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 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT00969332
Description: None
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT00969332
Study Brief: A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Omegaven 0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria. Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday 4 None 35 59 53 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Necrotizing Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT General disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT General disorders None View
Metabolic Acidosis SYSTEMATIC_ASSESSMENT General disorders None View
Bowel Rejection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute Life Threatening Event SYSTEMATIC_ASSESSMENT General disorders None View
Increased Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increased International Normalized Ratio SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Clinical Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View