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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT01415934
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT01415934
Study Brief: Statin Discontinuation in Advanced Illness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Continue Statins Participant will continue on statins as per usual 39 None 4 192 4 192 View
Discontinue Statins Participant will stop taking their statin drugs discontinue statins: patients will be randomized to either continue taking statins or discontinue. 45 None 6 189 7 189 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal Ideation and severe depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hip Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Low Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pulmonary Embolus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rectal Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rehospitalization SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Psychological Distress SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Encephalpathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View