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 @ 5:01 AM
Ignite Modification Date: 2025-12-26 @ 4:02 AM
NCT ID: NCT05163418
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected from baseline to 12 months visit for the groups with treatment(flat and high arches feet). No follow-up was done with the normal feet group therefore adverse event data was only collected for baseline visit.
Study: NCT05163418
Study Brief: Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging 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
Flat Feet People with flat feet according to foot posture index (validated by clinical assessment) Foot orthoses for high arches feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics. 0 None 0 34 4 34 View
High Arches Feet People with high arches feet according to foot posture index (validated by clinical assessment) Foot orthosis for flat feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics. 0 None 0 11 4 11 View
Normal Arches Feet (Control Group) Control group 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Foot pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View