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 @ 2:41 AM
Ignite Modification Date: 2025-12-26 @ 1:19 AM
NCT ID: NCT00517933
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00517933
Study Brief: Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sildenafil 20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks None None 13 89 72 89 View
Placebo 20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks None None 15 91 62 91 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory, thoracic, or mediastinal disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection or infestation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders None View
GI disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Colitis ischemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peptic ulcer hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View