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 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT00989833
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00989833
Study Brief: Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Terbutaline Placebo budesonide once daily and terbutaline before exercise and as needed None None 0 22 10 22 View
Budesonide/Terbutaline Budesonide once daily and terbutaline before exercise and as needed None None 0 21 7 21 View
Budesonide/Formoterol Placebo budesonide once daily and budesonide/formoterol before exercise and as needed None None 0 23 9 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Common cold SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
Slight Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View