Table 4 Frequency of adverse events (mild to moderate-WHO grading) from days 1–7 after treatment initiation

(Using ITT populations)

(N = 138)

(N = 279)

(N = 280)

Abdominal pain--n(%)

5(3.6)

6(2.1)

13(4.60

0.26

Anorexia--n(%)

1(0.72)

8(2.9)

12(4.3)

0.13

Joint ache--n(%)

2(1.4)

2(0.71)

2(0.71)

0.71

Cough--n(%)

9(6.5)

13(4.7)

18(6.4)

0.61

Diarrhoea--n(%)

4(2.8)

8(2.8)

9(3.2)

0.96

Fatigue--n(%)

3(2.2)

7(2.5)

4(1.4)

0.65

Fever--n(%)

2(1.4)

6(2.2)

3(1.1)

0.58

Rash--n(%)

4(2.9)

18(6.4)

16(5.7)

0.31

Vomiting--n(%)

8(5.8)

31(11.1)

27(9.6)

0.21

TOTAL--n(%)

38(27.5)

99(35.5)

106(37.9)

0.09