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Table 4 Treatment-emergent adverse events of any cause occurring in ≥2% of all subjects in any treatment group (safety population)

From: Safety and efficacy of pyronaridine-artesunate in uncomplicated acute malaria: an integrated analysis of individual patient data from six randomized clinical trials

Adverse event

PA

MQ + AS

AL

CQ

All comparators

 

(n = 2815)

(n = 423)

(n = 603)

(n = 228)

(n = 1254)

Any adverse event

1611 (57.2)

190 (44.9)

384 (63.7)

72 (31.6)

646 (51.5)

Blood and lymphatic system disorders

Anaemia

128 (4.5)

17 (4.0)

18 (3.0)

1 (0.4)

36 (2.9)

Basophilia

9 (0.3)

9 (2.1)

1 (0.2)

0

10 (0.8)

Eosinophilia

101 (3.6)

5 (1.2)

27 (4.5)

4 (1.8)

36 (2.9)

Lymphocytosis

21 (0.7)

0

16 (2.7)

0

16 (1.3)

Neutropenia

55 (2.0)

0

27 (4.5)

0

27 (2.2)

Gastrointestinal disorders

Abdominal pain

98 (3.5)

7 (1.7)

31 (5.1)

2 (0.9)

40 (3.2)

Diarrhoea

41 (1.5)

9 (2.1)

6 (1.0)

2 (0.9)

17 (1.4)

Vomiting

124 (4.4)

9 (2.1)

23 (3.8)

7 (3.1)

39 (3.1)

General disorders

Fatigue

49 (1.7)

6 (1.4)

3 (0.5)

11 (4.8)

20 (1.6)

Influenza-like illness

49 (1.7)

0

21 (3.5)

0

21 (1.7)

Pyrexia

66 (2.3)

4 (0.9)

18 (3.0)

2 (0.9)

24 (1.9)

Infections and infestations

Bronchitis

52 (1.8)

6 (1.4)

12 (2.0)

3 (1.3)

21 (1.7)

Nasopharyngitis

74 (2.6)

11 (2.6)

8 (1.3)

6 (2.6)

25 (2.0)

Rhinitis

19 (0.7)

2 (0.5)

12 (2.0)

0

14 (1.1)

Upper RTI

100 (3.6)

4 (0.9)

31 (5.1)

0

35 (2.8)

Urinary tract infection

34 (1.2)

3 (0.7)

12 (2.0)

1 (0.4)

16 (1.3)

Investigations

AST increased

63 (2.2)

1 (0.2)

14 (2.3)

0

15 (1.2)

Blood albumin decreased

21 (0.7)

0

16 (2.7)

0

16 (1.3)

Blood CPK increased

26 (0.9)

4 (0.9)

3 (0.5)

8 (3.5)

15 (1.2)

Blood glucose decreased

33 (1.2)

0

19 (3.2)

0

19 (1.5)

ECG QT prolongation

6 (0.2)

5 (1.2)

1 (0.2)

6 (2.6)

12 (1.0)

Eosinophil count increased

58 (2.1)

6 (1.4)

2 (0.3)

0

8 (0.6)

Platelet count increased

59 (2.1)

3 (0.7)

20 (3.3)

0

23 (1.8)

Metabolism and nutrition disorders

Anorexia

85 (3.0)

13 (3.1)

10 (1.7)

10 (4.4)

33 (2.6)

Musculoskeletal and connective tissue disorders

Myalgia

107 (3.8)

19 (4.5)

1 (0.2)

21 (9.2)

41 (3.3)

Nervous system disorders

Dizziness

39 (1.4)

28 (6.6)

1 (0.2)

6 (2.6)

35 (2.8)

Headache

297 (10.6)

44 (10.4)

46 (7.6)

34 (14.9)

124 (9.9)

Respiratory, thoracic and mediastinal disorders

Cough

167 (5.9)

10 (2.4)

55 (9.1)

5 (2.2)

70 (5.6)

  1. Data are n (%). PA, pyronaridine-artesunate; MQ + AS, mefloquine plus artesunate; AL, artemether-lumefantrine; CQ, chloroquine; RTI, respiratory tract infection; AST aspartate aminotransferase; CPK, creatine phosphokinase; ECG, electrocardiograph.
  2. Values underlined are for adverse events occurring in ≥2% of patients in one group versus any other group.