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 @ 6:52 PM
Ignite Modification Date: 2025-12-25 @ 4:24 PM
NCT ID: NCT05097157
Description: None
Frequency Threshold: 0
Time Frame: Subject data was collected throughout subject participation in the study, approximately 9 months.
Study: NCT05097157
Study Brief: Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment With Device Subjects received up to 5 treatments with the device, spaced 4 weeks apart. Potenza: Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body. 0 None 0 79 37 79 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pinpoint bleeding SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dryness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scabbing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tightness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Breakout SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Burn SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tearing SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye twitch SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash/skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blanching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pinpoint dots SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pustule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain/tenderness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Streaking SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Stabbing sensastion post pinpoint bleeding SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Histamine SYSTEMATIC_ASSESSMENT General disorders None View
Skin Textural Irregularity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tingling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View