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 @ 3:24 PM
Ignite Modification Date: 2025-12-25 @ 1:42 PM
NCT ID: NCT02040792
Description: One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
Frequency Threshold: 1
Time Frame: None
Study: NCT02040792
Study Brief: A 28-Day Parallel Group Study of TD-4208 in 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
Placebo Placebo Placebo None None 0 71 8 71 View
44 mcg TD-4208 TD-4208 None None 1 68 1 68 View
88 mcg TD-4208 TD-4208 None None 0 71 6 71 View
175 mcg TD-4208 TD-4208 None None 2 71 10 71 View
350 mcg TD-4208 TD-4208 None None 1 74 15 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina Unstable None Cardiac disorders None View
Hypertension None Vascular disorders None View
Intestinal Obstruction None Gastrointestinal disorders None View
Supraventricular tachycardia None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache None General disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
COPD None Respiratory, thoracic and mediastinal disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Oropharyngeal pain None General disorders None View