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 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:26 AM
NCT ID: NCT05209360
Description: \[Not Specified\]
Frequency Threshold: 0.05
Time Frame: Study participants were monitored/assessed for adverse advents throughout the duration of the study visit, up to 4 hours. Participants were also instructed to call or email the research team if any adverse events related to the study occurred after completion of the study visit, up to 6 months.
Study: NCT05209360
Study Brief: Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CDO Only Participants completed testing while wearing a CDO with no wedges. Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot. 0 None 0 20 1 20 View
NoCDO Participants completed testing without an orthosis or wedge, wearing shoes only. 0 None 0 20 0 20 View
Medial Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot. Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot. 0 None 0 20 1 20 View
Lateral Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot. Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot. 0 None 0 20 1 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders None View