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Table 2 Detection results of the main safety signals of bevacizumab

From: Five years of safety profile of bevacizumab: an analysis of real-world pharmacovigilance and randomized clinical trials

Adverse event

PRR

ROR(95%CI)

Number of report

Vascular disorders

 Periphlebitis

108.375

108.395(33.378, 352.0159)

4

 Varicose vein ruptured

41.407

41.425(20.432,, 83.98553)

9

Skin and subcutaneous tissue disorders

 Melanoderma

76.2

76.237(37.474, 155.09632)

5

Respiratory, thoracic and mediastinal disorders

 Laryngeal necrosis

365.765

365.868(103.237, 1296.6254)

6

 Acquired tracheo-oesophageal fistula

182.882

182.934(63.467, 527.2818)

6

 Dysaesthesia pharynx

156.756

156.823(67.871, 362.35614)

9

Renal and urinary disorders

 Ureteric fistula

406.406

406.501(97.139, 1701.1043)

5

 Glomerular vascular disorder

365.765

366.283(207.98, 645.07720)

30

Nervous system disorders

 Secondary cerebellar degeneration

58.1

58.071(21.895, 154.02121)

5

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

 Malignant glioma

171

170.746(64.987, 448.61810)

7

 Optic glioma

155

155.275(79.438, 303.51222)

14

Metabolism and nutrition disorders

 Hyperamylasaemia

11.2

11.213(4.115, 30.55387)

4

Investigations

 Transaminases

112.543

112.575(42.784, 296.20913)

6

 Prothrombin level decreased

54.865

54.911(32.924, 91.57980)

18

 Protein urine

48.057

48.117(31.84, 72.715137)

27

 Protein urine present

47.01

47.314(39.438, 56.763721)

190

 kL-6 increased

46.446

46.455(15.945, 135.34621)

4

Injury, poisoning and procedural complications

 Stomal varices

549

548.88(169.015, 1782.4994)

9

 Anastomotic fistula

457

457.53(193.96, 1079.2618)

15

Infections and infestations

 Suspected transmission of an infectious agent via product

277

278.447(215.665, 359.506111)

190

 Bacterial endophthalmitis

106

106.068(50.478, 222.87923)

10

Hepatobiliary disorders

 Hepatic atrophy

128

127.925(83.936, 194.96963)

33

General disorders and administration site conditions

 Acral peeling skin syndrome

2926.12

2927.779(380.666, 22,518.1481)

12

 Radiation interaction

121.922

121.95(41.679, 356.82110)

5

 Perforation

58.465

58.577(41.648, 82.388171)

41

Gastrointestinal disorders

 Malignant gastrointestinal obstruction

97.537

97.565(37.851, 251.48515)

6

 Gastrointestinal perforation

90.464

91.503(78.927,106.083655)

243

 Rectourethral fistula

87.087

87.107(31.372, 241.86214)

5

 Tongue geographic

53.341

53.358(23.549,120.90132)

7

 Peritoneal disorder

48.03

48.059(26.51,87.12266)

13

Eye disorders

 Ciliary hyperaemia

243.843

244.108(136.931, 435.17123)

23

 Retinal pigment epithelial tear

131.02

131.242(87.513, 196.82167)

36

Blood and lymphatic system disorders

 Splenic artery thrombosis

94.828

94.859(39.616, 227.13618)

7

 Intravascular haemolysis

45.285

45.312(25.065, 81.91470)

13

 Microangiopathic haemolytic anaemia

22.168

22.182(12.832, 38.342154)

14

 Myelosuppression

20.619

20.922(18.658,23.4623808)

322

 Bone marrow failure

19.597

19.95(17.991, 22.1244915)

395

 Hypersplenism

19.05

19.055(7.668, 47.34964)

5

Surgical and medical procedures

 Portal vein embolisation

244

243.901(70.603, 842.5625)

71

Product issues

 Product contamination microbial

22.5

22.546(13.716, 37.062184)

17

Endocrine disorders

 Primary adrenal insufficiency

39.3

39.339(15.295, 101.17931)

5

 Congenital, familial and genetic disorders

 bRCA2 gene mutation

65

65.037(21.583, 195.97615)

4

Cardiac disorders

 Cardiac ventricular thrombosis

11.6

11.572(6.484, 20.651253)

12