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 @ 4:11 PM
Ignite Modification Date: 2025-12-25 @ 2:11 PM
NCT ID: NCT00857766
Description: None
Frequency Threshold: 5
Time Frame: 16 week observation
Study: NCT00857766
Study Brief: A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With 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
FSC DISKUS 250/50 mcg Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device. None None 8 123 9 123 View
Matching Placebo Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device. None None 8 126 7 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchial carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Metastases to spine SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Metastatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View