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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:44 PM
NCT ID: NCT00436969
Description: All subjects that received study treatment are included in the safety population.
Frequency Threshold: 5
Time Frame: The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months
Study: NCT00436969
Study Brief: ORTHOVISC Shoulder Osteoarthritis Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone). None None 3 87 6 87 View
Investigational Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder. None None 10 183 19 183 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest Pain - Cardiac Cath to Rule Out Cad NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (14.0) View
Knee Pain Both Knees NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View
Shoulder Pain (Index Shoulder) Right Shoulder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View
Breast Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (14.0) View
Patient has cancer, did not specify to PI where cancer is, never returned, lost to follow-up NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (14.0) View
Total Shoulder Arthroplasty Plus Bone Graft Glenoid Scapular Right Shoulder NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (14.0) View
Left Shoulder Pain Non-Study Shoulder - Surgery 6/10/09 NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View
Quadruple Bypass 5/6/09 NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (14.0) View
Iliopsoas Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View
Open Heart Surgery After Aortic Valve Disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (14.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View