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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT02851992
Description: Adverse Events are reported via a complication case report form completed by the Investigator
Frequency Threshold: 0
Time Frame: up to 2 years
Study: NCT02851992
Study Brief: A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GTS Cementless Stem Total Hip arthroplasty with GTS cementless stem (standard and lateralized) with different cup and bearing options (metal-on-polyethylene or ceramic-on-polyethylene) GTS cementless stem: Total Hip Arthroplasty 0 None 11 281 32 281 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Other hip related, Cupule conflict /psoas, cup too wide SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall of patient resulting in revision SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dislocation, 2/ DISLOCATION ON 06/26/15 SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other hip related, psoas tendonitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acetabular implant failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other hip related, left iliac fracture due to fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femoral implant failure and fracture of femoral shaft SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other general complication and Thrombophlebitis of the calf SYSTEMATIC_ASSESSMENT General disorders None View
Other general complication SYSTEMATIC_ASSESSMENT General disorders None View
Revision of cup & liner due to instability SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Withdrawn, Conflict with The Patient / Trial / Stop of Follow-Up SYSTEMATIC_ASSESSMENT Social circumstances None View
Instability SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
LTF SYSTEMATIC_ASSESSMENT Social circumstances None View
Withdrawn, not willing to return SYSTEMATIC_ASSESSMENT Social circumstances None View
Other hip related, bursitis trochanterica SYSTEMATIC_ASSESSMENT General disorders None View
Dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other hip related, the patient doesn't execute functional kine SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fracture of femoral neck SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Haemorrhage SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other general complication, results and scores affected by knee pathology SYSTEMATIC_ASSESSMENT General disorders None View
Femoral implant fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other general complication, total hip replacement SYSTEMATIC_ASSESSMENT General disorders None View
Other general complication, total knee replacement SYSTEMATIC_ASSESSMENT General disorders None View
Other general complication, Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT General disorders None View
Superficial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nerve injury, dropfoot left SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other general complication, coxarthrosis contralateral hip SYSTEMATIC_ASSESSMENT General disorders None View
Other general complication, coxarthrosis contralateral SYSTEMATIC_ASSESSMENT General disorders None View
Other general complications SYSTEMATIC_ASSESSMENT General disorders None View
Nerve injury, paralysis of the extra popliteal sciatic nerve SYSTEMATIC_ASSESSMENT Nervous system disorders None View