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Table 4 Four adverse reaction signals on the 27 system organ class levels of TKI drugs

From: Pharmacovigilance study of adverse reactions of anti-HER-2 drugs for the treatment of HER-2-positive breast cancer based on the FAERS database

System organ class

Tucatinib

Neratinib

Lapatinib

ROR

(95%CI)

PRR

(95%CI)

IC

(95%CI)

EBGM

(95%CI)

ROR

(95%CI)

PRR

(95%CI)

IC

(95%CI)

EBGM

(95%CI)

ROR

(95%CI)

PRR

(95%CI)

IC

(95%CI)

EBGM

(95%CI)

Eye disorders

0.66

(0.54– 0.81)

0.66

(0.54– 0.81)

-0.59

(-0.88– -0.28)

0.67

(0.54– 0.82)

0.43

(0.32– 0.59)

0.44

(0.32– 0.59)

-1.19

(-1.63– -0.72)

0.44

(0.32– 0.60)

0.53

(0.46– 0.62)

0.53

(0.46– 0.62)

-0.89

(-1.10– -0.66)

0.54

(0.47– 0.63)

Blood and lymphatic system disorders

0.20

(0.17– 0.25)

0.21

(0.17– 0.26)

-2.24

(-2.52– -1.94)

0.21

(0.17– 0.26)

0.18

(0.14– 0.23)

0.18

(0.14– 0.24)

-2.43

(-2.79– -2.03)

0.19

(0.14– 0.24)

0.49

(0.45– 0.54)

0.51

(0.47– 0.55)

-0.96

(-1.09– -0.84)

0.51

(0.47– 0.56)

Vascular disorders

0.53

(0.44– 0.64)

0.53

(0.44– 0.64)

-0.90

(-1.17– -0.62)

0.53

(0.44– 0.64)

0.36

(0.27– 0.47)

0.36

(0.27– 0.48)

-1.46

(-1.85– -1.04)

0.36

(0.28– 0.48)

0.54

(0.48– 0.61)

0.55

(0.48– 0.62)

-0.86

(-1.03– -0.68)

0.55

(0.49– 0.62)

Cardiac disorders

0.28

(0.22– 0.36)

0.28

(0.22– 0.36)

-1.81

(-2.15– -1.43)

0.29

(0.22– 0.37)

0.12

(0.08– 0.20)

0.13

(0.08– 0.20)

-2.97

(-3.55– -2.25)

0.13

(0.08– 0.20)

0.90

(0.82– 0.99)

0.90

(0.82– 0.99)

-0.14

(-0.28– -0.01)

0.90

(0.82– 0.99)

Gastrointestinal disorders

2.20

(2.10– 2.31)

1.95

(1.87– 2.02)

0.95

(0.88– 1.02)

1.93

(1.84– 2.03)

4.70

(4.47– 4.95)

3.36

(3.25– 3.47)

1.73

(1.65– 1.79)

3.31

(3.14– 3.48)

2.50

(2.42– 2.58)

2.15

(2.10– 2.21)

1.07

(1.02– 1.11)

2.10

(2.03– 2.17)

Reproductive system and breast disorders

0.29

(0.18– 0.46)

0.29

(0.18– 0.46)

-1.78

(-2.39– -1.06)

0.29

(0.18– 0.46)

0.49

(0.31– 0.75)

0.49

(0.31– 0.75)

-1.03

(-1.63– -0.37)

0.49

(0.31– 0.76)

0.54

(0.43– 0.68)

0.54

(0.43– 0.68)

-0.87

(-1.19– -0.53)

0.55

(0.44– 0.69)

Renal and urinary disorders

0.94

(0.78– 1.13)

0.94

(0.78– 1.13)

-0.09

(-0.36– 0.19)

0.94

(0.78– 1.14)

0.98

(0.78– 1.22)

0.98

(0.78– 1.22)

-0.03

(-0.36– 0.30)

0.98

(0.78– 1.22)

0.64

(0.55– 0.74)

0.64

(0.56– 0.75)

-0.62

(-0.84– -0.4)

0.65

(0.56– 0.75)

Social circumstances

0.99

(0.73– 1.34)

0.99

(0.73– 1.33)

-0.02

(-0.46– 0.42)

0.99

(0.73– 1.34)

0.56

(0.35– 0.92)

0.57

(0.35– 0.92)

-0.82

(-1.48– -0.08)

0.57

(0.35– 0.93)

0.20

(0.13– 0.31)

0.20

(0.13– 0.31)

-2.27

(-2.83– -1.60)

0.21

(0.14– 0.32)

Pregnancy, puerperium and perinatal conditions

0.10

(0.01– 0.68)

0.10

(0.01– 0.68)

-3.37

(-4.55– -0.47)

0.10

(0.01– 0.69)

0.58

(0.22– 1.55)

0.58

(0.22– 1.55)

-0.78

(-1.95– 0.64)

0.58

(0.22– 1.55)

0.17

(0.06– 0.45)

0.17

(0.06– 0.45)

-2.54

(-3.57– -0.98)

0.17

(0.06– 0.46)

General disorders and administration site conditions

1.15

(1.09– 1.21)

1.12

(1.07– 1.18)

0.17

(0.09– 0.24)

1.12

(1.06– 1.18)

0.95

(0.88– 1.02)

0.95

(0.90– 1.01)

-0.07

(-0.17– 0.04)

0.96

(0.89– 1.03)

1.12

(1.08– 1.16)

1.10

(1.07– 1.13)

0.14

(0.08– 0.19)

1.10

(1.06– 1.14)

Skin and subcutaneous tissue disorders

0.76

(0.71– 0.82)

0.78

(0.73– 0.84)

-0.36

(-0.47– -0.24)

0.78

(0.72– 0.84)

0.44

(0.39– 0.50)

0.47

(0.42– 0.52)

-1.10

(-1.27– -0.92)

0.47

(0.41– 0.53)

1.45

(1.40– 1.51)

1.39

(1.35– 1.44)

0.47

(0.41– 0.52)

1.38

(1.33– 1.43)

Endocrine disorders

0.54

(0.32– 0.89)

0.54

(0.32– 0.89)

-0.89

(-1.57– -0.12)

0.54

(0.33– 0.90)

0.22

(0.08– 0.58)

0.22

(0.08– 0.58)

-2.20

(-3.25– -0.66)

0.22

(0.08– 0.58)

0.36

(0.24– 0.54)

0.36

(0.24– 0.54)

-1.45

(-1.99– -0.83)

0.37

(0.25– 0.55)

Immune system disorders

0.38

(0.26– 0.56)

0.38

(0.26– 0.56)

-1.38

(-1.90– -0.79)

0.38

(0.26– 0.56)

0.24

(0.13– 0.44)

0.24

(0.14– 0.44)

-2.03

(-2.77– -1.10)

0.25

(0.14– 0.44)

0.45

(0.36– 0.57)

0.45

(0.36– 0.57)

-1.13

(-1.45– -0.78)

0.46

(0.36– 0.58)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

0.58

(0.52– 0.65)

0.60

(0.54– 0.66)

-0.74

(-0.90– -0.58)

0.60

(0.54– 0.67)

0.39

(0.33– 0.45)

0.40

(0.34– 0.47)

-1.31

(-1.55– -1.07)

0.40

(0.34– 0.47)

0.84

(0.79– 0.90)

0.85

(0.80– 0.90)

-0.23

(-0.32– -0.14)

0.85

(0.80– 0.91)

Psychiatric disorders

0.60

(0.53– 0.69)

0.61

(0.54– 0.70)

-0.70

(-0.89– -0.51)

0.61

(0.54– 0.70)

0.38

(0.31– 0.46)

0.39

(0.32– 0.47)

-1.36

(-1.64– -1.05)

0.39

(0.32– 0.48)

0.33

(0.30– 0.37)

0.34

(0.30– 0.38)

-1.53

(-1.70– -1.36)

0.35

(0.31– 0.39)

Respiratory, thoracic and mediastinal disorders

0.54

(0.48– 0.60)

0.55

(0.49– 0.62)

-0.85

(-1.02– -0.68)

0.55

(0.49– 0.62)

0.47

(0.40– 0.55)

0.48

(0.42– 0.56)

-1.04

(-1.26– -0.81)

0.49

(0.42– 0.57)

0.83

(0.78– 0.89)

0.84

(0.79– 0.89)

-0.24

(-0.34– -0.15)

0.84

(0.79– 0.90)

Congenital, familial and genetic disorders

1.58

(1.01– 2.46)

1.58

(1.01– 2.45)

0.65

(-0.03– 1.24)

1.57

(1.01– 2.44)

0.12

(0.02– 0.84)

0.12

(0.02– 0.84)

-3.08

(-4.28– -0.20)

0.12

(0.02– 0.84)

0.20

(0.09– 0.44)

0.20

(0.09– 0.44)

-2.31

(-3.23– -1.04)

0.20

(0.09– 0.45)

Surgical and medical procedures

4.16

(3.73– 4.65)

4.05

(3.64– 4.51)

1.98

(1.80– 2.13)

3.94

(3.53– 4.40)

3.26

(2.80– 3.79)

3.20

(2.76– 3.70)

1.66

(1.42– 1.86)

3.15

(2.71– 3.66)

1.22

(1.07– 1.39)

1.22

(1.06– 1.39)

0.27

(0.08– 0.47)

1.21

(1.06– 1.38)

Musculoskeletal and connective tissue disorders

0.63

(0.56– 0.70)

0.64

(0.58– 0.71)

-0.64

(-0.79– -0.48)

0.64

(0.58– 0.72)

0.52

(0.45– 0.60)

0.53

(0.47– 0.61)

-0.90

(-1.10– -0.69)

0.54

(0.47– 0.62)

0.46

(0.43– 0.50)

0.48

(0.44– 0.52)

-1.05

(-1.16– -0.93)

0.48

(0.45– 0.52)

Injury, poisoning and procedural complications

1.27

(1.16– 1.38)

1.25

(1.15– 1.36)

0.32

(0.19– 0.45)

1.25

(1.15– 1.36)

1.90

(1.73– 2.08)

1.82

(1.68– 1.98)

0.86

(0.73– 0.99)

1.81

(1.66– 1.98)

0.48

(0.44– 0.52)

0.49

(0.45– 0.54)

-1.01

(-1.13– -0.88)

0.50

(0.46– 0.54)

Nervous system disorders

1.51

(1.41– 1.62)

1.47

(1.37– 1.56)

0.54

(0.44– 0.65)

1.46

(1.36– 1.56)

0.91

(0.82– 1.01)

0.91

(0.83– 1.01)

-0.13

(-0.28– 0.03)

0.92

(0.82– 1.02)

0.85

(0.80– 0.90)

0.86

(0.81– 0.91)

-0.21

(-0.30– -0.13)

0.86

(0.81– 0.91)

Investigations

0.98

(0.91– 1.05)

0.98

(0.92– 1.05)

-0.03

(-0.13– 0.08)

0.98

(0.91– 1.05)

0.52

(0.47– 0.59)

0.55

(0.49– 0.61)

-0.87

(-1.03– -0.70)

0.55

(0.49– 0.62)

0.66

(0.62– 0.70)

0.68

(0.64– 0.71)

-0.55

(-0.63– -0.47)

0.68

(0.65– 0.72)

Infections and infestations

0.79

(0.71– 0.88)

0.80

(0.72– 0.89)

-0.32

(-0.48– -0.16)

0.80

(0.72– 0.89)

0.75

(0.65– 0.86)

0.75

(0.66– 0.86)

-0.40

(-0.60– -0.20)

0.76

(0.66– 0.87)

1.04

(0.97– 1.11)

1.04

(0.98– 1.10)

0.05

(-0.04– 0.14)

1.04

(0.97– 1.10)

Hepatobiliary disorders

0.88

(0.74– 1.05)

0.89

(0.75– 1.05)

-0.17

(-0.43– 0.08)

0.89

(0.75– 1.05)

0.35

(0.25– 0.49)

0.35

(0.25– 0.49)

-1.49

(-1.95– -0.99)

0.35

(0.25– 0.49)

1.31

(1.19– 1.44)

1.30

(1.19– 1.43)

0.37

(0.23– 0.51)

1.29

(1.18– 1.42)

Ear and labyrinth disorders

0.69

(0.46– 1.04)

0.69

(0.46– 1.04)

-0.54

(-1.11– 0.07)

0.69

(0.46– 1.04)

0.45

(0.24– 0.84)

0.45

(0.24– 0.84)

-1.14

(-1.94– -0.20)

0.45

(0.24– 0.84)

0.61

(0.46– 0.81)

0.61

(0.46– 0.81)

-0.71

(-1.11– -0.28)

0.61

(0.46– 0.82)

Metabolism and nutrition disorders

1.48

(1.34– 1.65)

1.46

(1.33– 1.62)

0.54

(0.39– 0.69)

1.46

(1.32– 1.62)

2.02

(1.81– 2.26)

1.97

(1.77– 2.19)

0.97

(0.80– 1.13)

1.96

(1.75– 2.19)

1.45

(1.35– 1.55)

1.43

(1.34– 1.53)

0.50

(0.40– 0.60)

1.42

(1.32– 1.52)

Product issues

0.81

(0.51– 1.29)

0.81

(0.51– 1.29)

-0.30

(-0.95– 0.38)

0.81

(0.51– 1.29)

0.27

(0.10– 0.72)

0.27

(0.10– 0.72)

-1.88

(-2.94– -0.36)

0.27

(0.10– 0.73)

0.71

(0.52– 0.98)

0.71

(0.52– 0.98)

-0.48

(-0.94– -0.01)

0.72

(0.52– 0.99)

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Breast Cancer Research

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