Table 1 Clinical characteristics.

From: A real-world analysis of FDA Adverse Event Reporting System (FAERS) events for liposomal and conventional doxorubicins

Characteristics

CDOX

Doxil

Myocet

Total

Patient age, years

 Mean

49.24

57.37

54.64

50.14

 < 18, n (%)

650 (1.77)

9 (0.21)

3 (0.96)

662 (1.60)

 18–64, n (%)

3321 (9.05)

378 (8.96)

9 (2.87)

3708 (8.99)

 ≥ 65, n (%)

1174 (3.20)

181 (4.29)

14 (4.46)

1369 (3.32)

 Unknown

31,570 (85.99)

3653 (86.54)

288 (91.72)

35,511 (86.09)

Wt, kg

 Mean

57.68

72.22

70.80

59.61

Reporting country, n (%)

 Austria

244 (0.66)

70 (1.66)

18 (5.73)

332 (0.80)

 Canada

2895 (7.89)

320 (7.58)

(0)

3215 (7.79)

 China

798 (2.17)

15 (0.36)

(0)

813 (1.97)

 Germany

2490 (6.78)

243 (5.76)

121 (38.54)

2854 (6.92)

 Spain

893 (2.43)

141 (3.34)

32 (10.19)

1066 (2.58)

 France

2160 (5.88)

271 (6.42)

13 (4.14)

2444 (5.92)

 United Kingdom

2169 (5.91)

168 (3.98)

6 (1.91)

2343 (5.68)

 Italy

1791 (4.88)

204 (4.83)

54 (17.20)

2049 (4.97)

 Japan

2033 (5.54)

183 (4.34)

2 (0.64)

2218 (5.38)

 Poland

638 (1.74)

55 (1.30)

35 (11.15)

728 (1.76)

 United states

11,564 (31.50)

1680 (39.80)

4 (1.27)

13,248 (32.12)

 Other countries

9040 (24.62)

871 (20.63)

29 (9.24)

9940 (24.10)

Reporters, n (%)

 Consumer

3433 (9.35)

513 (12.15)

8 (2.55)

3954 (9.59)

 Health-professional

4681 (12.75)

569 (13.48)

24 (7.64)

5274 (12.79)

 Lawyer

266 (0.72)

228 (5.40)

(0)

494 (1.20)

 Physician

15,609 (42.51)

1753 (41.53)

224 (71.34)

17,586 (42.63)

 Other health-professional

8749 (23.83)

685 (16.23)

47 (14.97)

9481 (22.98)

 Pharmacist

1626 (4.43)

237 (5.61)

10 (3.18)

1873 (4.54)

 Unknown

2351 (6.40)

236 (5.59)

1 (0.32)

2588 (6.27)

Indications, n (%)

 Acute leukaemia

1747 (4.76)

66 (1.56)

17 (5.41)

1830 (4.44)

  Acute lymphocytic leukaemia

1187 (67.95)

25 (37.88)

17 (100.00)

1229 (67.16)

  Other acute leukaemia

560 (32.05)

41 (62.12)

(0)

601 (32.84)

 Malignant lymphoma

12,448 (33.90)

755 (17.89)

63 (20.06)

13,266 (32.16)

  Diffuse large B-cell lymphoma

4999 (40.16)

400 (52.98)

28 (44.44)

5427 (40.91)

  B-cell lymphoma

1773 (14.24)

47 (6.23)

9 (14.29)

1829 (13.79)

  Non-Hodgkin's lymphoma

1689 (13.57)

76 (10.07)

13 (20.63)

1778 (13.40)

  Other lymphoma

3987 (32.03)

232 (30.72)

13 (20.64)

4232 (31.9)

Breast cancer

3787 (10.31)

400 (9.48)

170 (54.14)

4357 (10.56)

Lung cancer

89 (0.24)

11 (0.26)

1 (0.32)

101 (0.24)

Ovarian cancer

671 (1.83)

807 (19.12)

2 (0.64)

1480 (3.59)

Sarcoma

1943 (5.29)

161 (3.81)

(0)

2104 (5.10)

 Osteosarcoma

345 (17.76)

19 (11.80)

(0)

364 (17.30)

 Ewing's sarcoma

352 (18.12)

14 (8.70)

(0)

366 (17.40)

 Kaposi's sarcoma

84 (4.32)

37 (22.98)

(0)

121 (5.75)

 Other sarcoma

1162 (59.8)

91 (56.52)

(0)

1253 (59.55)

Nephroblastoma

86 (0.23)

3 (0.07)

(0)

89 (0.22)

Renal cancer

143 (0.39)

9 (0.21)

(0)

152 (0.37)

Multiple myeloma

1325 (3.61)

334 (7.91)

2(0.64)

1661 (4.03)

Other cancer/unkown indication

14,476 (39.43)

1675 (39.68)

59(3.64)

16,210 (7.03)

Reporting year, n (%)

 2004–2007

3042 (8.29)

577 (13.67)

4 (1.27)

3623 (8.78)

 2008–2011

4006 (10.91)

502 (11.89)

33 (10.51)

4541 (11.01)

 2012–2015

6721 (18.31)

626 (14.83)

134 (42.68)

7481 (18.14)

 2016–2019

12,164 (33.13)

1143 (27.08)

73 (23.25)

13,380 (32.44)

 2020–2022

10,782 (29.37)

1373 (32.53)

70 (22.29)

12,225 (29.64)

Sex, n (%)

 Female

17,331 (47.20)

2751 (65.17)

248 (78.98)

20,330 (49.28)

 Male

12,724 (34.66)

993 (23.53)

33 (10.51)

13,750 (33.33)

 Unknown

6660 (18.14)

477 (11.30)

33 (10.51)

7170 (17.38)

 Total

36,715 (100.00)

4221 (100.00)

314 (100.00)

41,250 (100.00)

  1. CDOX conventional doxorubicin, Doxil pegylated-liposome doxorubicin, Myocet non-pegylated-liposome doxorubicin, n the number of cases.