Table 5 The signal strength of reports of Tafamidis at the PT level in the FAERS database

General disorders and administration site conditions

Death

2359

8.57 (8.21–8.95)

7.76 (13988.63)

2.95 (1.28)

7.71 (7.44)

Disease progression

189

4.44 (3.85–5.12)

4.41 (497.21)

2.14 (0.47)

4.40 (3.90)

Therapeutic response unexpected

114

8.25 (6.86–9.93)

8.21 (716.75)

3.03 (1.36)

8.15 (6.99)

Oedema peripheral

99

3.55 (2.91–4.33)

3.54 (179.96)

1.82 (0.15)

3.53 (2.99)

Oedema

50

3.26 (2.47–4.31)

3.26 (77.94)

1.70 (0.03)

3.25 (2.57)

Sudden death

22

9.34 (6.14–14.22)

9.33 (162.17)

3.21 (1.54)

9.26 (6.51)

Pre-existing condition improved

20

9.96 (6.41–15.47)

9.95 (159.41)

3.30 (1.63)

9.86 (6.82)

Cardiac disorders

Cardiac failure

532

20.62 (18.90–22.49)

20.14 (9499.32)

4.30 (2.64)

19.77 (18.38)

Atrial fibrillation

251

7.69 (6.79–8.72)

7.62 (1434.16)

2.92 (1.25)

7.57 (6.82)

Cardiac failure congestive

199

15.31 (13.30–17.62)

15.18 (2598.36)

3.90 (2.24)

14.97 (13.31)

Cardiac failure chronic

188

106.45 (91.55–123.79)

105.56 (17617.51)

6.58 (4.91)

95.60 (84.26)

Cardiac disorder

183

6.18 (5.34–7.15)

6.14 (783.06)

2.61 (0.94)

6.11 (5.40)

Cardiomyopathy

45

11.55 (8.61–15.50)

11.53 (428.00)

3.51 (1.85)

11.41 (8.92)

Left ventricular hypertrophy

43

36.74 (27.09–49.82)

36.67 (1439.28)

5.15 (3.48)

35.41 (27.44)

Atrial flutter

43

18.91 (13.98–25.57)

18.87 (714.35)

4.21 (2.55)

18.54 (14.40)

Mitral valve incompetence

32

12.13 (8.56–17.20)

12.12 (322.56)

3.58 (1.92)

11.99 (8.95)

Cardiac failure acute

29

11.85 (8.22–17.09)

11.84 (284.36)

3.55 (1.88)

11.71 (8.62)

Coronary artery disease

29

6.54 (4.54–9.42)

6.53 (134.98)

2.70 (1.03)

6.49 (4.78)

Ventricular tachycardia

28

6.05 (4.17–8.78)

6.05 (117.24)

2.59 (0.92)

6.02 (4.41)

Pericardial effusion

28

3.76 (2.59–5.45)

3.76 (56.45)

1.91 (0.24)

3.75 (2.75)

Tricuspid valve incompetence

26

15.02 (10.19–22.13)

15.00 (334.79)

3.89 (2.22)

14.79 (10.70)

Chronic left ventricular failure

24

128.84 (84.21–197.11)

128.70 (2695.10)

6.84 (5.16)

114.17 (79.99)

Left ventricular dysfunction

22

10.18 (6.69–15.50)

10.17 (180.12)

3.33 (1.67)

10.08 (7.09)

Vascular disorders

Essential hypertension

31

41.95 (29.28–60.1)

41.90 (1187.90)

5.33 (3.66)

40.26 (29.80)

Orthostatic hypotension

20

3.25 (2.09–5.04)

3.25 (31.01)

1.70 (0.03)

3.24 (2.24)

Gastrointestinal disorders

Dysphagia

176

6.18 (5.33–7.17)

6.14 (753.90)

2.61 (0.95)

6.11 (5.39)

Respiratory, thoracic, and mediastinal disorders

Dyspnoea exertional

91

6.24 (5.08–7.67)

6.22 (396.38)

2.63 (0.96)

6.19 (5.21)

Pleural effusion

71

3.95 (3.13–4.98)

3.94 (155.10)

1.97 (0.31)

3.93 (3.23)

Pulmonary oedema

52

3.77 (2.87–4.96)

3.77 (105.38)

1.91 (0.24)

3.76 (2.99)

Musculoskeletal and connective tissue disorders

Back disorder

20

3.68 (2.37–5.71)

3.67 (38.80)

1.87 (0.21)

3.66 (2.54)

Injury, poisoning, and procedural complications

Hip fracture

54

5.16 (3.95–6.75)

5.15 (179.91)

2.36 (0.69)

5.13 (4.10)

Nervous system disorders

Cerebrovascular accident

168

4.03 (3.46–4.69)

4.01 (378.15)

2.00 (0.33)

3.99 (3.52)

Dementia

83

7.88 (6.35–9.78)

7.85 (492.66)

2.96 (1.30)

7.80 (6.51)

Carpal tunnel syndrome

48

9.88 (7.43–13.13)

9.86 (378.39)

3.29 (1.62)

9.77 (7.7)

Polyneuropathy

36

7.59 (5.47–10.54)

7.58 (204.11)

2.91 (1.25)

7.53 (5.72)

Cerebral infarction

24

3.66 (2.45–5.46)

3.66 (46.14)

1.87 (0.20)

3.65 (2.61)

Dizziness postural

20

5.80 (3.73–9.00)

5.79 (78.84)

2.53 (0.86)

5.76 (3.99)

Ear and labyrinth disorders

Hypoacusis

319

15.90 (14.22–17.77)

15.68 (4322.21)

3.95 (2.28)

15.46 (14.08)

Deafness

39

4.17 (3.04–5.71)

4.16 (93.32)

2.05 (0.39)

4.15 (3.19)

Metabolism and nutrition disorders

Fluid retention

132

8.08 (6.80–9.59)

8.04 (807.24)

3.00 (1.33)

7.98 (6.91)

Gout

42

7.11 (5.24–9.63)

7.09 (218.38)

2.82 (1.15)

7.05 (5.47)

Weight fluctuation

31

6.21 (4.36–8.84)

6.20 (134.40)

2.62 (0.96)

6.17 (4.59)

Hyperlipidaemia

29

13.29 (9.21–19.18)

13.28 (325.00)

3.71 (2.05)

13.12 (9.65)

Hypervolaemia

25

5.28 (3.56–7.82)

5.27 (86.09)

2.39 (0.73)

5.25 (3.78)

Surgical and medical procedures

Cardiac pacemaker insertion

41

25.87 (18.97–35.28)

25.83 (953.93)

4.66 (2.99)

25.20 (19.44)

Heart transplant

28

93.40 (63.40–137.60)

93.28 (2338.68)

6.42 (4.74)

85.43 (61.77)

Investigations

Body height decreased

89

28.89 (23.39–35.68)

28.78 (2320.28)

4.81 (3.14)

28.01 (23.47)

Ejection fraction decreased

33

5.47 (3.88–7.70)

5.46 (119.71)

2.44 (0.78)

5.44 (4.08)

N-terminal prohormone brain natriuretic peptide increased

20

27.65 (17.73–43.12)

27.62 (499.48)

4.75 (3.08)

26.91 (18.55)