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Table 2 Analysis of potential confounding factors

From: Drug-associated hyperammonaemia: a Bayesian analysis of the WHO Pharmacovigilance Database

Drug

Single suspect cases (%)

Mean number of suspect drugs

Drug interruption (%)

Liver dysfunction (%)

Kidney dysfunction (%)

Informativity score NI0 (%)

Extrinsic imputability

Glycine (N = 3)

100.0

1.0

0.0

0.0

0.0

66.7

B2

Sunitinib (N = 13)

92.3

1.2

53.8

23.1

7.7

30.8

B2

Sorafenib (N = 18)

77.8

1.8

27.8

0.0

0.0

22.2

B2

Deferasirox (N = 34)

73.5

1.4

8.8

38.2

32.4

73.5

B4

Valpromide (N = 27)

70.4

1.4

37.0

3.7

0.0

3.7

B4

Valproic acid (N = 1722)

66.4

1.7

42.6

4.9

1.0

28.2

B4

Asparaginase (N = 87)

64.4

2.3

54.0

12.6

0.0

6.9

B4

Regorafenib (N = 11)

63.6

1.5

18.2

18.2

0.0

18.2

B2

Eltrombopag (N = 8)

62.5

1.8

37.5

37.5

0.0

0.0

B1

Crisantaspase (N = 7)

57.1

1.9

14.3

0.0

0.0

0.0

B2

Acetazolamide (N = 6)

50.0

1.8

66.7

0.0

0.0

16.7

B2

Zonisamide (N = 12)

50.0

6.8

25.0

16.7

8.3

50.0

B4

Paracetamol (N = 52)

48.1

2.6

21.2

65.4

23.1

19.2

B2

Amphotericin b (N = 9)

44.4

2.9

77.8

11.1

0.0

0.0

B4

Cannabidiol (N = 6)

33.3

2.7

33.3

33.3

0.0

33.3

B1

Carbamazepine (N = 43)

32.6

3.4

37.2

7.0

0.0

34.9

B3

Pegaspargase (N = 33)

30.3

3.3

3.0

33.3

9.1

42.4

B4

Capecitabine (N = 30)

30.0

2.8

63.3

3.3

0.0

16.7

B2

Tolvaptan (N = 10)

30.0

3.2

50.0

20.0

10.0

20.0

B1

Haloperidol (N = 14)

28.6

4.3

0.0

28.6

7.1

50.0

B4

Ramucirumab (N = 7)

28.6

3.4

0.0

14.3

0.0

42.9

B2

Dactinomycin (N = 4)

25.0

2.5

0.0

100.0

25.0

0.0

B2

Lamotrigine (N = 24)

25.0

3.1

58.3

8.3

0.0

29.2

B3

Fluorouracil (N = 301)

21.3

3.5

35.9

1.0

4.3

20.3

B4

Lenvatinib (N = 10)

20.0

2.7

60.0

10.0

0.0

10.0

B3

Ciclosporin (N = 16)

18.8

4.4

18.8

12.5

18.8

37.5

B1

Tacrolimus (N = 60)

18.3%

4.3

30.0

3.3

3.3

66.7

B2

Gemcitabine (N = 19)

15.8

2.2

15.8

10.5

0.0

36.8

B2

Olanzapine (N = 45)

15.6

3.1

20.0

11.1

2.2

48.9

B2

Levetiracetam (N = 56)

14.3

5.5

42.9

5.4

5.4

26.8

B2

Topiramate (N = 154)

14.3

3.5

29.9

4.5

1.3

46.1

B4

Bevacizumab (N = 58)

13.8

4.4

55.2

5.2

1.7

17.2

B2

Lorazepam (N = 15)

13.3

5.7

26.7

20.0

0.0

33.3

B2

Phenytoin (N = 38)

13.2

4.7

42.1

5.3

2.6

42.1

B3

Stiripentol (N = 8)

12.5

5.5

37.5

12.5

12.5

25.0

B2

Lacosamide (N = 19)

10.5

4.2

57.9

5.3

5.3

21.1

B2

Hydrocortisone (N = 10)

10.0

5.6

20.0

10.0

0.0

30.0

B1

Oxcarbazepine (N = 20)

10.0

3.4

55.0

10.0

0.0

35.0

B2

Risperidone (N = 39)

7.7

3.7

43.6

2.6

0.0

28.2

B2

Sofosbuvir (N = 13)

7.7

2.0

53.8

7.7

15.4

38.5

B2

Prednisone (N = 27)

7.4

5.8

37.0

11.1

11.1

33.3

B1

Citalopram (N = 14)

7.1

3.6

42.9

14.3

0.0

50.0

B1

Quetiapine (N = 28)

7.1

3.2

39.3

10.7

7.1

21.4

B2

Clonazepam (N = 15)

6.7

7.5

0.0

13.3

0.0

73.3

B2

Cyclophosphamide (N = 30)

6.7

4.4

13.3

23.3

3.3

40.0

B2

Lithium (N = 15)

6.7

4.4

13.3

0.0%

6.7

60.0

B2

Irinotecan (N = 56)

5.4

5.4

35.7

1.8%

5.4

32.1

B2

Methotrexate (N = 50)

4.0

5.0

20.0

34.0

14.0

40.0

B2

Oxaliplatin (N = 133)

3.0

4.5

28.6

2.3

3.8

27.1

B2

Folinic acid (N = 35)

2.9

5.4

28.6

2.9

8.6

40.0

B2

Vincristine (N = 39)

2.6

4.9

15.4

28.2

7.7

41.0

B2

Mycophenolic acid (N = 50)

2.0

4.8

20.0

0.0

8.0

52.0

B2

Antithymocyte immunoglobulin (N = 6)

0.0

6.0

50.0

0.0

16.7

33.3

B1

Basiliximab (N = 35)

0.0

5.1

54.3

0.0

0.0

22.9

B2

Clobazam (N = 15)

0.0

5.3

86.7

0.0

0.0

13.3

B3

Cytarabine (N = 36)

0.0

4.7

11.1

33.3

5.6

47.2

B2

Daunorubicin (N = 14)

0.0

5.0

14.3

50.0

7.1

50.0

B2

Dexamethasone (N = 38)

0.0

4.5

31.6

13.2

2.6

57.9

B1

Ethosuximide (N = 3)

0.0

3.3

33.3

0.0

0.0

33.3

B2

Etoposide (N = 23)

0.0

5.0

56.5

13.0

8.7

34.8

B2

Gemtuzumab (N = 3)

0.0

3.0

0.0

33.3

33.3

33.3

B2

Melphalan (N = 9)

0.0

4.8

22.2

0.0

22.2

33.3

B2

Methylprednisolone (N = 26)

0.0

6.0

42.3

3.8

0.0

50.0

B2

Mitoxantrone (N = 15)

0.0

4.5

40.0

6.7

6.7

53.3

B2

Ondansetron (N = 8)

0.0

5.3

87.5

25.0

12.5

0.0

B2

Oxazepam (N = 6)

0.0

4.3

100.0

33.3

0.0

0.0

B1

Phenobarbital (N = 48)

0.0

4.6

41.7%

4.2

4.2

22.9

B3

Propofol (N = 11)

0.0

4.8

36.4

18.2

0.0

27.3

B2

Ribavirin (N = 27)

0.0

3.3

22.2

14.8

7.4

40.7

B2

Rovalpituzumab tesirine (N = 4)

0.0

2.3

0.0

0.0

0.0

100.0

B2

Trihexyphenidyl (N = 4)

0.0

3.5

0.0

0.0

0.0

75.0

B2

  1. In this table are represented for each drug the percentage of cases where a single drug was suspected, the mean number of suspect drugs per case, the percentage of interruption of the suspect drug, the percentage of liver and kidney dysfunction, percentage of informativity score NI0 and the extrinsic imputability. NI0 corresponds to absence of both time to onset and discontinuation. For the extrinsic imputability, B4 is quoted when the effect is expected (described in the summary of product characteristics), B3 if the effect is widely published with this drug in reference databases and/or books, B2 if cases are published in a scientific journal, B1, if the effect is not published