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 @ 6:33 PM
Ignite Modification Date: 2025-12-25 @ 4:03 PM
NCT ID: NCT00809757
Description: One subject in the randomized to levalbuterol UDV group was not dosed
Frequency Threshold: 2
Time Frame: 4 weeks
Study: NCT00809757
Study Brief: A Safety, Efficacy and Tolerability Study in Pediatric Subjects With 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
Levalbuterol UDV LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID None None 3 63 27 63 View
Placebo PBO MDI Placebo: Placebo (2 actuations) MDI TID None None 0 68 28 68 View
Levalbuterol MDI LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID None None 1 65 31 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Metapneumovirus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Status Asthmaticus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Sinusitis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Dermatitis Diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.1) View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View