Table 3 New signal strength of partial preferred terms (PTs) of pertuzumab from FAERS database

Blood and lymphatic system disorders

Myelosuppression*

305

86.09 (76.72–96.59)

84.32 (16461.01)

6.35 (5.66)^a

81.77 (74.26)

Haematotoxicity*

8

3.89 (1.95–7.79)

3.89 (6.40)

1.96 (0.98)

3.89 (2.18)

Cardiac disorders

Cardiotoxicity*

70

35.04 (27.66–44.38)

34.88 (837.72)

5.11 (4.03) ^a

34.44 (28.26)

Cardiac dysfunction*

27

34.95 (23.90-51.11)

34.89 (124.62)

5.11 (3.49) ^a

34.45 (25.07)

Left ventricular dysfunction

27

17.27 (11.83–25.23)

17.24 (117.22)

4.10 (2.81)^b

17.14 (12.48)

Ventricular hypokinesia

8

12.39 (6.18–24.81)

12.38 (9.80)

3.62 (1.81) ^b

12.33 (6.89)

Cardiomyopathy*

22

6.98 (4.59–10.60)

6.97 (64.34)

2.80 (1.84) ^b

6.95 (4.90)

Mitral valve incompetence*

9

4.38 (2.28–8.42)

4.38 (8.74)

2.13 (1.11)

4.37 (2.53)

Sinus tachycardia*

10

3.44 (1.85–6.40)

3.44 (9.11)

1.78 (0.96)

3.43 (2.04)

Tachycardia*

65

3.33 (2.61–4.25)

3.32 (374.13)

1.73 (1.36)

3.32 (2.70)

Gastrointestinal disorders

Enterocolitis infectious*

6

29.56 (13.22–66.11)

29.55 (6.09)

4.87 (2.18) ^b

29.24 (14.91)

Enterocolitis*

11

8.58 (4.75–15.51)

8.58 (17.11)

3.10 (1.71) ^b

8.55 (5.21)

Intestinal perforation*

10

3.87 (2.08–7.20)

3.87 (9.97)

1.95 (1.05)

3.87 (2.30)

Colitis*

27

3.15 (2.16–4.60)

3.15 (61.50)

1.65 (1.13)

3.14 (2.29)

Haemorrhoids*

15

3.09 (1.86–5.13)

3.09 (18.64)

1.63 (0.98)

3.09 (2.02)

General disorders and administration site conditions

Device related thrombosis*

5

19.48 (8.08–46.97)

19.48 (4.08)

4.27 (1.77) ^b

19.34 (9.26)

Mucosal disorder*

5

19.26 (7.99–46.42)

19.25 (4.07)

4.26 (1.77) ^b

19.12 (9.16)

Hyperpyrexia

14

16.56 (9.79–28.01)

16.54 (31.35)

4.04 (2.39) ^b

16.45 (10.59)

Performance status decreased*

11

10.92 (6.04–19.75)

10.92 (18.09)

3.44 (1.90) ^b

10.88 (6.63)

Temperature intolerance*

12

4.91 (2.79–8.65)

4.91 (16.54)

2.29 (1.30)

4.90 (3.05)

Hepatobiliary disorders

Hepatic lesion*

6

5.99 (2.69–13.34)

5.98 (4.52)

2.58 (1.16)

5.97 (3.05)

Immune system disorders

Neutropenic sepsis

20

11.75 (7.57–18.23)

11.73 (60.65)

3.55 (2.29) ^b

11.69 (8.09)

Erysipelas*

13

10.51 (6.10-18.13)

10.51 (25.07)

3.39 (1.96) ^b

10.47 (6.64)

Paronychia

10

9.81 (5.27–18.26)

9.80 (14.61)

3.29 (1.77) ^b

9.77 (5.81)

Subcutaneous abscess*

9

7.52 (3.91–14.46)

7.51 (11.03)

2.91 (1.51) ^b

7.49 (4.33)

Rash pustular*

11

6.29 (3.48–11.37)

6.29 (15.50)

2.65 (1.47)

6.27 (3.82)

Anaphylactic shock

28

5.40 (3.72–7.82)

5.39 (94.26)

2.43 (1.68) ^b

5.38 (3.94)

Cellulitis*

48

3.83 (2.89–5.09)

3.82 (227.82)

1.93 (1.46)

3.82 (3.01)

Gastroenteritis*

12

3.67 (2.08–6.46)

3.67 (13.80)

1.87 (1.06)

3.66 (2.28)

Injury, poisoning and procedural complications

Radiation necrosis*

5

47.26 (19.52-114.45)

47.24 (4.34)

5.54 (2.29) ^b

46.44 (22.16)

Radiation skin injury

6

22.37 (10.01–49.97)

22.36 (5.95)

4.47 (2.00) ^b

22.18 (11.32)

Investigations

Carbohydrate antigen 15 − 3 increased*

6

36.77 (16.42–82.31)

36.75 (6.17)

5.18 (2.31) ^b

36.27 (18.48)

Mean platelet volume decreased*

7

36.31 (17.22–76.55)

36.29 (8.40)

5.16 (2.45) ^b

35.81 (19.19)

Ejection fraction decreased

109

31.58 (26.13–38.17)

31.35 (2017.95)

4.95 (4.10) ^a

31.00 (26.45)

Echocardiogram abnormal*

5

18.64 (7.73–44.93)

18.63 (4.06)

4.21 (1.75) ^b

18.51 (8.87)

Red cell increased

12

11.85 (6.72–20.89)

11.84 (21.87)

3.56 (2.02) ^b

11.79 (7.33)

Pulse absent*

8

9.02 (4.51–18.06)

9.02 (9.17)

3.17 (1.58) ^b

8.99 (5.03)

Blood magnesium decreased*

13

6.42 (3.72–11.06)

6.41 (21.82)

2.68 (1.55) ^b

6.40 (4.06)

SARS-CoV-2 test positive*

15

3.98 (2.40–6.60)

3.97 (22.83)

1.99 (1.20)

3.97 (2.60)

Metabolism and nutrition disorders

Dehydration*

127

4.21 (3.54–5.02)

4.19 (1696.31)

2.06 (1.73) ^b

4.18 (3.61)

Hypomagnesaemia*

12

3.93 (2.23–6.93)

3.93 (14.51)

1.97 (1.12)

3.93 (2.44)

Nervous system disorders

Polyneuropathy*

24

9.06 (6.07–13.53)

9.05 (82.58)

3.17 (2.12)

9.02 (6.45)

Intracranial pressure increased*

6

4.87 (2.18–10.84)

4.86 (4.12)

2.28 (1.02)

4.86 (2.48)

Respiratory, thoracic and mediastinal disorders

Nasal ulcer*

6

14.95 (6.70-33.35)

14.94 (5.68)

3.89 (1.75) ^b

14.86 (7.59)

Interstitial lung disease*

136

12.78 (10.79–15.13)

12.67 (2844.95)

3.66 (3.09) ^a

12.61 (10.95)

Pneumonitis*

52

8.54 (6.50-11.22)

8.52 (381.76)

3.09 (2.35) ^b

8.49 (6.76)

Lung infiltration*

13

7.85 (4.55–13.54)

7.85 (23.31)

2.97 (1.72) ^b

7.83 (4.96)

Bronchospasm*

23

7.36 (4.88–11.08)

7.35 (71.54)

2.87 (1.91) ^b

7.33 (5.20)

Pulmonary hypertension*

16

3.23 (1.98–5.28)

3.23 (22.11)

1.69 (1.03)

3.23 (2.14)

Skin and subcutaneous tissue disorders

Onychomadesis*

21

26.77 (17.41–41.16)

26.74 (74.04)

4.73 (3.07) ^a

26.48 (18.48)

Dermatitis acneiform*

20

14.86 (9.57–23.06)

14.84 (63.04)

3.88 (2.50) ^b

14.76 (10.22)

Nail discolouration*

10

10.13 (5.44–18.85)

10.12 (14.72)

3.33 (1.79)

10.09 (6.00)

Vascular disorders

Cyanosis*

15

4.85 (2.92–8.06)

4.85 (25.70)

2.28 (1.37)

4.84 (3.17)

Lymphoedema*

14

8.39 (4.96–14.18)

8.38 (27.55)

3.06 (1.81) ^b

8.36 (5.39)

Circulatory collapse*

13

3.49 (2.02–6.01)

3.48 (15.57)

1.80 (1.04)

3.48 (2.21)