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 @ 3:09 AM
Ignite Modification Date: 2025-12-26 @ 1:48 AM
NCT ID: NCT02975505
Description: The study team collected adverse event information from the participants weekly.
Frequency Threshold: 0
Time Frame: Between baseline and year 4 of study
Study: NCT02975505
Study Brief: Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual SBP Target Target Systolic Home Blood Pressure 130-140 mm Hg 2 None 22 42 10 42 View
Strict SBP Target Target Systolic Home Blood Pressure \<120 mm Hg Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home) 5 None 30 66 18 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
All-cause hospitalization SYSTEMATIC_ASSESSMENT Investigations hospitalization View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute kidney injury or ER visit SYSTEMATIC_ASSESSMENT Renal and urinary disorders hospitalization View