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 @ 5:54 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT02634268
Description: Adverse events were monitored without regard to the specific Adverse Event Term.
Frequency Threshold: 0
Time Frame: We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Study: NCT02634268
Study Brief: INtervention Study In overweiGHT Patients With 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
Usual Care Participants continue with usual diet and exercise activities as they desire 9 None 75 338 90 338 View
Lifestyle Intervention Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity 4 None 78 346 95 346 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiovascular SYSTEMATIC_ASSESSMENT General disorders None View
Dermatological SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematological SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Metabolic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychological SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary/Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal/Urologic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hepatobiliary SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiovascular SYSTEMATIC_ASSESSMENT General disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Dermatological SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematological SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Metabolic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychological SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary/Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal/Urologic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hepatobiliary SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View