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 @ 7:59 PM
Ignite Modification Date: 2025-12-25 @ 5:33 PM
NCT ID: NCT00694304
Description: None
Frequency Threshold: 5
Time Frame: Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period
Study: NCT00694304
Study Brief: Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vortioxetine 2.5, 5, or 10 mg/Day None None None 18 535 256 535 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations 12.1 View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 12.1 View
Adjustment disorder with mixed anxiety and depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders 12.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders 12.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations 12.1 View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 12.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 12.1 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 12.1 View
Benign salivary gland neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 12.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders 12.1 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders 12.1 View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders 12.1 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders 12.1 View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 12.1 View
Dermatitis herpetiformis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 12.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations 12.1 View
Accidental overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 12.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations 12.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations 12.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 12.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders 12.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders 12.1 View