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 @ 3:56 AM
Ignite Modification Date: 2025-12-26 @ 2:47 AM
NCT ID: NCT01797302
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT01797302
Study Brief: Vitamin D and Vascular Health in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vitamin D3 1000 IU Vitamin D3 1000 IU tablet by mouth once daily for 6 months Vitamin D3: Tablet form 0 None 0 74 20 74 View
Vitamin D3 2000 IU Vitamin D3 2000 IU tablet once daily by mouth for 6 months Vitamin D3: Tablet form 0 None 1 75 24 75 View
Vitamin D3 600 IU Vitamin D3 600 IU tablet by mouth once daily for 6 months Vitamin D3: Tablet form 0 None 0 76 26 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Flu like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Dysmenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Bronchial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Irregular menstruation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Otitis media NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Rhinitis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Stomach pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Surgical and medical procedures other NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (4.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Injury, poisoning, and proc complications other NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Skin and subcutaneous disorders other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View