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; subjects^a
General disorders and administration site conditions	14	(29.2)
Influenza-like illness	1	(2.1)
Injection site hematoma	12	(25.0)
Injection site swelling	2	(4.2)
Infections and infestations	3	(6.3)
Acute tonsillitis	1	(2.1)
Bronchitis	1	(2.1)
Nasopharyngitis	1	(2.1)
Oral herpes	1	(2.1)
Musculoskeletal and connective tissue disorders	1	(2.1)
Tenosynovitis	1	(2.1)
Trigger finger	1	(2.1)
Reproductive system and breast disorders	1	(2.1)
Uterine polyp	1	(2.1)
Vaginal hemorrhage	1	(2.1)
Total	15	(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.