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 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:00 AM
NCT ID: NCT04255394
Description: Definitions according to ISO14155:2013
Frequency Threshold: 0
Time Frame: All adverse events up to 10 years post-op
Study: NCT04255394
Study Brief: Exceed ABT Acetabular Cup Cementless System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A MoP Exceed ABT cup with Cobalt Chrome head Ringloc-X poly Liner (called MOP, metal on Poly) 36 None 63 208 1 208 View
Group B CoC Exceed ABT cup with Ceramic head and ceramic Liner (called CoC, ceramic on ceramic) 25 None 89 449 2 449 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Device Revision NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Dislocation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fracture of femur or acetabulum NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Trochanteric Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Total Knee Replacement NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Total Hip replacement contralateral NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Initial cup instability NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Noise from the hip NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Aortic Stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sciatic Nerve Encace NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hysterectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heterotopic Ossification NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Facet joint NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain syndrom NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain - Intermittent NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Severe hip pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Deep vein Trombosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Swelling finger NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Colostomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Femoral subsidence NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Congestive Heart Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BILAT BK AMPUTATIONS NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Ankle replacement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Calcar Crack NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Injury after fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
LUMBAR SPINAL STENOSIS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sponteneous bleeds NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Trochanteric Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Thigh Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
vertrebral collapse NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CVA NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Terminally Ill NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain hip NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Groin Discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PSOAS Strain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain in left lateral thigh after fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall on shoulder without injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
RIGHT CARPAL TUNNEL DECOMPRESSION NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View