Table 4 TEAEs occurring in at least 2 patients

Patient with any TEAE

4 (100)

16 (80.0)

17 (77.3)

37 (80.4)

Gastrointestinal disorders

1 (25.0)

8 (40.0)

8 (36.4)

17 (37.0)

 Abdominal pain upper

0

3 (15.0)

2 (9.1)

5 (10.9)

 Diarrhea

0

2 (10.0

2 (9.1)

4 (8.7)

 Nausea

0

3 (15.0)

1 (4.5)

4 (8.7)

 Abdominal discomfort

0

2 (10.0)

0

2 (4.3)

 Dyspepsia

0

0

2 (9.1)

2 (4.3)

 Vomiting

0

1 (5.0)

1 (4.5)

2 (4.3)

Infections and infestations

2 (50.0)

4 (20.0)

9 (40.9)

15 (32.6)

 Upper respiratory tract infection

1 (25.0)

2 (10.0)

6 (27.3)

9 (19.6)

 Sinusitis

0

1 (5.0)

4 (18.2)

5 (10.9)

 Gastroenteritis viral

0

0

2 (9.1)

2 (4.3)

 Tooth infection

0

1 (5.0)

1 (4.5)

2 (4.3)

Musculoskeletal and connective tissue disorders

2 (50.0)

2 (10.0)

2 (9.1)

6 (13.0)

 Back pain

1 (25.0)

1 (5.0)

0

2 (4.3)

 Pain in extremity

0

1 (5.0)

1 (4.5)

2 (4.3)

Injury, poisoning and procedural complications

0

2 (10.0)

3 (13.6)

5 (10.9)

 Ligament sprain

0

0

3 (13.6)

3 (6.5)

Nervous system disorders

2 (50.0)

1 (5.0)

2 (9.1)

5 (10.9)

 Headache

1 (25.0)

1 (5.0)

2 (9.1)

4 (8.7)

General disorders and administration site conditions

0

0

2 (9.1)

2 (4.3)

 Fatigue

0

0

2 (9.1)

2 (4.3)

Immune system disorders

0

1 (5.0)

1 (4.5)

2 (4.3)

 Hypersensitivity

0

1 (5.0)

1 (4.5)

2 (4.3)

Neoplasms benign, malignant and unspecified (incl. cysts and polyps)

1 (25.0)

1 (5.0)

0

2 (4.3)

 Skin papilloma

1 (25.0)

1 (5.0)

0

2 (4.3)

Respiratory, thoracic and mediastinal disorders

0

1 (5.0)

1 (4.5)

2 (4.3)

 Cough

0

1 (5.0)

1 (4.5)

2 (4.3)