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 @ 3:00 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT03923933
Description: None
Frequency Threshold: 0
Time Frame: 28 days
Study: NCT03923933
Study Brief: Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo This group will receive 3 milligrams of bumetanide per day for a week plus placebo (starch) that will simulate the chlorthalidone dose of the treatment group. In case the dose is well tolerated, the dose of bumetanide will be increased to 4 milligrams per day. Bumetanide: Bumetanide 0 None 0 16 4 16 View
Treatment Grup This group will receive 3 milligrams of bumetanide plus 50 milligrams of chlorthalidone per day, for a week. If the dose is well tolerated, it will be increased to 4 milligrams of bumetanide and 100 milligrams of chlorthalidone per day. Chlorthalidone: Chlorthalidone Bumetanide: Bumetanide 0 None 1 16 11 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Major adverse cardiovascular events SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Creatinine Increase SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hypokalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hyperuricemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View