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: 2025-12-25 @ 3:54 AM
Ignite Modification Date: 2025-12-26 @ 2:44 AM
NCT ID: NCT02512302
Description: A serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
Frequency Threshold: 5
Time Frame: up to week 5
Study: NCT02512302
Study Brief: Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe 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
Seebri® Breezhaler® With Activated Charcoal : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal None None 0 27 5 27 View
SUN-101 Via eFlow Nebulizer 50 mcg glycopyrrolate via Electronic Nebulizer SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer None None 0 29 1 29 View
SUN-101 Via eFlow Nebulizer With Activated Charcoal 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal None None 0 29 3 29 View
Seebri® Breezhaler® 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI None None 0 28 3 28 View
: Glycopyrrolate Injection 50 mcg glycopyrrolate via IV infusion Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV None None 0 27 4 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View