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Table 4 Characteristics of AE reports for different BCR-ABL1 TKIs

From: Pharmacovigilance study of BCR-ABL1 tyrosine kinase inhibitors: a safety analysis of the FDA adverse event reporting system

Characteristics

Imatinib

Nilotinib

Dasatinib

Bosutinib

Ponatinib

All BCR-ABL1 TKIs

Number of events

39,746

17,351

19,633

3978

5281

85,989

Age (year), n (%)

< 18

659

(1.66)

75

(0.43)

270 (1.38)

5

(0.13)

39

(0.74)

1048

(1.22)

18–44

3293

(8.29)

1635 (9.42)

2059 (10.49)

391

(9.83)

565 (10.70)

7943

(9.24)

45–64

6504

(16.36)

3064 (17.66)

4537 (23.11)

1169 (29.39)

916 (17.35)

16,190 (18.83)

65–74

3558

(8.95)

1614 (9.30)

2196 (11.19)

809 (20.34)

498 (9.43)

8675 (10.09)

≥ 75

2961

(7.45)

1129 (6.51)

1509 (7.69)

714 (17.95)

354 (6.70)

6667

(7.75)

Unknown

22,771 (57.29)

9834 (56.68)

9062 (46.16)

890 (22.37)

2909 (55.08)

45,466 (52.87)

Median (IQR)

60

(46, 71)

59

(46, 70)

59

(47, 69)

64

(53, 74)

44

(58, 69)

60

(46, 70)

Gender, n (%)

Female

16,898 (42.51)

7326 (42.22)

9226 (46.99)

1803 (45.32)

2037 (38.57)

37,290 (43.37)

Male

19,419 (48.86)

8310 (47.89)

8745 (44.54)

1770 (44.49)

2523 (47.78)

40,767 (47.41)

Unknown

3429

(8.63)

1715 (9.88)

1662 (8.47)

405 (10.18)

721 (13.65)

7932

(9.22)

Reported region, n (%)

North America

13,109 (32.98)

7120 (41.04)

16,995 (86.56)

3311 (83.23)

3673 (69.55)

44,208 (51.41)

Asia

8279

(20.83)

2992 (17.24)

961 (4.89)

296

(7.44)

702 (13.29)

13,230 (15.39)

Europe

4476

(11.26)

2395 (13.80)

1230 (6.26)

315

(7.92)

677 (12.82)

9093 (10.57)

South America

852

(2.14)

538 (3.10)

220 (1.12)

41

(1.03)

147 (2.78)

1798

(2.09)

Africa

878

(2.21)

153 (0.88)

67 (0.34)

14

(0.35)

30

(0.57)

1142

(1.33)

Oceania

630

(1.59)

241 (1.39)

112 (0.57)

1

(0.03)

42

(0.80)

1026

(1.19)

Unknown

11,522 (28.99)

3912 (22.55)

48

(0.24)

0

(0)

10

(0.19)

15,492 (18.02)

Outcome of AEs, n (%)

Other outcomes

11,433 (28.77)

5249 (30.25)

4586 (23.36)

805 (20.24)

1326 (25.11)

23,399 (27.21)

Death

15,660 (39.40)

3634 (20.94)

1884 (9.60)

375

(9.43)

1694 (32.08)

23,247 (27.03)

Hospitalization (initial or prolonged)

4796

(12.07)

2832 (16.32)

3546 (18.06)

626 (15.74)

1655 (31.34)

13,455 (15.65)

Life-threatening

569

(1.43)

370 (2.13)

339 (1.73)

34

(0.85)

75

(1.42)

1387

(1.61)

Disability

287

(0.72)

145 (0.84)

64

(0.33)

9

(0.23)

18

(0.34)

523

(0.61)

Unknown

7001

(17.61)

5121 (29.51)

9214 (46.93)

2129 (53.52)

513 (9.71)

23,978 (27.88)