| 1 |
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 |
77 |
6.42(5.1, 8.07) |
6.16(4.97, 7.64) |
335.34 |
2.62(2.3) |
6.16(5.09) |
| 2 |
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 |
65 |
11.38(8.88, 14.59) |
10.97(8.67, 13.88) |
590.69 |
3.45(3.1) |
10.96(8.91) |
| 3 |
infections and infestations |
感染及侵染类疾病 |
真菌感染 |
fungal infection |
62 |
69.94(54.24, 90.19) |
67.33(53.22, 85.18) |
4038.79 |
6.07(5.7) |
67.09(54.23) |
| 4 |
infections and infestations |
感染及侵染类疾病 |
尿路感染 |
urinary tract infection |
56 |
12.22(9.36, 15.95) |
11.83(9.17, 15.26) |
556.71 |
3.56(3.18) |
11.83(9.46) |
| 5 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
糖尿病酮症酸中毒 |
diabetic ketoacidosis |
47 |
70.94(53.05, 94.86) |
68.93(52.39, 90.69) |
3135.69 |
6.1(5.69) |
68.67(53.85) |
| 6 |
investigations |
各类检查 |
血葡萄糖升高 |
blood glucose increased |
39 |
9.22(6.71, 12.66) |
9.02(6.59, 12.34) |
278.72 |
3.17(2.72) |
9.02(6.91) |
| 7 |
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 |
23 |
4.47(2.96, 6.75) |
4.42(2.93, 6.67) |
61.11 |
2.14(1.56) |
4.42(3.13) |
| 8 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
糖尿病控制不佳 |
diabetes mellitus inadequate control |
20 |
44.93(28.9, 69.87) |
44.4(28.85, 68.34) |
846.54 |
5.47(4.85) |
44.29(30.61) |
| 9 |
renal and urinary disorders |
肾脏及泌尿系统疾病 |
尿频 |
pollakiuria |
17 |
16.73(10.37, 26.98) |
16.56(10.35, 26.51) |
248.51 |
4.05(3.38) |
16.55(11.09) |
| 10 |
investigations |
各类检查 |
尿酮体检出 |
urine ketone body present |
17 |
393.9(243.02, 638.46) |
389.83(243.55, 623.98) |
6453.56 |
8.58(7.9) |
381.59(254.74) |
| 11 |
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 |
16 |
86.5(52.8, 141.7) |
85.67(52.48, 139.84) |
1332.68 |
6.41(5.72) |
85.27(56.42) |
| 12 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
酮症酸中毒 |
ketoacidosis |
15 |
78.48(47.15, 130.62) |
77.77(46.72, 129.46) |
1131.97 |
6.27(5.56) |
77.44(50.56) |
| 13 |
investigations |
各类检查 |
血葡萄糖异常 |
blood glucose abnormal |
14 |
26.83(15.85, 45.42) |
26.61(15.68, 45.17) |
344.61 |
4.73(4) |
26.57(17.1) |
| 14 |
infections and infestations |
感染及侵染类疾病 |
特发性阴囊坏疽 |
fournier's gangrene |
14 |
120.34(70.99, 204.01) |
119.32(70.29, 202.55) |
1631.96 |
6.89(6.15) |
118.55(76.22) |
| 15 |
renal and urinary disorders |
肾脏及泌尿系统疾病 |
排尿困难 |
dysuria |
13 |
15.18(8.79, 26.2) |
15.07(8.71, 26.09) |
170.66 |
3.91(3.15) |
15.05(9.53) |
| 16 |
cardiac disorders |
心脏器官疾病 |
心悸 |
palpitations |
12 |
4.09(2.32, 7.22) |
4.07(2.31, 7.19) |
27.83 |
2.02(1.24) |
4.07(2.53) |
| 17 |
investigations |
各类检查 |
糖化血红蛋白升高 |
glycosylated haemoglobin increased |
12 |
15.81(8.96, 27.91) |
15.71(8.9, 27.74) |
165.16 |
3.97(3.18) |
15.69(9.76) |
| 18 |
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 |
11 |
9.23(5.1, 16.7) |
9.17(5.09, 16.51) |
80.11 |
3.2(2.38) |
9.17(5.58) |
| 19 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
糖尿病酮症 |
diabetic ketosis |
11 |
760.86(415.41, 1393.6) |
755.76(411.63, 1387.59) |
7957.41 |
9.5(8.67) |
725.35(437.15) |
| 20 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
低血糖 |
hypoglycaemia |
10 |
10.48(5.62, 19.51) |
10.42(5.57, 19.51) |
85.14 |
3.38(2.52) |
10.41(6.19) |
| 21 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
糖尿病 |
diabetes mellitus |
10 |
5.67(3.05, 10.56) |
5.64(3.01, 10.56) |
38.22 |
2.5(1.64) |
5.64(3.35) |
| 22 |
infections and infestations |
感染及侵染类疾病 |
外阴阴道真菌感染 |
vulvovaginal mycotic infection |
9 |
103.03(53.41, 198.75) |
102.47(53.67, 195.66) |
899.27 |
6.67(5.77) |
101.9(58.81) |
| 23 |
infections and infestations |
感染及侵染类疾病 |
生殖器真菌感染 |
genital infection fungal |
9 |
504.34(259.59, 979.85) |
501.57(257.58, 976.66) |
4374.35 |
8.93(8.02) |
488(279.95) |
| 24 |
infections and infestations |
感染及侵染类疾病 |
阴道感染 |
vaginal infection |
6 |
51.27(22.98, 114.43) |
51.09(22.87, 114.11) |
293.85 |
5.67(4.6) |
50.95(26.03) |
| 25 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
酮症 |
ketosis |
6 |
195.32(87.24, 437.27) |
194.6(87.13, 434.65) |
1143.32 |
7.59(6.51) |
192.53(98.09) |
| 26 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
代谢性酸中毒 |
metabolic acidosis |
5 |
6.07(2.52, 14.61) |
6.06(2.51, 14.64) |
21.12 |
2.6(1.44) |
6.06(2.91) |
| 27 |
renal and urinary disorders |
肾脏及泌尿系统疾病 |
尿潴留 |
urinary retention |
5 |
6.44(2.68, 15.49) |
6.42(2.66, 15.51) |
22.89 |
2.68(1.53) |
6.42(3.08) |
| 28 |
infections and infestations |
感染及侵染类疾病 |
念珠菌感染 |
candida infection |
5 |
9.04(3.76, 21.76) |
9.02(3.73, 21.79) |
35.65 |
3.17(2.02) |
9.02(4.32) |
| 29 |
investigations |
各类检查 |
血葡萄糖波动 |
blood glucose fluctuation |
5 |
21.67(9, 52.17) |
21.61(8.95, 52.2) |
98.18 |
4.43(3.27) |
21.59(10.35) |
| 30 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
糖尿病代谢失代偿 |
diabetic metabolic decompensation |
4 |
71.6(26.79, 191.39) |
71.43(26.81, 190.32) |
276.7 |
6.15(4.88) |
71.15(31.26) |
| 31 |
investigations |
各类检查 |
肾小球滤过率降低 |
glomerular filtration rate decreased |
4 |
10.41(3.9, 27.78) |
10.39(3.9, 27.68) |
33.93 |
3.38(2.11) |
10.38(4.57) |
| 32 |
renal and urinary disorders |
肾脏及泌尿系统疾病 |
血尿症 |
haematuria |
4 |
5.45(2.04, 14.55) |
5.44(2.04, 14.49) |
14.51 |
2.44(1.18) |
5.44(2.39) |
| 33 |
renal and urinary disorders |
肾脏及泌尿系统疾病 |
尿急 |
micturition urgency |
4 |
13.77(5.16, 36.75) |
13.74(5.16, 36.61) |
47.22 |
3.78(2.51) |
13.73(6.04) |
| 34 |
infections and infestations |
感染及侵染类疾病 |
坏疽 |
gangrene |
4 |
24.9(9.33, 66.48) |
24.85(9.33, 66.21) |
91.43 |
4.63(3.37) |
24.81(10.91) |
| 35 |
reproductive system and breast disorders |
生殖系统及乳腺疾病 |
外阴阴道瘙痒 |
vulvovaginal pruritus |
4 |
29.52(11.06, 78.81) |
29.45(11.05, 78.47) |
109.76 |
4.88(3.61) |
29.4(12.93) |
| 36 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
2 型糖尿病 |
type 2 diabetes mellitus |
4 |
5.48(2.05, 14.62) |
5.47(2.05, 14.57) |
14.61 |
2.45(1.18) |
5.47(2.41) |
| 37 |
infections and infestations |
感染及侵染类疾病 |
尿道炎 |
urethritis |
4 |
294.61(109.56, 792.19) |
293.89(110.3, 783.06) |
1148.84 |
8.18(6.9) |
289.19(126.4) |
| 38 |
renal and urinary disorders |
肾脏及泌尿系统疾病 |
多尿 |
polyuria |
3 |
14.2(4.57, 44.09) |
14.17(4.55, 44.16) |
36.71 |
3.82(2.41) |
14.16(5.49) |
| 39 |
gastrointestinal disorders |
胃肠系统疾病 |
胃肠道刺激 |
gastrointestinal tract irritation |
3 |
93.12(29.91, 289.86) |
92.95(29.82, 289.7) |
271.48 |
6.53(5.11) |
92.48(35.76) |
| 40 |
reproductive system and breast disorders |
生殖系统及乳腺疾病 |
外阴阴道疼痛 |
vulvovaginal pain |
3 |
20.8(6.7, 64.6) |
20.76(6.66, 64.7) |
56.37 |
4.37(2.96) |
20.74(8.03) |
| 41 |
reproductive system and breast disorders |
生殖系统及乳腺疾病 |
生殖器不适 |
genital discomfort |
3 |
204.16(65.36, 637.73) |
203.78(65.38, 635.14) |
598.6 |
7.65(6.23) |
201.51(77.7) |
| 42 |
renal and urinary disorders |
肾脏及泌尿系统疾病 |
肾疼痛 |
renal pain |
3 |
10.29(3.31, 31.94) |
10.27(3.3, 32.01) |
25.09 |
3.36(1.94) |
10.27(3.98) |
| 43 |
general disorders and administration site conditions |
全身性疾病及给药部位各种反应 |
口渴 |
thirst |
3 |
6.25(2.01, 19.4) |
6.24(2, 19.45) |
13.2 |
2.64(1.23) |
6.24(2.42) |
| 44 |
investigations |
各类检查 |
尿中带血 |
blood urine present |
3 |
6.78(2.18, 21.05) |
6.77(2.17, 21.1) |
14.75 |
2.76(1.34) |
6.77(2.62) |
| 45 |
infections and infestations |
感染及侵染类疾病 |
生殖器感染 |
genital infection |
3 |
290.87(92.86, 911.05) |
290.34(93.15, 904.93) |
851.3 |
8.16(6.73) |
285.74(109.92) |
| 46 |
vascular disorders |
血管与淋巴管类疾病 |
直立性低血压 |
orthostatic hypotension |
3 |
7.47(2.41, 23.19) |
7.46(2.39, 23.25) |
16.77 |
2.9(1.48) |
7.46(2.89) |
| 47 |
investigations |
各类检查 |
糖化血红蛋白异常 |
glycosylated haemoglobin abnormal |
3 |
51.67(16.62, 160.64) |
51.58(16.55, 160.76) |
148.37 |
5.68(4.27) |
51.43(19.91) |
| 48 |
metabolism and nutrition disorders |
代谢及营养类疾病 |
食欲增加 |
increased appetite |
3 |
6.46(2.08, 20.04) |
6.45(2.07, 20.1) |
13.8 |
2.69(1.27) |
6.44(2.5) |
| 49 |
infections and infestations |
感染及侵染类疾病 |
尿路细菌感染 |
urinary tract infection bacterial |
3 |
37.23(11.98, 115.7) |
37.17(11.93, 115.85) |
105.37 |
5.21(3.8) |
37.09(14.36) |
| 50 |
infections and infestations |
感染及侵染类疾病 |
坏死性筋膜炎 |
necrotising fasciitis |
3 |
29.71(9.56, 92.3) |
29.66(9.52, 92.44) |
82.94 |
4.89(3.47) |
29.61(11.47) |
| 51 |
investigations |
各类检查 |
血酮体升高 |
blood ketone body increased |
3 |
147.41(47.28, 459.67) |
147.15(47.21, 458.63) |
431.93 |
7.19(5.77) |
145.96(56.36) |