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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT01528332
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT01528332
Study Brief: Blue Light Device for Pain Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pain Relief Patch Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes None None 0 85 62 85 View
Control PRP Device Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes None None 0 86 60 86 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
General Disorders None General disorders MedDRA 15.0 View
Gastrointestinal disorders None Gastrointestinal disorders MedDRA 15.0 View
Infections and Infestations None Infections and infestations MedDRA 15.0 View
Ear and labyrinth disorders None Ear and labyrinth disorders MedDRA 15.0 View
Respiratory, thoracic and mediastinal disorders None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Psychiatric disorders None Psychiatric disorders MedDRA 15.0 View
Back Pain None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Headache None Nervous system disorders MedDRA 15.0 View