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 @ 10:21 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT01801735
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01801735
Study Brief: Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Meloxicam 10 mg Participants were administered Meloxicam 10 mg once daily for up to 52 weeks. None None 35 600 65 600 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Angina pectoris None Cardiac disorders None View
Cardiac failure acute None Cardiac disorders None View
Cardiac failure congestive None Cardiac disorders None View
Coronary artery disease None Cardiac disorders None View
Coronary artery stenosis None Cardiac disorders None View
Diverticulum intestinal hemorrhagic None Gastrointestinal disorders None View
Duodenal ulcer hemorrhage None Gastrointestinal disorders None View
Gastric ulcer hemorrhage None Gastrointestinal disorders None View
Gastroesophageal reflux disease None Gastrointestinal disorders None View
Chest pain None General disorders None View
Non-cardiac chest pain None General disorders None View
Drug-induced liver injury None Hepatobiliary disorders None View
Appendicitis perforated None Infections and infestations None View
Bronchitis None Infections and infestations None View
Diverticulitis None Infections and infestations None View
Lobar pneumonia None Infections and infestations None View
Meningitis bacterial None Infections and infestations None View
Sepsis None Infections and infestations None View
Staphylococcal sepsis None Infections and infestations None View
Post procedural complication None Injury, poisoning and procedural complications None View
Road traffic accident None Injury, poisoning and procedural complications None View
Spinal compression fracture None Injury, poisoning and procedural complications None View
Costochondritis None Musculoskeletal and connective tissue disorders None View
Breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung squamous cell carcinoma, stage unspecified None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Transitional cell carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Carotid artery stenosis None Nervous system disorders None View
Hemorrhagic cerebral infarction None Nervous system disorders None View
Fourth nerve paralysis None Nervous system disorders None View
Renal failure acute None Renal and urinary disorders None View
Acute respiratory distress syndrome None Respiratory, thoracic and mediastinal disorders None View
Acute respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Medical device removal None Surgical and medical procedures None View
Aortic aneurysm rupture None Vascular disorders None View
Hypertensive crisis None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Urinary tract infection None Infections and infestations None View