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 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT01551420
Description: Definitions of adverse events are consistent with clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: Adverse event data were collected non-systematically as events were reported. They were also summarized at annual IRB continuing reviews from baseline to after 9-12 weeks of home use.
Study: NCT01551420
Study Brief: Home Study of an Advanced Upper Limb Prosthesis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Advanced Upper Limb Prosthetic Device IMU Controlled Subjects with upper limb amputation who are trained to use a DEKA Arm with IMU controls Advanced upper limb prosthetic device IMU controlled: Advanced upper limb prosthetic IMU controlled 0 None 0 39 5 39 View
Advanced Upper Limb Prosthetic EMG-PR Controlled Subjects with TR or TH upper limb amputation who are trained to use a DEKA Arm with EMG-PR Controls Advanced upper limb prosthetic EMG-PR controlled: Advanced upper limb prosthetic EMG-PR controlled 0 None 0 13 1 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adverse event NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Musculoskeletal pain View
Unrelated adverse event NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Unrelated Event View
Unrelated adverse event NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Car accident View
Adverse Event NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Skin irritation View
Adverse event NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Injury View