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Table 3 Adverse events

From: A randomized trial on effectiveness of artemether-lumefantrine versus artesunate plus amodiaquine for unsupervised treatment of uncomplicated Plasmodium falciparum malaria in Ghanaian children

Type of adverse event

ASAQ

AL

  
 

n = 123

n = 123

OR

p value a

Vomiting of study drugs:

    

   at least once

15

11

0.71 (0.31–1.61)

0.408

   twice

6

3

0.49 (0.12–1.99)

0.318

 

n = 117

n = 120

RR

p value b

Deaths/hospitalizations

0

0

  

Anaemiac

82

78

0.90 (0.66–1.23)

0.511

Respiratory symptoms

27

25

0.90 (0.52–1.54)

0.692

Gastrointestinal symptoms

12

10

0.78 (0.34–1.81)

0.565

Dermatological symptoms

3

2

0.63 (0.10–3.76)

0.610

Other symptoms

2

2

0.95 (0.13–6.72)

0.956

Severity of adverse event

    
 

n = 117

n = 120

RR

p value b

Mild

57

46

0.72 (0.49–1.07)

0.104

Moderate

45

54

1.19 (0.80–1.77)

0.382

Severe

15

22

1.45 (0.75–2.79)

0.268

SAE

2

2

0.96 (0.13–6.80)

0.966

  1. Please note:
  2. Adverse events were classified by means of the Division of Microbiology and Infectious Diseases pediatric toxicity tables [18].
  3. a Tested by logistic regression.
  4. b Tested by Cox regression.
  5. c Defined as Hb concentration <10 g/dl (age <2 years) and <11 g/dl (age >2 years).
  6. ASAQ, artesunate plus amodiaquine; AL, artemether-lumefantrine; OR, odds ratio; RR, relative risk
  7. SAE, serious adverse even
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Malaria Journal

ISSN: 1475-2875

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