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Table 3 Baseline characteristics of ICIs-treated patients with or without AKI events reported from FAERS database

From: Risk factors of immune checkpoint inhibitor-associated acute kidney injury: evidence from clinical studies and FDA pharmacovigilance database

Characteristics

All cases (N = 135,531)

AKI (N = 2948)

Non-AKI (N = 132,583)

Reporter

 Total data

135,186

2945

132,241

 Healthcare professional

112,981(83.6%)

2841(96.5%)

110,140(83.3%)

 Non-healthcare professional

22,205(16.4%)

104(3.5%)

22,101(16.7%)

Sex

 Total data

119,777

2810

116,967

 Male

74,398(62.1%)

1882(67.0%)

72,516(62.0%)

 Female

45,379(37.9%)

928(33.0%)

44,451(38.0%)

Age

 Total data

95,464

2679

92,785

  < 65YR

44,321(46.4%)

1074(40.1%)

43,247(46.6%)

  ≥ 65YR

51,143(53.6%)

1605(59.9%)

49,538(53.4%)

Reported countries

 Total data

135,118

2938

132,180

 United States, US

56,363(41.7%)

1112(37.8%)

55,251(41.8%)

 Japan, JP

20,905(15.5%)

269(9.2%)

20,636(15.6%)

 France, FR

11,520(8.5%)

468(15.9%)

11,052(8.4%)

 Germany, DE

7422(5.5%)

278(9.5%)

7144(5.4%)

 Canada, CA

4755(3.5%)

58(2.0%)

4697(3.6%)

 United Kingdom, GB

3600(2.7%)

157(5.3%)

3443(2.6%)

 Australia, AU

3122(2.3%)

55(1.9%)

3067(2.3%)

 Italy, IT

3012(2.2%)

63(2.1%)

2949(2.2%)

 China, CN

2613(1.9%)

11(0.4%)

2602(2.0%)

 Spain, ES

2504(1.9%)

76(2.6%)

2428(1.8%)

 Other countries

19,302(14.3%)

391(13.3%)

18,911(14.3%)

Indications

 Total data

135,531

2948

132,583

 Lung cancer

38,720(28.6%)

755(25.6%)

37,965(28.6%)

 Melanoma

29,989(22.1%)

787(26.7%)

29,202(22.0%)

 Renal cancer

10,888(8.0%)

330(11.2%)

10,558(8.0%)

 Hepatocellular carcinoma

2768(2.0%)

69(2.3%)

2699(2.0%)

 Head and neck cancer

2651(2.0%)

44(1.5%)

2607(2.0%)

 Gastric cancer

2436(1.8%)

41(1.4%)

2395(1.8%)

 Bladder cancer

2065(1.5%)

97(3.3%)

1968(1.5%)

 Colorectal cancer

2034(1.5%)

54(1.8%)

1980(1.5%)

 Other cancers

43,980(32.5%)

771(26.2%)

43,209(32.6%)

  1. ICI Immune checkpoint inhibitor, AKI Acute kidney injury