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Table 3 Summary of the solicited treatment emergent adverse events (TEAEs) reported at least once by 37 patients

From: Fixed dose artesunate amodiaquine – a phase IIb, randomized comparative trial with non-fixed artesunate amodiaquine

 

TEAEs (% of patients)

Possibly or probably drug-related TEAEs (% of patients)

Description

FD ASAQ

NF ASAQ

All

FD ASAQ

NF ASAQ

All

(N = 26)

(N = 28)

(N = 54)

(N = 26)

(N = 28)

(N = 54)

At least one TEAE

18 (69.2)

19 (67.9)

37 (68.5)

5 (19.2)

5 (17.9)

10 (18.5)

Headache

10 (38.5)

12 (42.9)

22 (40.7)

-

-

-

Weakness

8 (30.8)

11 (39.3)

19 (35.2)

-

2 (7.1)

2 (3.7)

Anorexia

7 (26.9)

7 (25.0)

14 (25.9)

1 (3.8)

-

1 (1.9)

Nausea

6 (23.1)

8 (28.6)

14 (25.9)

-

-

-

Abdominal pain

6 (23.1)

7 (25.0)

13 (24.1)

1 (3.8)

1 (3.6)

2 (3.7)

Itching

6 (23.1)

3 (10.7)

9 (16.7)

3 (11.5)

2 (7.1)

5 (9.3)

Vomiting

4 (15.4)

2 (7.1)

6 (11.1)

-

-

-

Diarrhoea

2 (7.7)

2 (7.1)

4 (7.4)

-

1 (3.6)

1 (1.9)

Rhinitis

2 (7.7)

2 (7.1)

4 (7.4)

1 (3.8)

-

1 (1.9)

Cough

1 (3.8)

2 (7.1)

3 (5.6)

-

-

-

  1. All FD vs NF ASAQ comparisons were not statistically significant.