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Table 6 Most frequently reported adverse events that occurred at a frequency of >10% in either group of patients enrolled in comparator studies [7, 8, 52]

From: Safety profile of Coartem®: the evidence base

Adverse event preferred term

AL n(%) n = 314

MAS n(%) n = 105

Pyrexia

183 (58.3)

63 (60.0)

Headache

166 (52.9)

46 (43.8)

Dizziness

123 (39.2)

37 (35.2)

Anorexia

108 (34.4)

37 (35.2)

Asthenia

108 (34.4)

33 (31.4)

Arthralgia

99 (31.5)

31 (29.5)

Nausea

82 (26.1)

34 (32.4)

Myalgia

74 (23.6)

19 (18.1)

Sleep disorder

70 (22.3)

30 (28.6)

Chills

67 (21.3)

20 (19.0)

Vomiting

50 (15.9)

22 (21.0)

Abdominal pain

61 (19.4)

20 (19.0)

Palpitation

55 (17.5)

17 (16.2)

Hepatomegaly

48 (15.3)

8 (7.6)

Splenomegaly

40 (12.7)

12 (11.4)

Fatigue

34 (10.8)

8 (7.6)

  1. AL: artemether/lumefantrine; MAS: mefloquine/artesunate