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: 2025-12-24 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT02877004
Description: All Adverse Events that met criteria for being Serious Adverse Events were recorded and followed up; In addition, adverse events not meeting SAE criteria and considered to be potentially related to the LLLT were also documented.
Frequency Threshold: 0
Time Frame: Adverse events were collected during LLLT treatment for each group (4 weeks for group A; 6 weeks for group B; 12 weeks for group C).
Study: NCT02877004
Study Brief: LLLT for Reducing Waste Circumference and Weight
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Laser for 4 Weeks 3 Low-Level Laser Therapy Treatments Weekly 3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks 0 None 0 20 0 20 View
Laser for 6 Weeks 2 Low-Level Laser Therapy Treatments Weekly 2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks 0 None 0 20 0 20 View
Laser for 12 Weeks 1 Low-Level Laser Therapy Treatment Weekly 1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks 0 None 1 20 0 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):