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 @ 1:26 AM
Ignite Modification Date: 2025-12-25 @ 11:37 PM
NCT ID: NCT00371293
Description: Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
Frequency Threshold: 1
Time Frame: None
Study: NCT00371293
Study Brief: The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CPAP Participants will receive CPAP therapy. CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep. None None 0 58 10 58 View
Combination Participants will receive CPAP therapy and take part in a weight loss program. Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity. CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep. None None 0 62 10 62 View
Weight Loss Participants will take part in a weight loss program. Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity. None None 0 61 9 61 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
High Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Laryngitis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Type II Diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Motor Vehicle Accident None Injury, poisoning and procedural complications None View
Self Committed to Hospital None General disorders None View
Tendonitis of Shoulder None Musculoskeletal and connective tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Knee Replacement Surgery None Surgical and medical procedures None View
Rotator Cuff Surgery None Surgical and medical procedures None View
Knee Pain None Musculoskeletal and connective tissue disorders None View
Leg Cramps None Cardiac disorders None View
Palpitations None Cardiac disorders None View
Pain in ankle/ lower back None Musculoskeletal and connective tissue disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Flu SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nostril Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsening of Respiratory Allergy Symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
"Shakiness" After IVGTT None Nervous system disorders None View
Burning Sensation after IVGTT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lump at site of IV SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising/Tenderness- IV SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomited during IVGTT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash from Lead SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dehydration None General disorders None View
Sprained Wrist/ Bruised Knee None Musculoskeletal and connective tissue disorders None View
Right Flank Pain None General disorders None View
Tooth Extraction and Implant None Surgical and medical procedures None View
Possible Urinary Tract Infection None Renal and urinary disorders None View
New diagnosis of fibromyalgia None Musculoskeletal and connective tissue disorders None View
Intestinal Cramping None Gastrointestinal disorders None View
Right Shoulder Pain None Musculoskeletal and connective tissue disorders None View
Ankle Injury None Musculoskeletal and connective tissue disorders None View
Abdominal Pain/ Kidney Stone None Renal and urinary disorders None View
Eye Irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Depression None Psychiatric disorders None View
Swelling in legs and ankles None Cardiac disorders None View
Wisdom Teeth Removal None Surgical and medical procedures None View
Panic Attack None Psychiatric disorders None View