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 @ 6:40 PM
Ignite Modification Date: 2025-12-25 @ 4:11 PM
NCT ID: NCT00419757
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00419757
Study Brief: An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Symbicort SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily None None 4 127 69 127 View
Budesonide budesonide HFA pMDI 160 μg x 2 actuations twice daily None None 0 123 48 123 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Status Asthmaticus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pharyngitis Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pharyngolaryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View