Skip to main content

Table 1 Baseline characteristics of patients with hematologic and lymphatic system adverse events related to chimeric antigen receptor T-Cell therapy

From: Hematologic and lymphatic disorders associated with chimeric antigen receptor T-cell therapy: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database

Clinical characteristics

Tisagenlecleucel

(N = 545)

Axicabtagene ciloleucel

(N = 790)

Brexucabtagene

toleucel

(N = 97)

Lisocabtagene maraleucel

(N = 30)

Idecabtagene vicleucel

N=(96)

Ciltacabtagene autoleucel

(N = 42)

Total

(N = 1,600)

Gender

 Female

202(37.1%)

302(38.2%)

23(23.7%)

13(43.3%)

42(43.8%)

15(35.7%)

597(37.3%)

 Male

296(54.3%)

404(51.1%)

72(74.2%)

17(56.7%)

40(41.7%)

14(33.3%)

843(52.7%)

 Missing

47(8.6%)

84(10.6%)

2(2.1%)

0(0%)

14(14.6%)

13(31.0%)

160(10.0%)

Age in years, median(IQR)

21(12–58)

60(49–67)

63(55.75–69.25)

65.5(56.5–70)

66(62–72)

58.5(54.25-66)

57(32–67)

Age group

 < 18 years

189(34.7%)

2(0.3%)

1(1.0%)

0(0%)

0(0%)

0(0%)

192(12.0%)

 18–65 years

174(31.9%)

423(53.5%)

41(42.3%)

14(46.7%)

29(30.2%)

15(35.7%)

696(43.5%)

 ≥ 65 years

82(15.0%)

221(28.0%)

38(39.2%)

16(53.3%)

42(43.8%)

7(16.7%)

406(25.4%)

 Missing

100(18.3%)

144(18.2%)

17(17.5%)

0(0%)

25(26.0%)

20(47.6%)

306(19.1%)

Country

 US

355(65.1%)

366(46.3%)

54(55.7%)

17(56.7%)

55(57.3%)

34(81.0%)

881(55.1%)

 JP

31(5.7%)

2(0.3%)

0(0%)

12(40.0%)

4(4.2%)

0(0%)

49(3.1%)

 AU

26(4.8%)

6(0.8%)

0(0%)

0(0%)

0(0%)

1(2.4%)

33(2.1%)

 FR

26(4.8%)

73(9.2%)

13(13.4%)

0(0%)

21(21.9%)

4(9.5%)

137(8.6%)

 ES

18(3.3%)

67(8.5%)

2(2.1%)

0(0%)

0(0%)

2(4.8%)

89(5.6%)

 CN

0(0%)

99(12.5%)

2(2.1%)

0(0%)

0(0%)

1(2.4%)

102(6.4%)

 DE

11(2.0%)

57(7.2%)

6(6.2%)

0(0%)

2(2.1%)

0(0%)

76(4.8%)

 IT

5(0.9%)

29(3.7%)

6(6.2%)

0(0%)

0(0%)

0(0%)

40(2.5%)

 Other country

64(11.7%)

91(11.5%)

14(14.4%)

1(3.3%)

14(14.6%)

0(0%)

184(11.5%)

 Missing

9(1.7%)

0(0%)

0(0%)

0(0%)

0(0%)

0(0%)

9(0.6%)

Reporter type

 Healthcare professional

466(85.5%)

725(91.8%)

88(90.7%)

28(93.3%)

76(79.2%)

31(73.8%)

1414(88.4%)

 Consumer

70(12.8%)

42(5.3%)

1(1.0%)

0(0%)

15(15.6%)

8(19.0%)

136(8.5%)

 Missing

9(1.7%)

23(2.9%)

8(8.2%)

2(6.7%)

5(5.2%)

3(7.1%)

50(3.1%)

Outcome

 Death

98(18.0%)

110(13.9%)

18(18.6%)

8(26.7%)

5(5.2%)

5(11.9%)

244(15.3%)

 Disability

1(0.2%)

6(0.8%)

2(2.1%)

0(0%)

2(2.1%)

0(0%)

11(0.7%)

 Hospitalization

115(21.1%)

218(27.6%)

34(35.1%)

8(26.7%)

21(21.9%)

11(26.2%)

407(25.4%)

 Life-threatening

46(8.4%)

23(2.9%)

3(3.1%)

1(3.3%)

1(1.0%)

1(2.4%)

75(4.7%)

 Other events

277(50.8%)

411(52.0%)

39(40.2%)

11(36.7%)

66(68.8%)

24(57.1%)

828(51.8%)

 Missing

8(1.5%)

22(2.8%)

1(1.0%)

2(6.7%)

1(1.0%)

1(2.4%)

35(2.2%)