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 @ 4:01 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT00565266
Description: does not differ from clinicaltrials.gov definitions
Frequency Threshold: 2.5
Time Frame: 1 year
Study: NCT00565266
Study Brief: Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
2xICS beclomethasone dipropionate 160 mcg twice daily (2xICS) None None 4 195 6 195 View
Tio + 1xICS tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS) None None 3 203 2 203 View
LABA + 1xICS salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS) None None 4 196 2 196 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hospitalization due to pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
unrelated events SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
urgent care visit due to asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View