Table 2 Signal strength of voxelotor reports at the top 30 preferred term (PT) levels
PT | N | ROR (95%Cl) | PRR (χ2) | EBGM (EBGM05) | IC (IC025) |
|---|---|---|---|---|---|
Sickle cell anaemia with crisis | 10,561 | 3782.72(3638.29-3932.88) | 2995.16(8101356) | 9.59(9.44) | 768.15(738.82) |
Acute chest syndrome | 288 | 709.84(610.88-824.82) | 705.81(120362) | 8.71(7.22) | 419.51(361.03) |
Sickle cell disease | 165 | 675.08(554.74-821.52) | 672.89(67001.0) | 8.67(6.62) | 407.67(335.00) |
Double heterozygous sickling disorders | 3 | 619.09(147.95-2590.64) | 619.05(1156.98) | 8.60(0.25) | 387.28(92.55) |
Hypersplenism | 51 | 146.72(109.41-196.75) | 146.57(6456.41) | 7.01(4.79) | 128.46(95.80) |
Retinopathy sickle cell | 3 | 238.11(67.85-835.62) | 238.10(575.50) | 7.60(0.37) | 193.64(55.18) |
Pharmacophobia | 5 | 107.49(42.79-270.01) | 107.47(477.66) | 6.61(1.27) | 97.43(38.78) |
Emergency care | 105 | 51.89(42.65–63.14) | 51.79(4979.75) | 5.63(4.80) | 49.36(40.56) |
Reticulocyte count abnormal | 7 | 76.84(35.65-165.62) | 76.83(487.61) | 6.16(1.80) | 71.58(33.21) |
Abdominal symptom | 27 | 43.76(29.77–64.32) | 43.73(1081.56) | 5.39(3.53) | 41.99(28.57) |
Sickle cell anaemia | 24 | 42.35(28.15–63.70) | 42.33(930.30) | 5.35(3.39) | 40.70(27.06) |
Disease complication | 125 | 33.24(27.81–39.73) | 33.16(3777.97) | 5.01(4.43) | 32.16(26.91) |
Therapy cessation | 1036 | 26.43(24.84–28.13) | 25.91(24226.5) | 4.66(4.54) | 25.30(23.78) |
Delayed haemolytic transfusion reaction | 3 | 79.37(24.53-256.85) | 79.37(215.55) | 6.20(0.43) | 73.77(22.80) |
Product use complaint | 295 | 27.43(24.43–30.80) | 27.28(7277.08) | 4.73(4.44) | 26.60(23.69) |
Insurance issue | 195 | 26.28(22.79–30.30) | 26.18(4606.36) | 4.68(4.30) | 25.56(22.16) |
Expulsion of medication | 11 | 41.58(22.76–75.98) | 41.57(418.70) | 5.32(2.38) | 40.00(21.89) |
Priapism | 81 | 28.07(22.51–35.01) | 28.03(2055.26) | 4.77(4.05) | 27.31(21.90) |
Coronavirus infection | 152 | 26.36(22.43–30.97) | 26.28(3605.30) | 4.68(4.23) | 25.65(21.83) |
Therapy interrupted | 845 | 21.53(20.10-23.06) | 21.19(15938.0) | 4.38(4.24) | 20.78(19.40) |
Haemoglobin increased | 76 | 24.29(19.34–30.50) | 24.25(1655.63) | 4.57(3.86) | 23.72(18.89) |
Intentional product misuse to child | 3 | 51.59(16.18–164.50) | 51.59(141.74) | 5.62(0.43) | 49.18(15.42) |
Reticulocyte count increased | 16 | 24.28(14.79–39.87) | 24.28(348.88) | 4.57(2.63) | 23.74(14.46) |
Product dose omission issue | 5223 | 14.94(14.51–15.37) | 13.50(60149.0) | 3.74(3.69) | 13.34(12.96) |
Haemoglobin abnormal | 79 | 15.90(12.73–19.86) | 15.88(1084.86) | 3.97(3.40) | 15.65(12.53) |
Infusion | 7 | 22.43(10.61–47.44) | 22.43(140.27) | 4.46(1.57) | 21.97(10.39) |
Bone marrow transplant | 24 | 15.86(10.60-23.74) | 15.85(328.94) | 3.97(2.72) | 15.63(10.44) |
Blood bilirubin decreased | 9 | 18.95(9.80-36.65) | 18.95(150.27) | 4.22(1.83) | 18.63(9.63) |
Central venous catheter removal | 7 | 19.16(9.07–40.47) | 19.16(118.27) | 4.23(1.51) | 18.83(8.91) |
Reticulocytopenia | 3 | 28.40(9.02–89.43) | 28.40(77.17) | 4.79(0.38) | 27.66(8.78) |