Table 3.
Preferred terms associated with adverse hyperglycemia in the Standardized MedDRA Queries (SMQ; 20000041)
| Preferred terms | Code | Total | Atypical | Typical | ||
|---|---|---|---|---|---|---|
| Cases * | Reporting ratio (%) | Cases * | Reporting ratio (%) | |||
| Total | 241478 | 21151 | 8.8 | 3948 | 1.6 | |
| Abnormal loss of weight | 10000159 | 532 | 28 | 5.3 | 9 | 1.7 |
| Abnormal weight gain | 10000188 | 134 | 33 | 24.6 | 0 | 0 |
| Acidosis | 10000486 | 1956 | 102 | 5.2 | 44 | 2.2 |
| Altered state of consciousness | 10001854 | 3306 | 303 | 9.2 | 111 | 3.4 |
| Anti-GAD antibody positive | 10059728 | 23 | 2 | 8.7 | 0 | 0 |
| Anti-insulin antibody increased | 10053815 | 51 | 0 | 0 | 0 | 0 |
| Anti-insulin antibody positive | 10053814 | 115 | 0 | 0 | 0 | 0 |
| Anti-insulin receptor antibody increased | 10068226 | 0 | 0 | 0 | 0 | 0 |
| Anti-insulin receptor antibody positive | 10068225 | 3 | 0 | 0 | 0 | 0 |
| Anti-islet cell antibody positive | 10049439 | 4 | 1 | 25 | 0 | 0 |
| Blood 1,5-anhydroglucitol decreased | 10065367 | 0 | 0 | 0 | 0 | 0 |
| Blood cholesterol increased | 10005425 | 10887 | 1648 | 15.1 | 63 | 0.6 |
| Blood glucose abnormal | 10005554 | 1547 | 116 | 7.5 | 12 | 0.8 |
| Blood glucose fluctuation | 10049803 | 2267 | 76 | 3.4 | 6 | 0.3 |
| Blood glucose increased | 10005557 | 35838 | 1398 | 3.9 | 241 | 0.7 |
| Blood insulin abnormal | 10005606 | 7 | 0 | 0 | 0 | 0 |
| Blood insulin decreased | 10005613 | 23 | 1 | 4.3 | 1 | 4.3 |
| Blood lactic acid increased | 10005635 | 826 | 47 | 5.7 | 6 | 0.7 |
| Blood osmolarity increased | 10005697 | 112 | 16 | 14.3 | 3 | 2.7 |
| Blood triglycerides increased | 10005839 | 5404 | 1199 | 22.2 | 35 | 0.6 |
| Body mass index decreased | 10005895 | 59 | 14 | 23.7 | 0 | 0 |
| Body mass index increased | 10005897 | 112 | 29 | 25.9 | 0 | 0 |
| Central obesity | 10065941 | 81 | 7 | 8.6 | 1 | 1.2 |
| Coma | 10010071 | 10703 | 1018 | 9.5 | 253 | 2.4 |
| Dehydration | 10012174 | 27804 | 1067 | 3.8 | 1025 | 3.7 |
| Depressed level of consciousness | 10012373 | 10200 | 819 | 8 | 333 | 3.3 |
| Diabetes complicating pregnancy | 10012596 | 3 | 1 | 33.3 | 0 | 0 |
| Diabetes mellitus | 10012601 | 15780 | 5523 | 35 | 98 | 0.6 |
| Diabetes mellitus inadequate control | 10012607 | 3689 | 825 | 22.4 | 25 | 0.7 |
| Diabetes with hyperosmolarity | 10012631 | 27 | 8 | 29.6 | 0 | 0 |
| Diabetic coma | 10012650 | 1045 | 551 | 52.7 | 1 | 0.1 |
| Diabetic hepatopathy | 10071265 | 0 | 0 | 0 | 0 | 0 |
| Diabetic hyperglycaemic coma | 10012668 | 80 | 7 | 8.8 | 1 | 1.3 |
| Diabetic hyperosmolar coma | 10012669 | 170 | 66 | 38.8 | 7 | 4.1 |
| Diabetic ketoacidosis | 10012671 | 2725 | 1090 | 40 | 26 | 1 |
| Diabetic ketoacidotic hyperglycaemic coma | 10012672 | 32 | 6 | 18.8 | 0 | 0 |
| Fructosamine increased | 10017395 | 5 | 0 | 0 | 0 | 0 |
| Gestational diabetes | 10018209 | 594 | 140 | 23.6 | 15 | 2.5 |
| Glucose tolerance decreased | 10018428 | 13 | 0 | 0 | 0 | 0 |
| Glucose tolerance impaired | 10018429 | 1058 | 260 | 24.6 | 6 | 0.6 |
| Glucose tolerance impaired in pregnancy | 10018430 | 3 | 1 | 33.3 | 0 | 0 |
| Glucose tolerance test abnormal | 10018433 | 36 | 3 | 8.3 | 0 | 0 |
| Glucose urine present | 10018478 | 318 | 23 | 7.2 | 15 | 4.7 |
| Glycosuria | 10018473 | 384 | 140 | 36.5 | 5 | 1.3 |
| Glycosuria during pregnancy | 10018475 | 1 | 0 | 0 | 0 | 0 |
| Glycosylated haemoglobin increased | 10018484 | 2569 | 171 | 6.7 | 11 | 0.4 |
| Hunger | 10020466 | 1575 | 142 | 9 | 8 | 0.5 |
| Hypercholesterolaemia | 10020603 | 2210 | 256 | 11.6 | 26 | 1.2 |
| Hyperglycaemia | 10020635 | 7844 | 1382 | 17.6 | 129 | 1.6 |
| Hyperglycaemic hyperosmolar nonketotic syndrome | 10063554 | 184 | 98 | 53.3 | 7 | 3.8 |
| Hyperglycaemic seizure | 10071394 | 5 | 0 | 0 | 0 | 0 |
| Hyperglycaemic unconsciousness | 10071286 | 10 | 0 | 0 | 0 | 0 |
| Hyperlactacidaemia | 10020660 | 333 | 13 | 3.9 | 5 | 1.5 |
| Hyperlipidaemia | 10062060 | 4585 | 747 | 16.3 | 45 | 1 |
| Hyperosmolar state | 10020697 | 113 | 24 | 21.2 | 3 | 2.7 |
| Hyperphagia | 10020710 | 632 | 157 | 24.8 | 4 | 0.6 |
| Hypertriglyceridaemia | 10020869 | 1127 | 154 | 13.7 | 14 | 1.2 |
| Hypoglycaemia | 10020993 | 10839 | 672 | 6.2 | 99 | 0.9 |
| Hypoinsulinaemia | 10070070 | 1 | 0 | 0 | 0 | 0 |
| Impaired fasting glucose | 10056997 | 67 | 22 | 32.8 | 0 | 0 |
| Impaired insulin secretion | 10052341 | 21 | 0 | 0 | 0 | 0 |
| Increased appetite | 10021654 | 2646 | 494 | 18.7 | 21 | 0.8 |
| Increased insulin requirement | 10021664 | 31 | 2 | 6.5 | 0 | 0 |
| Insulin autoimmune syndrome | 10022472 | 23 | 0 | 0 | 0 | 0 |
| Insulin resistance | 10022489 | 297 | 75 | 25.3 | 0 | 0 |
| Insulin resistance syndrome | 10022490 | 18 | 6 | 33.3 | 0 | 0 |
| Insulin resistant diabetes | 10022491 | 27 | 8 | 29.6 | 0 | 0 |
| Insulin tolerance test abnormal | 10022494 | 3 | 0 | 0 | 0 | 0 |
| Insulin-requiring type 2 diabetes mellitus | 10053247 | 122 | 60 | 49.2 | 0 | 0 |
| Ketoacidosis | 10023379 | 640 | 250 | 39.1 | 3 | 0.5 |
| Ketonuria | 10023388 | 188 | 63 | 33.5 | 5 | 2.7 |
| Ketosis | 10023391 | 100 | 13 | 13 | 3 | 3 |
| Lactic acidosis | 10023676 | 4561 | 119 | 2.6 | 61 | 1.3 |
| Latent autoimmune diabetes in adults | 10066389 | 16 | 0 | 0 | 0 | 0 |
| Lipids increased | 10024592 | 368 | 57 | 15.5 | 1 | 0.3 |
| Loss of consciousness | 10024855 | 28249 | 1750 | 6.2 | 355 | 1.3 |
| Metabolic acidosis | 10027417 | 5512 | 253 | 4.6 | 121 | 2.2 |
| Metabolic syndrome | 10052066 | 392 | 197 | 50.3 | 2 | 0.5 |
| Neonatal diabetes mellitus | 10028933 | 3 | 0 | 0 | 1 | 33.3 |
| Obesity | 10029883 | 2787 | 1211 | 43.5 | 23 | 0.8 |
| Overweight | 10033307 | 442 | 114 | 25.8 | 3 | 0.7 |
| Pancreatogenous diabetes | 10033660 | 6 | 2 | 33.3 | 0 | 0 |
| Polydipsia | 10036067 | 1026 | 271 | 26.4 | 16 | 1.6 |
| Polyuria | 10036142 | 1444 | 197 | 13.6 | 27 | 1.9 |
| Slow response to stimuli | 10041045 | 161 | 37 | 23 | 7 | 4.3 |
| Thirst | 10043458 | 2595 | 224 | 8.6 | 40 | 1.5 |
| Type 1 diabetes mellitus | 10067584 | 1252 | 590 | 47.1 | 7 | 0.6 |
| Type 2 diabetes mellitus | 10067585 | 5272 | 2862 | 54.3 | 16 | 0.3 |
| Underweight | 10048828 | 111 | 8 | 7.2 | 2 | 1.8 |
| Unresponsive to stimuli | 10045555 | 5657 | 442 | 7.8 | 123 | 2.2 |
| Urine ketone body present | 10057597 | 304 | 31 | 10.2 | 13 | 4.3 |
| Weight decreased | 10047895 | 42275 | 1765 | 4.2 | 466 | 1.1 |
| Weight increased | 10047899 | 30417 | 5070 | 16.7 | 867 | 2.9 |
*With adverse events of interest.