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Table 1 Characteristics of included studies

From: Safety of dihydroartemisinin-piperaquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria among children in Africa: a systematic review and meta-analysis of randomized control trials

S. No

Study ID

Study design

Study setting and period

Transmission

Follow up

Subjects

Patient important outcome

DHA-PQ

AL

   

Number of participants

Inclusion age

DHA-PQ

AL

    

1

Kamya-2007-UGA [30]

Single-blind, RCT

Rural health center, March,2006-July, 2006

High transmission

42 days

253

256

6 months–10 years

Vomiting

65

65

   
 

Diarrhoea

25

19

   

Anorexia

90

91

   

Abdominal pain

19

20

   

weakness/malaise

85

103

   

Cough

136

133

   

Coryza

127

121

   

Pruritus

14

22

   

SAE

4

2

   

2

Zongo-2007-BNF [31]

Single blind RCT

Government health dispensaries, August 2006-January 2007

High transmission

42 days

196

197

6 months–10 years

Early vomiting

7

3

   
 

Vomiting

20

27

   

Diarrhoea

14

13

   

Anorexia

8

6

   

Abdominal pain

10

21

   

Cough

49

52

   

Weakness/Malaise

5

3

   

Pruritus

5

11

   

Headache

11

22

   

3

Mens-2008-KEN [32]

Open label RCT

Health center,

Apr 2007 to Jul 2007

High transmission

28 days

73

73

6 months–12 years

Headache

43

39

   
 

Abdominal pain

25

26

   

Weakness

19

30

   

Anorexia

8

10

   

Diarrhoea

9

7

   

Cough

16

17

   

Vomiting

11

9

   

Pruritus

4

3

   

SAE

1

0

   

4

Yeka-2008-UGA [33]

Single-blind, RCT

Health center, August 2006-April 2007

N/A

42 days

234

227

6 months–10 years

Vomiting

35

35

   
 

Diarrhoea

26

23

   

Anorexia

47

49

   

Abdominal pain

17

24

   

Weakness/malaise

28

27

   

Cough

164

150

   

Coryza

159

150

   

Pruritus

8

3

   

SAE

5

2

   

5

Bassat-2009-AFR [34]

Open-label, RCT

Four rural sites and one peri-urban site,

August 2005 and July 2006.

Mesoendemic

1038

510

6–59 months

Early vomiting

22

4

   
 

Vomiting

71

35

   

Splenomegaly

41

19

   

Hepatomegaly

6

3

   

5 Prolonged QTc interval (Fridericia’s correction)

2

1

   

Electrocardiogram QT prolonged

26

13

   

Urticarial

1

2

   

Hypersensitivity

2

1

   

Neutropenia

18

12

   

Alanine aminotransferase increased

20

19

   

Electrocardiogram QT prolonged

26

13

   

SAE

18

5

   

6

Arinaitwe-2009-UGA [35]

Open-label RCT

Local antenatal clinics in Tororo, August 2007-July 2008

High transmission

63 days

119

111

6 weeks–12 months

Vomiting

23

20

   
 

Diarrhoea

79

86

   

Anorexia

3

0

   

Weakness

1

0

   

Cough

177

153

   

Pruritus

0

0

   

SAE

3

1

   

7

Borrmann-2011–KEN [36]

Not described, RCT

Pingilikani study site,

September 2005 to April 2008

Perennial transmission

84 days

233

241

6–59 months

Early vomiting

7

4

   

8

Nambozi-2011-ZAM [37]

Open-label, RCT

Peri-urban health centers,

September 2005 and May 2006

Mesoendemic

42 days

203

101

6–59 months

Anorexia

14

8

   
 

Cough

42

15

   

Diarrhoea

14

4

   

Fever

24

14

   

Respiratory tract Infection

22

9

   

Vomiting

5

4

   

SAE

4

3

   

9

4ABC-2011-AFR [38]

Open label, RCT

Rural, urban or health facilities, 9 July 2007 and 19 June 2009

Mesoendemic, perennial and high transmission

63 days

1475

1226

6–59 months

Death up to day 63

1

3

   
 

Hepatomegaly

5

8

   

Splenomegaly

88

80

   

Anemia

141

38

   

Diarrhoea

166

142

   

Vomiting

123

102

   

Pyrexia

371

339

   

Hgb decrease

103

83

   

Anorexia

130

121

   

Cough

470

387

   

ALAT above normal range at day 0

10

16

   

ALAT above normal range at day 7

3

4

   

ALAT above normal range at day 28

4

1

   

Creatinine above normal range at day 0

2

0

   

Creatinine above normal range at day 7

0

0

   

Creatinine above normal range at day 28

0

2

   

SAE

10

6

   

10

Agarwal -2013-KEN [39]

An open label RCT

District hospital, October 2010 to August 2011

High transmission

42 days

137

137

6–59 months

Early vomiting

7

5

   
 

SAE

1

2

   

11

Ogutu-2014-KEN [40]

Open-label, RCT

Nyando District hospital, March, 2010-30 November, 2011

Not described

42 days

227

227

6–59 months

Cough

40

37

   
 

Anemia

8

10

   

Fever

14

7

   

Tinea capitis

12

10

   

Rhinitis

13

4

   

Gastroenteritis

5

9

   

Loss of appetite

6

3

   

Otitis media

5

7

   

12

Onyamboko-2014-DRC [41]

Open label, RCT

Urban district of Kinshasa (DRC) (Hospitals), September 2011 and November 2012

Intense and perennial

42 days

228

228

3–59 months

Early vomiting

21

5

   
 

Vomiting

17

2

   

173

Kakuru-2014-UGA [42]

Not described, RCT

District Hospital, August 2007 and April 2008

High transmission

28 days

21

22

6 weeks -12 months

Vomiting

8

18

   
 

Diarrhoea

27

23

   

Anorexia

6

4

   

Weakness/malaise

2

2

   

Cough

64

74

   

14

Nji-2015-CAM [43]

Open-label, RCT

Two distinct ecological regions, 2009 to April 2013

Low to moderate transmission

42 days

288

144

6 months-10 years

Abdominal pain

13

5

   
 

Anorexia

12

1

   

Diarrhoea

9

4

   

Vomiting

27

8

   

Fatigue

4

3

   

Fever

3

2

   

Cough

18

9

   

Joint pain

2

2

   

Rash

16

4

   

SAE

0

1

   

15

Ursing-2016-GUB [44]

Open-label, RCT

Bandimand Belem Health Centers, November 2012 and July 2015

Low to high transmission

42 days

157

155

6 months–15 years

Early vomiting

7

4

   

16

Grandesso-2018-NIG [45]

Open label, RCT

Health center,

7 June 2013 and 22 September 2014

Not reported

42 days

221

221

6–59 months

Early vomiting

1

0

   
 

Fever

94

94

   

Cough

36

22

   

Rhinorrhea

27

17

   

Diarrhoea

14

15

   

Conjunctivitis

7

15

   

Pyoderma

6

6

   

Vomiting

6

5

   

Anorexia

4

1

   

Abdominal pain

0

1

   

Hepatomegaly

1

0

   

Splenomegaly

2

1

   

Another AE

40

45

   

SAE

2

1

   

Early vomiting

1

2

   

17

Yeka-2019-UGA [46]

Single-blind RCT

Health center and Hospital, October 2015-December, 2016

High transmission

42 days

299

300

6–59 months

Vomiting

56

61

   

Diarrhoea

155

114

   

Anorexia

12

3

   
 

Abdominal pain

41

45

Cough

233

203

Headaches

18

24

Pallor

22

13

weakness/malaise

42

33

Skin rash

56

42

Cough

233

203

Pruritus

24

16

Pallor

22

13

SAE

6

6

Skin rash

56

42

   

Pruritus

24

16

   

SAE

6

6

   

18

Gansane-2021-BNF [47]

Open label, RCT

Primary health facility and district hospital, November 2017 to September 2018

Moderate to high transmission

42 days

360

360

6–59 months

Itchiness

0

1

   

Otitis media

0

1

   

Cough

17

21

   
 

Abdominal pain

13

4

Vomiting

33

54

Skin rash

3

2

SAE

0

1

Furunculosis

1

0

   

Vomiting

33

54

   

SAE

0

1

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