function Tests None Hepatobiliary disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
gout None Musculoskeletal and connective tissue disorders None View