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: 2025-12-26 @ 11:48 AM
Ignite Modification Date: 2025-12-26 @ 11:48 AM
NCT ID: NCT03672916
Description: ISO definitions are applicable
Frequency Threshold: 0
Time Frame: From surgery until the last study visit at 10 years post-op.
Study: NCT03672916
Study Brief: Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients Who Received the Allofit IT With BIOLOX Delta Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners 6 None 45 185 52 185 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Study-hip affected: Revisions of implant system SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Study-hip affected: Luxation/Dislocation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Study-hip affected: Periprosthetic femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Musculoskeletal (non-study hip) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary/Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Reported deaths with unknown causes SYSTEMATIC_ASSESSMENT General disorders None View
Oncological SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Infection (non-study hip) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal (non-study hip) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Oncological SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Others SYSTEMATIC_ASSESSMENT General disorders None View
Study-hip affected adverse events SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View