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: 2025-12-26 @ 10:58 AM
Ignite Modification Date: 2025-12-26 @ 10:58 AM
NCT ID: NCT03044106
Description: None
Frequency Threshold: 0
Time Frame: Data was collected on two visits separated by at least 1 week washout period. On the second visit, participants were asked about any adverse events. A survey on adverse events was sent 2 weeks after second visit asking for any information on adverse everts as well.
Study: NCT03044106
Study Brief: Cranial Laser Reflex Technique for Hamstring Function
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CLRT Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The aperture of the laser probe will be placed at posterior end of the reflex (a), turned on and moved to the anterior end of the reflex (b) at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times. 0 None 0 44 1 44 View
SHAM The laser is inactive, all other descriptions are the same as active. 0 None 0 44 2 44 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild soreness in Hamstring SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mild Headache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View