Table 1 Demographic characteristics on hepatotoxicity with HER2-targeted agents.

From: Real-world pharmacovigilance assessment of hepatotoxicity risk with HER2-Targeted drugs using FAERS database analysis

Characteristic

Cases, N (%)

Trastuzumab

T-DM1

T-DXd

Pertuzumab

TKIs

Total

1155

387

251

250

223

Gender

 

Female

1101 (95.3%)

376 (97.2%)

227 (90.4%)

246 (98.4%)

221 (99.1%)

Male

54 (4.7%)

11 (2.8%)

24 (9.6%)

4 (1.6%)

2 (0.9%)

Weight

 

<50 kg

51 (4.4%)

26 (6.7%)

31 (12.4%)

14 (5.6%)

38 (17.0%)

>100 kg

14 (1.2%)

6 (1.6%)

4 (1.6%)

1 (0.4%)

4 (1.8%)

50–100 kg

447 (38.7%)

144 (37.2%)

86 (34.3%)

137 (54.8%)

74 (33.2%)

Missing

643 (55.7%)

211 (54.5%)

130 (51.8%)

98 (39.2%)

107 (48.0%)

Age (years)

     

<18

2 (0.2%)

0 (0%)

6 (2.4%)

0 (0%)

0 (0%)

>85

1 (0.1%)

1 (0.3%)

1 (0.4%)

0 (0%)

2 (0.9%)

18–64.9

723 (62.6%)

216 (55.8%)

101 (40.2%)

181 (72.4%)

137 (61.4%)

65–85

143 (12.4%)

60 (15.5%)

54 (21.5%)

26 (10.4%)

38 (17.0%)

Missing

286 (24.8%)

110 (28.4%)

89 (35.5%)

43 (17.2%)

46 (20.6%)

Occupation

Physician

639 (55.3%)

240 (62.0%)

161 (64.1%)

99 (39.6%)

126 (56.5%)

Pharmacist

62 (5.4%)

36 (9.3%)

21 (8.4%)

13 (5.2%)

8 (3.6%)

Other health-professional

87 (7.5%)

20 (5.2%)

0 (0%)

8 (3.2%)

19 (8.5%)

Consumer

95 (8.2%)

55 (14.2%)

33 (13.1%)

20 (8.0%)

58 (26.0%)

Healthcare practitioner

267 (23.1%)

31 (8.0%)

36 (14.3%)

108 (43.2%)

11 (4.9%)

Missing

5 (0.4%)

5 (1.3%)

0 (0%)

2 (0.8%)

1 (0.4%)

Reporting region (Top five)

1

China

344 (29.8%)

United States

105 (27.1%)

Japan

54 (21.5%)

China

112 (44.8%)

Japan

62 (27.8%)

2

United States

127 (11.0%)

Japan

38 (9.8%)

United States

50 (19.9%)

United States

29 (11.6%)

United States

53 (23.8%)

3

France

70 (6.1%)

Canada

33 (8.5%)

Canada

46 (18.3%)

Germany

11 (4.4%)

China

14 (6.3%)

4

Canada

61 (5.3%)

France

27 (7.0%)

France

42 (16.7%)

Korea

11 (4.4%)

Italy

9 (4.0%)

5

Japan

60 (5.2%)

Germany

22 (5.7%)

China

11 (4.4%)

Italy

10 (4.0%)

France

8 (3.6%)

Main outcomes

Congenital Anomaly

1 (0.1%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Death

106 (9.2%)

43 (11.1%)

57 (22.7%)

23 (9.2%)

41 (18.4%)

Disability

9 (0.8%)

3 (0.8%)

0 (0%)

2 (0.8%)

1 (0.4%)

Hospitalization-Initial or Prolonged

282 (24.4%)

102 (26.4%)

50 (19.9%)

83 (33.2%)

44 (19.7%)

Life-Threatening

28 (2.4%)

15 (3.9%)

2 (0.8%)

7 (2.8%)

5 (2.2%)

Other Serious (Important Medical Event)

616 (53.3%)

165 (42.6%)

101 (40.2%)

97 (38.8%)

110 (49.3%)

Required Intervention to Prevent Permanent Impairment/Damage

0 (0%)

1 (0.3%)

1 (0.4%)

0 (0%)

0 (0%)

Missing

113 (9.8%)

58 (15.0%)

40 (15.9%)

38 (15.2%)

22 (9.9%)

Preferred Term of Indications (Top 3)

1

Breast cancer (959, 83.32%)

Breast cancer (330, 85.27%)

Breast cancer (191, 76.10%)

Breast cancer (231,92.40%)

Breast cancer (188,84.30%)

2

Gastric cancer (47, 4.08%)

Gastric cancer (1, 0.26%)

Gastric cancer (26, 10.36%)

Gastric cancer (1, 0.40%)

GC

(1, 0.45%)

3

CC

(5, 0.43%)

CC

(1, 0.26%)

NSCLC

(10, 3.98%)

OC

(1, 0.40%)

PC

(1, 0.45%)

  1. Note: T-DM1, Trastuzumab emtansine; T-DXd, Trastuzumab deruxtecan; TKIs, Lapatinib, neratinib, and tucatinib. NSCLC, Non-small cell lung cancer; GC, Gallbladder cancer; CC, Colorectal cancer; OC, Ovarian cancer; PC, Pancreatic cancer.