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 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT02034435
Description: None
Frequency Threshold: 0
Time Frame: Monitoring during 1 week of intervention/drug, washout period, and during cross-over to 1 week of remaining intervention/drug. Monitoring for adverse events continued up to 2 weeks after study completion.
Study: NCT02034435
Study Brief: Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aim 1- Low Sodium Low Sodium diet (50mEq/d) 0 None 0 28 7 28 View
Aim 1- High Sodium Low sodium diet (50mEq/d) plus sodium tablet (150 mEq/d) 0 None 0 28 10 28 View
Aim 2- Eplerenone Low sodium diet (50mEq/d) plus Eplerenone 0 None 0 16 3 16 View
Aim 2- Amlodipine Low sodium diet (50mEq/d) plus Amlodipine 0 None 0 16 3 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cramp NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
viral illness NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dizziness/Lightheadedness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Low glucose NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
IV infiltration or malfunction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
discomfort with swallowing pill NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View