AESI

n

Intensive phase

Continuation phase

Overall

No.

%

No.

%

No.

%

Hepatotoxicity^a

Elevated SGPT level

74

2

(2.7)

0

0

2

2.7

Elevated SGPT level

74

3

(4.1)

0

0

3

4.1

Renal insufficiency^b

Elevated creatinine clearance level

75

1

(1.3)

0

0

1

1.3

Hearing impairment^c

Left ear

46

2

(4.3)

0

0

2

4.3

Right ear

49

3

(6.1)

0

0

3

6.1

QTcF prolongation^d

70

18

(25.7)

2

2.7

18

(25.7)