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 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:07 AM
NCT ID: NCT00115934
Description: Serious Adverse Events: (a) death; (b)acute shunt failure requiring intervention; (c) cardiac arrest requiring CPR and medications; (d) cardiopulmonary insufficiency requiring ECMO; (e) cardiovascular re-operation (unplanned); (f) necrotizing enterocolitis requiring laparotomy; and (g) any other event considered serious by the study investigator.
Frequency Threshold: 5
Time Frame: Adverse events data were collected from the time of randomization through study completion. Adverse events through 12 months after randomization are presented.
Study: NCT00115934
Study Brief: Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MBTS Blalock-Taussig pulmonary artery shunt None None 146 275 249 275 View
RVPAS Right ventricular to pulmonary artery shunt None None 112 274 251 274 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Cardiac general SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Hemorrhage/bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Metabolic/laboratory SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (Unspecified) View
Musculoskeletal/soft tissue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Neurology SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Pulmonary/upper respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Renal/genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (Unspecified) View
Surgery/intra-operative injury SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders PHN coding dictionar View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders PHN coding dictionar View
Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders PHN coding dictionar View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders PHN coding dictionar View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders PHN coding dictionar View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders PHN coding dictionar View
Hematologic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders PHN coding dictionar View
Infectious SYSTEMATIC_ASSESSMENT Infections and infestations PHN coding dictionar View