Table 3 Top 30 reports with the strongest risk signals based on frequency screening of atezolizumab at the PTs in FAERS database.

From: Post marketing safety surveillance of atezolizumab based on a retrospective analysis of the FDA adverse events reporting system (FAERS)

PTs

N

ROR (95% CI)

PRR (χ2)

IC025/IC-2SD

EBGM05

Death

2186

3.11 (2.98,3.25)

3.02 (2994.05)

1.53

2.89

Disease progression

1120

11.68 (11.01,12.4)

11.45 (10,589.04)

3.4

10.68

Pyrexia

1047

3.61 (3.39,3.83)

3.55 (1926.44)

1.73

3.34

Anaemia

645

3.96 (3.66,4.28)

3.92 (1404.12)

1.85

3.62

Pneumonia

644

2.41 (2.23,2.61)

2.4 (525.19)

1.14

2.21

Febrile neutropenia

579

10.77 (9.92,11.69)

10.66 (5023.47)

3.26

9.73

Interstitial lung disease

566

14.52 (13.36,15.79)

14.38 (6954.45)

3.67

13.06

Pneumonitis

536

25.27 (23.19,27.54)

25.02 (12,076.6)

4.42

22.44

Decreased appetite

469

2.45 (2.23,2.68)

2.43 (396.8)

1.14

2.22

Platelet count decreased

446

4.96 (4.51,5.44)

4.92 (1390.12)

2.14

4.47

Neutrophil count decreased

442

13.57 (12.35,14.91)

13.47 (5038.65)

3.56

12.11

Hypothyroidism

425

16.56 (15.04,18.23)

16.43 (6067.54)

3.83

14.71

Colitis

413

13.97 (12.68,15.41)

13.87 (4870.81)

3.59

12.43

Hypertension

397

2.22 (2.01,2.45)

2.21 (264.03)

0.99

2

Acute kidney injury

395

3.18 (2.88,3.51)

3.16 (583.26)

1.5

2.86

Neutropenia

386

3.46 (3.13,3.82)

3.44 (667.86)

1.62

3.11

Hepatic function abnormal

353

11.73 (10.56,13.04)

11.66 (3404.27)

3.33

10.39

Thrombocytopenia

332

3.56 (3.2,3.97)

3.55 (606.21)

1.65

3.18

White blood cell counts decreased

325

3.53 (3.16,3.93)

3.51 (583.02)

1.64

3.14

Adrenal insufficiency

324

37.42 (33.49,41.82)

37.2 (11,020.62)

4.86

32.17

Sepsis

320

3.37 (3.02,3.77)

3.36 (529.76)

1.57

3

Alanine aminotransferase increased

308

5.85 (5.23,6.54)

5.82 (1223.53)

2.35

5.18

Proteinuria

301

19.94 (17.78,22.35)

19.83 (5281.8)

4.03

17.37

Aspartate aminotransferase increased

301

6.6 (5.89,7.39)

6.57 (1412.29)

2.51

5.83

Ascites

292

11.77 (10.48,13.21)

11.71 (2829.31)

3.31

10.32

Hyponatraemia

253

5.29 (4.67,5.99)

5.27 (871.06)

2.19

4.63

Hepatitis

249

11.72 (10.34,13.28)

11.67 (2402.91)

3.29

10.19

Intentional product use issue

242

3.42 (3.01,3.88)

3.41 (411.36)

1.57

3

General physical health deterioration

238

2.61 (2.3,2.97)

2.6 (234.75)

1.18

2.29

Liver disorder

234

6.36 (5.59,7.23)

6.33 (1045.12)

2.43

5.54

  1. χ2, chi-squared; ROR, reporting odds ratio; CI, confidence interval; PRR, proportional reporting ratio; EBGM, empirical Bayesian geometric mean; FAERS, Food and Drug Administration Adverse Event Reporting System; IC, information component; PTs, preferred terms.
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