Table 2 Frequency, severity, type and drug-relatedness of AE reports per study arm (‘as treated’ analysis)

From: Antimalarial artesunate–mefloquine versus praziquantel in African children with schistosomiasis: an open-label, randomized controlled trial

 

PZQ up to week 4 (n = 363)

AM up to week 4 (n = 361)

AM up to week 16 (n = 361)

Any AEs

14 (3.9; 2.3 to 6.4)a

29 (8.0; 5.6 to 11.3)a

41 (11.4; 8.5 to 15.0)

Any drug-related AEs

8 (2.2; 1.1 to 4.3)a

28 (7.8; 5.4 to 11.0)a

36 (10.0; 7.3 to 13.5)

Gastrointestinal disorders

8 (2.2)

26 (7.2)

31 (8.6)

Abdominal pain

5 (1.4)

15 (4.2)

18 (5.0)

Vomiting

4 (1.1)

12 (3.3)

14 (3.9)

Diarrhea

1 (0.3)

2 (0.6)

2 (0.6)

Odynophagia

–

–

1 (0.3)

Nervous system disorders

–

4 (1.1)

7 (1.9)

Headache

–

3 (0.8)

5 (1.4)

Vertigo

–

1 (0.3)

2 (0.6)

Other disorders

 Skin rash

–

1 (0.3)

1 (0.3)

 Hematuria

–

1 (0.3)

1 (0.3)

 Pyrexia

–

1 (0.3)

1 (0.3)

 Cough

–

–

1 (0.3)

SAEs

–

–

–

Death

–

–

–

Confirmed malaria cases

–

–

–

  1. Note 1: AM denotes artesunate–mefloquine; PZQ denotes praziquantel.
  2. Note 2: results are reported as n (%; 95% CI). All AEs (n = 41) reported in the AM arm up to week 16 were classified as mild (n = 5) or moderate (n = 36). No grade 3 (‘severe’) AEs were reported.
  3. aP values, determined with the Fischer’s exact test, were 0.019 and <0.001 for the comparisons between frequency of any AEs and any drug-related AEs, respectively, in the artesunate–mefloquine and praziquantel arms at week 4.
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