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 @ 5:34 PM
Ignite Modification Date: 2025-12-25 @ 3:06 PM
NCT ID: NCT02418468
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02418468
Study Brief: Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
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 Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) None None 2 13 4 13 View
Indacaterol 150 mcg Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) None None 1 11 2 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thoracic cage fractures non-spinal SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Epidermal and dermal conditions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Influenza viral infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Corneal injuries SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Joint related signs and symptoms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal and connective tissue disorders sign and symptoms NEC SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bronchospasm and obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Coughing and associated symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Inner ear signs and sympotoms SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View