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Table 5 Summary of adverse events among children in the per-protocol population (PP) from southwest Nigeria with acute uncomplicated malaria treated with artemether–lumefantrine or pyronaridine–artesunate

From: Efficacy and safety of pyronaridine–artesunate versus artemether–lumefantrine in the treatment of acute uncomplicated malaria in children in South-West Nigeria: an open-labelled randomized controlled trial

Event

All patients

Artemether–lumefantrine

Pyronaridine–artesunate

p

N = 172

N = 87

N = 85

Adverse event from any cause

53 (30.8)

27 (31.0)

26 (30.6)

0.949

Fever

58 (34.1)

24 (27.9)

34 (40.5)

0.106

Chills and rigors

33 (19.6)

16 (18.6)

17 (20.5)

0.847

Anorexia

29 (17.1)

16 (18.6)

13 (15.5)

0.685

Cough

28 (16.6)

14 (16.3)

14 (16.9)

1.000

Headache

27 (16.0)

12 (14.1)

15 (17.9)

0.536

Fatigue

22 (12.9)

11 (12.6)

11 (13.1)

1.000

Pallor

17 (10.1)

9 (10.6)

8 (9.6)

1.000

Abdominal pains

12 (7.1)

5 (5.8)

7 (8.3)

0.563

Vomiting

11 (6.4)

6 (7.0)

5 (5.9)

1.000

Diarrhea

11 (6.4)

4 (4.6)

5 (6.0)

0.744

Palpitations

6 (3.5)

3 (3.4)

3 (3.6)

1.000

Nausea

6 (3.5)

3 (3.5)

3 (3.6)

1.000

Rashes

1 (0.6)

0 (0.00)

1 (1.2)

1.000

  1. AL artemether–lumefantrine, PA pyronaridine–artesunate
  2. *Chi square was used but with Yate correction where cell counts were less than 5