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Table 6 Incidences and rates of most frequent adverse events (i.e., at least 2% of patients), FAS (to be placed after line 309)

From: Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice

Adverse Event (MedDRA PT)

Events

Patients

n

%

n

%

Amenorrhoea

69

12.08

58

6.71

Metrorrhagia

69

12.08

51

5.90

Vaginal haemorrhage

41

7.18

39

4.51

Menstruation irregular

28

4.90

25

2.89

Headache

27

4.73

27

3.12

Acne

20

3.50

20

2.31

Alopecia

18

3.15

18

2.08

Weight increased

17

2.98

17

1.97

Totala

571

100.00

865

100.00

  1. a67 events were not coded until cut-off date. FAS full analysis set, MedDRA Medical Dictionary for Regulatory Activities; PT preferred term. Order of illustration is based on the frequency of events