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 @ 12:08 AM
Ignite Modification Date: 2025-12-25 @ 10:08 PM
NCT ID: NCT00529958
Description: Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.
Frequency Threshold: 0
Time Frame: Two years post-operatively.
Study: NCT00529958
Study Brief: Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patellar Tendon (PT) ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft 0 None 0 110 20 110 View
Hamstring (HT) ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft 0 None 1 110 22 110 View
Double-Bundle (DB) ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft 0 None 2 110 38 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Septic Arthritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Massive Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Deep Vein Thrombosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Failed Meniscal Repair NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hamstring Injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tibial Periostitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Deep Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Superficial Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sensory Nerve Problems NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stitch Abscess NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Meniscal Cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Patellar Tendinopathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wound Dehiscence NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chondral Lesion NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Persistent Effusion/Inflammation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hardware Issues NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View