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Table 4 Adverse events in the intent-to-treat (safety) population

From: Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial

Outcome

Pyronaridine-artesunate

Artemether-lumefantrine

n = 355

n = 180

Adverse event of any causea

285 (80.3)

143 (79.4)

  Cough

44 (12.4)

28 (15.6)

  Upper respiratory tract infection

42 (11.8)

19 (10.6)

  Anemia

34 (9.6)

14 (7.8)

  Platelets increased

33 (9.3)

19 (10.6)

  Blood glucose decreased

32 (9.0)

19 (10.6)

  Bronchitis

28 (7.9)

10 (5.6)

  Vomiting

25 (7.0)

8 (4.4)

  Pyrexia

23 (6.5)

8 (4.4)

  Blood albumin decreased

21 (5.9)

16 (8.9)

  Influenza-like illness

19 (5.4)

8 (4.4)

Drug-related adverse eventsb

132 (37.2)

80 (44.4)

  Blood glucose decreased

29 (8.2)

15 (8.3)

  Platelet count increased

27 (7.6)

14 (7.8)

  Blood albumin decreased

19 (5.4)

16 (8.9)

  Anemia

15 (4.2)

11 (6.1)

  Blood potassium increased

15 (4.2)

6 (3.3)

  Hemoglobin decreased

15 (4.2)

5 (2.8)

  Upper respiratory tract infection

14 (3.9)

5 (2.8)

  AST increased

14 (3.9)

7 (3.9)

  Hematocrit decreased

14 (3.9)

5 (2.8)

  Vomiting

7 (2.0)

6 (3.3)

  Blood creatinine decreased

7 (2.0)

7 (3.9)

  1. All values are n (%). AST, aspartate aminotransferase.
  2. a Experienced by ≥5% of patients in either treatment group.
  3. b Experienced by ≥3% of patients in either treatment group.