Explore drug information in your own words.
Type a question in the search bar above to get started. Each question is answered independently.
Select a question to fill the search bar, then submit it or edit it first.
AI can make mistakes. Verify answers against the original sources before relying on them.
| Stem definition | Drug id | CAS RN |
|---|---|---|
| human origin | 5000 | 1256937-27-5 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Evolocumab is a human monoclonal IgG2 directed against human proprotein convertase subtilisin kexin 9 (PCSK9). Evolocumab binds to PCSK9 and inhibits circulating PCSK9 from binding to the low density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
|
| Dose | Unit | Route |
|---|---|---|
| 10 | mg | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 22, 2016 | PMDA | Astellas Pharma | |
| Aug. 28, 2015 | FDA | REPATHA | |
| May 21, 2015 | EMA |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Device difficult to use | 18066.60 | 24.73 | 4087 | 91894 | 13438 | 90519028 |
| Wrong technique in product usage process | 17041.13 | 24.73 | 5209 | 90772 | 66362 | 90466104 |
| Accidental exposure to product | 12270.90 | 24.73 | 3594 | 92387 | 38772 | 90493694 |
| Drug dose omission by device | 10099.12 | 24.73 | 2307 | 93674 | 7924 | 90524542 |
| Injection site pain | 7754.83 | 24.73 | 3733 | 92248 | 169966 | 90362500 |
| Injection site bruising | 4366.43 | 24.73 | 1751 | 94230 | 50556 | 90481910 |
| Product dose omission issue | 3006.83 | 24.73 | 2474 | 93507 | 289213 | 90243253 |
| Injection site haemorrhage | 2891.16 | 24.73 | 1098 | 94883 | 27220 | 90505246 |
| Device use error | 2631.05 | 24.73 | 735 | 95246 | 6486 | 90525980 |
| Myalgia | 2380.69 | 24.73 | 1752 | 94229 | 173373 | 90359093 |
| Rhinorrhoea | 2219.87 | 24.73 | 1299 | 94682 | 87017 | 90445449 |
| Incorrect dose administered by device | 2195.72 | 24.73 | 607 | 95374 | 5130 | 90527336 |
| Device issue | 1727.51 | 24.73 | 769 | 95212 | 28768 | 90503698 |
| Influenza like illness | 1723.29 | 24.73 | 1069 | 94912 | 79542 | 90452924 |
| Back pain | 1625.06 | 24.73 | 1833 | 94148 | 315342 | 90217124 |
| Product storage error | 1618.62 | 24.73 | 658 | 95323 | 19583 | 90512883 |
| Injury associated with device | 1425.30 | 24.73 | 410 | 95571 | 4054 | 90528412 |
| Low density lipoprotein increased | 1193.35 | 24.73 | 412 | 95569 | 7673 | 90524793 |
| Occupational exposure to product | 1052.72 | 24.73 | 286 | 95695 | 2245 | 90530221 |
| Injection site swelling | 1022.90 | 24.73 | 690 | 95291 | 59149 | 90473317 |
| Incorrect disposal of product | 949.44 | 24.73 | 218 | 95763 | 760 | 90531706 |
| Underdose | 937.91 | 24.73 | 629 | 95352 | 53388 | 90479078 |
| Intercepted product administration error | 849.50 | 24.73 | 196 | 95785 | 702 | 90531764 |
| Injection site erythema | 841.90 | 24.73 | 753 | 95228 | 97749 | 90434717 |
| Muscle spasms | 817.42 | 24.73 | 1161 | 94820 | 250722 | 90281744 |
| Injection site mass | 817.07 | 24.73 | 420 | 95561 | 21670 | 90510796 |
| Product communication issue | 788.14 | 24.73 | 204 | 95777 | 1297 | 90531169 |
| Drug ineffective | 561.73 | 24.73 | 393 | 95588 | 1383905 | 89148561 |
| Wrong technique in device usage process | 540.36 | 24.73 | 211 | 95770 | 5624 | 90526842 |
| Low density lipoprotein decreased | 484.22 | 24.73 | 100 | 95881 | 175 | 90532291 |
| Pain in extremity | 473.63 | 24.73 | 1290 | 94691 | 449239 | 90083227 |
| Blood glucose increased | 451.12 | 24.73 | 530 | 95451 | 94716 | 90437750 |
| Device defective | 431.83 | 24.73 | 156 | 95825 | 3330 | 90529136 |
| Oropharyngeal pain | 414.90 | 24.73 | 559 | 95422 | 114628 | 90417838 |
| Infusion related reaction | 410.60 | 24.73 | 6 | 95975 | 416774 | 90115692 |
| Product preparation error | 408.21 | 24.73 | 205 | 95776 | 10056 | 90522410 |
| Condition aggravated | 397.63 | 24.73 | 75 | 95906 | 595470 | 89936996 |
| Injection site pruritus | 370.17 | 24.73 | 365 | 95616 | 53469 | 90478997 |
| Injection site discolouration | 349.73 | 24.73 | 179 | 95802 | 9141 | 90523325 |
| Device malfunction | 346.50 | 24.73 | 237 | 95744 | 20740 | 90511726 |
| Injection site discomfort | 341.68 | 24.73 | 153 | 95828 | 5787 | 90526679 |
| Feeling abnormal | 329.94 | 24.73 | 616 | 95365 | 166619 | 90365847 |
| Fear of injection | 326.67 | 24.73 | 166 | 95815 | 8349 | 90524117 |
| Systemic lupus erythematosus | 310.92 | 24.73 | 18 | 95963 | 361878 | 90170588 |
| Circumstance or information capable of leading to medication error | 305.19 | 24.73 | 134 | 95847 | 4833 | 90527633 |
| Blood triglycerides increased | 304.93 | 24.73 | 187 | 95794 | 13574 | 90518892 |
| Contraindicated product administered | 297.96 | 24.73 | 9 | 95972 | 320130 | 90212336 |
| Product use issue | 290.95 | 24.73 | 14 | 95967 | 329905 | 90202561 |
| General physical health deterioration | 286.69 | 24.73 | 24 | 95957 | 355091 | 90177375 |
| Maternal exposure during pregnancy | 286.16 | 24.73 | 26 | 95955 | 360037 | 90172429 |
| Treatment failure | 281.20 | 24.73 | 9 | 95972 | 303919 | 90228547 |
| Blood cholesterol decreased | 264.09 | 24.73 | 93 | 95888 | 1838 | 90530628 |
| Acute kidney injury | 263.22 | 24.73 | 20 | 95961 | 320367 | 90212099 |
| Injection site urticaria | 259.10 | 24.73 | 187 | 95794 | 17824 | 90514642 |
| Wound | 257.38 | 24.73 | 16 | 95965 | 302964 | 90229502 |
| Injection site rash | 255.62 | 24.73 | 209 | 95772 | 23964 | 90508502 |
| Pyrexia | 255.46 | 24.73 | 196 | 95785 | 660289 | 89872177 |
| Pericarditis | 253.54 | 24.73 | 7 | 95974 | 270144 | 90262322 |
| Product use in unapproved indication | 249.97 | 24.73 | 31 | 95950 | 336205 | 90196261 |
| Glossodynia | 248.40 | 24.73 | 26 | 95955 | 321753 | 90210713 |
| Rheumatoid arthritis | 241.01 | 24.73 | 46 | 95935 | 362568 | 90169898 |
| Infection | 240.53 | 24.73 | 46 | 95935 | 362048 | 90170418 |
| Drug interaction | 227.79 | 24.73 | 17 | 95964 | 276436 | 90256030 |
| Vomiting | 224.21 | 24.73 | 305 | 95676 | 787988 | 89744478 |
| Neutropenia | 218.13 | 24.73 | 4 | 95977 | 224900 | 90307566 |
| Drug intolerance | 212.99 | 24.73 | 104 | 95877 | 447487 | 90084979 |
| Anaemia | 206.26 | 24.73 | 59 | 95922 | 352743 | 90179723 |
| Joint swelling | 197.45 | 24.73 | 147 | 95834 | 503153 | 90029313 |
| Therapeutic response unexpected | 192.07 | 24.73 | 170 | 95811 | 21710 | 90510756 |
| Stomatitis | 188.64 | 24.73 | 32 | 95949 | 274666 | 90257800 |
| Intentional product use issue | 188.61 | 24.73 | 10 | 95971 | 216882 | 90315584 |
| Psoriatic arthropathy | 185.39 | 24.73 | 15 | 95966 | 228320 | 90304146 |
| Lower respiratory tract infection | 184.09 | 24.73 | 24 | 95957 | 250635 | 90281831 |
| Inappropriate schedule of product administration | 182.18 | 24.73 | 454 | 95527 | 149479 | 90382987 |
| Impaired healing | 180.49 | 24.73 | 19 | 95962 | 234180 | 90298286 |
| Arthropathy | 178.94 | 24.73 | 82 | 95899 | 366160 | 90166306 |
| Thrombocytopenia | 174.32 | 24.73 | 12 | 95969 | 208713 | 90323753 |
| Injury | 160.10 | 24.73 | 13 | 95968 | 197336 | 90335130 |
| Pneumonia | 156.16 | 24.73 | 273 | 95708 | 637786 | 89894680 |
| Injection site induration | 155.86 | 24.73 | 111 | 95870 | 10357 | 90522109 |
| Low density lipoprotein abnormal | 154.96 | 24.73 | 41 | 95940 | 287 | 90532179 |
| Muscle injury | 154.04 | 24.73 | 8 | 95973 | 176646 | 90355820 |
| Hepatic enzyme increased | 153.88 | 24.73 | 96 | 95885 | 360640 | 90171826 |
| Glycosylated haemoglobin increased | 152.98 | 24.73 | 129 | 95852 | 15433 | 90517033 |
| Cough | 152.09 | 24.73 | 782 | 95199 | 368180 | 90164286 |
| Disease progression | 147.10 | 24.73 | 4 | 95977 | 156611 | 90375855 |
| Swelling | 146.27 | 24.73 | 137 | 95844 | 418921 | 90113545 |
| Type 2 diabetes mellitus | 145.57 | 24.73 | 21 | 95960 | 203223 | 90329243 |
| Influenza | 144.91 | 24.73 | 398 | 95583 | 138866 | 90393600 |
| Injection site vesicles | 138.53 | 24.73 | 74 | 95907 | 4126 | 90528340 |
| Oedema peripheral | 138.51 | 24.73 | 50 | 95931 | 257865 | 90274601 |
| Drug hypersensitivity | 135.98 | 24.73 | 175 | 95806 | 463434 | 90069032 |
| Overdose | 131.87 | 24.73 | 9 | 95972 | 157700 | 90374766 |
| Injection site extravasation | 130.53 | 24.73 | 94 | 95887 | 8925 | 90523541 |
| Osteoarthritis | 129.58 | 24.73 | 25 | 95956 | 195705 | 90336761 |
| C-reactive protein increased | 129.30 | 24.73 | 19 | 95962 | 181370 | 90351096 |
| Confusional state | 129.27 | 24.73 | 131 | 95850 | 386074 | 90146392 |
| Product administered at inappropriate site | 128.16 | 24.73 | 70 | 95911 | 4081 | 90528385 |
| Injection site indentation | 127.33 | 24.73 | 35 | 95946 | 288 | 90532178 |
| Nasopharyngitis | 125.77 | 24.73 | 799 | 95182 | 406305 | 90126161 |
| Discomfort | 125.51 | 24.73 | 67 | 95914 | 274268 | 90258198 |
| Blister | 124.63 | 24.73 | 57 | 95924 | 254941 | 90277525 |
| Oedema | 123.62 | 24.73 | 30 | 95951 | 200265 | 90332201 |
| White blood cell count decreased | 120.28 | 24.73 | 17 | 95964 | 167092 | 90365374 |
| Stent placement | 116.44 | 24.73 | 66 | 95915 | 4137 | 90528329 |
| Haemoglobin decreased | 110.84 | 24.73 | 19 | 95962 | 161937 | 90370529 |
| Wheezing | 110.58 | 24.73 | 57 | 95924 | 238023 | 90294443 |
| Hyponatraemia | 110.54 | 24.73 | 8 | 95973 | 133530 | 90398936 |
| Muscle disorder | 110.14 | 24.73 | 70 | 95911 | 5409 | 90527057 |
| Hypotension | 109.29 | 24.73 | 110 | 95871 | 325287 | 90207179 |
| Incorrect dose administered | 107.62 | 24.73 | 250 | 95731 | 78680 | 90453786 |
| Device failure | 107.01 | 24.73 | 75 | 95906 | 6822 | 90525644 |
| Irritable bowel syndrome | 106.73 | 24.73 | 43 | 95938 | 207405 | 90325061 |
| Hypokalaemia | 102.64 | 24.73 | 10 | 95971 | 131106 | 90401360 |
| Dysphonia | 100.88 | 24.73 | 213 | 95768 | 62871 | 90469595 |
| Unevaluable event | 100.56 | 24.73 | 196 | 95785 | 54652 | 90477814 |
| Joint range of motion decreased | 99.51 | 24.73 | 13 | 95968 | 135630 | 90396836 |
| Wound infection | 98.87 | 24.73 | 3 | 95978 | 106399 | 90426067 |
| Platelet count decreased | 96.11 | 24.73 | 15 | 95966 | 136954 | 90395512 |
| Gastrointestinal disorder | 95.41 | 24.73 | 79 | 95902 | 256608 | 90275858 |
| Seizure | 93.90 | 24.73 | 23 | 95958 | 152606 | 90379860 |
| Leukopenia | 93.00 | 24.73 | 3 | 95978 | 100707 | 90431759 |
| Inflammation | 91.89 | 24.73 | 37 | 95944 | 178555 | 90353911 |
| Cardiac operation | 90.90 | 24.73 | 55 | 95926 | 3894 | 90528572 |
| Device dispensing error | 90.83 | 24.73 | 24 | 95957 | 167 | 90532299 |
| Respiratory failure | 90.19 | 24.73 | 10 | 95971 | 118408 | 90414058 |
| Delirium | 90.10 | 24.73 | 5 | 95976 | 104354 | 90428112 |
| Hypercholesterolaemia | 89.77 | 24.73 | 4 | 95977 | 100888 | 90431578 |
| Sinus disorder | 87.52 | 24.73 | 142 | 95839 | 34305 | 90498161 |
| Pulmonary fibrosis | 87.39 | 24.73 | 7 | 95974 | 107496 | 90424970 |
| Arthralgia | 87.36 | 24.73 | 1230 | 94751 | 777292 | 89755174 |
| Tachycardia | 87.32 | 24.73 | 29 | 95952 | 157644 | 90374822 |
| Lip dry | 86.66 | 24.73 | 5 | 95976 | 100950 | 90431516 |
| Sepsis | 86.59 | 24.73 | 41 | 95940 | 179773 | 90352693 |
| Hypoacusis | 86.50 | 24.73 | 126 | 95855 | 27724 | 90504742 |
| Decreased appetite | 85.83 | 24.73 | 168 | 95813 | 376372 | 90156094 |
| Bursitis | 84.66 | 24.73 | 18 | 95963 | 131636 | 90400830 |
| Lung disorder | 84.00 | 24.73 | 27 | 95954 | 149856 | 90382610 |
| Pulmonary embolism | 83.89 | 24.73 | 18 | 95963 | 130802 | 90401664 |
| Intentional product misuse | 80.50 | 24.73 | 243 | 95738 | 89361 | 90443105 |
| Obesity | 77.66 | 24.73 | 10 | 95971 | 105497 | 90426969 |
| Oxygen saturation decreased | 77.18 | 24.73 | 11 | 95970 | 107472 | 90424994 |
| Paranasal sinus hypersecretion | 76.51 | 24.73 | 52 | 95929 | 4499 | 90527967 |
| Blood cholesterol abnormal | 73.70 | 24.73 | 43 | 95938 | 2847 | 90529619 |
| Medication error | 73.25 | 24.73 | 4 | 95977 | 84648 | 90447818 |
| Pleural effusion | 72.65 | 24.73 | 15 | 95966 | 111976 | 90420490 |
| Injection site warmth | 70.72 | 24.73 | 90 | 95891 | 17425 | 90515041 |
| Sneezing | 70.34 | 24.73 | 119 | 95862 | 29750 | 90502716 |
| Therapeutic product effect decreased | 70.27 | 24.73 | 116 | 95865 | 277455 | 90255011 |
| Injection site injury | 68.08 | 24.73 | 29 | 95952 | 970 | 90531496 |
| Depression | 67.72 | 24.73 | 135 | 95846 | 300466 | 90232000 |
| Injection site reaction | 67.56 | 24.73 | 233 | 95748 | 91847 | 90440619 |
| Nasal congestion | 67.35 | 24.73 | 218 | 95763 | 83196 | 90449270 |
| Septic shock | 66.98 | 24.73 | 6 | 95975 | 84154 | 90448312 |
| Injection site irritation | 65.67 | 24.73 | 53 | 95928 | 5962 | 90526504 |
| Hypertension | 65.49 | 24.73 | 256 | 95725 | 457276 | 90075190 |
| Red blood cell sedimentation rate increased | 65.43 | 24.73 | 6 | 95975 | 82589 | 90449877 |
| Coma | 64.22 | 24.73 | 3 | 95978 | 72629 | 90459837 |
| Fibromyalgia | 63.38 | 24.73 | 75 | 95906 | 206194 | 90326272 |
| Grip strength decreased | 63.02 | 24.73 | 11 | 95970 | 92565 | 90439901 |
| Abdominal pain | 62.16 | 24.73 | 213 | 95768 | 395508 | 90136958 |
| Depressed level of consciousness | 61.28 | 24.73 | 4 | 95977 | 72780 | 90459686 |
| Incorrect dose administered by product | 61.09 | 24.73 | 19 | 95962 | 250 | 90532216 |
| Therapy interrupted | 61.07 | 24.73 | 152 | 95829 | 49956 | 90482510 |
| Asthma | 60.54 | 24.73 | 102 | 95879 | 242058 | 90290408 |
| Lack of injection site rotation | 60.07 | 24.73 | 26 | 95955 | 905 | 90531561 |
| Product quality issue | 59.65 | 24.73 | 7 | 95974 | 79318 | 90453148 |
| Sleep disorder due to general medical condition, insomnia type | 59.45 | 24.73 | 31 | 95950 | 128663 | 90403803 |
| Interstitial lung disease | 59.34 | 24.73 | 6 | 95975 | 76399 | 90456067 |
| Drug-induced liver injury | 58.78 | 24.73 | 12 | 95969 | 90306 | 90442160 |
| Hypoxia | 58.05 | 24.73 | 5 | 95976 | 72394 | 90460072 |
| Nervousness | 57.97 | 24.73 | 118 | 95863 | 33938 | 90498528 |
| Bone pain | 57.47 | 24.73 | 170 | 95811 | 61813 | 90470653 |
| Hepatitis | 56.41 | 24.73 | 5 | 95976 | 70734 | 90461732 |
| Abdominal discomfort | 56.30 | 24.73 | 287 | 95694 | 477041 | 90055425 |
| Cardiac arrest | 55.19 | 24.73 | 21 | 95960 | 104914 | 90427552 |
| Application site swelling | 55.01 | 24.73 | 22 | 95959 | 625 | 90531841 |
| Coronary artery bypass | 54.80 | 24.73 | 33 | 95948 | 2316 | 90530150 |
| Psoriasis | 53.01 | 24.73 | 47 | 95934 | 147707 | 90384759 |
| Upper-airway cough syndrome | 52.21 | 24.73 | 72 | 95909 | 15063 | 90517403 |
| Lower limb fracture | 51.91 | 24.73 | 13 | 95968 | 85000 | 90447466 |
| Musculoskeletal stiffness | 51.88 | 24.73 | 152 | 95829 | 296380 | 90236086 |
| Product dispensing error | 51.03 | 24.73 | 64 | 95917 | 12209 | 90520257 |
| Injection site hypersensitivity | 50.72 | 24.73 | 33 | 95948 | 2654 | 90529812 |
| Deep vein thrombosis | 50.45 | 24.73 | 17 | 95964 | 91603 | 90440863 |
| Musculoskeletal disorder | 50.29 | 24.73 | 86 | 95895 | 21683 | 90510783 |
| Rash pruritic | 50.17 | 24.73 | 196 | 95785 | 82018 | 90450448 |
| Neutrophil count decreased | 49.80 | 24.73 | 8 | 95973 | 71524 | 90460942 |
| Memory impairment | 49.41 | 24.73 | 368 | 95613 | 196876 | 90335590 |
| Lipoprotein (a) increased | 48.95 | 24.73 | 12 | 95969 | 59 | 90532407 |
| Throat irritation | 48.46 | 24.73 | 137 | 95844 | 48558 | 90483908 |
| Alopecia | 48.03 | 24.73 | 317 | 95664 | 494754 | 90037712 |
| Rectal haemorrhage | 47.98 | 24.73 | 14 | 95967 | 82730 | 90449736 |
| Drug ineffective for unapproved indication | 47.43 | 24.73 | 7 | 95974 | 66637 | 90465829 |
| Bradycardia | 47.15 | 24.73 | 15 | 95966 | 83832 | 90448634 |
| Road traffic accident | 46.71 | 24.73 | 28 | 95953 | 107598 | 90424868 |
| Constipation | 46.71 | 24.73 | 147 | 95834 | 280248 | 90252218 |
| Rubber sensitivity | 46.71 | 24.73 | 32 | 95949 | 2805 | 90529661 |
| Fall | 46.49 | 24.73 | 309 | 95672 | 481501 | 90050965 |
| Somnolence | 46.12 | 24.73 | 95 | 95886 | 208989 | 90323477 |
| Hyperkalaemia | 45.82 | 24.73 | 7 | 95974 | 64957 | 90467509 |
| Liver disorder | 45.43 | 24.73 | 37 | 95944 | 121232 | 90411234 |
| Sleep disorder | 45.38 | 24.73 | 88 | 95893 | 197942 | 90334524 |
| Night sweats | 44.95 | 24.73 | 42 | 95939 | 128724 | 90403742 |
| No adverse event | 44.30 | 24.73 | 9 | 95972 | 67973 | 90464493 |
| Limb discomfort | 43.82 | 24.73 | 113 | 95868 | 37947 | 90494519 |
| Multiple sclerosis relapse | 43.66 | 24.73 | 3 | 95978 | 52302 | 90480164 |
| Colitis ulcerative | 43.66 | 24.73 | 6 | 95975 | 60260 | 90472206 |
| Osteoporosis | 43.48 | 24.73 | 24 | 95957 | 96507 | 90435959 |
| Muscle tightness | 43.48 | 24.73 | 62 | 95919 | 13377 | 90519089 |
| Injection site paraesthesia | 43.37 | 24.73 | 19 | 95962 | 681 | 90531785 |
| Pulmonary oedema | 43.09 | 24.73 | 7 | 95974 | 62073 | 90470393 |
| Death | 42.94 | 24.73 | 295 | 95686 | 456256 | 90076210 |
| Cardiac failure | 42.80 | 24.73 | 32 | 95949 | 109464 | 90423002 |
| Respiratory tract congestion | 42.02 | 24.73 | 91 | 95890 | 27319 | 90505147 |
| Alanine aminotransferase increased | 42.02 | 24.73 | 38 | 95943 | 118300 | 90414166 |
| Hepatic cirrhosis | 42.01 | 24.73 | 8 | 95973 | 63245 | 90469221 |
| Suicidal ideation | 41.91 | 24.73 | 13 | 95968 | 73842 | 90458624 |
| Therapy cessation | 41.91 | 24.73 | 108 | 95873 | 36253 | 90496213 |
| Needle issue | 41.77 | 24.73 | 62 | 95919 | 13872 | 90518594 |
| Aspartate aminotransferase increased | 41.65 | 24.73 | 29 | 95952 | 102908 | 90429558 |
| Dehydration | 41.51 | 24.73 | 90 | 95891 | 194357 | 90338109 |
| Blepharospasm | 41.42 | 24.73 | 5 | 95976 | 55440 | 90477026 |
| Autoimmune disorder | 40.95 | 24.73 | 15 | 95966 | 76729 | 90455737 |
| Dizziness | 40.46 | 24.73 | 861 | 95120 | 588423 | 89944043 |
| Increased tendency to bruise | 40.17 | 24.73 | 56 | 95925 | 11834 | 90520632 |
| Application site pain | 40.08 | 24.73 | 36 | 95945 | 4684 | 90527782 |
| Application site haemorrhage | 39.76 | 24.73 | 21 | 95960 | 1144 | 90531322 |
| Exostosis | 39.18 | 24.73 | 5 | 95976 | 53129 | 90479337 |
| Loss of personal independence in daily activities | 39.17 | 24.73 | 52 | 95929 | 136053 | 90396413 |
| Foot deformity | 38.66 | 24.73 | 8 | 95973 | 59643 | 90472823 |
| Renal failure | 37.76 | 24.73 | 50 | 95931 | 130957 | 90401509 |
| Gastrointestinal haemorrhage | 37.08 | 24.73 | 25 | 95956 | 90223 | 90442243 |
| Loss of consciousness | 36.98 | 24.73 | 57 | 95924 | 140181 | 90392285 |
| Blood creatinine increased | 36.67 | 24.73 | 32 | 95949 | 101354 | 90431112 |
| White blood cell count increased | 36.12 | 24.73 | 13 | 95968 | 67228 | 90465238 |
| Nail disorder | 36.12 | 24.73 | 9 | 95972 | 59058 | 90473408 |
| Coeliac disease | 35.99 | 24.73 | 3 | 95978 | 44607 | 90487859 |
| Ill-defined disorder | 35.91 | 24.73 | 90 | 95891 | 184801 | 90347665 |
| Dyspepsia | 35.80 | 24.73 | 100 | 95881 | 198060 | 90334406 |
| Aphonia | 35.76 | 24.73 | 54 | 95927 | 12265 | 90520201 |
| Abortion spontaneous | 35.55 | 24.73 | 7 | 95974 | 54049 | 90478417 |
| Myocardial infarction | 35.12 | 24.73 | 212 | 95769 | 105760 | 90426706 |
| Immunodeficiency | 34.62 | 24.73 | 3 | 95978 | 43231 | 90489235 |
| Lipids increased | 34.45 | 24.73 | 20 | 95961 | 1312 | 90531154 |
| Acute respiratory failure | 34.31 | 24.73 | 3 | 95978 | 42915 | 90489551 |
| Anxiety | 33.85 | 24.73 | 191 | 95790 | 309581 | 90222885 |
| Vascular graft | 33.80 | 24.73 | 17 | 95964 | 836 | 90531630 |
| Hypocalcaemia | 33.76 | 24.73 | 3 | 95978 | 42365 | 90490101 |
| Dyspnoea | 33.62 | 24.73 | 695 | 95286 | 880260 | 89652206 |
| Mental status changes | 33.45 | 24.73 | 4 | 95977 | 44675 | 90487791 |
| Insomnia | 33.08 | 24.73 | 212 | 95769 | 333262 | 90199204 |
| Pneumonitis | 32.95 | 24.73 | 4 | 95977 | 44166 | 90488300 |
| Encephalopathy | 32.77 | 24.73 | 5 | 95976 | 46439 | 90486027 |
| Red blood cell count decreased | 32.68 | 24.73 | 5 | 95976 | 46346 | 90486120 |
| High density lipoprotein decreased | 32.47 | 24.73 | 25 | 95956 | 2626 | 90529840 |
| Surgery | 32.40 | 24.73 | 113 | 95868 | 44774 | 90487692 |
| Gastrooesophageal reflux disease | 32.28 | 24.73 | 81 | 95900 | 166256 | 90366210 |
| Burning sensation | 32.22 | 24.73 | 143 | 95838 | 63309 | 90469157 |
| Device delivery system issue | 31.53 | 24.73 | 21 | 95960 | 1757 | 90530709 |
| Coronary artery occlusion | 31.49 | 24.73 | 42 | 95939 | 8512 | 90523954 |
| Therapy non-responder | 31.40 | 24.73 | 250 | 95731 | 136454 | 90396012 |
| Taste disorder | 31.24 | 24.73 | 13 | 95968 | 61533 | 90470933 |
| Hypoglycaemia | 30.55 | 24.73 | 18 | 95963 | 69830 | 90462636 |
| Syncope | 30.34 | 24.73 | 59 | 95922 | 132604 | 90399862 |
| Hepatotoxicity | 30.01 | 24.73 | 6 | 95975 | 45836 | 90486630 |
| Haematochezia | 30.00 | 24.73 | 19 | 95962 | 70894 | 90461572 |
| Pneumonia aspiration | 29.83 | 24.73 | 4 | 95977 | 40936 | 90491530 |
| Rash maculo-papular | 29.83 | 24.73 | 4 | 95977 | 40929 | 90491537 |
| Unresponsive to stimuli | 29.58 | 24.73 | 3 | 95978 | 38118 | 90494348 |
| Intercepted product storage error | 29.37 | 24.73 | 13 | 95968 | 478 | 90531988 |
| International normalised ratio increased | 29.34 | 24.73 | 7 | 95974 | 47309 | 90485157 |
| Hip arthroplasty | 28.85 | 24.73 | 23 | 95958 | 76185 | 90456281 |
| Joint dislocation | 28.85 | 24.73 | 6 | 95975 | 44576 | 90487890 |
| Renal impairment | 28.61 | 24.73 | 42 | 95939 | 105379 | 90427087 |
| Haematocrit decreased | 28.40 | 24.73 | 5 | 95976 | 41827 | 90490639 |
| Cellulitis | 28.26 | 24.73 | 33 | 95948 | 91304 | 90441162 |
| Subclavian vein thrombosis | 28.23 | 24.73 | 21 | 95960 | 2095 | 90530371 |
| Blood glucose abnormal | 28.11 | 24.73 | 42 | 95939 | 9450 | 90523016 |
| Treatment noncompliance | 27.79 | 24.73 | 10 | 95971 | 51717 | 90480749 |
| Dry mouth | 27.57 | 24.73 | 101 | 95880 | 183958 | 90348508 |
| Plasma cell myeloma | 27.46 | 24.73 | 5 | 95976 | 40823 | 90491643 |
| Platelet aggregation abnormal | 27.33 | 24.73 | 6 | 95975 | 16 | 90532450 |
| Agitation | 27.01 | 24.73 | 19 | 95962 | 67079 | 90465387 |
| Disease recurrence | 26.69 | 24.73 | 4 | 95977 | 37649 | 90494817 |
| Staphylococcal infection | 26.65 | 24.73 | 9 | 95972 | 48430 | 90484036 |
| Colitis | 26.62 | 24.73 | 21 | 95960 | 69921 | 90462545 |
| Device leakage | 26.49 | 24.73 | 42 | 95939 | 9949 | 90522517 |
| Hepatic failure | 26.43 | 24.73 | 5 | 95976 | 39723 | 90492743 |
| Blood alkaline phosphatase increased | 26.33 | 24.73 | 9 | 95972 | 48070 | 90484396 |
| Orthostatic hypotension | 26.31 | 24.73 | 6 | 95975 | 41821 | 90490645 |
| Muscular weakness | 26.11 | 24.73 | 334 | 95647 | 206332 | 90326134 |
| Sleep disorder due to a general medical condition | 25.95 | 24.73 | 105 | 95876 | 44633 | 90487833 |
| Hypercalcaemia | 25.79 | 24.73 | 3 | 95978 | 34237 | 90498229 |
| Emotional distress | 25.74 | 24.73 | 4 | 95977 | 36658 | 90495808 |
| Injection site hypoaesthesia | 25.61 | 24.73 | 13 | 95968 | 652 | 90531814 |
| Flatulence | 25.54 | 24.73 | 99 | 95882 | 41268 | 90491198 |
| Liver function test abnormal | 25.39 | 24.73 | 11 | 95970 | 50834 | 90481632 |
| Haematemesis | 25.29 | 24.73 | 3 | 95978 | 33723 | 90498743 |
| Swelling face | 25.23 | 24.73 | 160 | 95821 | 81192 | 90451274 |
| Adverse reaction | 25.20 | 24.73 | 79 | 95902 | 29633 | 90502833 |
| Body temperature increased | 25.13 | 24.73 | 8 | 95973 | 44702 | 90487764 |
| Coronary arterial stent insertion | 24.79 | 24.73 | 22 | 95959 | 2818 | 90529648 |
| Gamma-glutamyltransferase increased | 24.78 | 24.73 | 5 | 95976 | 37947 | 90494519 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Wrong technique in product usage process | 11924.21 | 26.44 | 3820 | 61038 | 38815 | 42517662 |
| Device difficult to use | 10967.25 | 26.44 | 2281 | 62577 | 2315 | 42554162 |
| Accidental exposure to product | 7574.43 | 26.44 | 2277 | 62581 | 18116 | 42538361 |
| Drug dose omission by device | 6207.43 | 26.44 | 1500 | 63358 | 4386 | 42552091 |
| Injection site pain | 3223.53 | 26.44 | 1626 | 63232 | 56172 | 42500305 |
| Injection site bruising | 2278.48 | 26.44 | 800 | 64058 | 10725 | 42545752 |
| Myalgia | 2233.03 | 26.44 | 1534 | 63324 | 94546 | 42461931 |
| Product dose omission issue | 2196.13 | 26.44 | 1837 | 63021 | 152528 | 42403949 |
| Injection site haemorrhage | 2078.93 | 26.44 | 751 | 64107 | 10985 | 42545492 |
| Incorrect dose administered by device | 1925.35 | 26.44 | 506 | 64352 | 2250 | 42554227 |
| Rhinorrhoea | 1805.53 | 26.44 | 907 | 63951 | 30887 | 42525590 |
| Influenza like illness | 1684.58 | 26.44 | 866 | 63992 | 30974 | 42525503 |
| Device use error | 1625.42 | 26.44 | 457 | 64401 | 2740 | 42553737 |
| Back pain | 1475.16 | 26.44 | 1416 | 63442 | 140360 | 42416117 |
| Product storage error | 1303.16 | 26.44 | 527 | 64331 | 10613 | 42545864 |
| Device issue | 1156.57 | 26.44 | 512 | 64346 | 12997 | 42543480 |
| Low density lipoprotein decreased | 1049.26 | 26.44 | 268 | 64590 | 1036 | 42555441 |
| Injection site swelling | 854.64 | 26.44 | 447 | 64411 | 16526 | 42539951 |
| Underdose | 696.76 | 26.44 | 388 | 64470 | 16278 | 42540199 |
| Muscle spasms | 692.93 | 26.44 | 750 | 64108 | 85294 | 42471183 |
| Injury associated with device | 675.04 | 26.44 | 192 | 64666 | 1205 | 42555272 |
| Low density lipoprotein increased | 648.97 | 26.44 | 260 | 64598 | 5095 | 42551382 |
| Injection site mass | 638.56 | 26.44 | 295 | 64563 | 8280 | 42548197 |
| Incorrect disposal of product | 561.13 | 26.44 | 130 | 64728 | 292 | 42556185 |
| Nasopharyngitis | 560.10 | 26.44 | 664 | 64194 | 83332 | 42473145 |
| Intercepted product administration error | 551.00 | 26.44 | 135 | 64723 | 420 | 42556057 |
| Arthralgia | 511.81 | 26.44 | 1027 | 63831 | 204211 | 42352266 |
| Blood cholesterol decreased | 488.75 | 26.44 | 142 | 64716 | 971 | 42555506 |
| Acute kidney injury | 431.93 | 26.44 | 34 | 64824 | 367303 | 42189174 |
| Product communication issue | 376.50 | 26.44 | 116 | 64742 | 993 | 42555484 |
| Product preparation error | 373.30 | 26.44 | 170 | 64688 | 4608 | 42551869 |
| Injection site discomfort | 370.06 | 26.44 | 138 | 64720 | 2208 | 42554269 |
| Injection site erythema | 358.85 | 26.44 | 275 | 64583 | 19920 | 42536557 |
| Drug ineffective | 351.76 | 26.44 | 269 | 64589 | 629928 | 41926549 |
| Device defective | 317.26 | 26.44 | 113 | 64745 | 1575 | 42554902 |
| Pain in extremity | 315.88 | 26.44 | 703 | 64155 | 149901 | 42406576 |
| Anaemia | 305.18 | 26.44 | 35 | 64823 | 280243 | 42276234 |
| Wrong technique in device usage process | 303.60 | 26.44 | 125 | 64733 | 2632 | 42553845 |
| Drug interaction | 294.06 | 26.44 | 32 | 64826 | 266967 | 42289510 |
| Neutropenia | 282.86 | 26.44 | 4 | 64854 | 199427 | 42357050 |
| Device malfunction | 266.59 | 26.44 | 189 | 64669 | 12138 | 42544339 |
| Condition aggravated | 259.21 | 26.44 | 43 | 64815 | 260711 | 42295766 |
| Circumstance or information capable of leading to medication error | 256.10 | 26.44 | 108 | 64750 | 2420 | 42554057 |
| Oropharyngeal pain | 250.40 | 26.44 | 316 | 64542 | 42194 | 42514283 |
| Pneumonia | 246.80 | 26.44 | 171 | 64687 | 421978 | 42134499 |
| Thrombocytopenia | 227.80 | 26.44 | 16 | 64842 | 190263 | 42366214 |
| Blood glucose increased | 225.28 | 26.44 | 403 | 64455 | 73296 | 42483181 |
| Occupational exposure to product | 215.34 | 26.44 | 61 | 64797 | 376 | 42556101 |
| Pyrexia | 213.00 | 26.44 | 173 | 64685 | 393869 | 42162608 |
| Hypotension | 212.88 | 26.44 | 64 | 64794 | 257567 | 42298910 |
| Feeling abnormal | 203.61 | 26.44 | 374 | 64484 | 69412 | 42487065 |
| Sepsis | 202.20 | 26.44 | 31 | 64827 | 199303 | 42357174 |
| Injection site discolouration | 197.50 | 26.44 | 83 | 64775 | 1843 | 42554634 |
| Product use in unapproved indication | 190.97 | 26.44 | 27 | 64831 | 184429 | 42372048 |
| Musculoskeletal pain | 183.98 | 26.44 | 240 | 64618 | 33100 | 42523377 |
| Injection site pruritus | 182.39 | 26.44 | 135 | 64723 | 9270 | 42547207 |
| Injection site urticaria | 178.46 | 26.44 | 92 | 64766 | 3291 | 42553186 |
| General physical health deterioration | 169.21 | 26.44 | 17 | 64841 | 151229 | 42405248 |
| Low density lipoprotein abnormal | 165.34 | 26.44 | 49 | 64809 | 362 | 42556115 |
| Respiratory failure | 164.97 | 26.44 | 7 | 64851 | 128125 | 42428352 |
| Therapeutic response unexpected | 161.71 | 26.44 | 136 | 64722 | 11245 | 42545232 |
| Platelet count decreased | 156.53 | 26.44 | 15 | 64843 | 138566 | 42417911 |
| Vomiting | 149.22 | 26.44 | 133 | 64725 | 289590 | 42266887 |
| Blood triglycerides increased | 146.20 | 26.44 | 149 | 64709 | 15747 | 42540730 |
| Disease progression | 141.88 | 26.44 | 24 | 64834 | 143632 | 42412845 |
| Pancytopenia | 137.70 | 26.44 | 11 | 64847 | 117732 | 42438745 |
| Injection site rash | 133.81 | 26.44 | 92 | 64766 | 5620 | 42550857 |
| Haemoglobin decreased | 133.34 | 26.44 | 21 | 64837 | 132450 | 42424027 |
| White blood cell count decreased | 132.85 | 26.44 | 9 | 64849 | 110387 | 42446090 |
| Hyponatraemia | 132.42 | 26.44 | 5 | 64853 | 101457 | 42455020 |
| Nasal congestion | 130.63 | 26.44 | 191 | 64667 | 29310 | 42527167 |
| Adverse event | 130.12 | 26.44 | 170 | 64688 | 23470 | 42533007 |
| Product administered at inappropriate site | 129.03 | 26.44 | 72 | 64786 | 3026 | 42553451 |
| Completed suicide | 128.54 | 26.44 | 4 | 64854 | 96461 | 42460016 |
| Injection site vesicles | 125.77 | 26.44 | 54 | 64804 | 1266 | 42555211 |
| Overdose | 125.45 | 26.44 | 9 | 64849 | 105255 | 42451222 |
| Fractional exhaled nitric oxide increased | 124.88 | 26.44 | 57 | 64801 | 1552 | 42554925 |
| Device failure | 120.41 | 26.44 | 66 | 64792 | 2677 | 42553800 |
| Renal failure | 119.84 | 26.44 | 35 | 64823 | 143691 | 42412786 |
| Injection site reaction | 117.46 | 26.44 | 132 | 64726 | 15589 | 42540888 |
| Sinus disorder | 116.02 | 26.44 | 97 | 64761 | 7953 | 42548524 |
| Fear of injection | 115.94 | 26.44 | 58 | 64800 | 1945 | 42554532 |
| Oedema peripheral | 111.87 | 26.44 | 34 | 64824 | 136042 | 42420435 |
| Decreased appetite | 111.47 | 26.44 | 79 | 64779 | 193058 | 42363419 |
| Multiple organ dysfunction syndrome | 110.88 | 26.44 | 10 | 64848 | 97025 | 42459452 |
| Septic shock | 108.76 | 26.44 | 8 | 64850 | 91664 | 42464813 |
| Glycosylated haemoglobin increased | 102.56 | 26.44 | 112 | 64746 | 12812 | 42543665 |
| Hyperkalaemia | 101.55 | 26.44 | 5 | 64853 | 80453 | 42476024 |
| Seizure | 101.15 | 26.44 | 29 | 64829 | 120532 | 42435945 |
| Incorrect dose administered by product | 97.69 | 26.44 | 22 | 64836 | 41 | 42556436 |
| Application site mass | 97.64 | 26.44 | 19 | 64839 | 8 | 42556469 |
| Gastrointestinal haemorrhage | 97.18 | 26.44 | 16 | 64842 | 97710 | 42458767 |
| Dehydration | 95.81 | 26.44 | 48 | 64810 | 141719 | 42414758 |
| Plantar fasciitis | 95.32 | 26.44 | 59 | 64799 | 3011 | 42553466 |
| Pulmonary embolism | 92.84 | 26.44 | 33 | 64825 | 119579 | 42436898 |
| Dysphonia | 89.94 | 26.44 | 158 | 64700 | 28292 | 42528185 |
| Influenza | 89.67 | 26.44 | 252 | 64606 | 61923 | 42494554 |
| Hypokalaemia | 88.81 | 26.44 | 5 | 64853 | 71716 | 42484761 |
| Myoglobin blood increased | 87.89 | 26.44 | 60 | 64798 | 3622 | 42552855 |
| Leukopenia | 87.32 | 26.44 | 7 | 64851 | 74739 | 42481738 |
| Adverse reaction | 85.80 | 26.44 | 61 | 64797 | 3932 | 42552545 |
| Inappropriate schedule of product administration | 85.45 | 26.44 | 330 | 64528 | 95572 | 42460905 |
| Sensation of foreign body | 84.17 | 26.44 | 58 | 64800 | 3555 | 42552922 |
| Tachycardia | 83.53 | 26.44 | 25 | 64833 | 101062 | 42455415 |
| Blood cholesterol increased | 82.59 | 26.44 | 147 | 64711 | 26594 | 42529883 |
| Pleural effusion | 82.18 | 26.44 | 23 | 64835 | 97143 | 42459334 |
| Memory impairment | 80.87 | 26.44 | 212 | 64646 | 50010 | 42506467 |
| Fall | 80.73 | 26.44 | 146 | 64712 | 234374 | 42322103 |
| Cardiac failure | 80.36 | 26.44 | 31 | 64827 | 106825 | 42449652 |
| Secretion discharge | 80.28 | 26.44 | 77 | 64781 | 7558 | 42548919 |
| Hypoacusis | 79.77 | 26.44 | 119 | 64739 | 18583 | 42537894 |
| Paranasal sinus hypersecretion | 79.76 | 26.44 | 38 | 64820 | 1143 | 42555334 |
| Blood creatinine increased | 79.34 | 26.44 | 34 | 64824 | 109969 | 42446508 |
| Hypoxia | 77.58 | 26.44 | 8 | 64850 | 69778 | 42486699 |
| Confusional state | 75.77 | 26.44 | 86 | 64772 | 167511 | 42388966 |
| Intentional product use issue | 75.47 | 26.44 | 10 | 64848 | 71823 | 42484654 |
| Injection site induration | 74.30 | 26.44 | 53 | 64805 | 3434 | 42553043 |
| Cardiac arrest | 73.87 | 26.44 | 37 | 64821 | 109283 | 42447194 |
| Muscular weakness | 73.30 | 26.44 | 286 | 64572 | 83212 | 42473265 |
| Oxygen saturation decreased | 73.00 | 26.44 | 7 | 64851 | 64680 | 42491797 |
| Neutrophil count decreased | 71.20 | 26.44 | 7 | 64851 | 63408 | 42493069 |
| Treatment failure | 70.08 | 26.44 | 7 | 64851 | 62617 | 42493860 |
| Stent placement | 69.91 | 26.44 | 61 | 64797 | 5299 | 42551178 |
| Bradycardia | 69.08 | 26.44 | 22 | 64836 | 85462 | 42471015 |
| Respiratory tract congestion | 68.83 | 26.44 | 71 | 64787 | 7607 | 42548870 |
| Device dispensing error | 68.61 | 26.44 | 18 | 64840 | 79 | 42556398 |
| Mobility decreased | 68.42 | 26.44 | 160 | 64698 | 35146 | 42521331 |
| Pain | 68.28 | 26.44 | 619 | 64239 | 244229 | 42312248 |
| Agitation | 67.45 | 26.44 | 9 | 64849 | 64305 | 42492172 |
| Interstitial lung disease | 67.42 | 26.44 | 18 | 64840 | 78444 | 42478033 |
| Deep vein thrombosis | 67.38 | 26.44 | 17 | 64841 | 76940 | 42479537 |
| Constipation | 67.32 | 26.44 | 89 | 64769 | 162202 | 42394275 |
| Ascites | 67.06 | 26.44 | 5 | 64853 | 56673 | 42499804 |
| Coma | 65.48 | 26.44 | 4 | 64854 | 53550 | 42502927 |
| Somnolence | 65.31 | 26.44 | 71 | 64787 | 141034 | 42415443 |
| Cardiac operation | 64.90 | 26.44 | 50 | 64808 | 3645 | 42552832 |
| Delirium | 63.99 | 26.44 | 4 | 64854 | 52515 | 42503962 |
| Unevaluable event | 63.85 | 26.44 | 153 | 64705 | 34135 | 42522342 |
| Upper-airway cough syndrome | 63.72 | 26.44 | 53 | 64805 | 4313 | 42552164 |
| Infection | 61.80 | 26.44 | 48 | 64810 | 112020 | 42444457 |
| Intentional product misuse | 58.41 | 26.44 | 217 | 64641 | 61683 | 42494794 |
| High density lipoprotein decreased | 58.32 | 26.44 | 48 | 64810 | 3849 | 42552628 |
| Cough | 56.80 | 26.44 | 464 | 64394 | 177639 | 42378838 |
| Abdominal pain | 55.81 | 26.44 | 130 | 64728 | 190341 | 42366136 |
| C-reactive protein increased | 55.72 | 26.44 | 14 | 64844 | 63546 | 42492931 |
| Musculoskeletal disorder | 55.25 | 26.44 | 59 | 64799 | 6579 | 42549898 |
| Renal impairment | 54.94 | 26.44 | 52 | 64806 | 110176 | 42446301 |
| Product use issue | 54.88 | 26.44 | 24 | 64834 | 76727 | 42479750 |
| Brain natriuretic peptide increased | 54.29 | 26.44 | 59 | 64799 | 6711 | 42549766 |
| Sneezing | 53.74 | 26.44 | 57 | 64801 | 6306 | 42550171 |
| Hallucination | 53.74 | 26.44 | 11 | 64847 | 57496 | 42498981 |
| Lactic acidosis | 53.52 | 26.44 | 4 | 64854 | 45257 | 42511220 |
| Rash pruritic | 53.21 | 26.44 | 141 | 64717 | 33462 | 42523015 |
| Pneumonia aspiration | 52.53 | 26.44 | 7 | 64851 | 50071 | 42506406 |
| International normalised ratio increased | 52.32 | 26.44 | 6 | 64852 | 48162 | 42508315 |
| Haematuria | 52.10 | 26.44 | 12 | 64846 | 57787 | 42498690 |
| Syncope | 51.80 | 26.44 | 45 | 64813 | 99361 | 42457116 |
| Injection site injury | 51.55 | 26.44 | 20 | 64838 | 358 | 42556119 |
| Lack of injection site rotation | 51.50 | 26.44 | 22 | 64836 | 509 | 42555968 |
| Plasma cell myeloma | 51.49 | 26.44 | 6 | 64852 | 47572 | 42508905 |
| Pneumonitis | 51.36 | 26.44 | 3 | 64855 | 41715 | 42514762 |
| Death | 51.14 | 26.44 | 465 | 64393 | 470720 | 42085757 |
| Muscle tightness | 50.95 | 26.44 | 52 | 64806 | 5501 | 42550976 |
| Hypoglycaemia | 50.91 | 26.44 | 14 | 64844 | 59840 | 42496637 |
| Muscle disorder | 50.65 | 26.44 | 40 | 64818 | 3024 | 42553453 |
| Injection site extravasation | 49.98 | 26.44 | 40 | 64818 | 3082 | 42553395 |
| Injection site irritation | 49.19 | 26.44 | 31 | 64827 | 1633 | 42554844 |
| Exostosis | 48.55 | 26.44 | 51 | 64807 | 5580 | 42550897 |
| Injection site hypoaesthesia | 48.41 | 26.44 | 15 | 64843 | 131 | 42556346 |
| Cardio-respiratory arrest | 47.52 | 26.44 | 15 | 64843 | 58621 | 42497856 |
| No adverse event | 47.45 | 26.44 | 3 | 64855 | 39018 | 42517459 |
| Rectal haemorrhage | 47.38 | 26.44 | 9 | 64849 | 49597 | 42506880 |
| Headache | 46.27 | 26.44 | 562 | 64296 | 238807 | 42317670 |
| Rhabdomyolysis | 46.16 | 26.44 | 31 | 64827 | 77988 | 42478489 |
| Hepatic failure | 46.12 | 26.44 | 3 | 64855 | 38097 | 42518380 |
| Haematochezia | 45.52 | 26.44 | 16 | 64842 | 58420 | 42498057 |
| Injection site indentation | 45.14 | 26.44 | 12 | 64846 | 56 | 42556421 |
| Haemoptysis | 44.90 | 26.44 | 8 | 64850 | 46159 | 42510318 |
| Fatigue | 44.27 | 26.44 | 918 | 63940 | 434723 | 42121754 |
| Mental status changes | 43.90 | 26.44 | 6 | 64852 | 42109 | 42514368 |
| Incorrect dose administered | 43.69 | 26.44 | 178 | 64680 | 52796 | 42503681 |
| Hypersensitivity | 42.46 | 26.44 | 220 | 64638 | 72150 | 42484327 |
| Stomatitis | 42.38 | 26.44 | 12 | 64846 | 50317 | 42506160 |
| Aggression | 42.21 | 26.44 | 8 | 64850 | 44155 | 42512322 |
| Product dispensing error | 42.12 | 26.44 | 55 | 64803 | 7584 | 42548893 |
| Melaena | 41.65 | 26.44 | 5 | 64853 | 38741 | 42517736 |
| Colitis | 41.32 | 26.44 | 10 | 64848 | 46562 | 42509915 |
| Therapy cessation | 41.06 | 26.44 | 94 | 64764 | 20356 | 42536121 |
| Thrombosis | 40.82 | 26.44 | 27 | 64831 | 68484 | 42487993 |
| Needle issue | 40.80 | 26.44 | 58 | 64800 | 8669 | 42547808 |
| Drug resistance | 40.57 | 26.44 | 3 | 64855 | 34245 | 42522232 |
| Blood creatine phosphokinase increased | 40.32 | 26.44 | 163 | 64695 | 48175 | 42508302 |
| Chest discomfort | 39.85 | 26.44 | 197 | 64661 | 63419 | 42493058 |
| Respiratory distress | 39.07 | 26.44 | 8 | 64850 | 41812 | 42514665 |
| Medication error | 39.00 | 26.44 | 3 | 64855 | 33151 | 42523326 |
| Haematocrit decreased | 38.79 | 26.44 | 4 | 64854 | 34904 | 42521573 |
| Coronary artery bypass | 38.71 | 26.44 | 42 | 64816 | 4768 | 42551709 |
| Cellulitis | 38.44 | 26.44 | 23 | 64835 | 61562 | 42494915 |
| Injection site paraesthesia | 37.74 | 26.44 | 13 | 64845 | 163 | 42556314 |
| Blood bilirubin increased | 37.62 | 26.44 | 9 | 64849 | 42243 | 42514234 |
| Pulmonary oedema | 37.54 | 26.44 | 17 | 64841 | 53255 | 42503222 |
| Cardiac failure congestive | 37.49 | 26.44 | 45 | 64813 | 85557 | 42470920 |
| Cardiogenic shock | 37.33 | 26.44 | 5 | 64853 | 35635 | 42520842 |
| Acute respiratory failure | 37.22 | 26.44 | 7 | 64851 | 38851 | 42517626 |
| Injection site laceration | 36.73 | 26.44 | 9 | 64849 | 28 | 42556449 |
| Transaminases increased | 35.95 | 26.44 | 4 | 64854 | 32881 | 42523596 |
| Haemorrhage | 35.91 | 26.44 | 24 | 64834 | 60539 | 42495938 |
| Jaundice | 35.88 | 26.44 | 5 | 64853 | 34584 | 42521893 |
| Application site swelling | 35.86 | 26.44 | 15 | 64843 | 329 | 42556148 |
| White blood cell count increased | 35.71 | 26.44 | 12 | 64846 | 45075 | 42511402 |
| Lipoprotein (a) increased | 35.04 | 26.44 | 15 | 64843 | 349 | 42556128 |
| Therapy interrupted | 34.85 | 26.44 | 93 | 64765 | 22157 | 42534320 |
| Blood alkaline phosphatase increased | 34.52 | 26.44 | 5 | 64853 | 33592 | 42522885 |
| Oedema | 34.51 | 26.44 | 18 | 64840 | 51983 | 42504494 |
| Hepatic function abnormal | 34.00 | 26.44 | 18 | 64840 | 51549 | 42504928 |
| Blood triglycerides decreased | 33.65 | 26.44 | 11 | 64847 | 116 | 42556361 |
| Chronic obstructive pulmonary disease | 33.57 | 26.44 | 28 | 64830 | 63086 | 42493391 |
| Psychotic disorder | 33.37 | 26.44 | 3 | 64855 | 29205 | 42527272 |
| Suicidal ideation | 32.96 | 26.44 | 16 | 64842 | 48145 | 42508332 |
| High density lipoprotein increased | 32.67 | 26.44 | 15 | 64843 | 414 | 42556063 |
| Device physical property issue | 32.50 | 26.44 | 23 | 64835 | 1471 | 42555006 |
| Alanine aminotransferase increased | 32.21 | 26.44 | 53 | 64805 | 88353 | 42468124 |
| Musculoskeletal discomfort | 31.73 | 26.44 | 54 | 64804 | 9422 | 42547055 |
| Vascular graft | 31.66 | 26.44 | 23 | 64835 | 1533 | 42554944 |
| Aspartate aminotransferase increased | 31.27 | 26.44 | 43 | 64815 | 77120 | 42479357 |
| COVID-19 | 30.91 | 26.44 | 83 | 64775 | 115865 | 42440612 |
| Shock | 30.71 | 26.44 | 4 | 64854 | 29117 | 42527360 |
| Sinus congestion | 30.60 | 26.44 | 45 | 64813 | 6935 | 42549542 |
| Hepatic cytolysis | 30.03 | 26.44 | 3 | 64855 | 26841 | 42529636 |
| Neck pain | 29.79 | 26.44 | 107 | 64751 | 29907 | 42526570 |
| Cerebral haemorrhage | 29.78 | 26.44 | 11 | 64847 | 38955 | 42517522 |
| Anaphylactic reaction | 29.56 | 26.44 | 14 | 64844 | 42729 | 42513748 |
| Injection site haematoma | 29.41 | 26.44 | 24 | 64834 | 1901 | 42554576 |
| Unresponsive to stimuli | 29.35 | 26.44 | 6 | 64852 | 31397 | 42525080 |
| Dysarthria | 29.17 | 26.44 | 12 | 64846 | 39795 | 42516682 |
| Urinary retention | 28.93 | 26.44 | 14 | 64844 | 42200 | 42514277 |
| Urinary tract infection | 28.85 | 26.44 | 68 | 64790 | 99216 | 42457261 |
| Injection site scab | 28.56 | 26.44 | 8 | 64850 | 47 | 42556430 |
| Throat irritation | 28.51 | 26.44 | 62 | 64796 | 12974 | 42543503 |
| Sleep disorder due to general medical condition, insomnia type | 28.28 | 26.44 | 21 | 64837 | 1448 | 42555029 |
| Injection site warmth | 28.09 | 26.44 | 27 | 64831 | 2656 | 42553821 |
| Application site haemorrhage | 28.08 | 26.44 | 14 | 64844 | 466 | 42556011 |
| Sluggishness | 27.88 | 26.44 | 32 | 64826 | 3864 | 42552613 |
| Pneumocystis jirovecii pneumonia | 27.69 | 26.44 | 3 | 64855 | 25178 | 42531299 |
| Ventricular fibrillation | 27.65 | 26.44 | 6 | 64852 | 30117 | 42526360 |
| Acute respiratory distress syndrome | 27.63 | 26.44 | 6 | 64852 | 30102 | 42526375 |
| Chronic kidney disease | 27.63 | 26.44 | 19 | 64839 | 47222 | 42509255 |
| Pulmonary fibrosis | 27.34 | 26.44 | 4 | 64854 | 26677 | 42529800 |
| Increased upper airway secretion | 27.29 | 26.44 | 26 | 64832 | 2530 | 42553947 |
| Abnormal behaviour | 27.03 | 26.44 | 4 | 64854 | 26447 | 42530030 |
| Tremor | 26.90 | 26.44 | 68 | 64790 | 96861 | 42459616 |
| Gamma-glutamyltransferase increased | 26.89 | 26.44 | 8 | 64850 | 32489 | 42523988 |
| Blood cholesterol abnormal | 26.78 | 26.44 | 23 | 64835 | 1956 | 42554521 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Wrong technique in product usage process | 28493.88 | 22.89 | 8292 | 121621 | 79056 | 110380330 |
| Device difficult to use | 26117.26 | 22.89 | 5703 | 124210 | 13102 | 110446284 |
| Accidental exposure to product | 17163.36 | 22.89 | 4953 | 124960 | 45055 | 110414331 |
| Drug dose omission by device | 15059.92 | 22.89 | 3474 | 126439 | 11042 | 110448344 |
| Injection site pain | 8573.04 | 22.89 | 4167 | 125746 | 173755 | 110285631 |
| Injection site bruising | 4947.25 | 22.89 | 1962 | 127951 | 49301 | 110410085 |
| Product dose omission issue | 4941.12 | 22.89 | 3604 | 126309 | 318178 | 110141208 |
| Injection site haemorrhage | 4417.86 | 22.89 | 1605 | 128308 | 31423 | 110427963 |
| Device use error | 4200.17 | 22.89 | 1140 | 128773 | 7949 | 110451437 |
| Incorrect dose administered by device | 4082.55 | 22.89 | 1050 | 128863 | 5764 | 110453622 |
| Device issue | 2978.32 | 22.89 | 1220 | 128693 | 33315 | 110426071 |
| Myalgia | 2934.47 | 22.89 | 2279 | 127634 | 220102 | 110239284 |
| Rhinorrhoea | 2901.67 | 22.89 | 1690 | 128223 | 100976 | 110358410 |
| Influenza like illness | 2462.30 | 22.89 | 1442 | 128471 | 86970 | 110372416 |
| Back pain | 2388.46 | 22.89 | 2539 | 127374 | 368457 | 110090929 |
| Product storage error | 1945.93 | 22.89 | 789 | 129124 | 20939 | 110438447 |
| Injury associated with device | 1765.90 | 22.89 | 494 | 129419 | 3895 | 110455491 |
| Underdose | 1483.07 | 22.89 | 926 | 128987 | 62628 | 110396758 |
| Injection site swelling | 1405.85 | 22.89 | 886 | 129027 | 60904 | 110398482 |
| Incorrect disposal of product | 1364.23 | 22.89 | 316 | 129597 | 1012 | 110458374 |
| Injection site mass | 1153.43 | 22.89 | 568 | 129345 | 24045 | 110435341 |
| Product communication issue | 1122.97 | 22.89 | 307 | 129606 | 2199 | 110457187 |
| Low density lipoprotein decreased | 1104.98 | 22.89 | 270 | 129643 | 1152 | 110458234 |
| Muscle spasms | 1096.68 | 22.89 | 1486 | 128427 | 276671 | 110182715 |
| Low density lipoprotein increased | 885.47 | 22.89 | 367 | 129546 | 10299 | 110449087 |
| Wrong technique in device usage process | 857.33 | 22.89 | 318 | 129595 | 6583 | 110452803 |
| Injection site erythema | 847.95 | 22.89 | 776 | 129137 | 93400 | 110365986 |
| Product preparation error | 841.67 | 22.89 | 356 | 129557 | 10523 | 110448863 |
| Device defective | 795.99 | 22.89 | 259 | 129654 | 3563 | 110455823 |
| Drug ineffective | 746.74 | 22.89 | 433 | 129480 | 1520107 | 108939279 |
| Device malfunction | 676.73 | 22.89 | 404 | 129509 | 25154 | 110434232 |
| Intercepted product administration error | 664.48 | 22.89 | 163 | 129750 | 709 | 110458677 |
| Pain in extremity | 611.14 | 22.89 | 1590 | 128323 | 485528 | 109973858 |
| Blood cholesterol decreased | 602.11 | 22.89 | 193 | 129720 | 2523 | 110456863 |
| Acute kidney injury | 582.65 | 22.89 | 43 | 129870 | 635387 | 109823999 |
| Oropharyngeal pain | 564.73 | 22.89 | 744 | 129169 | 134532 | 110324854 |
| Injection site discomfort | 547.54 | 22.89 | 230 | 129683 | 6677 | 110452709 |
| Condition aggravated | 537.15 | 22.89 | 106 | 129807 | 734730 | 109724656 |
| Feeling abnormal | 512.72 | 22.89 | 828 | 129085 | 179883 | 110279503 |
| Injection site discolouration | 438.07 | 22.89 | 214 | 129699 | 8889 | 110450497 |
| Drug interaction | 425.54 | 22.89 | 46 | 129867 | 500137 | 109959249 |
| Infusion related reaction | 421.05 | 22.89 | 5 | 129908 | 381157 | 110078229 |
| Blood glucose increased | 417.19 | 22.89 | 637 | 129276 | 131859 | 110327527 |
| Neutropenia | 400.74 | 22.89 | 8 | 129905 | 374612 | 110084774 |
| Anaemia | 399.31 | 22.89 | 79 | 129834 | 547007 | 109912379 |
| Product use in unapproved indication | 388.65 | 22.89 | 38 | 129875 | 447339 | 110012047 |
| Pyrexia | 385.20 | 22.89 | 296 | 129617 | 897969 | 109561417 |
| Fear of injection | 382.99 | 22.89 | 194 | 129719 | 8717 | 110450669 |
| General physical health deterioration | 372.40 | 22.89 | 35 | 129878 | 425260 | 110034126 |
| Injection site pruritus | 340.73 | 22.89 | 358 | 129555 | 50900 | 110408486 |
| Thrombocytopenia | 339.34 | 22.89 | 17 | 129896 | 348868 | 110110518 |
| Arthralgia | 335.12 | 22.89 | 1800 | 128113 | 777832 | 109681554 |
| Vomiting | 330.76 | 22.89 | 350 | 129563 | 910325 | 109549061 |
| Nasopharyngitis | 330.10 | 22.89 | 1116 | 128797 | 393245 | 110066141 |
| Blood triglycerides increased | 290.19 | 22.89 | 234 | 129679 | 23692 | 110435694 |
| Therapeutic response unexpected | 284.55 | 22.89 | 231 | 129682 | 23612 | 110435774 |
| Injection site urticaria | 283.24 | 22.89 | 202 | 129711 | 17013 | 110442373 |
| Pneumonia | 282.82 | 22.89 | 370 | 129543 | 876344 | 109583042 |
| Treatment failure | 277.79 | 22.89 | 11 | 129902 | 277223 | 110182163 |
| Circumstance or information capable of leading to medication error | 275.96 | 22.89 | 131 | 129782 | 5102 | 110454284 |
| Completed suicide | 263.98 | 22.89 | 4 | 129909 | 242377 | 110217009 |
| Device failure | 252.92 | 22.89 | 137 | 129776 | 7070 | 110452316 |
| Product use issue | 251.78 | 22.89 | 34 | 129879 | 311661 | 110147725 |
| Hypotension | 250.26 | 22.89 | 153 | 129760 | 523696 | 109935690 |
| Product administered at inappropriate site | 239.35 | 22.89 | 120 | 129793 | 5273 | 110454113 |
| Systemic lupus erythematosus | 236.25 | 22.89 | 16 | 129897 | 254322 | 110205064 |
| Pemphigus | 236.01 | 22.89 | 3 | 129910 | 214567 | 110244819 |
| Contraindicated product administered | 229.49 | 22.89 | 16 | 129897 | 248251 | 110211135 |
| Intentional product use issue | 229.09 | 22.89 | 16 | 129897 | 247890 | 110211496 |
| Overdose | 225.35 | 22.89 | 12 | 129901 | 233782 | 110225604 |
| Maternal exposure during pregnancy | 222.92 | 22.89 | 21 | 129892 | 254862 | 110204524 |
| Stomatitis | 219.38 | 22.89 | 29 | 129884 | 270213 | 110189173 |
| Infection | 219.05 | 22.89 | 76 | 129837 | 362124 | 110097262 |
| Injection site rash | 218.44 | 22.89 | 197 | 129716 | 23222 | 110436164 |
| Sepsis | 215.36 | 22.89 | 59 | 129854 | 327287 | 110132099 |
| Rheumatoid arthritis | 212.72 | 22.89 | 46 | 129867 | 299567 | 110159819 |
| Pericarditis | 208.84 | 22.89 | 12 | 129901 | 219102 | 110240284 |
| Hyponatraemia | 207.21 | 22.89 | 12 | 129901 | 217641 | 110241745 |
| Respiratory failure | 201.59 | 22.89 | 13 | 129900 | 215319 | 110244067 |
| Pancytopenia | 201.26 | 22.89 | 11 | 129902 | 209602 | 110249784 |
| Unevaluable event | 200.92 | 22.89 | 295 | 129618 | 58932 | 110400454 |
| Oedema peripheral | 200.39 | 22.89 | 68 | 129845 | 328592 | 110130794 |
| Platelet count decreased | 198.85 | 22.89 | 20 | 129893 | 230423 | 110228963 |
| Wound | 198.05 | 22.89 | 22 | 129891 | 234415 | 110224971 |
| Drug intolerance | 197.90 | 22.89 | 116 | 129797 | 406396 | 110052990 |
| Disease progression | 193.80 | 22.89 | 28 | 129885 | 244006 | 110215380 |
| White blood cell count decreased | 192.59 | 22.89 | 22 | 129891 | 229368 | 110230018 |
| Helicobacter infection | 190.05 | 22.89 | 5 | 129908 | 181872 | 110277514 |
| Injection site vesicles | 188.23 | 22.89 | 96 | 129817 | 4375 | 110455011 |
| Incorrect dose administered | 186.06 | 22.89 | 390 | 129523 | 103251 | 110356135 |
| Inappropriate schedule of product administration | 185.95 | 22.89 | 594 | 129319 | 203043 | 110256343 |
| Haemoglobin decreased | 185.31 | 22.89 | 34 | 129879 | 248693 | 110210693 |
| Injection site induration | 181.37 | 22.89 | 131 | 129782 | 11252 | 110448134 |
| Injection site extravasation | 180.49 | 22.89 | 125 | 129788 | 10044 | 110449342 |
| Psoriatic arthropathy | 178.07 | 22.89 | 14 | 129899 | 196747 | 110262639 |
| Glossodynia | 175.06 | 22.89 | 26 | 129887 | 221978 | 110237408 |
| Injection site indentation | 169.64 | 22.89 | 44 | 129869 | 250 | 110459136 |
| C-reactive protein increased | 168.47 | 22.89 | 27 | 129886 | 217892 | 110241494 |
| Sinus disorder | 168.36 | 22.89 | 200 | 129713 | 32528 | 110426858 |
| Lower respiratory tract infection | 167.19 | 22.89 | 40 | 129873 | 243066 | 110216320 |
| Influenza | 166.12 | 22.89 | 506 | 129407 | 168595 | 110290791 |
| Confusional state | 165.42 | 22.89 | 184 | 129729 | 468496 | 109990890 |
| Folliculitis | 163.46 | 22.89 | 8 | 129905 | 167645 | 110291741 |
| Hypokalaemia | 159.59 | 22.89 | 15 | 129898 | 182433 | 110276953 |
| Stent placement | 157.54 | 22.89 | 101 | 129812 | 7133 | 110452253 |
| Cough | 155.04 | 22.89 | 1000 | 128913 | 460641 | 109998745 |
| Decreased appetite | 151.88 | 22.89 | 202 | 129711 | 475644 | 109983742 |
| Injury | 151.32 | 22.89 | 16 | 129897 | 177249 | 110282137 |
| Occupational exposure to product | 151.26 | 22.89 | 51 | 129862 | 788 | 110458598 |
| Oedema | 149.49 | 22.89 | 32 | 129881 | 209944 | 110249442 |
| Leukopenia | 148.67 | 22.89 | 6 | 129907 | 148785 | 110310601 |
| Hypoacusis | 145.81 | 22.89 | 193 | 129720 | 34998 | 110424388 |
| Low density lipoprotein abnormal | 145.42 | 22.89 | 45 | 129868 | 520 | 110458866 |
| Impaired healing | 144.15 | 22.89 | 28 | 129885 | 196689 | 110262697 |
| Dysphonia | 143.64 | 22.89 | 292 | 129621 | 75637 | 110383749 |
| Glycosylated haemoglobin increased | 142.92 | 22.89 | 157 | 129756 | 23462 | 110435924 |
| Seizure | 141.48 | 22.89 | 42 | 129871 | 221143 | 110238243 |
| Joint swelling | 141.30 | 22.89 | 188 | 129725 | 442657 | 110016729 |
| Device dispensing error | 140.55 | 22.89 | 36 | 129877 | 193 | 110459193 |
| Drug hypersensitivity | 139.64 | 22.89 | 198 | 129715 | 453892 | 110005494 |
| Multiple organ dysfunction syndrome | 139.52 | 22.89 | 10 | 129903 | 151700 | 110307686 |
| Incorrect dose administered by product | 138.74 | 22.89 | 37 | 129876 | 238 | 110459148 |
| Tachycardia | 137.92 | 22.89 | 47 | 129866 | 226598 | 110232788 |
| Septic shock | 137.64 | 22.89 | 13 | 129900 | 157515 | 110301871 |
| Oxygen saturation decreased | 137.05 | 22.89 | 13 | 129900 | 156969 | 110302417 |
| Nasal congestion | 132.20 | 22.89 | 330 | 129583 | 97952 | 110361434 |
| Pulmonary embolism | 131.34 | 22.89 | 44 | 129869 | 214430 | 110244956 |
| Muscle disorder | 130.27 | 22.89 | 87 | 129826 | 6585 | 110452801 |
| Liver injury | 127.30 | 22.89 | 14 | 129899 | 150399 | 110308987 |
| Delirium | 126.81 | 22.89 | 8 | 129905 | 135017 | 110324369 |
| Arthropathy | 122.49 | 22.89 | 95 | 129818 | 287427 | 110171959 |
| Hepatic enzyme increased | 122.17 | 22.89 | 118 | 129795 | 320774 | 110138612 |
| Hyperkalaemia | 121.91 | 22.89 | 10 | 129903 | 135786 | 110323600 |
| Cardiac operation | 121.47 | 22.89 | 80 | 129833 | 5915 | 110453471 |
| Hypoxia | 120.66 | 22.89 | 8 | 129905 | 129507 | 110329879 |
| Coma | 120.36 | 22.89 | 4 | 129909 | 117865 | 110341521 |
| Abdominal pain | 120.35 | 22.89 | 265 | 129648 | 512724 | 109946662 |
| Paranasal sinus hypersecretion | 119.38 | 22.89 | 72 | 129841 | 4562 | 110454824 |
| Depressed level of consciousness | 117.61 | 22.89 | 3 | 129910 | 112275 | 110347111 |
| Inflammation | 115.97 | 22.89 | 41 | 129872 | 193197 | 110266189 |
| Cardiac arrest | 112.63 | 22.89 | 45 | 129868 | 196708 | 110262678 |
| Osteoarthritis | 112.63 | 22.89 | 37 | 129876 | 182586 | 110276800 |
| Muscle injury | 112.12 | 22.89 | 16 | 129897 | 140791 | 110318595 |
| Medication error | 109.67 | 22.89 | 3 | 129910 | 105363 | 110354023 |
| Pleural effusion | 106.14 | 22.89 | 38 | 129875 | 177671 | 110281715 |
| Injection site injury | 105.37 | 22.89 | 42 | 129871 | 1062 | 110458324 |
| Type 2 diabetes mellitus | 103.99 | 22.89 | 39 | 129874 | 177193 | 110282193 |
| Interstitial lung disease | 103.85 | 22.89 | 19 | 129894 | 139315 | 110320071 |
| Cardiac failure | 102.45 | 22.89 | 46 | 129867 | 187580 | 110271806 |
| Lung disorder | 101.72 | 22.89 | 42 | 129871 | 180005 | 110279381 |
| Renal failure | 101.49 | 22.89 | 71 | 129842 | 226503 | 110232883 |
| Gastrointestinal haemorrhage | 101.25 | 22.89 | 34 | 129879 | 165484 | 110293902 |
| Bradycardia | 100.41 | 22.89 | 29 | 129884 | 155488 | 110303898 |
| Needle issue | 100.07 | 22.89 | 114 | 129799 | 17726 | 110441660 |
| Myelosuppression | 97.04 | 22.89 | 3 | 129910 | 94337 | 110365049 |
| Epilepsy | 96.97 | 22.89 | 5 | 129908 | 100204 | 110359182 |
| Wound infection | 95.99 | 22.89 | 4 | 129909 | 96461 | 110362925 |
| Wheezing | 95.80 | 22.89 | 95 | 129818 | 255135 | 110204251 |
| Neutrophil count decreased | 95.70 | 22.89 | 14 | 129899 | 120927 | 110338459 |
| Swelling | 95.56 | 22.89 | 166 | 129747 | 350875 | 110108511 |
| Therapeutic product effect decreased | 93.95 | 22.89 | 89 | 129824 | 244227 | 110215159 |
| Blister | 93.23 | 22.89 | 78 | 129835 | 227298 | 110232088 |
| Somnolence | 93.07 | 22.89 | 128 | 129785 | 297321 | 110162065 |
| Lack of injection site rotation | 92.98 | 22.89 | 39 | 129874 | 1127 | 110458259 |
| Dehydration | 92.87 | 22.89 | 115 | 129798 | 279396 | 110179990 |
| Obesity | 92.33 | 22.89 | 12 | 129901 | 113339 | 110346047 |
| Lactic acidosis | 91.85 | 22.89 | 4 | 129909 | 92807 | 110366579 |
| Drug ineffective for unapproved indication | 91.14 | 22.89 | 8 | 129905 | 102830 | 110356556 |
| Blood creatinine increased | 90.61 | 22.89 | 51 | 129862 | 182838 | 110276548 |
| Fall | 89.29 | 22.89 | 385 | 129528 | 603097 | 109856289 |
| Therapy cessation | 89.00 | 22.89 | 176 | 129737 | 44681 | 110414705 |
| Hepatitis | 88.73 | 22.89 | 4 | 129909 | 90050 | 110369336 |
| Ascites | 88.66 | 22.89 | 5 | 129908 | 92803 | 110366583 |
| Bursitis | 88.07 | 22.89 | 22 | 129891 | 129896 | 110329490 |
| Sneezing | 87.09 | 22.89 | 144 | 129769 | 31840 | 110427546 |
| Cardio-respiratory arrest | 85.88 | 22.89 | 16 | 129897 | 115820 | 110343566 |
| Joint range of motion decreased | 85.81 | 22.89 | 19 | 129894 | 121813 | 110337573 |
| Memory impairment | 85.64 | 22.89 | 457 | 129456 | 196487 | 110262899 |
| Irritable bowel syndrome | 85.45 | 22.89 | 43 | 129870 | 164172 | 110295214 |
| Peripheral venous disease | 85.37 | 22.89 | 3 | 129910 | 84114 | 110375272 |
| Product dispensing error | 84.25 | 22.89 | 100 | 129813 | 16245 | 110443141 |
| Upper-airway cough syndrome | 83.36 | 22.89 | 98 | 129815 | 15759 | 110443627 |
| Lip dry | 82.97 | 22.89 | 10 | 129903 | 100073 | 110359313 |
| Respiratory tract congestion | 82.77 | 22.89 | 138 | 129775 | 30719 | 110428667 |
| Pulmonary fibrosis | 82.64 | 22.89 | 11 | 129902 | 102031 | 110357355 |
| High density lipoprotein decreased | 82.38 | 22.89 | 62 | 129851 | 5671 | 110453715 |
| Asthma | 82.08 | 22.89 | 104 | 129809 | 250187 | 110209199 |
| Deep vein thrombosis | 81.69 | 22.89 | 31 | 129882 | 139856 | 110319530 |
| Musculoskeletal disorder | 79.91 | 22.89 | 115 | 129798 | 22549 | 110436837 |
| Rectal haemorrhage | 79.87 | 22.89 | 21 | 129892 | 119812 | 110339574 |
| Muscle tightness | 78.88 | 22.89 | 92 | 129821 | 14670 | 110444716 |
| Blood cholesterol abnormal | 78.36 | 22.89 | 51 | 129862 | 3695 | 110455691 |
| Application site mass | 77.80 | 22.89 | 17 | 129896 | 38 | 110459348 |
| Musculoskeletal pain | 77.07 | 22.89 | 421 | 129492 | 182602 | 110276784 |
| Hypertension | 76.91 | 22.89 | 323 | 129590 | 509761 | 109949625 |
| Gastrointestinal disorder | 76.81 | 22.89 | 103 | 129810 | 241849 | 110217537 |
| Constipation | 76.52 | 22.89 | 194 | 129719 | 357592 | 110101794 |
| Application site swelling | 75.22 | 22.89 | 31 | 129882 | 856 | 110458530 |
| Rash maculo-papular | 74.11 | 22.89 | 3 | 129910 | 74219 | 110385167 |
| Bone pain | 73.61 | 22.89 | 205 | 129708 | 64928 | 110394458 |
| International normalised ratio increased | 73.61 | 22.89 | 8 | 129905 | 86764 | 110372622 |
| Rash pruritic | 71.88 | 22.89 | 266 | 129647 | 97803 | 110361583 |
| Drug-induced liver injury | 71.13 | 22.89 | 26 | 129887 | 120041 | 110339345 |
| Coronary artery bypass | 70.95 | 22.89 | 58 | 129855 | 5984 | 110453402 |
| Renal impairment | 70.87 | 22.89 | 70 | 129843 | 188375 | 110271011 |
| Hypercholesterolaemia | 70.75 | 22.89 | 11 | 129902 | 90826 | 110368560 |
| Encephalopathy | 69.98 | 22.89 | 7 | 129906 | 81048 | 110378338 |
| Pneumonitis | 67.69 | 22.89 | 6 | 129907 | 76525 | 110382861 |
| Liver disorder | 67.16 | 22.89 | 42 | 129871 | 142201 | 110317185 |
| Agitation | 66.10 | 22.89 | 25 | 129888 | 113026 | 110346360 |
| Alanine aminotransferase increased | 66.01 | 22.89 | 71 | 129842 | 183702 | 110275684 |
| Intentional product misuse | 65.88 | 22.89 | 320 | 129593 | 132584 | 110326802 |
| Sedation | 65.81 | 22.89 | 4 | 129909 | 69679 | 110389707 |
| Injection site irritation | 65.80 | 22.89 | 51 | 129862 | 4873 | 110454513 |
| Hypoglycaemia | 65.71 | 22.89 | 27 | 129886 | 116077 | 110343309 |
| Injection site warmth | 65.33 | 22.89 | 91 | 129822 | 17314 | 110442072 |
| Nervousness | 65.31 | 22.89 | 138 | 129775 | 36713 | 110422673 |
| Pneumonia aspiration | 65.21 | 22.89 | 9 | 129904 | 81224 | 110378162 |
| Depression | 64.84 | 22.89 | 176 | 129737 | 317159 | 110142227 |
| Aspartate aminotransferase increased | 64.16 | 22.89 | 56 | 129857 | 159880 | 110299506 |
| Injection site reaction | 63.12 | 22.89 | 239 | 129674 | 88831 | 110370555 |
| Discomfort | 62.62 | 22.89 | 97 | 129816 | 214610 | 110244776 |
| Application site haemorrhage | 62.62 | 22.89 | 32 | 129881 | 1464 | 110457922 |
| Fibromyalgia | 62.54 | 22.89 | 65 | 129848 | 170844 | 110288542 |
| Mental status changes | 62.14 | 22.89 | 8 | 129905 | 76114 | 110383272 |
| Haematochezia | 62 | 22.89 | 29 | 129884 | 115495 | 110343891 |
| Blood bilirubin increased | 61.98 | 22.89 | 8 | 129905 | 75964 | 110383422 |
| Therapy interrupted | 61.50 | 22.89 | 162 | 129751 | 49660 | 110409726 |
| Limb discomfort | 61.15 | 22.89 | 143 | 129770 | 40711 | 110418675 |
| Pulmonary oedema | 60.99 | 22.89 | 21 | 129892 | 100638 | 110358748 |
| Hypocalcaemia | 60.99 | 22.89 | 4 | 129909 | 65362 | 110394024 |
| Red blood cell sedimentation rate increased | 59.82 | 22.89 | 10 | 129903 | 78292 | 110381094 |
| Melaena | 59.19 | 22.89 | 6 | 129907 | 68751 | 110390635 |
| Injection site paraesthesia | 58.95 | 22.89 | 25 | 129888 | 743 | 110458643 |
| Acute respiratory failure | 58.87 | 22.89 | 9 | 129904 | 75251 | 110384135 |
| Musculoskeletal discomfort | 58.81 | 22.89 | 102 | 129811 | 23436 | 110435950 |
| Hypomagnesaemia | 58.45 | 22.89 | 3 | 129910 | 60367 | 110399019 |
| Syncope | 57.65 | 22.89 | 93 | 129820 | 202443 | 110256943 |
| Colitis | 57.57 | 22.89 | 24 | 129889 | 102299 | 110357087 |
| No adverse event | 57.37 | 22.89 | 9 | 129904 | 73830 | 110385556 |
| White blood cell count increased | 57.32 | 22.89 | 21 | 129892 | 96821 | 110362565 |
| Device delivery system issue | 57.17 | 22.89 | 34 | 129879 | 2099 | 110457287 |
| Haematemesis | 57.03 | 22.89 | 3 | 129910 | 59105 | 110400281 |
| Lower limb fracture | 56.73 | 22.89 | 10 | 129903 | 75338 | 110384048 |
| Hepatotoxicity | 55.99 | 22.89 | 5 | 129908 | 63395 | 110395991 |
| Fractional exhaled nitric oxide increased | 55.41 | 22.89 | 24 | 129889 | 752 | 110458634 |
| Anaphylactic reaction | 55.00 | 22.89 | 33 | 129880 | 114267 | 110345119 |
| Lipoprotein (a) increased | 54.66 | 22.89 | 15 | 129898 | 109 | 110459277 |
| Muscular weakness | 53.31 | 22.89 | 485 | 129428 | 247983 | 110211403 |
| Hepatic cirrhosis | 53.10 | 22.89 | 8 | 129905 | 67618 | 110391768 |
| Suicidal ideation | 52.90 | 22.89 | 22 | 129891 | 93915 | 110365471 |
| Coronary artery occlusion | 52.66 | 22.89 | 78 | 129835 | 15694 | 110443692 |
| Altered state of consciousness | 52.40 | 22.89 | 4 | 129909 | 57622 | 110401764 |
| Injection site haematoma | 51.38 | 22.89 | 45 | 129868 | 5101 | 110454285 |
| Throat irritation | 51.37 | 22.89 | 159 | 129754 | 53393 | 110405993 |
| Increased tendency to bruise | 51.05 | 22.89 | 66 | 129847 | 11692 | 110447694 |
| Rhabdomyolysis | 50.96 | 22.89 | 40 | 129873 | 120361 | 110339025 |
| Application site pain | 50.77 | 22.89 | 46 | 129867 | 5453 | 110453933 |
| Colitis ulcerative | 50.72 | 22.89 | 14 | 129899 | 77349 | 110382037 |
| Device physical property issue | 50.06 | 22.89 | 39 | 129874 | 3755 | 110455631 |
| Myocardial infarction | 49.70 | 22.89 | 391 | 129522 | 191692 | 110267694 |
| Haematocrit decreased | 49.29 | 22.89 | 9 | 129904 | 66108 | 110393278 |
| Lymphocyte count decreased | 49.27 | 22.89 | 5 | 129908 | 57238 | 110402148 |
| Unresponsive to stimuli | 49.06 | 22.89 | 8 | 129905 | 63782 | 110395604 |
| Hepatic function abnormal | 48.56 | 22.89 | 22 | 129891 | 89273 | 110370113 |
| Cellulitis | 48.31 | 22.89 | 46 | 129867 | 125970 | 110333416 |
| Osteoporosis | 48.14 | 22.89 | 21 | 129892 | 87131 | 110372255 |
| Grip strength decreased | 48.10 | 22.89 | 17 | 129896 | 80157 | 110379229 |
| Blood alkaline phosphatase increased | 48.10 | 22.89 | 12 | 129901 | 70923 | 110388463 |
| Hallucination | 47.81 | 22.89 | 30 | 129883 | 101402 | 110357984 |
| Haematuria | 47.46 | 22.89 | 19 | 129894 | 82986 | 110376400 |
| Product quality issue | 47.05 | 22.89 | 16 | 129897 | 77283 | 110382103 |
| Jaundice | 46.53 | 22.89 | 7 | 129906 | 59229 | 110400157 |
| Plasma cell myeloma | 46.00 | 22.89 | 9 | 129904 | 62927 | 110396459 |
| Off label use | 45.41 | 22.89 | 1380 | 128533 | 1498805 | 108960581 |
| Shock | 45.30 | 22.89 | 5 | 129908 | 53583 | 110405803 |
| Red blood cell count decreased | 44.99 | 22.89 | 11 | 129902 | 65912 | 110393474 |
| Injection site hypoaesthesia | 44.90 | 22.89 | 20 | 129893 | 671 | 110458715 |
| Hepatocellular injury | 44.71 | 22.89 | 4 | 129909 | 50638 | 110408748 |
| Night sweats | 44.61 | 22.89 | 55 | 129858 | 133928 | 110325458 |
| Autoimmune disorder | 44.55 | 22.89 | 11 | 129902 | 65472 | 110393914 |
| Headache | 44.41 | 22.89 | 1353 | 128560 | 881024 | 109578362 |
| Aggression | 44.27 | 22.89 | 8 | 129905 | 59202 | 110400184 |
| Multiple sclerosis relapse | 44.26 | 22.89 | 4 | 129909 | 50236 | 110409150 |
| Respiratory distress | 44.16 | 22.89 | 13 | 129900 | 68861 | 110390525 |
| Dysarthria | 43.79 | 22.89 | 22 | 129891 | 84099 | 110375287 |
| Leukocytosis | 43.12 | 22.89 | 6 | 129907 | 53822 | 110405564 |
| Hypercalcaemia | 43.10 | 22.89 | 3 | 129910 | 46654 | 110412732 |
| Loss of consciousness | 43.06 | 22.89 | 105 | 129808 | 196201 | 110263185 |
| Alopecia | 42.84 | 22.89 | 252 | 129661 | 364501 | 110094885 |
| Acute respiratory distress syndrome | 42.45 | 22.89 | 6 | 129907 | 53192 | 110406194 |
| Cardiogenic shock | 42.33 | 22.89 | 8 | 129905 | 57330 | 110402056 |
| Gamma-glutamyltransferase increased | 42.29 | 22.89 | 10 | 129903 | 61299 | 110398087 |
| Gait disturbance | 42.13 | 22.89 | 506 | 129407 | 277702 | 110181684 |
| Drug level increased | 41.51 | 22.89 | 4 | 129909 | 47715 | 110411671 |
| Adverse event | 40.98 | 22.89 | 243 | 129670 | 108566 | 110350820 |
| Taste disorder | 40.74 | 22.89 | 13 | 129900 | 65374 | 110394012 |
| Road traffic accident | 40.25 | 22.89 | 40 | 129873 | 107358 | 110352028 |
| Sluggishness | 40.16 | 22.89 | 47 | 129866 | 7520 | 110451866 |
| Pulmonary hypertension | 40.14 | 22.89 | 8 | 129905 | 55212 | 110404174 |
| Psychotic disorder | 40.05 | 22.89 | 6 | 129907 | 50931 | 110408455 |
| Blood pressure systolic increased | 39.87 | 22.89 | 24 | 129889 | 82967 | 110376419 |
| Orthostatic hypotension | 39.83 | 22.89 | 14 | 129899 | 66235 | 110393151 |
| Blepharospasm | 39.76 | 22.89 | 8 | 129905 | 54843 | 110404543 |
| Haemoptysis | 39.72 | 22.89 | 17 | 129896 | 71337 | 110388049 |
| Coeliac disease | 39.26 | 22.89 | 3 | 129910 | 43184 | 110416202 |
| Psoriasis | 39.16 | 22.89 | 65 | 129848 | 139928 | 110319458 |
| Nail disorder | 38.89 | 22.89 | 10 | 129903 | 57925 | 110401461 |
| Basal cell carcinoma | 38.84 | 22.89 | 4 | 129909 | 45266 | 110414120 |
| Transaminases increased | 38.79 | 22.89 | 13 | 129900 | 63377 | 110396009 |
| Cerebral haemorrhage | 38.59 | 22.89 | 14 | 129899 | 64954 | 110394432 |
| Dyspnoea | 38.58 | 22.89 | 998 | 128915 | 1105874 | 109353512 |
| Hypervolaemia | 38.49 | 22.89 | 6 | 129907 | 49454 | 110409932 |
| Bacteraemia | 38.38 | 22.89 | 3 | 129910 | 42387 | 110416999 |
| COVID-19 | 38.24 | 22.89 | 153 | 129760 | 244907 | 110214479 |
| Burning sensation | 37.47 | 22.89 | 171 | 129742 | 69041 | 110390345 |
| Vascular graft | 37.42 | 22.89 | 26 | 129887 | 2099 | 110457287 |
| Respiratory arrest | 37.38 | 22.89 | 11 | 129902 | 58288 | 110401098 |
| Clostridium difficile colitis | 37.22 | 22.89 | 4 | 129909 | 43774 | 110415612 |
| Dizziness | 36.55 | 22.89 | 1076 | 128837 | 697117 | 109762269 |
| Haemorrhage | 36.36 | 22.89 | 43 | 129870 | 106649 | 110352737 |
| Blood glucose abnormal | 36.30 | 22.89 | 59 | 129854 | 12857 | 110446529 |
| Anxiety | 36.10 | 22.89 | 247 | 129666 | 344831 | 110114555 |
| Stevens-Johnson syndrome | 35.80 | 22.89 | 6 | 129907 | 46895 | 110412491 |
| Surgery | 35.44 | 22.89 | 118 | 129795 | 41165 | 110418221 |
| Treatment noncompliance | 35.22 | 22.89 | 21 | 129892 | 72969 | 110386417 |
| Device related infection | 35.21 | 22.89 | 3 | 129910 | 39516 | 110419870 |
| Injection site laceration | 35.09 | 22.89 | 11 | 129902 | 133 | 110459253 |
| Clostridium difficile infection | 34.99 | 22.89 | 9 | 129904 | 52120 | 110407266 |
| Disease recurrence | 34.61 | 22.89 | 14 | 129899 | 60770 | 110398616 |
| Sleep disorder due to a general medical condition | 34.60 | 22.89 | 137 | 129776 | 51975 | 110407411 |
| Liver function test abnormal | 34.46 | 22.89 | 19 | 129894 | 68931 | 110390455 |
| Circulatory collapse | 33.95 | 22.89 | 5 | 129908 | 42988 | 110416398 |
| Body temperature increased | 33.87 | 22.89 | 11 | 129902 | 54702 | 110404684 |
| Drug resistance | 33.74 | 22.89 | 12 | 129901 | 56362 | 110403024 |
| Thrombosis | 33.72 | 22.89 | 47 | 129866 | 108615 | 110350771 |
| Neck pain | 33.71 | 22.89 | 254 | 129659 | 122876 | 110336510 |
| High density lipoprotein increased | 33.20 | 22.89 | 21 | 129892 | 1448 | 110457938 |
| Fatigue | 33.13 | 22.89 | 1745 | 128168 | 1214213 | 109245173 |
| Blood lactate dehydrogenase increased | 33.12 | 22.89 | 6 | 129907 | 44328 | 110415058 |
| Myelodysplastic syndrome | 32.98 | 22.89 | 3 | 129910 | 37481 | 110421905 |
| Intentional self-injury | 32.92 | 22.89 | 3 | 129910 | 37426 | 110421960 |
| Pericardial effusion | 32.87 | 22.89 | 13 | 129900 | 57204 | 110402182 |
| Secretion discharge | 32.66 | 22.89 | 73 | 129840 | 20171 | 110439215 |
| Staphylococcal infection | 32.53 | 22.89 | 21 | 129892 | 69923 | 110389463 |
| Aphonia | 32.48 | 22.89 | 56 | 129857 | 12804 | 110446582 |
| Head discomfort | 32.34 | 22.89 | 70 | 129843 | 18930 | 110440456 |
| Adverse reaction | 32.31 | 22.89 | 92 | 129821 | 29502 | 110429884 |
| Urinary retention | 32.30 | 22.89 | 21 | 129892 | 69662 | 110389724 |
| Ventricular fibrillation | 32.18 | 22.89 | 5 | 129908 | 41308 | 110418078 |
| Pallor | 32.16 | 22.89 | 13 | 129900 | 56454 | 110402932 |
| Lipids increased | 32.10 | 22.89 | 23 | 129890 | 1950 | 110457436 |
| Nausea | 31.81 | 22.89 | 1160 | 128753 | 1234530 | 109224856 |
| Full blood count abnormal | 31.77 | 22.89 | 13 | 129900 | 56039 | 110403347 |
| Drug delivery system malfunction | 31.73 | 22.89 | 18 | 129895 | 1017 | 110458369 |
| Hyperglycaemia | 31.53 | 22.89 | 32 | 129881 | 85058 | 110374328 |
| Sleep disorder due to general medical condition, insomnia type | 31.49 | 22.89 | 47 | 129866 | 105596 | 110353790 |
| Oral candidiasis | 31.47 | 22.89 | 7 | 129906 | 44753 | 110414633 |
| Blood pressure diastolic decreased | 31.23 | 22.89 | 3 | 129910 | 35882 | 110423504 |
| Candida infection | 30.89 | 22.89 | 9 | 129904 | 48000 | 110411386 |
| Loss of personal independence in daily activities | 30.77 | 22.89 | 83 | 129830 | 149937 | 110309449 |
| Hemiparesis | 30.60 | 22.89 | 7 | 129906 | 43896 | 110415490 |
| Injection site scab | 30.52 | 22.89 | 15 | 129898 | 631 | 110458755 |
| Cardiac disorder | 30.44 | 22.89 | 173 | 129740 | 76107 | 110383279 |
| Blood pressure fluctuation | 30.24 | 22.89 | 26 | 129887 | 74798 | 110384588 |
| Rubber sensitivity | 30.06 | 22.89 | 24 | 129889 | 2394 | 110456992 |
| Back disorder | 29.97 | 22.89 | 72 | 129841 | 20850 | 110438536 |
| Emotional distress | 29.61 | 22.89 | 8 | 129905 | 44839 | 110414547 |
| Coagulopathy | 29.58 | 22.89 | 6 | 129907 | 40905 | 110418481 |
| Ejection fraction decreased | 29.55 | 22.89 | 6 | 129907 | 40874 | 110418512 |
| Application site urticaria | 29.24 | 22.89 | 11 | 129902 | 237 | 110459149 |
| Dry mouth | 29.23 | 22.89 | 128 | 129785 | 199820 | 110259566 |
| Chronic kidney disease | 29.06 | 22.89 | 28 | 129885 | 76263 | 110383123 |
| Diabetic ketoacidosis | 28.74 | 22.89 | 7 | 129906 | 42051 | 110417335 |
| Blood calcium decreased | 28.70 | 22.89 | 4 | 129909 | 35841 | 110423545 |
| Cardiomyopathy | 28.66 | 22.89 | 3 | 129910 | 33522 | 110425864 |
| Coronary arterial stent insertion | 28.54 | 22.89 | 35 | 129878 | 5880 | 110453506 |
| Sleep disorder | 28.53 | 22.89 | 128 | 129785 | 198516 | 110260870 |
| Spinal operation | 28.01 | 22.89 | 48 | 129865 | 10924 | 110448462 |
| Drug eruption | 27.98 | 22.89 | 14 | 129899 | 53645 | 110405741 |
| Haematoma | 27.96 | 22.89 | 17 | 129896 | 58459 | 110400927 |
| Lacrimation increased | 27.95 | 22.89 | 90 | 129823 | 30860 | 110428526 |
| Foot deformity | 27.87 | 22.89 | 11 | 129902 | 48469 | 110410917 |
| COVID-19 pneumonia | 27.81 | 22.89 | 5 | 129908 | 37138 | 110422248 |
| Plantar fasciitis | 27.60 | 22.89 | 32 | 129881 | 5069 | 110454317 |
| Injection site hypersensitivity | 27.51 | 22.89 | 23 | 129890 | 2448 | 110456938 |
| Immunodeficiency | 27.46 | 22.89 | 6 | 129907 | 38832 | 110420554 |
| Neutrophil count increased | 27.43 | 22.89 | 4 | 129909 | 34648 | 110424738 |
| Blood creatine phosphokinase increased | 27.38 | 22.89 | 163 | 129750 | 72914 | 110386472 |
| Catheterisation cardiac | 27.27 | 22.89 | 35 | 129878 | 6156 | 110453230 |
| Small intestinal obstruction | 27.24 | 22.89 | 3 | 129910 | 32210 | 110427176 |
| Bacterial infection | 27.21 | 22.89 | 10 | 129903 | 46026 | 110413360 |
| Abortion spontaneous | 27.04 | 22.89 | 4 | 129909 | 34278 | 110425108 |
| Increased upper airway secretion | 26.95 | 22.89 | 32 | 129881 | 5200 | 110454186 |
| Chronic obstructive pulmonary disease | 26.69 | 22.89 | 55 | 129858 | 109103 | 110350283 |
| Proteinuria | 26.69 | 22.89 | 7 | 129906 | 40011 | 110419375 |
| Iron deficiency anaemia | 26.54 | 22.89 | 3 | 129910 | 31556 | 110427830 |
| Angioedema | 26.39 | 22.89 | 47 | 129866 | 98453 | 110360933 |
| Withdrawal syndrome | 26.34 | 22.89 | 3 | 129910 | 31377 | 110428009 |
| Metastases to bone | 26.33 | 22.89 | 3 | 129910 | 31369 | 110428017 |
| Blood triglycerides decreased | 26.09 | 22.89 | 10 | 129903 | 227 | 110459159 |
| Sinus congestion | 26.09 | 22.89 | 87 | 129826 | 30372 | 110429014 |
| Anaphylactic shock | 26.06 | 22.89 | 14 | 129899 | 51532 | 110407854 |
| Metastases to liver | 25.99 | 22.89 | 5 | 129908 | 35381 | 110424005 |
| Blood triglycerides abnormal | 25.83 | 22.89 | 13 | 129900 | 576 | 110458810 |
| Finger deformity | 25.78 | 22.89 | 4 | 129909 | 33088 | 110426298 |
| Abnormal behaviour | 25.71 | 22.89 | 7 | 129906 | 39032 | 110420354 |
| Dry throat | 25.70 | 22.89 | 42 | 129871 | 9196 | 110450190 |
| Urosepsis | 25.58 | 22.89 | 3 | 129910 | 30672 | 110428714 |
| Myoglobin blood increased | 25.37 | 22.89 | 28 | 129885 | 4204 | 110455182 |
| Intercepted product storage error | 25.33 | 22.89 | 14 | 129899 | 752 | 110458634 |
| Atelectasis | 25.30 | 22.89 | 6 | 129907 | 36706 | 110422680 |
| Vascular stent stenosis | 25.28 | 22.89 | 18 | 129895 | 1511 | 110457875 |
| Acute hepatic failure | 25.05 | 22.89 | 6 | 129907 | 36462 | 110422924 |
| Cardiac failure congestive | 25.01 | 22.89 | 92 | 129821 | 150908 | 110308478 |
| Pruritus | 24.86 | 22.89 | 875 | 129038 | 580685 | 109878701 |
| Full blood count decreased | 24.74 | 22.89 | 4 | 129909 | 32095 | 110427291 |
| Intestinal obstruction | 24.73 | 22.89 | 16 | 129897 | 53211 | 110406175 |
| Skin lesion | 24.70 | 22.89 | 15 | 129898 | 51616 | 110407770 |
| Hallucination, visual | 24.45 | 22.89 | 8 | 129905 | 39597 | 110419789 |
| Mouth ulceration | 24.45 | 22.89 | 13 | 129900 | 48125 | 110411261 |
| Osteonecrosis | 24.29 | 22.89 | 5 | 129908 | 33736 | 110425650 |
| Therapeutic response decreased | 24.13 | 22.89 | 48 | 129865 | 96451 | 110362935 |
| Atrial fibrillation | 23.69 | 22.89 | 165 | 129748 | 229477 | 110229909 |
| Glycosylated haemoglobin decreased | 23.64 | 22.89 | 14 | 129899 | 858 | 110458528 |
| Heart rate decreased | 23.53 | 22.89 | 38 | 129875 | 82718 | 110376668 |
| Gastrooesophageal reflux disease | 23.49 | 22.89 | 120 | 129793 | 179856 | 110279530 |
| Application site discomfort | 23.47 | 22.89 | 11 | 129902 | 416 | 110458970 |
| Osteomyelitis | 23.29 | 22.89 | 7 | 129906 | 36593 | 110422793 |
| Gastric disorder | 23.20 | 22.89 | 89 | 129824 | 33268 | 110426118 |
| Sensation of foreign body | 23.19 | 22.89 | 37 | 129876 | 7938 | 110451448 |
| Laboratory test abnormal | 23.19 | 22.89 | 108 | 129805 | 43971 | 110415415 |
| Subdural haematoma | 23.15 | 22.89 | 7 | 129906 | 36447 | 110422939 |
None
| Source | Code | Description |
|---|---|---|
| ATC | C10AX13 | CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Other lipid modifying agents |
| FDA CS | M0001357 | Antibodies, Monoclonal |
| MeSH PA | D000091362 | PCSK9 Inhibitors |
| MeSH PA | D000924 | Anticholesteremic Agents |
| MeSH PA | D000960 | Hypolipidemic Agents |
| MeSH PA | D000963 | Antimetabolites |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D011480 | Protease Inhibitors |
| MeSH PA | D015842 | Serine Proteinase Inhibitors |
| MeSH PA | D057847 | Lipid Regulating Agents |
| FDA MoA | N0000191730 | PCSK9 Inhibitors |
| FDA EPC | N0000191731 | PCSK9 Inhibitor |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35821 | anticholesteremic drug |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypercholesterolemia | indication | 13644009 | |
| Cardiovascular disease | indication | 49601007 | DOID:1287 |
| Familial hypercholesterolemia - homozygous | indication | 238078005 | |
| Familial hypercholesterolemia - heterozygous | indication | 238079002 | |
| Complex dyslipidemia | indication | 109041000119107 |
None
None
None
None
None
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Proprotein convertase subtilisin/kexin type 9 | Enzyme | INHIBITOR | Kd | 9.72 | IUPHAR | SCIENTIFIC LITERATURE |
| ID | Source |
|---|---|
| D10557 | KEGG_DRUG |
| 4034786 | VANDF |
| CHEBI:755001 | CHEBI |
| CHEMBL2364655 | ChEMBL_ID |
| C577155 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7343 | IUPHAR_LIGAND_ID |
| DB09303 | DRUGBANK_ID |
| 1665684 | RXNORM |
| 236233 | MMSL |
| 31213 | MMSL |
| d08383 | MMSL |
| 016368 | NDDF |
| 716068004 | SNOMEDCT_US |
| 763586000 | SNOMEDCT_US |
| C3529352 | UMLSCUI |
| 9643 | INN_ID |
| LKC0U3A8NJ | UNII |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72511-143 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72511-393 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72511-501 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72511-750 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72511-760 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |