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Table 3 The haemorrhage signals on the PT level

From: Haemorrhage-related adverse events profles of lenvatinib and pembrolizumab alone or in combination: a real-world pharmacovigilance study based on FAERS database

PT

SOC

Freq

ROR(95%CI)

IC(IC025)

Lenvatinib

Tumour haemorrhage

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

116

61.82(51.2-74.64)

5.85(4.18)

Cerebral haemorrhage

Nervous system disorders

114

4.83(4.01–5.8)

2.26(0.6)

Oesophageal varices haemorrhage

Gastrointestinal disorders

79

57.2(45.55–71.83)

5.75(4.08)

Upper gastrointestinal haemorrhage

Gastrointestinal disorders

43

3.33(2.47–4.49)

1.73(0.06)

Gastric haemorrhage

Gastrointestinal disorders

34

4.58(3.27–6.42)

2.19(0.52)

Arterial haemorrhage

Vascular disorders

31

39.6(27.63–56.77)

5.24(3.58)

Mouth haemorrhage

Gastrointestinal disorders

22

4.59(3.02–6.97)

2.19(0.52)

Tracheal haemorrhage

Injury, poisoning and procedural complications

20

101.74(64.03-161.65)

6.51(4.83)

Pulmonary haemorrhage

Respiratory, thoracic and mediastinal disorders

19

4.02(2.56–6.32)

2(0.34)

Duodenal ulcer haemorrhage

Gastrointestinal disorders

17

9.44(5.86–15.23)

3.23(1.56)

Haemobilia

Hepatobiliary disorders

17

60.57(37.05–99.01)

5.83(4.15)

Intra-abdominal haemorrhage

Gastrointestinal disorders

15

10.17(6.11–16.92)

3.33(1.66)

Gastric ulcer haemorrhage

Gastrointestinal disorders

14

4.06(2.4–6.86)

2.01(0.35)

Hepatic haemorrhage

Hepatobiliary disorders

12

25.26(14.23–44.84)

4.62(2.95)

Oesophageal haemorrhage

Gastrointestinal disorders

11

12.62(6.96–22.88)

3.64(1.97)

Cerebellar haemorrhage

Nervous system disorders

8

7.78(3.88–15.6)

2.95(1.28)

Diverticulum intestinal haemorrhagic

Gastrointestinal disorders

8

4.11(2.05–8.23)

2.03(0.37)

Adrenal haemorrhage

Endocrine disorders

6

16.44(7.33–36.88)

4.01(2.34)

Gastric varices haemorrhage

Gastrointestinal disorders

6

24.78(11.01–55.79)

4.59(2.92)

Thalamus haemorrhage

Nervous system disorders

6

8.71(3.9-19.47)

3.11(1.44)

Intracranial tumour haemorrhage

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

5

19.64(8.09–47.64)

4.27(2.59)

Small intestinal haemorrhage

Gastrointestinal disorders

5

3.64(1.51–8.77)

1.86(0.19)

Venous haemorrhage

Vascular disorders

4

16.84(6.26–45.28)

4.05(2.37)

Pharyngeal haemorrhage

Respiratory, thoracic and mediastinal disorders

4

4.69(1.75–12.52)

2.22(0.55)

Respiratory tract haemorrhage

Respiratory, thoracic and mediastinal disorders

4

9.05(3.38–24.22)

3.16(1.49)

Tongue haemorrhage

Gastrointestinal disorders

4

5.32(1.99–14.23)

2.41(0.74)

Haemorrhagic cerebral infarction

Nervous system disorders

3

7.78(2.5-24.26)

2.95(1.28)

Haemorrhagic tumour necrosis

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

3

131.95(39.21-444.08)

6.84(5.08)

Bronchial haemorrhage

Respiratory, thoracic and mediastinal disorders

3

12.45(3.98–38.91)

3.62(1.94)

Brain stem haemorrhage

Nervous system disorders

3

5.1(1.64–15.88)

2.34(0.67)

Putamen haemorrhage

Nervous system disorders

3

13.4(4.28–41.9)

3.72(2.05)

Pembrolizumab

Tumour haemorrhage

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

66

11.43(8.94–14.62)

3.46(1.8)

Small intestinal haemorrhage

Gastrointestinal disorders

18

4.45(2.79–7.09)

2.14(0.47)

Enterocolitis haemorrhagic

Gastrointestinal disorders

12

4.62(2.61–8.18)

2.19(0.52)

Gastritis haemorrhagic

Gastrointestinal disorders

10

3.39(1.82–6.32)

1.75(0.08)

Adrenal haemorrhage

Endocrine disorders

6

5.52(2.46–12.37)

2.44(0.77)

Haemobilia

Hepatobiliary disorders

4

4.54(1.69–12.19)

2.17(0.49)

Tracheal haemorrhage

Injury, poisoning and procedural complications

3

4.66(1.49–14.58)

2.2(0.52)

Intracranial tumour haemorrhage

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

3

3.92(1.25–12.24)

1.96(0.28)

Stomatitis haemorrhagic

Gastrointestinal disorders

3

12.65(3.98–40.18)

3.61(1.91)

Spinal cord haemorrhage

Nervous system disorders

3

3.34(1.07–10.43)

1.73(0.05)

Combination therapy

Cerebral haemorrhage

Nervous system disorders

41

3.8(2.79–5.16)

1.92(0.25)

Upper gastrointestinal haemorrhage

Gastrointestinal disorders

33

5.61(3.98–7.9)

2.48(0.82)

Tumour haemorrhage

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

31

34.49(24.17–49.21)

5.08(3.41)

Pulmonary haemorrhage

Respiratory, thoracic and mediastinal disorders

14

6.51(3.85-11)

2.7(1.03)

Haemorrhagic stroke

Nervous system disorders

14

5.56(3.29–9.4)

2.47(0.8)

Gastric haemorrhage

Gastrointestinal disorders

13

3.84(2.23–6.61)

1.94(0.27)

Subarachnoid haemorrhage

Nervous system disorders

11

3.42(1.9–6.19)

1.77(0.11)

Mouth haemorrhage

Gastrointestinal disorders

9

4.11(2.14–7.9)

2.04(0.37)

Oesophageal varices haemorrhage

Gastrointestinal disorders

6

8.99(4.03–20.06)

3.16(1.49)

Renal haemorrhage

Renal and urinary disorders

5

7.59(3.15–18.26)

2.92(1.25)

Large intestinal haemorrhage

Gastrointestinal disorders

5

7.04(2.93–16.94)

2.81(1.14)

Small intestinal haemorrhage

Gastrointestinal disorders

5

8.01(3.33–19.28)

3(1.33)

Intra-abdominal haemorrhage

Gastrointestinal disorders

4

5.91(2.21–15.76)

2.56(0.89)

Oesophageal haemorrhage

Gastrointestinal disorders

3

7.48(2.41–23.25)

2.9(1.23)

Tracheal haemorrhage

Injury, poisoning and procedural complications

3

30.52(9.76–95.5)

4.91(3.23)

Pharyngeal haemorrhage

Respiratory, thoracic and mediastinal disorders

3

7.71(2.48–23.97)

2.94(1.27)

Stoma site haemorrhage

Injury, poisoning and procedural complications

3

4.6(1.48–14.29)

2.2(0.53)

Spinal cord haemorrhage

Nervous system disorders

3

21.88(7.01–68.3)

4.44(2.76)

Hepatic haemorrhage

Hepatobiliary disorders

3

13.58(4.36–42.28)

3.75(2.08)

Brain stem haemorrhage

Nervous system disorders

3

11.22(3.61–34.9)

3.48(1.81)