Table 5 Adverse events by preferred term and system organ class – safety population (N = 399)

 Blood and lymphatic system disorders

6 (4.5)

19 (7.1)

Anemia

6 (4.5)

19 (7.1)

 Eye disorders

4 (3)

15 (5.6)

Conjunctivitis

4 (3)

15 (5.6)

 Gastrointestinal disorders^a

53 (39.8)^a

77 (28.9)^a

Abdominal distension^a

10 (7.5)^a

5 (1.9)^a

Diarrhea^a

24 (18.0)^a

46 (17.3)^a

Gastroenteritis^a

15 (11.3)^a

10 (3.8)^a

Vomiting

6 (4.5)

7 (2.6)

 Respiratory, thoracic and mediastinal disorders

71 (53.4)

141 (53)

Bronchitis

38 (28.6)

83 (31.2)

Cough

11 (8.3)

16 (6)

Nasopharyngitis

7 (5.3)

15 (5.6)

Rhinorrhea

15 (11.3)

29 (10.9)

 Blood and lymphatic system disorders

1 (0.8)

1 (0.4)

Anemia

1 (0.8)

1 (0.4)

 Gastrointestinal disorders

0 (0)

1 (0.4)

Gastrointestinal motility disorder

0 (0)

1 (0.4)

 Nervous system disorders

1 (0.8)

0 (0)

Meningitis bacterial^b

1 (0.8)

0 (0)

 Respiratory, thoracic and mediastinal disorders

1 (0.8)

0 (0)

Lower respiratory tract infection

1 (0.8)

0 (0)

 Infections and infestations

1 (0.8)

1 (0.4)

Plasmodium falciparum infection^c

1 (0.8)

1 (0.4)

Adverse events causing treatment discontinuation

2 (1.5)

1 (0.4)

 Gastrointestinal disorders

2 (1.5)

1 (0.4)

Vomiting^d

2 (1.5)

1 (0.4)