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Table 3 Main type of clinical symptoms (number and percentage) before treatment and adverse events 3 and 24 h after praziquantel administration in Schistosoma haematobium-infected preschool-aged children (n = 168) and school-aged children (n = 173)

From: Efficacy and safety of ascending doses of praziquantel against Schistosoma haematobium infection in preschool-aged and school-aged children: a single-blind randomised controlled trial

 

Preschool-aged children (PSAC)a

School-aged children (SAC)b

Symptoms

Placebo

20 mg/kg

40 mg/kg

60 mg/kg

Overall

Placebo

20 mg/kg

40 mg/kg

60 mg/kg

Overall

(n = 41)

(n = 40)

(n = 44)

(n = 43)

(n = 168)

(n = 38)

(n = 45)

(n = 46)

(n = 44)

(n = 173)

Before treatment

 Moderate

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

 Mild

24 (58.5)

19 (47.5)

26 (59.1)

19 (44.2)

88 (52.4)

20 (52.6)

26 (57.8)

25 (54.3)

21 (47.7)

92 (53.2)

 None

17 (41.5)

21 (52.5)

18 (40.9)

24 (55.8)

80 (47.6)

18 (47.4)

19 (42.2)

21 (45.7)

23 (52.3)

81 (46.8)

 Fever

6 (14.1)

3 (7.5)

7 (15.9)

5 (11.6)

21 (12.5)

5 (13.2)

7 (15.6)

5 (10.9)

6 (13.6)

23 (13.3)

 Headache

8 (19.5)

6 (15.0)

13 (29.5)

10 (23.3)

37 (22.0)

3 (7.9)

7 (15.6)

10 (21.7)

7 (15.9)

27 (15.6)

 Nausea

3 (7.3)

4 (10.0)

3 (6.8)

1 (2.3)

11 (6.5)

2 (5.3)

1 (2.2)

4 (8.7)

5 (11.4)

12 (6.9)

 Vomiting

1 (2.4)

1 (2.5)

1 (2.3)

2 (4.7)

5 (3.0)

0 (0.0)

0 (0.0)

1 (2.2)

0 (0.0)

1 (0.6)

 Diarrhoea

4 (9.6)

4 (10.0)

4 (9.1)

5 (11.6)

17 (10.1)

0 (0.0)

1 (2.2)

3 (6.5)

2 (4.5)

6 (3.5)

 Dizziness

2 (4.9)

0 (0.0)

0 (0.0)

0 (0.0)

2 (1.2)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

 Stomach ache

2 (4.9)

5 (12.5)

8 (18.2)

4 (9.3)

19 (11.3)

1 (2.6)

6 (13.3)

6 (13.0)

4 (9.1)

17 (9.8)

3 h post-treatment

 Moderate

0 (0.0)

0 (0.0)

0 (0.0)

1 (2.3)

1 (0.6)

1 (2.6)

2 (4.4)

4 (8.7)

5 (11.4)

12 (6.9)

 Mild

6 (14.6)

8 (20.0)

15 (34.1)

23 (53.5)

52 (31.0)

18 (47.4)

23 (51.1)

21 (45.7)

26 (59.1)

88 (50.9)

 None

35 (85.4)

32 (80.0)

29 (65.9)

19 (44.2)

115 (68.5)

19 (50.0)

20 (44.4)

21 (45.7)

13 (29.5)

73 (42.2)

 Fever

3 (7.3)

3 (7.5)

2 (4.5)

4 (9.3)

12 (7.1)

6 (15.8)

4 (8.9)

8 (17.4)

12 (27.3)

30 (17.3)

 Headache

1 (2.4)

2 (5.0)

1 (2.3)

7 (16.3)

11 (6.5)

8 (21.1)

10 (22.2)

6 (13.0)

6 (13.6)

30 (17.3)

 Nausea

1 (2.4)

1 (2.5)

4 (9.1)

5 (11.6)

11 (6.5)

4 (10.5)

3 (6.7)

9 (19.6)

14 (31.8)

30 (17.3)

 Vomiting

0 (0.0)

1 (2.5)

3 (6.8)

9 (20.9)

13 (7.7)

1 (2.6)

3 (6.7)

8 (17.4)

10 (22.7)

22 (12.7)

 Diarrhoea

0 (0.0)

1 (2.5)

1 (2.3)

3 (7.0)

5 (3.0)

3 (7.9)

3 (6.7)

2 (4.3)

0 (0.0)

8 (4.6)

 Dizziness

1 (2.4)

1 (2.5)

2 (4.5)

4 (9.3)

8 (4.8)

5 (13.2)

4 (8.9)

8 (17.4)

5 (11.4)

22 (12.7)

 Stomach ache

3 (7.3)

4 (10.0)

4 (9.1)

2 (4.7)

13 (7.7)

5 (13.2)

11 (24.4)

9 (19.6)

12 (27.3)

37 (21.4)

24 h post-treatment

 Moderate

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

 Mild

4 (9.6)

7 (17.5)

8 (18.2)

6 (14.0)

25 (14.9)

12 (31.6)

12 (26.7)

12 (26.1)

11 (25.0)

47 (27.2)

 None

37 (90.2)

33 (82.5)

36 (81.8)

37 (86.0)

143 (85.1)

26 (68.4)

33 (73.3)

34 (73.9)

33 (75.0)

126 (72.8)

 Fever

2 (4.9)

4 (10.0)

2 (4.5)

2 (4.7)

10 (6.0)

5 (13.2)

7 (15.6)

5 (10.9)

6 (13.6)

23 (13.3)

 Headache

1 (2.4)

1 (2.5)

1 (2.3)

2 (4.7)

5 (3.0)

3 (7.9)

7 (15.6)

10 (21.7)

7 (15.9)

27 (15.6)

 Nausea

1 (2.4)

0 (0.0)

0 (0.0)

3 (7.0)

4 (2.4)

2 (5.3)

1 (2.2)

4 (8.7)

5 (11.4)

12 (6.9)

 Vomiting

0 (0.0)

0 (0.0)

0 (0.0)

3 (7.0)

3 (1.8)

0 (0.0)

0 (0.0)

1 (2.2)

0 (0.0)

1 (0.6)

 Diarrhoea

1 (2.4)

2 (5.0)

5 (11.4)

0 (0.0)

8 (4.8)

0 (0.0)

1 (2.2)

3 (6.5)

2 (4.5)

6 (3.5)

 Dizziness

1 (2.4)

0 (0.0)

0 (0.0)

1 (2.3)

1 (0.6)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

 Stomach ache

2 (4.9)

0 (0.0)

2 (4.5)

2 (4.7)

6 (3.6)

1 (2.6)

6 (13.3)

6 (13.0)

4 (9.1)

17 (9.8)

  1. a2 children were absent (placebo (n = 1) and 60 mg/kg (n = 1)) following treatment and were not assessed for adverse events
  2. b1 child was absent (20 mg/kg treatment arm) following treatment and was not assessed for adverse events