Table 2 Adverse events occurring in ≥2% of patients in any age group (safety population)

Patients with any AEs^a

23 (39.0)

32 (39.5)

55 (39.3)

Infections and infestations

12 (20.3)

12 (14.8)

24 (17.1)

 Bronchitis

2 (3.4)

1 (1.2)

3 (2.1)

 Nasopharyngitis

3 (5.1)

0

3 (2.1)

 Pharyngitis

0

3 (3.7)

3 (2.1)

 Otitis media

2 (3.4)

0

2 (1.4)

 Sinusitis

0

2 (2.5)

2 (1.4)

 Upper respiratory tract infection

2 (3.4)

0

2 (1.4)

 Bacterial infection

0

2 (2.5)

2 (1.4)

 Oral herpes

0

2 (2.5)

2 (1.4)

Nervous system disorders

0

2 (2.5)

2 (1.4)

 Headache

0

2 (2.5)

2 (1.4)

Respiratory, thoracic and mediastinal disorders

4 (6.8)

2 (2.5)

6 (4.3)

 Upper respiratory tract inflammation

2 (3.4)

0

2 (1.4)

Gastrointestinal disorders

7 (11.9)

16 (19.8)

23 (16.4)

 Vomiting^b

5 (8.5)

9 (11.1)

14 (10.0)

 Constipation

1 (1.7)

2 (2.5)

3 (2.1)

 Diarrhea

0

3 (3.7)

3 (2.1)

Skin and subcutaneous tissue disorders

4 (6.8)

1 (1.2)

5 (3.6)

 Dry skin

2 (3.4)

0

2 (1.4)

Injury, poisoning and procedural complications

0

2 (2.5)

2 (1.4)

 Ligament sprain

0

2 (2.5)

2 (1.4)