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 @ 3:13 AM
Ignite Modification Date: 2025-12-26 @ 1:52 AM
NCT ID: NCT03141905
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT03141905
Study Brief: Sick-Day Protocol to Improve Outcomes 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
Sick-Day Protocol Sick-Day Protocol: Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring 3 None 0 159 7 159 View
Usual Care Usual Care: Standard clinical care 2 None 0 156 3 156 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Initiation of Hemodialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lab Alert: Glucose ≥ 499 mg/dL SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Lab Alert: Potassium ≥ 6.1 mEq/dL SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lab Alert: Hemoglobin ≤ 7.5 g/dL SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lab Alert: Co2 ≤ 15 mEq/L SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Lab Alert: Chloride ≥ 115 mEq/dL SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View