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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT01934218
Description: None
Frequency Threshold: 5
Time Frame: 25 months
Study: NCT01934218
Study Brief: Gel-One Treatment in Knee Osteoarthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gel-One 3 mL, a single intra-articular injection of Gel-One. 0 None 7 404 107 404 View
Placebo 3 mL, a single intra-articular injection of PBS. 0 None 6 410 113 410 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Oesophageal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View