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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:04 PM
NCT ID: NCT01272635
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01272635
Study Brief: Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Azythromycin Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day None None 18 307 179 307 View
Placebo Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day None None 15 300 180 300 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fracture None Injury, poisoning and procedural complications None View
Asthma exacerbation None Respiratory, thoracic and mediastinal disorders None View
Acute bronchitis/wheezing None Respiratory, thoracic and mediastinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Influenza None Respiratory, thoracic and mediastinal disorders None View
Salmonella None Injury, poisoning and procedural complications None View
Viral Enterocolitis None Infections and infestations None View
Complex Febrile Convulsion None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute nasopharyngitis None Respiratory, thoracic and mediastinal disorders None View
Acute Upper Respiratory Infection None Respiratory, thoracic and mediastinal disorders None View
Allergic rhinitis None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View