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 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:35 PM
NCT ID: NCT02587351
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT02587351
Study Brief: Beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metoprolol Succinate Metoprolol succinate extended release tablets (50 mg) starting dose followed by a dose titration procedure which will result in a final dose of 25mg (1/2 of one tablet daily), 50 mg, or 100 mg (two tablets daily). Metoprolol succinate: Extended release Metoprolol succinate 11 None 86 268 162 268 View
Placebo Matched placebo Placebo: Matching placebo 5 None 59 264 157 264 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-10 View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-10 View
Stroke SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-10 View
Arrhythmias SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-10 View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-10 View
Other Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-10 View
COPD Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-10 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-10 View
Other Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-10 View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD-10 View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ICD-10 View
Lung Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) ICD-10 View
Other Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) ICD-10 View
Infections, non-pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations ICD-10 View
Head, eyes, ears, nose and throat SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders ICD-10 View
Trauma/Falls SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ICD-10 View
Neurologic, non-stroke SYSTEMATIC_ASSESSMENT Nervous system disorders ICD-10 View
Psychiatric SYSTEMATIC_ASSESSMENT Psychiatric disorders ICD-10 View
Chest Pain, not otherwise specified SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-10 View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders ICD-10 View
Other SYSTEMATIC_ASSESSMENT General disorders ICD-10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COPD Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-10 View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-10 View
Acute Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ICD-10 View
Headache SYSTEMATIC_ASSESSMENT General disorders ICD-10 View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD-10 View
Dizziness SYSTEMATIC_ASSESSMENT General disorders ICD-10 View
Respiratory Infections SYSTEMATIC_ASSESSMENT Infections and infestations ICD-10 View