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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:25 PM
NCT ID: NCT01814332
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01814332
Study Brief: Analyzing Female Trauma Exposed Responses to a Medication
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GSK561679 GSK561679, oral administration, 350mg/day, 6 week administration GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration None None 1 63 55 63 View
Placebo Placebo compound treatment for comparison with IP Placebo: Placebo compound treatment for comparison with IP None None 1 65 55 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Asthma exacerbation None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Contusion None Injury, poisoning and procedural complications None View
Neck Pain None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Dizziness None Musculoskeletal and connective tissue disorders None View
Tinnitus None Ear and labyrinth disorders None View
Hot Flush None Endocrine disorders None View
Non-cardiac chest pain None Endocrine disorders None View
Vision Blurred None Eye disorders None View
Nausea None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Dry Mouth None Gastrointestinal disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Abdominal distension None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Irritability None General disorders None View
Disturbance in attention None General disorders None View
Hypersensitivity None General disorders None View
Upper Respiratory Tract Infection None Infections and infestations None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Muscle spasm None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Sedation None Nervous system disorders None View
Migraine None Nervous system disorders None View
Insomnia None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Rhinitis Allergic None Respiratory, thoracic and mediastinal disorders None View
Sinusitis None Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Pruritis None Skin and subcutaneous tissue disorders None View