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Table 6 Treatment-emergent adverse events occurring in ≥5% of subjects in Cohort 2 (all causalities)

From: Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study

System organ class preferred term, n (%)

AZCQ N = 124

AL N = 131

Gastrointestinal disorders

  

  Vomiting*

38 (30.6)

13 (9.9)

  Abdominal pain

4 (3.2)

14 (10.7)

Diarrhoea

4 (3.2)

8 (6.1)

Infections and infestations

  

  Infection parasitic

37 (29.8)

31 (23.7)

  Malaria

26 (21.0)

19 (14.5)

  Upper respiratory tract infection

9 (7.3)

12 (9.2)

  Bronchitis

4 (3.2)

9 (6.9)

  Respiratory tract infection

2 (1.6)

8 (6.1)

General disorders and administration site conditions

  

  Pyrexia

17 (13.7)

27 (20.6)

Respiratory, thoracic and mediastinal disorders

  

  Cough

15 (12.1)

13 (9.9)

Metabolism and nutrition disorders

  

  Decreased appetite

9 (7.3)

5 (3.8)

Nervous system disorders

  

Skin and subcutaneous tissue disorders

  

  Pruritus

8 (6.5)

2 (1.5)

  1. Medical Dictionary for Regulatory Activities (version 13.1) coding dictionary applied.
  2. *p < 0.0001 and p < 0.05 using Fisher’s exact test.