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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT00208494
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00208494
Study Brief: Metal on Metal Versus Ceramic on Metal Hip Replacement
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ceramic-on-Metal (COM) Total Hip Implant The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert. None None 40 194 137 194 View
Metal-on-Metal (MOM) Total Hip Implant The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert. None None 48 196 125 196 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bone Fracture None Musculoskeletal and connective tissue disorders None View
Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cardiovascular None Cardiac disorders None View
Central Nervous System None Nervous system disorders None View
Constitutional Symptom None General disorders None View
Dermatological None Skin and subcutaneous tissue disorders None View
Dislocation None Musculoskeletal and connective tissue disorders None View
Gastrointestinal None Gastrointestinal disorders None View
Genitourinary None Renal and urinary disorders None View
Hematological None Blood and lymphatic system disorders None View
Hematoma requiring drainage None Blood and lymphatic system disorders None View
Musculoskeletal None Musculoskeletal and connective tissue disorders None View
Operative Adverse Event (fracture of femur None Surgical and medical procedures None View
Operative Adverse Event (other complication None Surgical and medical procedures None View
Operative Adverse Event (seating acetabular prosthesis) None Surgical and medical procedures None View
Peripheral nervous system None Nervous system disorders None View
Respiratory system None Respiratory, thoracic and mediastinal disorders None View
Deep Infection None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Trochanteric Bursitis None Musculoskeletal and connective tissue disorders None View
Central Nervous System None Nervous system disorders None View
Genitourinary None Renal and urinary disorders None View
Respiratory system None Respiratory, thoracic and mediastinal disorders None View
Dermatological None Skin and subcutaneous tissue disorders None View
Hematological None Blood and lymphatic system disorders None View
Cardiovascular None Cardiac disorders None View
Gastrointestinal None Gastrointestinal disorders None View
Constitutional symptom None General disorders None View
Wound problem None Injury, poisoning and procedural complications None View
Musculoskeletal None Musculoskeletal and connective tissue disorders None View