soc_english soc_chinese pt_chinese pt_english 2018
Case Reports
2018
ROR(95% CI)
2018
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2018
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2018
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2018
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2019
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2019
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2019
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2019
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2019
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2019
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2020
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2020
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2020
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2020
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2020
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2020
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2021
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2021
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2021
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2021
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2021
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2021
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2022
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2022
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2022
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2022
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2022
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2022
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2023
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2023
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2023
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2023
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2023
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2023
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2024
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2024
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2024
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2024
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2024
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2024
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2025
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2025
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2025
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2025
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2025
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2025
EBGM(EBGM05)
1 metabolism and nutrition disorders 代谢及营养类疾病 糖尿病酮症酸中毒 diabetic ketoacidosis 5 33.94(13.96, 82.5) 33.15(13.99, 78.53) 155.7 5.05(3.88) 33.08(15.74) 10 42.23(22.53, 79.14) 41.34(22.52, 75.9) 391.74 5.36(4.5) 41.12(24.31) 6 80.33(35.54, 181.57) 77.64(35.45, 170.05) 452.48 6.27(5.18) 77.36(39.1) 8 153.44(75.05, 313.74) 144.8(74.36, 281.96) 1137.05 7.17(6.2) 144.06(79.19) 3 64.9(20.66, 203.86) 63.59(20.81, 194.35) 184.45 5.99(4.55) 63.45(24.35) 4 79.07(29.28, 213.48) 77.26(29, 205.86) 300.12 6.27(4.98) 76.99(33.54) 8 118.03(58.12, 239.73) 113.64(57.23, 225.66) 887.78 6.82(5.85) 112.92(62.42) 3 79.72(25.28, 251.38) 77.63(25.4, 237.26) 226.41 6.27(4.83) 77.43(29.62)
2 infections and infestations 感染及侵染类疾病 尿路感染 urinary tract infection 11 18.67(10.17, 34.28) 17.74(10.05, 31.32) 174.08 4.15(3.31) 17.72(10.66) 20 15.06(9.62, 23.58) 14.46(9.4, 22.26) 250.79 3.85(3.22) 14.43(9.92) 3 8.49(2.7, 26.66) 8.33(2.73, 25.46) 19.4 3.06(1.62) 8.33(3.2) 4 7.9(2.93, 21.3) 7.74(2.96, 20.22) 23.55 2.95(1.67) 7.74(3.38) 6 9.48(4.21, 21.35) 9.24(4.22, 20.24) 44.2 3.21(2.12) 9.24(4.68) 9 27.99(14.16, 55.32) 25.84(13.8, 48.38) 215.37 4.69(3.76) 25.82(14.6)
3 infections and infestations 感染及侵染类疾病 真菌感染 fungal infection 17 153.8(93.46, 253.07) 141.31(90.03, 221.8) 2349.26 7.13(6.43) 140.1(92.35) 39 141.5(101.69, 196.9) 129.77(96.71, 174.12) 4902.6 7(6.53) 127.6(96.78) 5 52.68(21.63, 128.32) 51.22(21.62, 121.33) 245.75 5.68(4.5) 51.1(24.26)
4 gastrointestinal disorders 胃肠系统疾病 恶心 nausea 15 5.3(3.13, 8.96) 4.99(3.06, 8.15) 48.5 2.32(1.58) 4.99(3.21) 19 3.06(1.93, 4.84) 2.97(1.93, 4.57) 25.23 1.57(0.93) 2.97(2.02)
5 investigations 各类检查 血葡萄糖升高 blood glucose increased 4 5.15(1.91, 13.84) 5.07(1.9, 13.51) 13.1 2.34(1.06) 5.06(2.21) 7 4.97(2.36, 10.49) 4.91(2.33, 10.34) 21.87 2.3(1.29) 4.91(2.63) 8 16.94(8.33, 34.43) 16.22(8.17, 32.21) 114.47 4.02(3.05) 16.21(8.95) 5 14(5.74, 34.2) 13.54(5.72, 32.07) 58.21 3.76(2.58) 13.54(6.41) 6 15.69(6.95, 35.43) 15.18(6.93, 33.25) 79.58 3.92(2.83) 15.17(7.67) 4 8.46(3.14, 22.75) 8.32(3.12, 22.17) 25.8 3.06(1.78) 8.31(3.63) 3 13.09(4.16, 41.22) 12.77(4.18, 39.03) 32.59 3.67(2.23) 12.76(4.89)
6 renal and urinary disorders 肾脏及泌尿系统疾病 尿频 pollakiuria 3 21.11(6.75, 66.04) 20.82(6.81, 63.63) 56.56 4.38(2.95) 20.79(8.01) 5 15.06(6.23, 36.39) 14.91(6.17, 36.02) 64.81 3.9(2.73) 14.88(7.11) 3 29.1(9.29, 91.17) 28.62(9.36, 87.47) 79.91 4.84(3.41) 28.59(10.99)
7 nervous system disorders 各类神经系统疾病 头晕 dizziness 7 3.9(1.84, 8.29) 3.81(1.84, 7.87) 14.6 1.93(0.91) 3.8(2.02) 4 4.88(1.8, 13.25) 4.75(1.82, 12.41) 11.92 2.25(0.95) 4.75(2.06)
8 general disorders and administration site conditions 全身性疾病及给药部位各种反应 无不良事件 no adverse event 4 6.43(2.39, 17.3) 6.32(2.37, 16.84) 17.98 2.66(1.38) 6.32(2.76) 12 9.55(5.38, 16.95) 9.33(5.28, 16.47) 89.38 3.22(2.42) 9.32(5.77) 12 31.72(17.65, 57.02) 29.64(17.12, 51.31) 332.39 4.89(4.07) 29.6(18.12) 6 14.41(6.36, 32.64) 13.84(6.32, 30.31) 71.64 3.79(2.69) 13.83(6.98) 4 7.63(2.82, 20.6) 7.45(2.85, 19.46) 22.4 2.9(1.61) 7.44(3.24) 14 25.61(14.82, 44.23) 23.61(14.18, 39.3) 303.91 4.56(3.8) 23.59(14.93) 11 7.98(4.35, 14.65) 7.62(4.32, 13.45) 63.7 2.93(2.09) 7.62(4.59)
9 infections and infestations 感染及侵染类疾病 外阴阴道真菌感染 vulvovaginal mycotic infection 5 403.29(164.34, 989.67) 393.62(162.94, 950.88) 1911.82 8.59(7.4) 384.31(181.33)
10 cardiac disorders 心脏器官疾病 心悸 palpitations 3 6.54(2.09, 20.46) 6.46(2.11, 19.74) 13.88 2.69(1.26) 6.46(2.49) 6 6.46(2.89, 14.47) 6.39(2.86, 14.27) 27.33 2.68(1.6) 6.39(3.26)
11 infections and infestations 感染及侵染类疾病 生殖器真菌感染 genital infection fungal 3 1371.19(418.92, 4488.05) 1351.42(416.93, 4380.47) 3736.91 10.28(8.79) 1247.54(462.56) 5 766.84(304.43, 1931.6) 758.64(301.97, 1905.93) 3439.31 9.43(8.21) 689.76(318.41)
12 investigations 各类检查 血葡萄糖异常 blood glucose abnormal 4 23.63(8.82, 63.31) 23.43(8.79, 62.43) 85.67 4.55(3.27) 23.36(10.24) 3 66.88(21.29, 210.1) 65.54(21.44, 200.31) 190.26 6.03(4.6) 65.38(25.09)
13 general disorders and administration site conditions 全身性疾病及给药部位各种反应 口渴 thirst 3 24.92(7.99, 77.69) 24.77(7.95, 77.2) 68.21 4.63(3.2) 24.69(9.53)
14 renal and urinary disorders 肾脏及泌尿系统疾病 排尿困难 dysuria 6 21.46(9.58, 48.08) 21.2(9.49, 47.35) 115.24 4.4(3.32) 21.14(10.77)
15 skin and subcutaneous tissue disorders 皮肤及皮下组织类疾病 皮疹 rash 14 3.64(2.14, 6.19) 3.56(2.14, 5.93) 25.95 1.83(1.09) 3.56(2.28)
16 metabolism and nutrition disorders 代谢及营养类疾病 低血糖 hypoglycaemia 5 15.03(6.22, 36.3) 14.88(6.16, 35.95) 64.63 3.89(2.73) 14.85(7.1)
17 investigations 各类检查 体重降低 weight decreased 8 3.78(1.88, 7.6) 3.73(1.88, 7.41) 16.04 1.9(0.95) 3.73(2.08)
18 investigations 各类检查 糖化血红蛋白升高 glycosylated haemoglobin increased 5 21.24(8.79, 51.34) 21.03(8.71, 50.8) 95.16 4.39(3.23) 20.97(10.02) 3 49.81(15.85, 156.51) 48.77(15.96, 149.06) 140.21 5.61(4.17) 48.69(18.68)
19 general disorders and administration site conditions 全身性疾病及给药部位各种反应 不良事件 adverse event 5 5.97(2.47, 14.41) 5.91(2.49, 14) 20.43 2.56(1.4) 5.91(2.83)
20 infections and infestations 感染及侵染类疾病 特发性阴囊坏疽 fournier's gangrene 5 100.36(41.34, 243.65) 99.3(41.11, 239.88) 480.31 6.62(5.44) 98.03(46.67) 3 219.9(69.83, 692.46) 216.1(69.33, 673.54) 636.07 7.74(6.3) 213.99(81.95)
21 infections and infestations 感染及侵染类疾病 坏疽 gangrene 3 40.04(12.83, 124.97) 39.79(12.77, 124.02) 112.87 5.31(3.88) 39.59(15.27)
22 injury, poisoning and procedural complications 各类损伤、中毒及操作并发症 可导致用药错误的情况或信息 circumstance or information capable of leading to medication error 3 16.6(5.33, 51.74) 16.5(5.29, 51.43) 43.62 4.04(2.62) 16.47(6.36) 4 78(28.9, 210.54) 76.26(28.62, 203.19) 296.12 6.25(4.96) 75.99(33.11) 3 68.04(21.65, 213.85) 66.62(21.8, 203.61) 193.5 6.05(4.62) 66.46(25.49)
23 metabolism and nutrition disorders 代谢及营养类疾病 酮症酸中毒 ketoacidosis 4 187.03(69.12, 506.06) 182.82(68.61, 487.12) 717.27 7.5(6.21) 181.28(78.82) 4 264.39(97.53, 716.7) 258.3(96.94, 688.23) 1013.31 8(6.7) 255.29(110.83)
24 metabolism and nutrition disorders 代谢及营养类疾病 正常血糖性糖尿病酮症酸中毒 euglycaemic diabetic ketoacidosis 5 214.93(87.96, 525.17) 208.89(88.18, 494.83) 1024.6 7.69(6.51) 206.88(97.96) 4 144.98(53.7, 391.44) 142.28(53.4, 379.1) 556.74 7.14(5.86) 141.15(61.48)
25 injury, poisoning and procedural complications 各类损伤、中毒及操作并发症 产品漏用问题 product dose omission issue 11 12.97(7.05, 23.88) 12.23(6.93, 21.59) 113.92 3.61(2.77) 12.22(7.33) 11 8.62(4.66, 15.95) 8.02(4.54, 14.16) 68.27 3(2.15) 8.02(4.79) 9 5.65(2.88, 11.1) 5.37(2.87, 10.05) 32.35 2.42(1.5) 5.37(3.05) 25 16.01(10.48, 24.46) 13.84(9.54, 20.08) 300.72 3.79(3.2) 13.83(9.7) 18 8.01(4.94, 12.99) 7.42(4.73, 11.65) 101.11 2.89(2.21) 7.42(4.95)
26 skin and subcutaneous tissue disorders 皮肤及皮下组织类疾病 荨麻疹 urticaria 3 9.46(3.01, 29.69) 9.28(3.04, 28.36) 22.2 3.21(1.78) 9.27(3.56)
27 renal and urinary disorders 肾脏及泌尿系统疾病 急性肾损伤 acute kidney injury 3 6.78(2.16, 21.3) 6.66(2.18, 20.35) 14.48 2.74(1.3) 6.66(2.56)
28 gastrointestinal disorders 胃肠系统疾病 腹痛 abdominal pain 3 7.09(2.26, 22.26) 6.96(2.28, 21.27) 15.36 2.8(1.37) 6.96(2.67)
29 metabolism and nutrition disorders 代谢及营养类疾病 酮症 ketosis 4 1830.36(656.85, 5100.44) 1780.58(655.3, 4838.18) 6676.64 10.71(9.37) 1671.07(708.91)
30 gastrointestinal disorders 胃肠系统疾病 呕吐 vomiting 5 5.52(2.26, 13.46) 5.36(2.26, 12.7) 17.86 2.42(1.25) 5.36(2.54)
31 metabolism and nutrition disorders 代谢及营养类疾病 食欲减退 decreased appetite 3 5.58(1.78, 17.51) 5.49(1.8, 16.78) 11.05 2.46(1.02) 5.49(2.11)
32 injury, poisoning and procedural complications 各类损伤、中毒及操作并发症 产品使用问题 product use issue 5 10.72(4.39, 26.15) 10.39(4.39, 24.61) 42.54 3.38(2.2) 10.38(4.92) 9 18.69(9.55, 36.57) 17.77(9.49, 33.27) 142.73 4.15(3.23) 17.76(10.12) 6 8.38(3.72, 18.87) 8.17(3.73, 17.89) 37.88 3.03(1.94) 8.17(4.14)
33 metabolism and nutrition disorders 代谢及营养类疾病 糖尿病控制不佳 diabetes mellitus inadequate control 4 104.14(38.55, 281.32) 101.75(38.19, 271.11) 397.29 6.66(5.38) 101.29(44.1) 6 142.93(63.28, 322.82) 138.93(63.43, 304.29) 815.39 7.11(6.02) 137.86(69.72) 6 227.03(99.47, 518.15) 215.03(98.18, 470.96) 1269.09 7.74(6.63) 213.45(107.01)
34 investigations 各类检查 尿酮体检出 urine ketone body present 3 757.19(237.25, 2416.61) 744.07(238.73, 2319.1) 2152.89 9.49(8.03) 719.58(272.5) 11 2893.72(1510.82, 5542.46) 2744.33(1465.71, 5138.38) 26119.64 11.21(10.32) 2376.33(1379.56)
35 metabolism and nutrition disorders 代谢及营养类疾病 糖尿病 diabetes mellitus 3 16.83(5.37, 52.72) 16.55(5.42, 50.58) 43.85 4.05(2.62) 16.54(6.36) 5 24.95(10.27, 60.62) 24.39(10.3, 57.78) 112.12 4.61(3.44) 24.36(11.59)
36 investigations 各类检查 血酮体升高 blood ketone body increased 3 2082.3(631.6, 6865.05) 2046.21(631.28, 6632.55) 5607.02 10.87(9.36) 1870.9(689.51)
37 metabolism and nutrition disorders 代谢及营养类疾病 糖尿病酮症 diabetic ketosis 7 3052.52(1355.58, 6873.72) 2952.24(1347.92, 6466.04) 17701.66 11.31(10.21) 2530.63(1283.08) 3 2124.74(648.89, 6957.27) 2068.36(650.74, 6574.22) 5785.88 10.91(9.42) 1930.53(715.56)
38 renal and urinary disorders 肾脏及泌尿系统疾病 尿急 micturition urgency 3 82.02(26.17, 257.04) 80.88(26.46, 247.19) 235.65 6.33(4.9) 80.52(30.96)
39 injury, poisoning and procedural complications 各类损伤、中毒及操作并发症 孕产妇在妊娠过程中的暴露 maternal exposure during pregnancy 3 11.33(3.6, 35.68) 11.06(3.62, 33.8) 27.49 3.47(2.03) 11.05(4.23)