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 @ 12:52 AM
Ignite Modification Date: 2025-12-25 @ 11:07 PM
NCT ID: NCT00393367
Description: None
Frequency Threshold: 2
Time Frame: 30 days
Study: NCT00393367
Study Brief: Budesonide Inhalation Suspension for Acute Asthma 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
Budesonide Inhalation Suspension (BIS) standardized treatment with nebulized Budesonide Inhalation Suspension (BIS) None None 3 91 30 91 View
Placebo (Saline) standardized treatment with nebulized saline None None 2 88 27 91 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization within 5 days of Emergency Department discharge home NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increased level of care NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
stomach ache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
sore throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
emesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
epistaxis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
chest pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
leg pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
rhinorrhea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View