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Table 3 The top 30 signal strengths of reports ranked by ROR at the PTs level and sorted by SOC

From: Assessment the real-world safety of intravitreal dexamethasone implant (Ozurdex): novel insights from a comprehensive pharmacovigilance analysis utilizing the FAERS database

System Organ Class (SOC)

Preferred Terms (PTs)

Case Reports

ROR (95% CI)

PRR (95% CI)

chisq

IC (IC025)

EBGM (EBGM05)

Eye disorders

Corneal decompensation

35

6285.32(4218.05, 9365.77)

6211.93(4197.43, 9193.27)

151198.7

12.08(11.54)

4321.65(3095.38)

Choroidal haematoma

3

6091.26(1574.36, 23567.22)

6085.16(1573.74, 23529.45)

12774.64

12.06(10.4)

4259.91(1373.2)

Vitreous loss

11

4019.51(2056.63, 7855.82)

4004.76(2056.66, 7798.13)

34343.75

11.61(10.7)

3123.93(1783.19)

Iris neovascularisation

6

1016.23(443.56, 2328.26)

1014.19(445.25, 2310.1)

5668.3

9.89(8.78)

946.65(473.07)

Corneal oedema

96

869.75(705.66, 1072.01)

841.92(692.07, 1024.22)

76122.36

9.63(9.33)

794.85(667.28)

Vitreous haemorrhage

80

591.48(471.62, 741.81)

575.72(464.06, 714.24)

44111.38

9.11(8.79)

553.33(457.81)

Rhegmatogenous retinal detachment

6

496.3(219.73, 1120.98)

495.3(221.75, 1106.29)

2860.08

8.9(7.81)

478.64(242.06)

Corneal degeneration

6

474.24(210.09, 1070.51)

473.29(211.9, 1057.13)

2736.55

8.84(7.75)

458.05(231.77)

Anterior chamber flare

5

450.08(184.64, 1097.11)

449.33(186, 1085.46)

2168.04

8.77(7.59)

435.57(206.67)

Necrotising retinitis

15

446.87(266.95, 748.03)

444.64(267.11, 740.16)

6438.04

8.75(8.03)

431.17(280.18)

Lens dislocation

5

441.69(181.24, 1076.39)

440.95(182.53, 1065.21)

2128.68

8.74(7.56)

427.7(202.98)

Atrophy of globe

3

418.03(132.54, 1318.47)

417.61(131.39, 1327.36)

1211.21

8.66(7.22)

405.71(155.16)

Scleral disorder

5

360.97(148.49, 877.54)

360.37(149.18, 870.56)

1747.53

8.46(7.28)

351.48(167.15)

Choroidal detachment

10

354.38(189.03, 664.39)

353.2(188.64, 661.32)

3426.83

8.43(7.56)

344.65(203.7)

Vitreous opacities

13

301.44(173.83, 522.73)

300.14(173.37, 519.59)

3795.63

8.2(7.43)

293.94(185.45)

Non-infectious endophthalmitis

13

269.06(155.25, 466.3)

267.9(154.75, 463.78)

3392.79

8.04(7.27)

262.96(165.98)

Macular fibrosis

12

259.98(146.72, 460.66)

258.94(146.67, 457.14)

3028.18

7.99(7.2)

254.32(157.58)

Sudden visual loss

4

258.5(96.1, 695.35)

258.16(96.89, 687.86)

1006.36

7.99(6.71)

253.57(110.79)

Corneal lesion

4

250.53(93.16, 673.73)

250.2(93.9, 666.65)

975.62

7.94(6.66)

245.88(107.46)

Injury, poisoning and procedural complications

Posterior capsule rupture

19

5776.52(3386.32, 9853.8)

5739.9(3381.24, 9743.9)

77635.67

12(11.27)

4087.79(2614.68)

Cataract traumatic

5

2370.4(919.07, 6113.55)

2366.45(923.66, 6062.92)

10133.37

10.99(9.74)

2028.53(918.1)

Hyphaema

10

381.93(203.6, 716.46)

380.66(203.3, 712.73)

3687.81

8.53(7.67)

370.75(219.02)

Open globe injury

3

370.77(117.77, 1167.26)

370.4(118.84, 1154.45)

1077.12

8.5(7.06)

361.01(138.28)

Foreign body in eye

16

314.59(191.45, 516.95)

312.92(191.7, 510.78)

4867.57

8.26(7.56)

306.19(202.07)

Surgical and medical procedures

Trabeculectomy

3

655.98(206.06, 2088.31)

655.32(206.17, 2082.92)

1873.51

9.29(7.84)

626.46(237.74)

Vitrectomy

9

280.46(144.86, 543.02)

279.62(143.6, 544.48)

2450.42

8.1(7.19)

274.24(157.78)

Infections and infestations

Endophthalmitis

226

811.95(706.68, 932.91)

750.8(654.54, 861.21)

160746.43

9.48(9.28)

713.14(634.91)

Hypopyon

20

483.72(309.34, 756.4)

480.5(306.14, 754.18)

9256.87

8.86(8.23)

464.8(319.75)

Investigations

Intraocular pressure increased

199

271.02(234.44, 313.31)

253.09(220.64, 290.31)

49106.52

7.96(7.75)

248.68(220.27)

Intraocular pressure decreased

46

964.11(713.76, 1302.28)

949.33(707.51, 1273.8)

40847.02

9.8(9.37)

889.9(691.96)