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 @ 2:45 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT00984659
Description: Safety data are presented for the Modified Intent-to-Treat (MITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication. Data summaries and analyses were based on the actual treatment received. One participant in the SAL 50 mcg arm was randomized but did not receive treatment.
Frequency Threshold: 0
Time Frame: None
Study: NCT00984659
Study Brief: Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary 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
Placebo Matching placebo via DISKUS, administered as one inhalation twice daily (BID) None None 4 75 14 75 View
SAL 50 mcg Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID None None 5 151 34 151 View
FSC 250/50 mcg Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period None None 3 139 37 139 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Impaired Gastric Emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diabetes Mellitus Inadequate Control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory Tract Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis Allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastric Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sinus Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Carpal tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Impaired Gastric Emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lip Swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint Swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lower Extremity Mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Adverse Drug Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hand Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ankle Fracture SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Epicondylitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle Strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes Mellitus Inadequate Control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Heart Rate Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lung Neoplasm Malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Seborrhoeic Keratosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Periorbital Edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Multiple Allergies SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View