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: 2025-12-26 @ 11:10 AM
Ignite Modification Date: 2025-12-26 @ 11:10 AM
NCT ID: NCT02951312
Description: AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Frequency Threshold: 5
Time Frame: 0-47 days
Study: NCT02951312
Study Brief: Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients 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
Glycopyrrolate Inhalation Solution 25 μg Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily None None 0 6 2 6 View
Glycopyrrolate Inhalation Solution75μg Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily None None 0 6 2 6 View
Glycopyrrolate Inhalation Solution 200 μg Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily None None 0 6 4 6 View
Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer ,once daily Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, once daily None None 0 6 2 6 View
Glycopyrrolate Inhalation Solution 500μg Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily None None 0 6 0 6 View
Glycopyrrolate Inhalation Solution1000mg Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily None None 0 6 2 6 View
Placebo Placebo Placebo None None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
catheter site related reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View