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Table 2 Performance and prevalence of adverse events that were well-predicted by the algorithm

From: Predicting potential adverse events using safety data from marketed drugs

Adverse Event

Median (25th – 75th quantile) Mode

Prevalence (%)

Sensitivity

Specificity

Positive Predictive Value

Negative Predictive Value

Comparator Drugs

Test Drugs

AGRANULOCYTOSIS

50 (50–100) 100

100 (100–100) 100

100 (100–100) 100

91 (82–91) 91

23

11

ANAEMIA

25 (17–33) 20

100 (100–100) 100

100 (100–100) 100

55 (45–64) 55

45

42

ANAPHYLACTIC REACTION

25 (20–33) 25

100 (100–100) 100

100 (100–100) 100

64 (56–73) 73

37

35

BONE MARROW FAILURE

100 (0–100) 100

100 (90–100) 100

100 (0–100) 100

91 (91–91) 91

14

5

BRONCHITIS

33 (25–50) 50

100 (100–100) 100

100 (100–100) 100

82 (73–90) 82

27

20

CEREBRAL HAEMORRHAGE

33 (0–50) 0

100 (90–100) 100

100 (0–100) 100

82 (82–91) 91

14

15

CHOLESTASIS

50 (50–100) 100

100 (100–100) 100

100 (100–100) 100

91 (82–91) 91

8

9

CONFUSIONAL STATE

25 (20–33) 25

100 (100–100) 100

100 (100–100) 100

70 (60–80) 73

50

33

DEEP VEIN THROMBOSIS

50 (33–100) 50

100 (100–100) 100

100 (100–100) 100

90 (82–91) 91

11

13

DIABETES MELLITUS

50 (0–100) 0

90 (90–100) 100

50 (0–100) 100

91 (82–91) 91

27

9

DIPLOPIA

100 (100–100) 100

100 (100–100) 100

100 (100–100) 100

91 (91–100) 91

17

4

EXTRAPYRAMIDAL DISORDER

100 (100–100) 100

100 (100–100) 100

100 (100–100) 100

91 (91–91) 91

21

4

FEBRILE NEUTROPENIA

50 (33–100) 50

100 (100–100) 100

100 (100–100) 100

90 (82–91) 91

7

15

GASTROINTESTINAL HAEMORRHAGE

33 (25–50) 25

100 (100–100) 100

100 (100–100) 100

73 (64–82) 73

27

31

HEPATIC FAILURE

33 (25–50) 33

100 (100–100) 100

100 (100–100) 100

73 (64–82) 73

29

25

HEPATOTOXICITY

25 (0–33) 0

90 (88–100) 100

50 (0–100) 100

73 (67–82) 73

25

27

HYPERCHOLESTEROLAEMIA

33 (0–50) 0

90 (89–100) 100

50 (0–100) 100

82 (80–91) 91

22

15

HYPERGLYCAEMIA

25 (17–40) 0

100 (89–100) 100

100 (50–100) 100

78 (67–82) 80

36

27

HYPERKINESIA

50 (50–100) 100

100 (100–100) 100

100 (100–100) 100

90 (82–91) 91

36

13

HYPERSENSITIVITY

20 (14–29) 17

100 (80–100) 100

100 (50–100) 100

44 (33–56) 50

67

58

HYPERTENSION

50 (33–67) 50

100 (86–100) 100

100 (67–100) 100

75 (62–83) 67

57

40

HYPOGLYCAEMIA

50 (25–100) 50

100 (90–100) 100

100 (50–100) 100

90 (82–91) 91

27

15

IMPAIRED HEALING

100 (50–100) 100

100 (100–100) 100

100 (100–100) 100

91 (90–91) 91

2

7

INFECTION

50 (33–67) 50

89 (86–100) 100

67 (50–100) 100

80 (73–89) 100

43

27

INSOMNIA

20 (14–25) 17

100 (100–100) 100

100 (100–100) 100

55 (45–64) 55

58

49

INTERSTITIAL LUNG DISEASE

50 (33–67) 50

100 (89–100) 100

100 (50–100) 100

89 (80–91) 90

12

18

JAUNDICE

33 (0–50) 0

90 (89–100) 100

50 (0–100) 100

82 (80–91) 91

40

15

LARYNGEAL OEDEMA

100 (67–100) 100

88 (79–100) 100

50 (33–100) 100

91 (82–91) 91

8

7

LEUKOPENIA

25 (25–33) 25

100 (100–100) 100

100 (100–100) 100

73 (64–82) 73

44

29

MYOCARDIAL INFARCTION

25 (0–40) 0

100 (88–100) 100

100 (0–100) 100

73 (67–82) 80

44

29

NEUROLEPTIC MALIGNANT SYNDROME

100 (100–100) 100

100 (100–100) 100

100 (100–100) 100

91 (91–100) 91

16

4

NEUROPATHY PERIPHERAL

40 (25–50) 50

86 (80–100) 100

67 (50–100) 100

67 (56–78) 67

60

42

NEUTROPENIA

50 (33–60) 50

100 (100–100) 100

100 (100–100) 100

75 (67–82) 78

23

38

OEDEMA

20 (14–33) 0

83 (75–100) 100

67 (50–100) 100

44 (33–55) 50

71

58

PANCREATITIS

50 (25–60) 50

90 (86–100) 100

75 (50–100) 100

80 (70–89) 78

33

29

PANCYTOPENIA

50 (25–67) 50

100 (90–100) 100

100 (50–100) 100

90 (82–91) 91

21

15

PNEUMONIA

50 (25–67) 50

89 (86–100) 100

50 (33–100) 100

86 (78–90) 100

37

22

PROTEINURIA

50 (33–50) 50

100 (100–100) 100

100 (100–100) 100

89 (82–91) 91

12

15

PULMONARY EMBOLISM

50 (25–100) 50

100 (90–100) 100

100 (50–100) 100

90 (82–91) 91

18

13

PULMONARY OEDEMA

50 (0–100) 0

90 (90–100) 100

50 (0–100) 100

90 (82–91) 91

17

9

RENAL FAILURE

50 (33–67) 50

100 (100–100) 100

100 (100–100) 100

89 (80–91) 91

28

18

RENAL IMPAIRMENT

50 (33–100) 50

100 (100–100) 100

100 (100–100) 100

91 (82–91) 91

27

11

SEIZURE

33 (0–50) 0

89 (86–100) 100

50 (0–100) 100

78 (70–88) 80

49

27

SEPSIS

50 (33–67) 50

100 (100–100) 100

100 (100–100) 100

88 (78–90) 100

20

24

SEROTONIN SYNDROME

100 (50–100) 100

100 (100–100) 100

100 (100–100) 100

91 (91–100) 100

13

7

STEVENS-JOHNSON SYNDROME

33 (20–50) 33

100 (90–100) 100

100 (50–100) 100

80 (73–89) 82

28

24

STOMATITIS

33 (0–50) 0

89 (86–100) 100

50 (0–100) 100

82 (75–90) 80

28

22

SUICIDAL BEHAVIOUR

25 (20–33) 33

100 (100–100) 100

100 (100–100) 100

82 (73–82) 82

24

22

SUPRAVENTRICULAR TACHYCARDIA

33 (25–50) 33

100 (100–100) 100

100 (100–100) 100

80 (73–90) 82

27

24

TACHYCARDIA

40 (25–50) 50

90 (86–100) 100

75 (50–100) 100

78 (67–88) 78

61

31

THROMBOCYTOPENIA

40 (25–50) 50

88 (83–100) 100

67 (50–100) 100

73 (62–80) 67

58

36

UPPER RESPIRATORY TRACT INFECTION

20 (17–33) 20

100 (86–100) 100

100 (50–100) 100

60 (50–70) 60

28

44

URINARY TRACT INFECTION

25 (20–40) 25

100 (88–100) 100

100 (67–100) 100

67 (56–75) 70

32

40