Table 11 Adverse events

Patients (total)

234 (100%)

232 (100%)

Patients with AEs^#

23 (9.8%)

18 (7.8%)

Adverse events (total)

33

26

Nervous system disorders

Headache

3

4

Dizziness

-

3

Eye disorders

Eyelid swelling

1

-

Cardiac and circulation disorders

Circulation disorder

-

1

Gastrointestinal disorders

Dysgeusia

-

1

Nausea

9

3

Regurgitation

1

1

Gastralgia

4

3

Obstipation

-

1

Diarrhoea

5

-

Metabolim and nutrition disorder

Anorexia

1

-

Urinary disorders

Incontinence

1

-

Reproductive system disorders

Colpitis

1

1

Fluor vaginalis

1

-

Tubal tumor

-

1

Immune system disorders

Allergy

1*

1

Skin and subcutaneous tissue disorders

Itching

1

1

Urticaria

1

1

Herpes labialis

-

1

General disorders

Intolerance

1

-

Weakness

1

-

Fever

1

-

Musculoskeletal, connective tissue and bone disorders

Back pain

-

1

Flank pain

-

2

Leg pain

-

1