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 @ 3:44 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT01883492
Description: None
Frequency Threshold: 0
Time Frame: 3 year after surgery
Study: NCT01883492
Study Brief: A Prospective Multi-center Study on Total Hip Arthroplasty With E1
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BIOLOX Delta Head Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s). Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup. Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1. Femoral Stem: JMDN classification/Class III device Acetabular Cup: JMDN classification: Class III device Acetabular Liner: JMDN classification: Class III device 0 None 0 62 2 62 View
CoCr Head Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s). Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup. CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1. Femoral Stem: JMDN classification/Class III device Acetabular Cup: JMDN classification: Class III device Acetabular Liner: JMDN classification: Class III device 0 None 0 67 1 67 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intraoperative Trochanteric Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Femoral Nerve Palsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Inappropriate femoral stem position NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View