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Table 4 Most common adverse events of any cause in the integrated safety analysis and CANTAM

From: Safety and efficacy of pyronaridine–artesunate paediatric granules in the treatment of uncomplicated malaria in children: insights from randomized clinical trials and a real-world study

Primary system class and preferred term

Integrated safety analysis

CANTAM

PA (N = 2599)

PA (N = 667)

AL (N = 358)

P valuea

N

% (95% CI)

N

% (95% CI)

N

% (95% CI)

Bronchitis

93

13.9 (11.5, 16.8)

53

14.8 (11.5, 18.9)

0.71

9

0.3 (0.2, 0.7)

 Vomiting

52

7.8 (6.0, 10.1)

12

3.4 (1.9, 5.8)

0.004

141

5.4 (4.6, 6.4)

 Cough

51

7.6 (5.9, 9.9)

24

6.7 (4.5, 9.8)

0.62

49

1.9 (1.4, 2.5)

Rhinitis

38

5.7 (4.2, 7.7)

27

7.5 (5.2, 10.8)

0.28

2

0.1 (0.01, 0.3)

 Anaemia

35

5.2 (3.8, 7.2)

17

4.7 (3.0, 7.5)

0.77

20

0.8 (0.5, 1.2)

Upper RTI

34

5.1 (3.7, 7.0)

12

3.4 (1.9, 5.8)

0.21

0

(0, 0.1)

Platelet count increased

30

4.5 (3.2, 6.3)

17

4.7 (3.0, 7.5)

0.88

0

(0, 0.1)

Blood glucose decreased

27

4.0 (2.8, 5.8)

15

4.2 (2.6, 6.8)

1.00

0

(0, 0.1)

AST increased

26

3.9 (2.7, 5.7)

16

4.5 (2.8, 7.1)

0.74

0

(0, 0.1)

ECG QT prolonged

21

3.1 (2.1, 4.8)

29

8.1 (5.7, 11.4)

0.0007

0

(0, 0.1)

 Pyrexia

20

3.0 (1.9, 4.6)

7

2.0 (1.0, 4.0)

0.41

140

5.4 (4.6, 6.3)

 Influenza like illness

17

2.5 (1.6, 4.0)

4

1.1 (0.4, 2.8)

0.17

14

0.5 (0.3, 0.9)

Blood albumin decreased

17

2.5 (1.6, 4.0)

14

3.9 (2.3, 6.5)

0.25

0

(0, 0.1)

 Neutropenia

15

2.2 (1.4, 3.7)

11

3.1 (1.7, 5.4)

0.41

0

(0, 0.1)

 Abdominal pain

15

2.2 (1.4, 3.7)

7

2.0 (1.0, 4.0)

0.83

12

0.5 (0.3, 0.8)

ALT increased

15

2.2 (1.4, 3.7)

6

1.7 (0.8, 3.6)

0.65

0

(0, 0.1)

Blood potassium increased

15

2.2 (1.4, 3.7)

4

1.1 (0.4, 2.8)

0.23

0

(0, 0.1)

Haemoglobin decreased

14

2.1 (1.3, 3.5)

6

1.7 (0.8, 3.6)

0.81

1

0.04 (0.002, 0.2)

Nasopharyngitis

14

2.1 (1.3, 3.5)

3

0.8 (0.2, 2.4)

0.20

7

0.3 (0.1, 0.6)

 Conjunctivitis

13

1.9 (1.1, 3.3)

5

1.4 (0.6, 3.2)

0.62

0

(0, 0.1)

Haematocrit decreased

13

1.9 (1.1, 3.3)

4

1.1 (0.4, 2.8)

0.44

0

(0, 0.1)

 Headache

11

1.6 (0.9, 2.9)

2

0.6 (0.1, 2.0)

0.24

15

0.6 (0.4, 1.0)

 Monocytosis

10

1.5 (0.8, 2.7)

10

2.8 (1.5, 5.1)

0.16

0

(0, 0.1)

Helminthic infection

9

1.3 (0.7, 2.5)

2

0.6 (0.1, 2.0)

0.35

0

(0, 0.1)

WBC count increased

9

1.3 (0.7, 2.5)

2

0.6 (0.1, 2.0)

0.35

0

(0, 0.1)

 Decreased appetite

8

1.2 (0.6, 2.3)

1

0.3 (0.14, 1.6)

0.17

13

0.5 (0.3, 0.9)

Infection parasitic

7

1.0 (0.5, 2.2)

1

0.3 (0.14, 1.6)

0.27

0

(0, 0.1)

 Splenomegaly

6

0.9 (0.4, 1.9)

4

1.1 (0.4, 2.8)

0.75

2

0.1 (0.01, 0.3)

 Diarrhoea

6

0.9 (0.4, 1.9)

4

1.1 (0.4, 2.8)

0.75

37

1.4 (1.0, 2.0)

Blood creatinine decreased

5

0.7 (0.3, 1.7)

6

1.7 (0.8, 3.6)

0.21

0

(0, 0.1)

Varicella

4

0.6 (0.2, 1.5)

4

1.1 (0.4, 2.8)

0.46

1

0.04 (0.002, 0.1)

Pneumonia

3

0.4 (0.1, 1.3)

5

1.4 (0.6, 3.2)

0.14

2

0.1 (0.01, 0.3)

 Enterocolitis

1

0.1 (0.008, 0.8)

4

1.1 (0.4, 2.8)

0.053

0

(0, 0.1)

  1. Adverse events occurring in at least 1% of patients in any treatment group are included. The full list of adverse events is available in Additional file 2
  2. ALT alanine aminotransferase, AST aspartate aminotransferase, ECG electrocardiograph, NA not applicable, RTI respiratory tract infection, WBC white blood cell
  3. aPyronaridine–artesunate (PA) versus artemether–lumefantrine (AL)
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Malaria Journal

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