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 @ 3:33 PM
Ignite Modification Date: 2025-12-25 @ 1:46 PM
NCT ID: NCT00569192
Description: All randomized patients who received at least one dose of study drug and who have at least one post dosing safety evaluation were included in the adverse event analysis.
Frequency Threshold: 5
Time Frame: None
Study: NCT00569192
Study Brief: A Study of 2 Doses of MAP0010 and Placebo in Asthmatic 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
Placebo Placebo delivered by nebulization twice daily for 12 weeks None None 1 110 33 110 View
0.135 mg MAP0010 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks None None 2 123 31 123 View
0.25 mg MAP0010 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks None None 0 123 42 123 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.1) View
Pneumonia Necrotising SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
Upper Respiratory Tract Infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.1) View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.1) View