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 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT00500318
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
Study: NCT00500318
Study Brief: A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aclidinium Aclidinium bromide, 200 micrograms, oral inhalation once per day. None None 2 86 16 86 View
Placebo Dose-matched placebo, oral inhalation, once per day. None None 3 95 18 95 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ileitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.1) View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (9.1) View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Chronic Obstructive Pulmonary Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.1) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.1) View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.1) View