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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT03351335
Description: The investigator asked the participants for adverse events (AEs) systematically at each visit.
Frequency Threshold: 0
Time Frame: Baseline up to Day 90
Study: NCT03351335
Study Brief: Open-label, Prospective Evaluation of the Ulthera® System for Lifting Submental (Under the Chin) and Neck Tissue in Chinese Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group EL 2: Ultherapy Participants received a single Ultherapy treatment at EL2 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 0.90 J, and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.30 J at baseline. 0 None 0 21 7 21 View
Group EL 3: Ultherapy Participants received a single Ultherapy treatment at EL3 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.00 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz and depth 3.0 mm at energy level 0.35 J at baseline. 0 None 0 19 1 19 View
Group EL 4: Ultherapy Participants received a single Ultherapy treatment at EL4 on the lower face, submental (under the chin) and neck area at dual depth using transducer DS 4 to 4.5 with treatment frequency 4 MHz and depth 4.5 mm at energy level 1.20 J and transducer DS 7 to 3.0 with treatment frequency 7 MHz, and depth 3.0 mm at energy level 0.45 J at baseline. 0 None 0 20 3 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bruising/Ecchymosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Edema SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Itching/Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Pigmentation Change (Hypo-, Hyperpigmentation) SYSTEMATIC_ASSESSMENT General disorders None View
Tenderness/Soreness/Pain/ Sensitivity to Touch SYSTEMATIC_ASSESSMENT General disorders None View
Erythema/Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tingling/Paresthesia/Numbness/ Nerve-related transient pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea, Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Welting/Raised Areas of Edema SYSTEMATIC_ASSESSMENT General disorders None View