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Table 3 Summary of severe adverse events recorded up to day 28, safety population (both studies)

From: Tolerability and safety of artesunate-amodiaquine and artemether-lumefantrine fixed dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria: two open-label, randomized trials in Nimba County, Liberia

 

Study-T (>5 years)

Study-E (6–59 months)

Patients N (%)

ASAQ

AL

ASAQ

AL

N = 496

N = 502

N = 149

N = 150

AEs with severity grade ≥ 3

Hepatitis

1 (0.2)

0

-

-

Stomatitis

-

-

0

1 (0.7)

Vomiting #

-

-

0

1 (0.7)

Malaria #

-

-

1 (0.7)

0

Pneumonia #

-

-

1 (0.7)

0

Splenomegaly

7 (1.4)

1 (0.2)

-

-

Thrombocytopenia

2 (0.4)

0

4 (2.7)

1 (0.7)

Leukocytosis

2 (0.4)

4 (0.8)

-

-

Neutropaenia

2 (0.4)

1 (0.2)

-

-

Anaemia

1 (0.2)

0

3 (2.0)

1 (0.7)

AST increased

3 (0.6)

1 (0.2)

-

-

ALT increased

1 (0.2)

0

-

-

Hepatomegaly

0

1 (0.2)

-

-

  1. AE adverse event, AST aspartate aminotransferase, ALT alanine aminotransferase.
  2. # These severe AEs were also reported as serious AEs (Study-E).