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Table 8 A brief overview of the hepatotoxic signaling associated with onasemnogene abparvovec

From: Postmarketing adverse events associated with onasemnogene abeparvovec: a real-world pharmacovigilance study

alert signal

age

Sex

whether the event abated

concomitant medications

0−2year

3-11year

12−17year

≥ 18year

Female

Male

Yes

No

aspartate aminotransferase increased

110

74

42

19

137

123

81

3

prednisolone (148)

famotidine (40)

nusinersen (24)

alanine aminotransferase increased

104

61

26

33

127

109

72

3

prednisolone (130)

famotidine (36)

nusinersen (18)

hepatic enzyme increased

81

34

8

16

118

103

22

1

prednisolone (61)

nusinersen (20)

famotidine (19)

liver function test increased

30

27

4

14

51

43

10

0

prednisolone (37)

nusinersen (5)

famotidine (3)

transaminases increased

36

17

10

9

42

38

18

0

prednisolone (40)

famotidine (16)

nusinersen (12)

hepatic function abnormal

17

5

2

7

18

14

21

0

prednisolone (21)

famotidine (11)

predonine (7)

hypertransaminasaemia (31)

12

8

3

4

13

13

6

0

prednisolone (9)

nusinersen (4)

gamma-glutamyltransferase increased

16

4

3

3

15

15

10

1

prednisolone (13)

famotidine (9)

acetaminophen (5)

blood bilirubin increased

12

6

0

1

12

8

7

1

prednisolone (10)

famotidine (5)

nusinersen (4)