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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT02101294
Description: No adverse events were recorded.
Frequency Threshold: 0
Time Frame: Adverse event data were collected at each typing session for the period of study data collection (1995-2008), over the course of thirteen years.
Study: NCT02101294
Study Brief: Study Protocol for CTS and Keyboard Controlled Randomized Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Interossei Lumbricals Neuro Interface Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout \[actual home row placement order: asdeihotlrn\], plus substitutions on the upper row \[qwfgjyuk;p\] and bottom row \[zxcvb'm,.\] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness. None None 0 31 0 31 View
Serious Events(If Any):
Other Events(If Any):