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Table 1 Baseline characteristics of haemorrhagic reports associated with lenvatinib, pembrolizumab and combination therapy from 2015 to 2024Q1

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

Characteristics

Report number, N (%)

Lenvatinib

Pembrolizumab

Combination therapy

Number of reports

1188

952

420

Gender

Female

435(36.62)

442(46.43)

243(57.86)

 

Male

727(61.2)

482(50.63)

174(41.43)

 

Unknown or missing

26(2.19)

28(2.94)

3(0.71)

Age (years)

< 18

6(0.51)

10(1.05)

4(0.95)

 

18 ≤ and ≤ 64

418(35.19)

295(30.99)

173(41.19)

 

> 64

568(47.81)

395(41.49)

190(45.24)

 

Unknown or missing

196(16.5)

252(26.47)

53(12.62)

Serious outcome

Death

227(19.11)

132(13.87)

72(17.14)

 

Life-threatening

45(3.79)

35(3.68)

13(3.1)

 

Hospitalization

751(63.22)

262(27.52)

267(63.57)

 

Disability

13(1.09)

20(2.1)

2(0.48)

 

Others

152(12.79)

503(52.84)

66(15.71)

Reported Countries (Top five)

Japan

465(39.14)

396(41.6)

82(19.52)

 

Americas

400(33.67)

256(26.89)

117(27.86)

 

China

107(9.01)

18(1.89)

29(6.9)

 

Canada

27(2.27)

18(1.89)

12(2.86)

 

France

17(1.43)

36(3.78)

20(4.76)

Reported Person

Physician

647(54.46)

461(48.42)

325(77.38)

 

Consumer

413(34.76)

338(35.5)

71(16.9)

 

Pharmacist

54(4.55)

51(5.36)

12(2.86)

 

Other health-professional

45(3.79)

51(5.36)

11(2.62)

 

Unknown

29(2.44)

51(5.36)

1(0.24)

Reporting year

2015

26(2.19)

29(3.05)

/

 

2016

60(5.05)

34(3.57)

/

 

2017

70(5.89)

50(5.25)

4(0.95)

 

2018

149(12.54)

89(9.35)

4(0.95)

 

2019

210(17.68)

102(10.71)

27(6.43)

 

2020

180(15.15)

89(9.35)

51(12.14)

 

2021

154(12.96)

95(9.98)

63(15)

 

2022

138(11.62)

148(15.55)

101(24.05)

 

2023

175(14.73)

252(26.47)

144(34.29)

 

2024Q1

26(2.19)

64(6.72)

26(6.19)