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 @ 7:00 PM
Ignite Modification Date: 2025-12-25 @ 4:33 PM
NCT ID: NCT05106257
Description: None
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT05106257
Study Brief: Optimizing Self-management COPD Treatment Through the American Lung Association Helpline
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Self-management Education (Short) Self-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information. 0 None 6 22 6 22 View
Self-management Education (Long) Self-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics. 0 None 2 24 10 24 View
Ground-based Walking Training (on) Ground-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD. 0 None 7 22 9 22 View
Ground-based Walking Training (Off) Not randomized to receive ground-based walking training. 0 None 1 24 7 24 View
Inhaler Training (on) Inhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again. 0 None 6 23 6 23 View
Inhaler Training (Off) Not randomized to receive inhaler training. 0 None 2 23 10 23 View
Caregiver Support (on) Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member. 0 None 2 23 7 23 View
Caregiver Support (Off) Not randomized to receive caregiver support. 0 None 6 23 9 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COPD exacerbation/ hospitalization SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Symptoms requiring immediate medical attention SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View