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Table 3 Signal strength of AEs of durvalumab at the PT level in FAERS database

From: A real-world disproportionality analysis of the US Food and Drug Administration (FDA) adverse event reporting system (FAERS) events for Durvalumab

PT

Case

(n)

ROR

(95% CI)

PRR

(χ²)

IC

(IC025)

EBGM

(EBGM05)

Death*

1719

3.19

(3.01–3.37)

3.00

(1760.73)

1.31

(1.23)

2.48

(2.35)

Malignant neoplasm progression

882

1.17

(1.09–1.26)

1.16

(18.53)

0.19

(0.09)

1.14

(1.06)

Radiation pneumonitis*

704

56.06

(45.94–68.42)

54.10

(5096.23)

3.06

(2.89)

8.34

(6.84)

Pneumonitis*

540

3.41

(3.08–3.77)

3.34

(646.53)

1.43

(1.28)

2.69

(2.43)

Pneumonia

288

1.68

(1.48–1.91)

1.67

(66.28)

0.65

(0.46)

1.57

(1.38)

Dyspnoea

263

1.53

(1.35–1.75)

1.53

(41.12)

0.53

(0.34)

1.45

(1.27)

Pyrexia

236

0.85

(0.75–0.98)

0.85

(5.37)

-0.20

(-0.40)

0.87

(0.76)

Interstitial lung disease

233

1.28

(1.11–1.47)

1.28

(12.28)

0.31

(0.11)

1.24

(1.08)

Diarrhoea

232

0.82

(0.71–0.93)

0.82

(8.72)

-0.26

(-0.46)

0.83

(0.73)

Neutrophil count decreased

219

2.37

(2.04–2.75)

2.35

(134.46)

1.04

(0.82)

2.06

(1.78)

Metastases to central nervous system*

209

9.07

(7.47–11.01)

8.98

(730.39)

2.30

(2.02)

4.92

(4.06)

Febrile neutropenia

190

1.71

(1.46-2.00)

1.70

(46.16)

0.67

(0.43)

1.59

(1.36)

Fatigue

186

0.65

(0.56–0.75)

0.65

(32.33)

-0.56

(-0.78)

0.68

(0.58)

Rash

170

0.77

(0.66–0.90)

0.77

(10.98)

-0.34

(-0.57)

0.79

(0.67)

Platelet count decreased

163

1.35

(1.14–1.59)

1.34

(12.43)

0.38

(0.13)

1.30

(1.10)

Myelosuppression

152

1.83

(1.53–2.18)

1.82

(46.89)

0.75

(0.49)

1.68

(1.41)

Hepatic function abnormal

131

1.24

(1.03–1.49)

1.24

(5.43)

0.28

(0.01)

1.21

(1.01)

Pleural effusion

131

1.78

(1.47–2.15)

1.77

(36.92)

0.72

(0.44)

1.64

(1.36)

Cough

125

1.70

(1.40–2.05)

1.69

(29.64)

0.66

(0.37)

1.58

(1.30)

Hypothyroidism

121

0.76

(0.63–0.92)

0.76

(8.21)

-0.35

(-0.62)

0.78

(0.65)

Off label use

121

0.45

(0.38–0.54)

0.46

(75.84)

-1.05

(-1.31)

0.48

(0.40)

Asthenia

119

0.78

(0.64–0.94)

0.78

(6.92)

-0.33

(-0.60)

0.80

(0.66)

Nausea

116

0.63

(0.52–0.76)

0.63

(23.60)

-0.61

(-0.88)

0.66

(0.54)

Lung disorder*

113

2.54

(2.06–3.13)

2.53

(81.10)

1.13

(0.81)

2.18

(1.77)

Drug-induced liver injury*

112

3.83

(3.07–4.78)

3.81

(161.86)

1.56

(1.22)

2.96

(2.37)

Decreased appetite

111

0.60

(0.49–0.72)

0.60

(28.13)

-0.68

(-0.96)

0.62

(0.52)

Disease progression

110

0.80

(0.66–0.98)

0.80

(4.84)

-0.29

(-0.57)

0.82

(0.67)

Vomiting

109

0.91

(0.75–1.11)

0.91

(0.85)

-0.12

(-0.41)

0.92

(0.75)

Colitis

109

0.92

(0.75–1.12)

0.92

(0.69)

-0.11

(-0.40)

0.93

(0.76)

Anaemia

108

0.73

(0.60–0.89)

0.73

(9.94)

-0.41

(-0.70)

0.75

(0.62)

  1. *, positive signal. The positive signal generation conditions were as follows: i) number of cases ≥ 3; ii) ROR 95% CI lower limit > 1; iii) PRR ≥ 2, χ²≥4; iv) IC025 > 0; v) EBGM05 > 2. Only the top 30 most frequent PTs are shown. PT, preferred term