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: 2025-12-26 @ 11:14 AM
Ignite Modification Date: 2025-12-26 @ 11:14 AM
NCT ID: NCT05538728
Description: Safety population Included all participants who were treated with Sculptra.
Frequency Threshold: 0
Time Frame: From Day 1 up to end of study (Up to 11 months)
Study: NCT05538728
Study Brief: An Open-label Study of Poly-l-lactic Acid for Correction of Wrinkles in the décolletage Area
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sculptra 8ml Participants received first treatment injection sub-dermally with Sculptra 8 milliliters (ml; current labeled total volume: reconstituted with 8 mL sterile water for injection \[SWFI\] + 1 mL lidocaine hydrochloride 2 percent \[%\]) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on Galderma Decolletage Scale (GDS) and best correction that achieved as agreed upon by the Treating Investigator and the participant. 0 None 0 16 5 16 View
Sculptra 17ml Participants received first treatment injection sub-dermally with Sculptra 17ml (reconstituted with 17 mL SWFI + 1 mL lidocaine hydrochloride 2%) at Day 1. After first treatment, if needed, an additional 3 treatment sessions were performed at 1 month (+ 2 weeks) interval. Treatment was continued till optimal correction, which was defined as at least one grade improvement on GDS and best correction that achieved as agreed upon by the Treating Investigator and the participant. 0 None 0 14 4 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedDRA (25.0) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (25.0) View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA (25.0) View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (25.0) View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (25.0) View
Injection site nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA (25.0) View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (25.0) View