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 @ 2:56 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT03803059
Description: An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation where a subject is administered any product or medical device, regardless of a causal relationship with the test article
Frequency Threshold: 0
Time Frame: The adverse event data were collected from Baseline up to 6 months post treatment.
Study: NCT03803059
Study Brief: Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Skinpen Precision System Microneedle treatment to neck areas. SkinPen Precision: Surgical instrument motors and accessories/attachments/Hydrogel 0 None 0 35 10 35 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Viral Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Kidney Stone removal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Root canal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Meniscus repair SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Biopsy on Jawline SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Afib Cardioversion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Sleep Apnea SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations None View