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 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:35 PM
NCT ID: NCT02985151
Description: Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.
Frequency Threshold: 0
Time Frame: Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.
Study: NCT02985151
Study Brief: Interventional Study to Evaluate the Appearance of Surgical Scars After Laser 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
High Energy Treatment Group Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings. Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy. 0 None 0 35 7 35 View
Low Energy Placebo Group Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy. 0 None 0 26 7 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Concussion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Basal Cell Carcinoma of the Skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View