BioMed Research International / 2015 / Article / Tab 4

Clinical Study

An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds

Table 4

Adverse events by system organ class ().

System organ class (MedDRA)
Preferred term
Number (%) of
subjectsa

General disorders and administration site conditions14(29.2)
 Influenza-like illness1(2.1)
 Injection site hematoma12(25.0)
 Injection site swelling2(4.2)
Infections and infestations3(6.3)
 Acute tonsillitis1(2.1)
 Bronchitis1(2.1)
 Nasopharyngitis1(2.1)
 Oral herpes1(2.1)
Musculoskeletal and connective tissue disorders1(2.1)
 Tenosynovitis1(2.1)
 Trigger finger1(2.1)
Reproductive system and breast disorders1(2.1)
 Uterine polyp1(2.1)
 Vaginal hemorrhage1(2.1)
Total15(31.3)

Percentages are based on the total number of subjects in the safety analysis data.
MedDRA = Medical Dictionary for Regulatory Activities, = number of subjects.

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