Table 5 Incidence of treatment-emergent adverse events in ≥ 5% of study population up to day 28 post-dose (safety analysis set)

At least 1 TEAE (n (%) E)

115 (80.4) 266

127 (85.8) 324

122 (83.6) 308

364 (83.3) 898

Infections and infestations (n (%) E)

74 (51.7) 102

76 (51.4) 106

63 (43.2) 82

213 (48.7) 290

 Malaria

43 (30.1) 44

45 (30.4) 48

34 (23.3) 34

122 (27.9) 126

 Bronchitis

13 (9.1) 16

13 (8.8) 19

10 (6.8) 11

36 (8.2) 46

 Rhinitis

11 (7.7) 11

9 (6.1) 10

10 (6.8) 10

30 (6.9) 31

  Plasmodium falciparum infection

9 (6.3) 9

10 (6.8) 10

7 (4.8) 7

26 (5.9) 26

Investigations (n (%) E)

58 (40.6) 75

68 (45.9) 100

70 (47.9) 95

196 (44.9) 270

 Electrocardiogram QT prolonged

27 (18.9) 29

41 (27.7) 48

44 (30.1) 56

112 (25.6) 133

 Neutrophil count decreased

18 (12.6) 18

11 (7.4) 11

12 (8.2) 13

41 (9.4) 42

 Haemoglobin decreased

9 (6.3) 9

20 (13.5) 22

11 (7.5) 11

40 (9.2) 42

Gastrointestinal disorders (n (%) E)

31 (21.7) 39

47 (31.8) 60

44 (30.1) 54

122 (27.9) 153

 Diarrhoea

11 (7.7) 12

21 (14.2) 21

20 (13.7) 20

52 (11.9) 53

 Vomiting

14 (9.8) 14

20 (13.5) 20

16 (11.0) 16

50 (11.4) 50

 Abdominal pain

5 (3.5) 5

8 (5.4) 9

12 (8.2) 13

25 (5.7) 27

General disorders and administration site conditions (n (%) E)

11 (7.7) 11

14 (9.5) 16

17 (11.6) 21

42 (9.6) 48

Pyrexia

5 (3.5) 5

12 (8.1) 13

9 (6.2) 11

26 (5.9) 29