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: 2025-12-26 @ 1:19 PM
Ignite Modification Date: 2025-12-26 @ 1:19 PM
NCT ID: NCT02791906
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02791906
Study Brief: Targeting Central Pulsatile Hemodynamics in Chronic Kidney Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ISMN Only Monotherapy with isosorbide mononitrate 0 None 0 4 4 4 View
ISMN AND Vitamin C Combination therapy with isosorbide mononitrate and vitamin C 0 None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urosepsis requiring hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Worsening renal AKI + Hyperkalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
2n degree AV block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness/dizziness/lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Ankle swelling SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Balance problems SYSTEMATIC_ASSESSMENT General disorders None View
Heart burn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sleep SYSTEMATIC_ASSESSMENT General disorders None View
Sweating SYSTEMATIC_ASSESSMENT General disorders None View