Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Belkyra

Medical condition to be studied

Fat tissue increased
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

600
Study design details

Main study objective

1. To assess the safety profile of BELKYRA routine Inj. in routine clinical practice in adult patients treated for SM fullness due to SMF2. To assess the effectiveness of BELKYRA Inj. in routine clinical practice in adult patients treated for SM fullness due to SMF.

Outcomes

All adverse events that occur during and/or after administration of BELKYRA injection treatment throughout the follow-up period, Investigators' and patients' rating of improvement of fullness associated with submental fat, during follow-up using validated scales.

Data analysis plan

Full analysis set - patients whose case report form were retrieved: the demographic data, baseline characteristics including diagnosis, treatment history, concurrent disease, etc. and concomitant medications • Safety analysis set– patients who received an initial BELKYRA Inj. treatment, completed the Follow-up/Exit Visits (non-treatment) within 3 months of the last BELKYRA Inj. treatment for safety information (via in-office visit or telephone) with case report forms retrieved• Effectiveness analysis– patients who received an initial BELKYRA Inj. treatment and have been evaluated for effectiveness of BELKYRA Inj. for the treatment of excess SMF by the investigator or by the patient.