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Table 7 AEs signals of eltrombopag ranked by ROR (Top 10)

From: Safety analysis of romiplostim, eltrombopag, and avatrombopag post-market approval: a pharmacovigilance study based on the FDA Adverse Event Reporting System

PT

n

ROR(95%Cl)

PRR(χ²)

IC2(IC025)

EBGM(EBGM05)

Reticulin increased

4(0.49)

412.89(129.48-1316.58)

412.82(1173.78)

8.21(6.38)

295.16(111.86)

Serum colour abnormal

3(0.37)

344.06(93.14-1270.98)

344.02(769.55)

8.01(6.16)

258.26(86.54)

Clonal evolution

15(1.85)

281.64(159.11-498.54)

281.47(3293.79)

7.79(6.09)

221.37(137.28)

Bone marrow reticulin fibrosis

14(1.73)

237.00(132.57–423.70)

236.86(2674.38)

7.59(5.89)

192.84(118.60)

Paroxysmal nocturnal haemoglobinuria

14(1.73)

123.56(70.97-215.12)

123.49(1519.24)

6.79(5.10)

110.40(69.42)

Platelet count increased

532(65.76)

107.43(98.17-117.55)

105.12(49805.35)

6.58(4.91)

95.50(88.56)

Platelet count abnormal

163(20.15)

63.42(54.12–74.32)

63.01(9375.24)

5.89(4.23)

59.44(52.05)

Bone marrow myelogram abnormal

4(0.49)

60.72(22.15-166.46)

60.71(221.85)

5.84(4.14)

57.39(24.68)

Red blood cell morphology abnormal

3(0.37)

59.55(18.60-190.69)

59.54(163.26)

5.82(4.11)

56.35(21.28)

Platelet disorder

57(7.05)

52.79(40.44–68.90)

52.67(2748.86)

5.65(3.98)

50.16(40.13)