| 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
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 21, 2015 | EMA | ||
| Aug. 28, 2015 | FDA | REPATHA | |
| Jan. 22, 2016 | PMDA | Astellas Pharma |
| 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 | 14548.49 | 26.92 | 4692 | 78107 | 57648 | 63348575 |
| Accidental exposure to product | 10527.33 | 26.92 | 3033 | 79766 | 24372 | 63381851 |
| Device difficult to use | 9197.25 | 26.92 | 2324 | 80475 | 10472 | 63395751 |
| Injection site pain | 7311.12 | 26.92 | 3491 | 79308 | 126309 | 63279914 |
| Injection site bruising | 4104.23 | 26.92 | 1668 | 81131 | 40242 | 63365981 |
| Product dose omission issue | 2958.44 | 26.92 | 2438 | 80361 | 231875 | 63174348 |
| Injection site haemorrhage | 2599.88 | 26.92 | 1032 | 81767 | 23282 | 63382941 |
| Drug dose omission by device | 2474.46 | 26.92 | 671 | 82128 | 4130 | 63402093 |
| Rhinorrhoea | 2220.71 | 26.92 | 1259 | 81540 | 64318 | 63341905 |
| Myalgia | 2018.17 | 26.92 | 1607 | 81192 | 144922 | 63261301 |
| Device issue | 1737.53 | 26.92 | 770 | 82029 | 23011 | 63383212 |
| Device use error | 1713.67 | 26.92 | 525 | 82274 | 5236 | 63400987 |
| Incorrect dose administered by device | 1688.68 | 26.92 | 487 | 82312 | 3861 | 63402362 |
| Influenza like illness | 1549.53 | 26.92 | 1007 | 81792 | 65817 | 63340406 |
| Back pain | 1455.78 | 26.92 | 1753 | 81046 | 262392 | 63143831 |
| Underdose | 1208.78 | 26.92 | 628 | 82171 | 26828 | 63379395 |
| Injury associated with device | 1205.60 | 26.92 | 361 | 82438 | 3305 | 63402918 |
| Product storage error | 1043.12 | 26.92 | 469 | 82330 | 14487 | 63391736 |
| Muscle spasms | 974.10 | 26.92 | 1106 | 81693 | 155044 | 63251179 |
| Injection site swelling | 915.28 | 26.92 | 639 | 82160 | 46933 | 63359290 |
| Low density lipoprotein increased | 839.66 | 26.92 | 315 | 82484 | 6042 | 63400181 |
| Occupational exposure to product | 732.70 | 26.92 | 216 | 82583 | 1862 | 63404361 |
| Injection site mass | 719.95 | 26.92 | 391 | 82408 | 18265 | 63387958 |
| Incorrect disposal of product | 682.93 | 26.92 | 162 | 82637 | 517 | 63405706 |
| Injection site erythema | 676.82 | 26.92 | 679 | 82120 | 82495 | 63323728 |
| Drug ineffective | 620.03 | 26.92 | 297 | 82502 | 1044468 | 62361755 |
| Wrong technique in device usage process | 536.69 | 26.92 | 195 | 82604 | 3403 | 63402820 |
| Pain in extremity | 496.54 | 26.92 | 1234 | 81565 | 330252 | 63075971 |
| Device defective | 487.91 | 26.92 | 156 | 82643 | 1806 | 63404417 |
| Low density lipoprotein decreased | 401.52 | 26.92 | 87 | 82712 | 157 | 63406066 |
| Oropharyngeal pain | 373.30 | 26.92 | 534 | 82265 | 93953 | 63312270 |
| Blood glucose increased | 363.13 | 26.92 | 495 | 82304 | 83261 | 63322962 |
| Condition aggravated | 358.39 | 26.92 | 50 | 82749 | 402167 | 63004056 |
| Device malfunction | 341.09 | 26.92 | 239 | 82560 | 17618 | 63388605 |
| Injection site discomfort | 328.43 | 26.92 | 147 | 82652 | 4483 | 63401740 |
| Injection site discolouration | 309.68 | 26.92 | 167 | 82632 | 7681 | 63398542 |
| Infusion related reaction | 290.93 | 26.92 | 6 | 82793 | 245515 | 63160708 |
| Acute kidney injury | 288.63 | 26.92 | 13 | 82786 | 263402 | 63142821 |
| Fear of injection | 273.09 | 26.92 | 149 | 82650 | 7015 | 63399208 |
| Injection site pruritus | 272.74 | 26.92 | 315 | 82484 | 44801 | 63361422 |
| Blood cholesterol decreased | 272.00 | 26.92 | 84 | 82715 | 860 | 63405363 |
| Contraindicated product administered | 263.27 | 26.92 | 4 | 82795 | 217644 | 63188579 |
| Intercepted product administration error | 260.55 | 26.92 | 67 | 82732 | 323 | 63405900 |
| Feeling abnormal | 259.93 | 26.92 | 588 | 82211 | 147804 | 63258419 |
| Drug interaction | 245.56 | 26.92 | 13 | 82786 | 229118 | 63177105 |
| Blood triglycerides increased | 245.16 | 26.92 | 170 | 82629 | 12318 | 63393905 |
| Anaemia | 242.04 | 26.92 | 45 | 82754 | 293385 | 63112838 |
| Product use issue | 241.15 | 26.92 | 11 | 82788 | 220509 | 63185714 |
| Treatment failure | 231.37 | 26.92 | 6 | 82793 | 199037 | 63207186 |
| Maternal exposure during pregnancy | 231.16 | 26.92 | 14 | 82785 | 220048 | 63186175 |
| Pyrexia | 227.86 | 26.92 | 169 | 82630 | 470309 | 62935914 |
| Rheumatoid arthritis | 213.46 | 26.92 | 37 | 82762 | 253782 | 63152441 |
| Neutropenia | 212.54 | 26.92 | 3 | 82796 | 175002 | 63231221 |
| Systemic lupus erythematosus | 211.50 | 26.92 | 16 | 82783 | 208902 | 63197321 |
| Injection site urticaria | 204.93 | 26.92 | 160 | 82639 | 13913 | 63392310 |
| Vomiting | 203.85 | 26.92 | 259 | 82540 | 559358 | 62846865 |
| Nasopharyngitis | 203.07 | 26.92 | 760 | 82039 | 253497 | 63152726 |
| Injection site rash | 201.44 | 26.92 | 179 | 82620 | 18630 | 63387593 |
| Drug intolerance | 197.17 | 26.92 | 78 | 82721 | 308583 | 63097640 |
| Product use in unapproved indication | 192.34 | 26.92 | 10 | 82789 | 179070 | 63227153 |
| General physical health deterioration | 188.96 | 26.92 | 21 | 82778 | 201381 | 63204842 |
| Circumstance or information capable of leading to medication error | 183.08 | 26.92 | 93 | 82706 | 3777 | 63402446 |
| Infection | 180.86 | 26.92 | 39 | 82760 | 229134 | 63177089 |
| Therapeutic response unexpected | 180.28 | 26.92 | 168 | 82631 | 18591 | 63387632 |
| Inappropriate schedule of product administration | 177.51 | 26.92 | 408 | 82391 | 103557 | 63302666 |
| Thrombocytopenia | 166.98 | 26.92 | 7 | 82792 | 151150 | 63255073 |
| Wound | 163.81 | 26.92 | 13 | 82786 | 163250 | 63242973 |
| Glossodynia | 152.71 | 26.92 | 25 | 82774 | 178851 | 63227372 |
| Pericarditis | 149.09 | 26.92 | 5 | 82794 | 131574 | 63274649 |
| Hypotension | 147.90 | 26.92 | 86 | 82713 | 272518 | 63133705 |
| Influenza | 141.72 | 26.92 | 385 | 82414 | 108337 | 63297886 |
| White blood cell count decreased | 137.00 | 26.92 | 12 | 82787 | 139092 | 63267131 |
| Haemoglobin decreased | 136.86 | 26.92 | 15 | 82784 | 145470 | 63260753 |
| Joint swelling | 136.13 | 26.92 | 136 | 82663 | 327530 | 63078693 |
| Intentional product use issue | 134.64 | 26.92 | 8 | 82791 | 127884 | 63278339 |
| Injection site vesicles | 133.47 | 26.92 | 69 | 82730 | 2908 | 63403315 |
| Oedema peripheral | 132.75 | 26.92 | 41 | 82758 | 189470 | 63216753 |
| Pneumonia | 129.35 | 26.92 | 250 | 82549 | 456517 | 62949706 |
| Product communication issue | 128.75 | 26.92 | 44 | 82755 | 635 | 63405588 |
| Injection site induration | 128.10 | 26.92 | 102 | 82697 | 9124 | 63397099 |
| Arthropathy | 124.62 | 26.92 | 76 | 82723 | 234716 | 63171507 |
| Glycosylated haemoglobin increased | 122.93 | 26.92 | 113 | 82686 | 12285 | 63393938 |
| Memory impairment | 122.92 | 26.92 | 356 | 82443 | 103902 | 63302321 |
| Cough | 119.89 | 26.92 | 721 | 82078 | 292022 | 63114201 |
| Overdose | 118.75 | 26.92 | 8 | 82791 | 115070 | 63291153 |
| Hyponatraemia | 117.79 | 26.92 | 7 | 82792 | 111893 | 63294330 |
| Injection site extravasation | 114.82 | 26.92 | 94 | 82705 | 8747 | 63397476 |
| Hypokalaemia | 113.99 | 26.92 | 5 | 82794 | 103799 | 63302424 |
| Product administered at inappropriate site | 113.15 | 26.92 | 63 | 82736 | 3086 | 63403137 |
| Sepsis | 113.00 | 26.92 | 30 | 82769 | 153093 | 63253130 |
| Seizure | 109.97 | 26.92 | 20 | 82779 | 132614 | 63273609 |
| Drug hypersensitivity | 108.53 | 26.92 | 148 | 82651 | 310539 | 63095684 |
| Pulmonary embolism | 107.31 | 26.92 | 13 | 82786 | 116671 | 63289552 |
| Platelet count decreased | 106.64 | 26.92 | 13 | 82786 | 116109 | 63290114 |
| Stomatitis | 106.59 | 26.92 | 25 | 82774 | 138700 | 63267523 |
| Swelling | 104.68 | 26.92 | 123 | 82676 | 275255 | 63130968 |
| Lower respiratory tract infection | 103.33 | 26.92 | 23 | 82776 | 132284 | 63273939 |
| Device failure | 97.75 | 26.92 | 73 | 82726 | 5938 | 63400285 |
| Respiratory failure | 97.06 | 26.92 | 10 | 82789 | 101848 | 63304375 |
| Incorrect dose administered | 96.45 | 26.92 | 230 | 82569 | 59738 | 63346485 |
| Low density lipoprotein abnormal | 94.12 | 26.92 | 27 | 82772 | 209 | 63406014 |
| Injection site indentation | 93.41 | 26.92 | 26 | 82773 | 178 | 63406045 |
| Intentional product misuse | 93.01 | 26.92 | 229 | 82570 | 60688 | 63345535 |
| Arthralgia | 91.99 | 26.92 | 1140 | 81659 | 568570 | 62837653 |
| Sneezing | 91.74 | 26.92 | 116 | 82683 | 18102 | 63388121 |
| Device dispensing error | 90.46 | 26.92 | 23 | 82776 | 105 | 63406118 |
| Dysphonia | 90.35 | 26.92 | 195 | 82604 | 47419 | 63358804 |
| Death | 90.14 | 26.92 | 224 | 82575 | 374157 | 63032066 |
| Sinus disorder | 89.90 | 26.92 | 134 | 82665 | 24419 | 63381804 |
| Tachycardia | 89.38 | 26.92 | 22 | 82777 | 118134 | 63288089 |
| Sleep disorder due to a general medical condition | 89.00 | 26.92 | 94 | 82705 | 12094 | 63394129 |
| Muscle disorder | 86.79 | 26.92 | 63 | 82736 | 4906 | 63401317 |
| Oxygen saturation decreased | 86.24 | 26.92 | 8 | 82791 | 88577 | 63317646 |
| C-reactive protein increased | 85.99 | 26.92 | 11 | 82788 | 94696 | 63311527 |
| Hepatic enzyme increased | 85.07 | 26.92 | 83 | 82716 | 202245 | 63203978 |
| Pleural effusion | 84.21 | 26.92 | 11 | 82788 | 93199 | 63313024 |
| Discomfort | 80.95 | 26.92 | 60 | 82739 | 167314 | 63238909 |
| Psoriatic arthropathy | 79.86 | 26.92 | 12 | 82787 | 91508 | 63314715 |
| Impaired healing | 79.71 | 26.92 | 18 | 82781 | 102524 | 63303699 |
| Stent placement | 78.14 | 26.92 | 53 | 82746 | 3702 | 63402521 |
| Paranasal sinus hypersecretion | 75.27 | 26.92 | 52 | 82747 | 3743 | 63402480 |
| Cardiac operation | 74.53 | 26.92 | 49 | 82750 | 3249 | 63402974 |
| Fall | 74.01 | 26.92 | 263 | 82536 | 392071 | 63014152 |
| Septic shock | 73.84 | 26.92 | 3 | 82796 | 66626 | 63339597 |
| Musculoskeletal pain | 73.59 | 26.92 | 276 | 82523 | 92001 | 63314222 |
| Confusional state | 73.39 | 26.92 | 122 | 82677 | 236258 | 63169965 |
| Injection site reaction | 71.02 | 26.92 | 202 | 82597 | 58322 | 63347901 |
| Cardiac arrest | 70.44 | 26.92 | 17 | 82782 | 92528 | 63313695 |
| Osteoarthritis | 67.86 | 26.92 | 20 | 82779 | 95323 | 63310900 |
| Dehydration | 67.36 | 26.92 | 76 | 82723 | 173278 | 63232945 |
| Depressed level of consciousness | 64.96 | 26.92 | 4 | 82795 | 62074 | 63344149 |
| Interstitial lung disease | 64.75 | 26.92 | 4 | 82795 | 61904 | 63344319 |
| Deep vein thrombosis | 64.55 | 26.92 | 15 | 82784 | 83785 | 63322438 |
| Injection site injury | 63.25 | 26.92 | 26 | 82773 | 640 | 63405583 |
| Therapeutic product effect decreased | 62.50 | 26.92 | 97 | 82702 | 193090 | 63213133 |
| Incorrect dose administered by product | 62.19 | 26.92 | 19 | 82780 | 187 | 63406036 |
| Adverse reaction | 61.21 | 26.92 | 71 | 82728 | 10132 | 63396091 |
| Neutrophil count decreased | 60.99 | 26.92 | 3 | 82796 | 56403 | 63349820 |
| Nasal congestion | 58.80 | 26.92 | 204 | 82595 | 65456 | 63340767 |
| Injury | 58.67 | 26.92 | 12 | 82787 | 73235 | 63332988 |
| Blister | 58.40 | 26.92 | 50 | 82749 | 129764 | 63276459 |
| Muscle injury | 58.33 | 26.92 | 8 | 82791 | 65337 | 63340886 |
| Lack of injection site rotation | 58.03 | 26.92 | 22 | 82777 | 434 | 63405789 |
| Muscular weakness | 57.59 | 26.92 | 313 | 82486 | 122040 | 63284183 |
| Decreased appetite | 57.44 | 26.92 | 154 | 82645 | 250898 | 63155325 |
| Suicidal ideation | 57.27 | 26.92 | 7 | 82792 | 62414 | 63343809 |
| Injection site warmth | 57.16 | 26.92 | 84 | 82715 | 15111 | 63391112 |
| Renal failure | 57.10 | 26.92 | 42 | 82757 | 117610 | 63288613 |
| Oedema | 56.97 | 26.92 | 28 | 82771 | 97594 | 63308629 |
| Hypoacusis | 56.62 | 26.92 | 108 | 82691 | 24043 | 63382180 |
| Somnolence | 56.59 | 26.92 | 91 | 82708 | 178594 | 63227629 |
| Blood cholesterol abnormal | 56.30 | 26.92 | 38 | 82761 | 2633 | 63403590 |
| Medication error | 55.84 | 26.92 | 3 | 82796 | 52281 | 63353942 |
| Alanine aminotransferase increased | 55.82 | 26.92 | 33 | 82766 | 103737 | 63302486 |
| Abdominal pain | 55.10 | 26.92 | 197 | 82602 | 293259 | 63112964 |
| Respiratory tract congestion | 55.08 | 26.92 | 90 | 82709 | 17742 | 63388481 |
| Bradycardia | 54.66 | 26.92 | 14 | 82785 | 73213 | 63333010 |
| Rash pruritic | 54.60 | 26.92 | 187 | 82612 | 59612 | 63346611 |
| Gastrointestinal haemorrhage | 54.27 | 26.92 | 19 | 82780 | 81157 | 63325066 |
| Application site swelling | 52.98 | 26.92 | 22 | 82777 | 556 | 63405667 |
| Constipation | 52.96 | 26.92 | 136 | 82663 | 224807 | 63181416 |
| Hyperkalaemia | 52.47 | 26.92 | 5 | 82794 | 54198 | 63352025 |
| Cardiac failure | 51.36 | 26.92 | 26 | 82773 | 89116 | 63317107 |
| Multiple sclerosis relapse | 51.10 | 26.92 | 3 | 82796 | 48475 | 63357748 |
| Aspartate aminotransferase increased | 51.02 | 26.92 | 27 | 82772 | 90250 | 63315973 |
| Unevaluable event | 50.74 | 26.92 | 165 | 82634 | 51221 | 63355002 |
| Pulmonary oedema | 50.72 | 26.92 | 6 | 82793 | 54867 | 63351356 |
| Loss of consciousness | 50.14 | 26.92 | 48 | 82751 | 118073 | 63288150 |
| Syncope | 49.48 | 26.92 | 48 | 82751 | 117337 | 63288886 |
| Injection site irritation | 48.63 | 26.92 | 45 | 82754 | 4933 | 63401290 |
| Type 2 diabetes mellitus | 48.07 | 26.92 | 12 | 82787 | 63856 | 63342367 |
| Needle issue | 45.92 | 26.92 | 62 | 82737 | 10314 | 63395909 |
| Throat irritation | 44.75 | 26.92 | 129 | 82670 | 37518 | 63368705 |
| Upper-airway cough syndrome | 44.23 | 26.92 | 64 | 82735 | 11354 | 63394869 |
| Device delivery system issue | 43.88 | 26.92 | 21 | 82778 | 748 | 63405475 |
| Depression | 43.82 | 26.92 | 122 | 82677 | 196370 | 63209853 |
| Bone pain | 42.35 | 26.92 | 162 | 82637 | 54479 | 63351744 |
| Dizziness | 41.88 | 26.92 | 790 | 82009 | 429135 | 62977088 |
| Blood creatinine increased | 41.79 | 26.92 | 32 | 82767 | 87812 | 63318411 |
| Abortion spontaneous | 41.60 | 26.92 | 6 | 82793 | 47189 | 63359034 |
| Cellulitis | 41.42 | 26.92 | 28 | 82771 | 81930 | 63324293 |
| Liver function test abnormal | 40.49 | 26.92 | 7 | 82792 | 48174 | 63358049 |
| Gastrointestinal disorder | 40.45 | 26.92 | 68 | 82731 | 131171 | 63275052 |
| Red blood cell sedimentation rate increased | 40.18 | 26.92 | 5 | 82794 | 43977 | 63362246 |
| Mental status changes | 40.12 | 26.92 | 3 | 82796 | 39596 | 63366627 |
| Neck pain | 40.11 | 26.92 | 188 | 82611 | 69130 | 63337093 |
| Mobility decreased | 40.03 | 26.92 | 283 | 82516 | 120876 | 63285347 |
| No adverse event | 39.60 | 26.92 | 4 | 82795 | 41401 | 63364822 |
| Encephalopathy | 38.92 | 26.92 | 3 | 82796 | 38617 | 63367606 |
| Red blood cell count decreased | 38.69 | 26.92 | 4 | 82795 | 40641 | 63365582 |
| Nervousness | 38.62 | 26.92 | 108 | 82691 | 30871 | 63375352 |
| Renal impairment | 38.56 | 26.92 | 35 | 82764 | 88320 | 63317903 |
| International normalised ratio increased | 38.46 | 26.92 | 7 | 82792 | 46418 | 63359805 |
| Drug-induced liver injury | 38.18 | 26.92 | 4 | 82795 | 40218 | 63366005 |
| Hepatitis | 37.65 | 26.92 | 4 | 82795 | 39784 | 63366439 |
| Pruritus | 37.55 | 26.92 | 671 | 82128 | 360782 | 63045441 |
| Dyspnoea | 37.51 | 26.92 | 622 | 82177 | 660691 | 62745532 |
| Hepatotoxicity | 36.98 | 26.92 | 3 | 82796 | 37038 | 63369185 |
| Limb discomfort | 36.46 | 26.92 | 103 | 82696 | 29613 | 63376610 |
| Application site haemorrhage | 36.37 | 26.92 | 21 | 82778 | 1103 | 63405120 |
| Loss of personal independence in daily activities | 36.32 | 26.92 | 44 | 82755 | 97246 | 63308977 |
| Musculoskeletal disorder | 36.27 | 26.92 | 82 | 82717 | 20562 | 63385661 |
| Product dispensing error | 35.95 | 26.92 | 55 | 82744 | 10250 | 63395973 |
| Orthostatic hypotension | 35.91 | 26.92 | 3 | 82796 | 36157 | 63370066 |
| Application site pain | 35.53 | 26.92 | 35 | 82764 | 4147 | 63402076 |
| Aphonia | 35.52 | 26.92 | 54 | 82745 | 10009 | 63396214 |
| Muscle tightness | 35.32 | 26.92 | 59 | 82740 | 11841 | 63394382 |
| White blood cell count increased | 34.89 | 26.92 | 10 | 82789 | 48551 | 63357672 |
| Coronary artery bypass | 34.62 | 26.92 | 27 | 82772 | 2342 | 63403881 |
| Inflammation | 34.26 | 26.92 | 34 | 82765 | 82239 | 63323984 |
| Therapy non-responder | 34.24 | 26.92 | 192 | 82607 | 75709 | 63330514 |
| Pneumonia aspiration | 33.93 | 26.92 | 3 | 82796 | 34537 | 63371686 |
| Psoriasis | 33.89 | 26.92 | 38 | 82761 | 86919 | 63319304 |
| Hypoglycaemia | 33.89 | 26.92 | 18 | 82781 | 60047 | 63346176 |
| Injection site paraesthesia | 33.85 | 26.92 | 16 | 82783 | 554 | 63405669 |
| Agitation | 33.58 | 26.92 | 18 | 82781 | 59739 | 63346484 |
| Abdominal discomfort | 33.47 | 26.92 | 263 | 82536 | 320622 | 63085601 |
| Drug ineffective for unapproved indication | 33.35 | 26.92 | 3 | 82796 | 34060 | 63372163 |
| Injection site hypersensitivity | 33.06 | 26.92 | 25 | 82774 | 2072 | 63404151 |
| Pulmonary fibrosis | 32.98 | 26.92 | 6 | 82793 | 39803 | 63366420 |
| Hepatic failure | 32.70 | 26.92 | 4 | 82795 | 35652 | 63370571 |
| Staphylococcal infection | 32.54 | 26.92 | 7 | 82792 | 41249 | 63364974 |
| Blood alkaline phosphatase increased | 32.48 | 26.92 | 8 | 82791 | 42959 | 63363264 |
| Increased tendency to bruise | 32.24 | 26.92 | 53 | 82746 | 10499 | 63395724 |
| Pneumonitis | 32.18 | 26.92 | 4 | 82795 | 35218 | 63371005 |
| Hepatic function abnormal | 32.10 | 26.92 | 5 | 82794 | 37137 | 63369086 |
| Pulmonary hypertension | 32.07 | 26.92 | 5 | 82794 | 37118 | 63369105 |
| Wheezing | 31.86 | 26.92 | 47 | 82752 | 95548 | 63310675 |
| Asthma | 31.66 | 26.92 | 75 | 82724 | 127486 | 63278737 |
| Emotional distress | 31.51 | 26.92 | 3 | 82796 | 32546 | 63373677 |
| Chronic kidney disease | 31.44 | 26.92 | 10 | 82789 | 45388 | 63360835 |
| Osteoporosis | 31.16 | 26.92 | 18 | 82781 | 57320 | 63348903 |
| Device leakage | 30.79 | 26.92 | 42 | 82757 | 7054 | 63399169 |
| Gamma-glutamyltransferase increased | 30.77 | 26.92 | 4 | 82795 | 34027 | 63372196 |
| Rash maculo-papular | 30.72 | 26.92 | 3 | 82796 | 31893 | 63374330 |
| Plasma cell myeloma | 30.65 | 26.92 | 5 | 82794 | 35900 | 63370323 |
| Back disorder | 30.56 | 26.92 | 53 | 82746 | 10964 | 63395259 |
| Rectal haemorrhage | 30.25 | 26.92 | 13 | 82786 | 49017 | 63357206 |
| High density lipoprotein decreased | 30.14 | 26.92 | 24 | 82775 | 2146 | 63404077 |
| Irritable bowel syndrome | 30.00 | 26.92 | 38 | 82761 | 82374 | 63323849 |
| Body temperature increased | 29.98 | 26.92 | 6 | 82793 | 37186 | 63369037 |
| Femur fracture | 29.27 | 26.92 | 9 | 82790 | 41747 | 63364476 |
| Laboratory test abnormal | 28.93 | 26.92 | 89 | 82710 | 26823 | 63379400 |
| Haematemesis | 28.93 | 26.92 | 3 | 82796 | 30409 | 63375814 |
| Melaena | 28.87 | 26.92 | 3 | 82796 | 30362 | 63375861 |
| Blood pressure systolic increased | 28.56 | 26.92 | 13 | 82786 | 47384 | 63358839 |
| Dysarthria | 28.54 | 26.92 | 10 | 82789 | 42701 | 63363522 |
| Hypertension | 28.16 | 26.92 | 231 | 82568 | 279072 | 63127151 |
| Treatment noncompliance | 28.11 | 26.92 | 7 | 82792 | 37318 | 63368905 |
| Atrial fibrillation | 27.82 | 26.92 | 70 | 82729 | 116566 | 63289657 |
| Lipids increased | 27.57 | 26.92 | 18 | 82781 | 1179 | 63405044 |
| Jaundice | 27.53 | 26.92 | 3 | 82796 | 29248 | 63376975 |
| Haematochezia | 27.44 | 26.92 | 18 | 82781 | 53526 | 63352697 |
| Neuropathy peripheral | 27.28 | 26.92 | 68 | 82731 | 113599 | 63292624 |
| 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 | 10953.20 | 27.91 | 3484 | 52793 | 32502 | 34868152 |
| Accidental exposure to product | 7049.64 | 27.91 | 1966 | 54311 | 10836 | 34889818 |
| Device difficult to use | 6243.08 | 27.91 | 1336 | 54941 | 1561 | 34899093 |
| Injection site pain | 3411.92 | 27.91 | 1522 | 54755 | 37483 | 34863171 |
| Product dose omission issue | 2483.08 | 27.91 | 1820 | 54457 | 117891 | 34782763 |
| Injection site bruising | 2325.58 | 27.91 | 767 | 55510 | 7896 | 34892758 |
| Myalgia | 2060.27 | 27.91 | 1417 | 54860 | 82693 | 34817961 |
| Injection site haemorrhage | 1957.94 | 27.91 | 695 | 55582 | 9073 | 34891581 |
| Drug dose omission by device | 1942.39 | 27.91 | 494 | 55783 | 1745 | 34898909 |
| Rhinorrhoea | 1874.48 | 27.91 | 885 | 55392 | 24783 | 34875871 |
| Incorrect dose administered by device | 1666.22 | 27.91 | 421 | 55856 | 1437 | 34899217 |
| Influenza like illness | 1607.71 | 27.91 | 816 | 55461 | 26818 | 34873836 |
| Back pain | 1494.01 | 27.91 | 1366 | 54911 | 120423 | 34780231 |
| Device issue | 1302.76 | 27.91 | 516 | 55761 | 9261 | 34891393 |
| Device use error | 1186.18 | 27.91 | 339 | 55938 | 2036 | 34898618 |
| Low density lipoprotein decreased | 950.87 | 27.91 | 244 | 56033 | 899 | 34899755 |
| Injection site swelling | 938.37 | 27.91 | 429 | 55848 | 11098 | 34889556 |
| Product storage error | 924.80 | 27.91 | 383 | 55894 | 7739 | 34892915 |
| Underdose | 745.68 | 27.91 | 388 | 55889 | 13392 | 34887262 |
| Muscle spasms | 675.25 | 27.91 | 712 | 55565 | 74289 | 34826365 |
| Injection site mass | 656.08 | 27.91 | 283 | 55994 | 6343 | 34894311 |
| Injury associated with device | 586.34 | 27.91 | 166 | 56111 | 957 | 34899697 |
| Nasopharyngitis | 564.40 | 27.91 | 627 | 55650 | 69341 | 34831313 |
| Arthralgia | 516.18 | 27.91 | 955 | 55322 | 169086 | 34731568 |
| Low density lipoprotein increased | 494.06 | 27.91 | 206 | 56071 | 4230 | 34896424 |
| Blood cholesterol decreased | 460.80 | 27.91 | 136 | 56141 | 928 | 34899726 |
| Injection site discomfort | 409.31 | 27.91 | 137 | 56140 | 1473 | 34899181 |
| Acute kidney injury | 408.97 | 27.91 | 20 | 56257 | 304968 | 34595686 |
| Device defective | 407.91 | 27.91 | 115 | 56162 | 651 | 34900003 |
| Injection site erythema | 373.48 | 27.91 | 262 | 56015 | 15637 | 34885017 |
| Incorrect disposal of product | 371.56 | 27.91 | 91 | 56186 | 262 | 34900392 |
| Wrong technique in device usage process | 350.30 | 27.91 | 120 | 56157 | 1392 | 34899262 |
| Pain in extremity | 341.86 | 27.91 | 677 | 55600 | 125836 | 34774818 |
| Drug interaction | 286.79 | 27.91 | 20 | 56257 | 225926 | 34674728 |
| Device malfunction | 285.75 | 27.91 | 189 | 56088 | 10232 | 34890422 |
| Drug ineffective | 273.58 | 27.91 | 203 | 56074 | 456548 | 34444106 |
| Anaemia | 265.89 | 27.91 | 32 | 56245 | 233303 | 34667351 |
| Oropharyngeal pain | 263.56 | 27.91 | 305 | 55972 | 35180 | 34865474 |
| Pneumonia | 227.57 | 27.91 | 153 | 56124 | 362474 | 34538180 |
| Condition aggravated | 214.85 | 27.91 | 28 | 56249 | 192168 | 34708486 |
| Hypotension | 211.39 | 27.91 | 49 | 56228 | 221600 | 34679054 |
| Thrombocytopenia | 206.63 | 27.91 | 11 | 56266 | 156236 | 34744418 |
| Injection site discolouration | 206.38 | 27.91 | 81 | 56196 | 1412 | 34899242 |
| Blood glucose increased | 194.42 | 27.91 | 369 | 55908 | 66349 | 34834305 |
| Injection site urticaria | 193.62 | 27.91 | 85 | 56192 | 1987 | 34898667 |
| Injection site pruritus | 187.44 | 27.91 | 125 | 56152 | 6858 | 34893796 |
| Feeling abnormal | 187.05 | 27.91 | 352 | 55925 | 62883 | 34837771 |
| Pyrexia | 186.36 | 27.91 | 158 | 56119 | 332855 | 34567799 |
| Sepsis | 182.00 | 27.91 | 26 | 56251 | 166535 | 34734119 |
| Musculoskeletal pain | 175.21 | 27.91 | 236 | 56041 | 31727 | 34868927 |
| Circumstance or information capable of leading to medication error | 172.81 | 27.91 | 75 | 56202 | 1704 | 34898950 |
| Therapeutic response unexpected | 166.94 | 27.91 | 133 | 56144 | 9624 | 34891030 |
| Respiratory failure | 155.94 | 27.91 | 4 | 56273 | 108568 | 34792086 |
| Intercepted product administration error | 155.80 | 27.91 | 43 | 56234 | 222 | 34900432 |
| General physical health deterioration | 152.49 | 27.91 | 15 | 56262 | 128254 | 34772400 |
| Product use in unapproved indication | 150.05 | 27.91 | 10 | 56267 | 117489 | 34783165 |
| Occupational exposure to product | 149.63 | 27.91 | 45 | 56232 | 330 | 34900324 |
| Platelet count decreased | 147.71 | 27.91 | 12 | 56265 | 119705 | 34780949 |
| Nasal congestion | 146.26 | 27.91 | 183 | 56094 | 22874 | 34877780 |
| Adverse event | 143.01 | 27.91 | 164 | 56113 | 18713 | 34881941 |
| Injection site vesicles | 141.74 | 27.91 | 51 | 56226 | 690 | 34899964 |
| Completed suicide | 139.55 | 27.91 | 4 | 56273 | 98164 | 34802490 |
| Vomiting | 138.92 | 27.91 | 117 | 56160 | 247504 | 34653150 |
| Haemoglobin decreased | 136.28 | 27.91 | 17 | 56260 | 120755 | 34779899 |
| Blood triglycerides increased | 133.41 | 27.91 | 138 | 56139 | 14021 | 34886633 |
| Device failure | 131.56 | 27.91 | 68 | 56209 | 2308 | 34898346 |
| Inappropriate schedule of product administration | 124.99 | 27.91 | 296 | 55981 | 62000 | 34838654 |
| Renal failure | 124.04 | 27.91 | 29 | 56248 | 130528 | 34770126 |
| Disease progression | 122.45 | 27.91 | 15 | 56262 | 108062 | 34792592 |
| White blood cell count decreased | 122.20 | 27.91 | 8 | 56269 | 95437 | 34805217 |
| Sinus disorder | 122.11 | 27.91 | 97 | 56180 | 6988 | 34893666 |
| Pancytopenia | 118.87 | 27.91 | 9 | 56268 | 95148 | 34805506 |
| Product administered at inappropriate site | 118.10 | 27.91 | 62 | 56215 | 2174 | 34898480 |
| Injection site rash | 117.90 | 27.91 | 77 | 56200 | 4076 | 34896578 |
| Overdose | 112.65 | 27.91 | 9 | 56268 | 91050 | 34809604 |
| Hyponatraemia | 111.86 | 27.91 | 5 | 56272 | 82686 | 34817968 |
| Injection site reaction | 110.33 | 27.91 | 120 | 56157 | 12913 | 34887741 |
| Oedema peripheral | 109.18 | 27.91 | 29 | 56248 | 119783 | 34780871 |
| Fear of injection | 108.37 | 27.91 | 52 | 56225 | 1500 | 34899154 |
| Influenza | 106.19 | 27.91 | 242 | 56035 | 49424 | 34851230 |
| Low density lipoprotein abnormal | 105.69 | 27.91 | 34 | 56243 | 319 | 34900335 |
| Dehydration | 103.31 | 27.91 | 40 | 56237 | 129929 | 34770725 |
| Seizure | 102.17 | 27.91 | 22 | 56255 | 104835 | 34795819 |
| Decreased appetite | 100.31 | 27.91 | 73 | 56204 | 166319 | 34734335 |
| Fractional exhaled nitric oxide increased | 99.84 | 27.91 | 44 | 56233 | 1038 | 34899616 |
| Application site mass | 96.57 | 27.91 | 19 | 56258 | 8 | 34900646 |
| Gastrointestinal haemorrhage | 96.11 | 27.91 | 14 | 56263 | 88463 | 34812191 |
| Incorrect dose administered by product | 93.40 | 27.91 | 20 | 56257 | 23 | 34900631 |
| Hyperkalaemia | 91.28 | 27.91 | 5 | 56272 | 69384 | 34831270 |
| Product communication issue | 88.71 | 27.91 | 31 | 56246 | 383 | 34900271 |
| Multiple organ dysfunction syndrome | 88.26 | 27.91 | 10 | 56267 | 76556 | 34824098 |
| Adverse reaction | 88.01 | 27.91 | 57 | 56220 | 2974 | 34897680 |
| Fall | 87.86 | 27.91 | 119 | 56158 | 202766 | 34697888 |
| Intentional product misuse | 87.44 | 27.91 | 213 | 56064 | 45398 | 34855256 |
| Septic shock | 86.38 | 27.91 | 8 | 56269 | 71826 | 34828828 |
| Death | 84.87 | 27.91 | 342 | 55935 | 397707 | 34502947 |
| Paranasal sinus hypersecretion | 84.01 | 27.91 | 38 | 56239 | 955 | 34899699 |
| Secretion discharge | 83.32 | 27.91 | 72 | 56205 | 5833 | 34894821 |
| Dysphonia | 81.62 | 27.91 | 140 | 56137 | 23243 | 34877411 |
| Leukopenia | 81.24 | 27.91 | 5 | 56272 | 62851 | 34837803 |
| Pulmonary embolism | 81.21 | 27.91 | 22 | 56255 | 89724 | 34810930 |
| Injection site induration | 81.12 | 27.91 | 53 | 56224 | 2807 | 34897847 |
| Blood creatinine increased | 80.98 | 27.91 | 26 | 56251 | 94950 | 34805704 |
| Hypokalaemia | 80.47 | 27.91 | 3 | 56274 | 58211 | 34842443 |
| Plantar fasciitis | 79.77 | 27.91 | 47 | 56230 | 2069 | 34898585 |
| Pleural effusion | 79.65 | 27.91 | 17 | 56260 | 81529 | 34819125 |
| Cardiac failure | 79.55 | 27.91 | 24 | 56253 | 91224 | 34809430 |
| Respiratory tract congestion | 78.92 | 27.91 | 71 | 56206 | 6068 | 34894586 |
| Memory impairment | 77.46 | 27.91 | 197 | 56080 | 43121 | 34857533 |
| Mobility decreased | 77.20 | 27.91 | 158 | 56119 | 29970 | 34870684 |
| Interstitial lung disease | 76.58 | 27.91 | 8 | 56269 | 65274 | 34835380 |
| Deep vein thrombosis | 76.53 | 27.91 | 8 | 56269 | 65240 | 34835414 |
| Device dispensing error | 75.32 | 27.91 | 18 | 56259 | 45 | 34900609 |
| Pain | 75.19 | 27.91 | 575 | 55702 | 204100 | 34696554 |
| Glycosylated haemoglobin increased | 74.97 | 27.91 | 92 | 56185 | 11268 | 34889386 |
| Blood cholesterol increased | 74.35 | 27.91 | 125 | 56152 | 20418 | 34880236 |
| Intentional product use issue | 73.72 | 27.91 | 6 | 56271 | 59810 | 34840844 |
| Hypoxia | 72.37 | 27.91 | 4 | 56273 | 55091 | 34845563 |
| Cardiac arrest | 70.93 | 27.91 | 33 | 56244 | 96126 | 34804528 |
| Confusional state | 70.34 | 27.91 | 77 | 56200 | 144083 | 34756571 |
| Tachycardia | 67.47 | 27.91 | 26 | 56251 | 84746 | 34815908 |
| Bradycardia | 67.27 | 27.91 | 19 | 56258 | 75399 | 34825255 |
| Sensation of foreign body | 65.63 | 27.91 | 46 | 56231 | 2737 | 34897917 |
| Muscular weakness | 65.16 | 27.91 | 261 | 56016 | 72636 | 34828018 |
| Agitation | 64.90 | 27.91 | 8 | 56269 | 57391 | 34843263 |
| Syncope | 62.06 | 27.91 | 35 | 56242 | 91416 | 34809238 |
| Sneezing | 60.34 | 27.91 | 57 | 56220 | 5185 | 34895469 |
| Hypoacusis | 60.07 | 27.91 | 100 | 56177 | 16201 | 34884453 |
| Myoglobin blood increased | 59.97 | 27.91 | 45 | 56232 | 2978 | 34897676 |
| Oxygen saturation decreased | 59.64 | 27.91 | 8 | 56269 | 53810 | 34846844 |
| Treatment failure | 59.49 | 27.91 | 4 | 56273 | 46693 | 34853961 |
| Cough | 59.15 | 27.91 | 429 | 55848 | 149711 | 34750943 |
| Incorrect dose administered | 59.14 | 27.91 | 171 | 56106 | 40344 | 34860310 |
| Cardiac operation | 58.87 | 27.91 | 45 | 56232 | 3062 | 34897592 |
| Upper-airway cough syndrome | 57.67 | 27.91 | 47 | 56230 | 3511 | 34897143 |
| Constipation | 57.58 | 27.91 | 82 | 56195 | 136900 | 34763754 |
| Ascites | 56.48 | 27.91 | 5 | 56272 | 46566 | 34854088 |
| Rash pruritic | 56.14 | 27.91 | 130 | 56147 | 26811 | 34873843 |
| Needle issue | 56.11 | 27.91 | 59 | 56218 | 6106 | 34894548 |
| Pneumonia aspiration | 55.16 | 27.91 | 3 | 56274 | 41900 | 34858754 |
| International normalised ratio increased | 54.99 | 27.91 | 6 | 56271 | 47321 | 34853333 |
| Infection | 54.58 | 27.91 | 40 | 56237 | 90875 | 34809779 |
| Hallucination | 53.97 | 27.91 | 9 | 56268 | 51489 | 34849165 |
| C-reactive protein increased | 53.38 | 27.91 | 11 | 56266 | 54087 | 34846567 |
| Injection site hypoaesthesia | 53.18 | 27.91 | 15 | 56262 | 85 | 34900569 |
| Product use issue | 52.65 | 27.91 | 18 | 56259 | 63198 | 34837456 |
| Fatigue | 52.41 | 27.91 | 862 | 55415 | 369791 | 34530863 |
| Stent placement | 52.40 | 27.91 | 52 | 56225 | 5026 | 34895628 |
| Muscle tightness | 52.23 | 27.91 | 51 | 56226 | 4833 | 34895821 |
| Hypoglycaemia | 52.11 | 27.91 | 12 | 56265 | 54628 | 34846026 |
| Muscle disorder | 51.96 | 27.91 | 39 | 56238 | 2582 | 34898072 |
| Rhabdomyolysis | 50.86 | 27.91 | 23 | 56254 | 68140 | 34832514 |
| Abdominal pain | 50.84 | 27.91 | 118 | 56159 | 163500 | 34737154 |
| Musculoskeletal disorder | 50.55 | 27.91 | 56 | 56221 | 6148 | 34894506 |
| Injection site extravasation | 50.09 | 27.91 | 40 | 56237 | 2902 | 34897752 |
| Injection site irritation | 49.69 | 27.91 | 29 | 56248 | 1254 | 34899400 |
| Headache | 49.53 | 27.91 | 517 | 55760 | 200118 | 34700536 |
| Cardio-respiratory arrest | 49.14 | 27.91 | 14 | 56263 | 55259 | 34845395 |
| Renal impairment | 48.88 | 27.91 | 48 | 56229 | 94465 | 34806189 |
| Cardiac failure congestive | 48.23 | 27.91 | 38 | 56239 | 83232 | 34817422 |
| Haematuria | 47.74 | 27.91 | 11 | 56266 | 50055 | 34850599 |
| Sleep disorder due to a general medical condition | 47.58 | 27.91 | 50 | 56227 | 5171 | 34895483 |
| Plasma cell myeloma | 47.17 | 27.91 | 6 | 56271 | 42031 | 34858623 |
| Somnolence | 46.20 | 27.91 | 67 | 56210 | 111049 | 34789605 |
| Device physical property issue | 43.30 | 27.91 | 23 | 56254 | 826 | 34899828 |
| Hypersensitivity | 41.93 | 27.91 | 202 | 56075 | 60833 | 34839821 |
| High density lipoprotein decreased | 41.50 | 27.91 | 38 | 56239 | 3322 | 34897332 |
| Lactic acidosis | 41.45 | 27.91 | 4 | 56273 | 34768 | 34865886 |
| Mental status changes | 41.39 | 27.91 | 6 | 56271 | 38077 | 34862577 |
| Unevaluable event | 41.39 | 27.91 | 131 | 56146 | 32459 | 34868195 |
| Aggression | 40.41 | 27.91 | 7 | 56270 | 38957 | 34861697 |
| Rectal haemorrhage | 40.09 | 27.91 | 8 | 56269 | 40241 | 34860413 |
| Melaena | 39.82 | 27.91 | 5 | 56272 | 35375 | 34865279 |
| Blood bilirubin increased | 39.45 | 27.91 | 7 | 56270 | 38289 | 34862365 |
| Haematochezia | 39.18 | 27.91 | 13 | 56264 | 46521 | 34854133 |
| Pulmonary oedema | 38.77 | 27.91 | 14 | 56263 | 47515 | 34853139 |
| Product dispensing error | 38.50 | 27.91 | 49 | 56228 | 6225 | 34894429 |
| Oedema | 38.13 | 27.91 | 13 | 56264 | 45728 | 34854926 |
| Application site swelling | 38.03 | 27.91 | 15 | 56262 | 265 | 34900389 |
| Brain natriuretic peptide increased | 37.61 | 27.91 | 46 | 56231 | 5613 | 34895041 |
| White blood cell count increased | 37.37 | 27.91 | 10 | 56267 | 41141 | 34859513 |
| Stomatitis | 37.36 | 27.91 | 11 | 56266 | 42503 | 34858151 |
| Colitis | 36.58 | 27.91 | 8 | 56269 | 37742 | 34862912 |
| Lack of injection site rotation | 36.37 | 27.91 | 14 | 56263 | 231 | 34900423 |
| Injection site injury | 35.35 | 27.91 | 14 | 56263 | 250 | 34900404 |
| Injection site paraesthesia | 35.27 | 27.91 | 12 | 56265 | 136 | 34900518 |
| Throat irritation | 35.13 | 27.91 | 62 | 56215 | 10523 | 34890131 |
| Cellulitis | 34.86 | 27.91 | 21 | 56256 | 52930 | 34847724 |
| Jaundice | 34.70 | 27.91 | 5 | 56272 | 31877 | 34868777 |
| Haemorrhage | 34.35 | 27.91 | 20 | 56257 | 51350 | 34849304 |
| Blood alkaline phosphatase increased | 33.68 | 27.91 | 5 | 56272 | 31170 | 34869484 |
| Respiratory distress | 33.67 | 27.91 | 8 | 56269 | 35657 | 34864997 |
| High density lipoprotein increased | 33.64 | 27.91 | 15 | 56262 | 364 | 34900290 |
| Thrombosis | 33.23 | 27.91 | 20 | 56257 | 50438 | 34850216 |
| Neck pain | 33.20 | 27.91 | 103 | 56174 | 25246 | 34875408 |
| Musculoskeletal discomfort | 33.14 | 27.91 | 52 | 56225 | 8016 | 34892638 |
| Haemoptysis | 32.76 | 27.91 | 8 | 56269 | 34998 | 34865656 |
| Device delivery system issue | 32.61 | 27.91 | 16 | 56261 | 485 | 34900169 |
| Alanine aminotransferase increased | 32.35 | 27.91 | 50 | 56227 | 80765 | 34819889 |
| Transaminases increased | 32.20 | 27.91 | 3 | 56274 | 26820 | 34873834 |
| Spinal operation | 31.97 | 27.91 | 31 | 56246 | 2913 | 34897741 |
| Chest discomfort | 31.53 | 27.91 | 172 | 56105 | 54358 | 34846296 |
| Injection site laceration | 31.48 | 27.91 | 8 | 56269 | 28 | 34900626 |
| Gamma-glutamyltransferase increased | 30.87 | 27.91 | 5 | 56272 | 29226 | 34871428 |
| Drug resistance | 30.86 | 27.91 | 3 | 56274 | 25924 | 34874730 |
| Cerebral haemorrhage | 30.77 | 27.91 | 9 | 56268 | 34928 | 34865726 |
| Unresponsive to stimuli | 30.77 | 27.91 | 4 | 56273 | 27565 | 34873089 |
| Sluggishness | 30.64 | 27.91 | 32 | 56245 | 3285 | 34897369 |
| Dysarthria | 30.56 | 27.91 | 9 | 56268 | 34773 | 34865881 |
| Medication error | 30.31 | 27.91 | 3 | 56274 | 25562 | 34875092 |
| Therapy cessation | 30.12 | 27.91 | 77 | 56200 | 16896 | 34883758 |
| Sinus congestion | 30.10 | 27.91 | 41 | 56236 | 5564 | 34895090 |
| Hepatic function abnormal | 30.05 | 27.91 | 17 | 56260 | 44346 | 34856308 |
| Chronic obstructive pulmonary disease | 30.03 | 27.91 | 21 | 56256 | 48897 | 34851757 |
| Loss of consciousness | 29.54 | 27.91 | 55 | 56222 | 82612 | 34818042 |
| Cardiogenic shock | 29.38 | 27.91 | 4 | 56273 | 26614 | 34874040 |
| Acute respiratory failure | 29.07 | 27.91 | 7 | 56270 | 30921 | 34869733 |
| Injection site warmth | 28.80 | 27.91 | 25 | 56252 | 2037 | 34898617 |
| Shock | 28.25 | 27.91 | 3 | 56274 | 24176 | 34876478 |
| Suicidal ideation | 28.04 | 27.91 | 15 | 56262 | 40373 | 34860281 |
| Aspartate aminotransferase increased | 28.03 | 27.91 | 41 | 56236 | 67742 | 34832912 |
| Bone pain | 27.97 | 27.91 | 85 | 56192 | 20601 | 34880053 |
| 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 | 24932.48 | 24.54 | 7500 | 104879 | 66375 | 79565634 |
| Accidental exposure to product | 15340.20 | 24.54 | 4262 | 108117 | 27060 | 79604949 |
| Device difficult to use | 13971.24 | 24.54 | 3331 | 109048 | 10054 | 79621955 |
| Injection site pain | 8242.86 | 24.54 | 3889 | 108490 | 125949 | 79506060 |
| Product dose omission issue | 5109.55 | 24.54 | 3562 | 108817 | 243975 | 79388034 |
| Injection site bruising | 4725.48 | 24.54 | 1876 | 110503 | 39126 | 79592883 |
| Drug dose omission by device | 4137.38 | 24.54 | 1082 | 111297 | 5168 | 79626841 |
| Injection site haemorrhage | 3987.17 | 24.54 | 1493 | 110886 | 26377 | 79605632 |
| Incorrect dose administered by device | 3303.26 | 24.54 | 864 | 111515 | 4125 | 79627884 |
| Device issue | 3067.57 | 24.54 | 1225 | 111154 | 25883 | 79606126 |
| Rhinorrhoea | 2975.83 | 24.54 | 1649 | 110730 | 74425 | 79557584 |
| Device use error | 2841.21 | 24.54 | 828 | 111551 | 6273 | 79625736 |
| Myalgia | 2599.12 | 24.54 | 2123 | 110256 | 183518 | 79448491 |
| Influenza like illness | 2333.34 | 24.54 | 1379 | 111000 | 70328 | 79561681 |
| Back pain | 2258.99 | 24.54 | 2445 | 109934 | 301735 | 79330274 |
| Underdose | 1886.91 | 24.54 | 925 | 111454 | 32226 | 79599783 |
| Injury associated with device | 1527.58 | 24.54 | 437 | 111942 | 3069 | 79628940 |
| Product storage error | 1506.91 | 24.54 | 637 | 111742 | 15589 | 79616420 |
| Injection site swelling | 1365.60 | 24.54 | 842 | 111537 | 46290 | 79585719 |
| Muscle spasms | 1288.80 | 24.54 | 1402 | 110977 | 173328 | 79458681 |
| Injection site mass | 1076.22 | 24.54 | 539 | 111840 | 19645 | 79612364 |
| Low density lipoprotein decreased | 1001.66 | 24.54 | 251 | 112128 | 970 | 79631039 |
| Incorrect disposal of product | 936.74 | 24.54 | 228 | 112151 | 757 | 79631252 |
| Device defective | 934.55 | 24.54 | 261 | 112118 | 1659 | 79630350 |
| Wrong technique in device usage process | 880.45 | 24.54 | 296 | 112083 | 3732 | 79628277 |
| Injection site erythema | 732.01 | 24.54 | 714 | 111665 | 77483 | 79554526 |
| Drug ineffective | 699.56 | 24.54 | 327 | 112052 | 1080586 | 78551423 |
| Low density lipoprotein increased | 693.76 | 24.54 | 306 | 112073 | 8316 | 79623693 |
| Device malfunction | 676.91 | 24.54 | 405 | 111974 | 21043 | 79610966 |
| Pain in extremity | 658.11 | 24.54 | 1530 | 110849 | 363008 | 79269001 |
| Acute kidney injury | 621.41 | 24.54 | 26 | 112353 | 519378 | 79112631 |
| Blood cholesterol decreased | 588.81 | 24.54 | 178 | 112201 | 1547 | 79630462 |
| Injection site discomfort | 547.60 | 24.54 | 223 | 112156 | 4943 | 79627066 |
| Oropharyngeal pain | 533.17 | 24.54 | 712 | 111667 | 108641 | 79523368 |
| Condition aggravated | 476.21 | 24.54 | 70 | 112309 | 501054 | 79130955 |
| Drug interaction | 467.35 | 24.54 | 30 | 112349 | 415153 | 79216856 |
| Nasopharyngitis | 441.47 | 24.54 | 1051 | 111328 | 252830 | 79379179 |
| Feeling abnormal | 428.99 | 24.54 | 789 | 111590 | 158410 | 79473599 |
| Anaemia | 413.94 | 24.54 | 66 | 112313 | 444949 | 79187060 |
| Injection site discolouration | 413.60 | 24.54 | 206 | 112173 | 7408 | 79624601 |
| Neutropenia | 379.19 | 24.54 | 5 | 112374 | 287705 | 79344304 |
| Arthralgia | 373.25 | 24.54 | 1693 | 110686 | 570110 | 79061899 |
| Pyrexia | 358.66 | 24.54 | 261 | 112118 | 678448 | 78953561 |
| Blood glucose increased | 340.53 | 24.54 | 594 | 111785 | 114381 | 79517628 |
| Thrombocytopenia | 331.87 | 24.54 | 9 | 112370 | 265250 | 79366759 |
| Completed suicide | 325.02 | 24.54 | 4 | 112375 | 245763 | 79386246 |
| Fear of injection | 319.05 | 24.54 | 172 | 112207 | 7302 | 79624707 |
| Hypotension | 309.45 | 24.54 | 117 | 112262 | 440200 | 79191809 |
| Infusion related reaction | 294.97 | 24.54 | 6 | 112373 | 230231 | 79401778 |
| Vomiting | 292.36 | 24.54 | 305 | 112074 | 665523 | 78966486 |
| Product use in unapproved indication | 281.76 | 24.54 | 18 | 112361 | 250341 | 79381668 |
| Injection site pruritus | 277.77 | 24.54 | 320 | 112059 | 41963 | 79590046 |
| Therapeutic response unexpected | 277.55 | 24.54 | 228 | 112151 | 19718 | 79612291 |
| General physical health deterioration | 276.60 | 24.54 | 32 | 112347 | 275206 | 79356803 |
| Injection site urticaria | 254.21 | 24.54 | 181 | 112198 | 12645 | 79619364 |
| Pneumonia | 248.71 | 24.54 | 341 | 112038 | 659905 | 78972104 |
| Device failure | 247.63 | 24.54 | 137 | 112242 | 6124 | 79625885 |
| Blood triglycerides increased | 240.75 | 24.54 | 215 | 112164 | 20825 | 79611184 |
| Sepsis | 232.91 | 24.54 | 48 | 112331 | 269380 | 79362629 |
| Intercepted product administration error | 224.71 | 24.54 | 62 | 112317 | 374 | 79631635 |
| Haemoglobin decreased | 222.69 | 24.54 | 26 | 112353 | 222093 | 79409916 |
| Circumstance or information capable of leading to medication error | 217.92 | 24.54 | 108 | 112271 | 3840 | 79628169 |
| Platelet count decreased | 213.16 | 24.54 | 16 | 112363 | 194648 | 79437361 |
| Product administered at inappropriate site | 211.58 | 24.54 | 106 | 112273 | 3859 | 79628150 |
| Overdose | 210.97 | 24.54 | 12 | 112367 | 184194 | 79447815 |
| Inappropriate schedule of product administration | 210.38 | 24.54 | 533 | 111846 | 133095 | 79498914 |
| Respiratory failure | 209.64 | 24.54 | 11 | 112368 | 180900 | 79451109 |
| Treatment failure | 208.75 | 24.54 | 7 | 112372 | 170479 | 79461530 |
| Hyponatraemia | 205.50 | 24.54 | 11 | 112368 | 177837 | 79454172 |
| Product use issue | 204.39 | 24.54 | 27 | 112352 | 209795 | 79422214 |
| White blood cell count decreased | 201.91 | 24.54 | 17 | 112362 | 188271 | 79443738 |
| Product communication issue | 200.24 | 24.54 | 70 | 112309 | 999 | 79631010 |
| Disease progression | 199.48 | 24.54 | 16 | 112363 | 184346 | 79447663 |
| Pancytopenia | 198.81 | 24.54 | 8 | 112371 | 165737 | 79466272 |
| Oedema peripheral | 196.43 | 24.54 | 56 | 112323 | 252232 | 79379777 |
| Injection site rash | 192.72 | 24.54 | 177 | 112202 | 17777 | 79614232 |
| Injection site vesicles | 190.50 | 24.54 | 91 | 112288 | 2981 | 79629028 |
| Incorrect dose administered | 190.25 | 24.54 | 367 | 112012 | 76263 | 79555746 |
| Sinus disorder | 187.66 | 24.54 | 193 | 112186 | 22271 | 79609738 |
| Contraindicated product administered | 184.36 | 24.54 | 9 | 112370 | 157529 | 79474480 |
| Rheumatoid arthritis | 180.42 | 24.54 | 37 | 112342 | 208433 | 79423576 |
| Influenza | 175.64 | 24.54 | 489 | 111890 | 129117 | 79502892 |
| Intentional product use issue | 170.88 | 24.54 | 11 | 112368 | 152101 | 79479908 |
| Infection | 169.97 | 24.54 | 64 | 112315 | 241648 | 79390361 |
| Hypokalaemia | 169.29 | 24.54 | 8 | 112371 | 144032 | 79487977 |
| Musculoskeletal pain | 168.14 | 24.54 | 415 | 111964 | 101939 | 79530070 |
| Injection site extravasation | 165.72 | 24.54 | 125 | 112254 | 9544 | 79622465 |
| Seizure | 162.40 | 24.54 | 34 | 112345 | 188800 | 79443209 |
| Memory impairment | 161.79 | 24.54 | 432 | 111947 | 111302 | 79520707 |
| Drug intolerance | 160.57 | 24.54 | 86 | 112293 | 264033 | 79367976 |
| Injection site induration | 159.62 | 24.54 | 123 | 112256 | 9696 | 79622313 |
| Maternal exposure during pregnancy | 150.08 | 24.54 | 11 | 112368 | 136527 | 79495482 |
| Pulmonary embolism | 149.48 | 24.54 | 30 | 112349 | 171624 | 79460385 |
| Leukopenia | 149.30 | 24.54 | 3 | 112376 | 116510 | 79515499 |
| Device dispensing error | 144.05 | 24.54 | 35 | 112344 | 115 | 79631894 |
| Incorrect dose administered by product | 135.48 | 24.54 | 36 | 112343 | 184 | 79631825 |
| Oxygen saturation decreased | 134.69 | 24.54 | 13 | 112366 | 129034 | 79502975 |
| Septic shock | 134.66 | 24.54 | 10 | 112369 | 122791 | 79509218 |
| Cardiac arrest | 134.28 | 24.54 | 38 | 112341 | 172058 | 79459951 |
| Multiple organ dysfunction syndrome | 134.15 | 24.54 | 9 | 112370 | 120237 | 79511772 |
| Tachycardia | 131.93 | 24.54 | 43 | 112336 | 177725 | 79454284 |
| Occupational exposure to product | 131.74 | 24.54 | 46 | 112333 | 654 | 79631355 |
| Nasal congestion | 130.61 | 24.54 | 315 | 112064 | 76237 | 79555772 |
| Unevaluable event | 130.41 | 24.54 | 260 | 112119 | 55325 | 79576684 |
| Renal failure | 130.32 | 24.54 | 60 | 112319 | 200908 | 79431101 |
| Hyperkalaemia | 129.29 | 24.54 | 8 | 112371 | 114390 | 79517619 |
| Stomatitis | 129.14 | 24.54 | 25 | 112354 | 146732 | 79485277 |
| Gastrointestinal haemorrhage | 128.23 | 24.54 | 26 | 112353 | 147693 | 79484316 |
| Dehydration | 127.36 | 24.54 | 98 | 112281 | 248089 | 79383920 |
| Coma | 127.36 | 24.54 | 3 | 112376 | 100646 | 79531363 |
| Sleep disorder due to a general medical condition | 127.17 | 24.54 | 127 | 112252 | 14150 | 79617859 |
| Interstitial lung disease | 126.88 | 24.54 | 8 | 112371 | 112592 | 79519417 |
| Cough | 125.15 | 24.54 | 915 | 111464 | 365874 | 79266135 |
| C-reactive protein increased | 122.32 | 24.54 | 18 | 112361 | 129009 | 79503000 |
| Depressed level of consciousness | 121.84 | 24.54 | 3 | 112376 | 96649 | 79535360 |
| Systemic lupus erythematosus | 121.82 | 24.54 | 14 | 112365 | 121135 | 79510874 |
| Pericarditis | 121.79 | 24.54 | 6 | 112373 | 104230 | 79527779 |
| Pleural effusion | 121.15 | 24.54 | 28 | 112351 | 145234 | 79486775 |
| Decreased appetite | 120.58 | 24.54 | 185 | 112194 | 342233 | 79289776 |
| Hypoxia | 120.45 | 24.54 | 6 | 112373 | 103237 | 79528772 |
| Fall | 120.17 | 24.54 | 324 | 112055 | 487305 | 79144704 |
| Paranasal sinus hypersecretion | 119.67 | 24.54 | 72 | 112307 | 3774 | 79628235 |
| Cardiac failure | 119.31 | 24.54 | 35 | 112344 | 154807 | 79477202 |
| Sneezing | 117.69 | 24.54 | 142 | 112237 | 19541 | 79612468 |
| Confusional state | 117.63 | 24.54 | 166 | 112213 | 317831 | 79314178 |
| Glycosylated haemoglobin increased | 113.61 | 24.54 | 138 | 112241 | 19122 | 79612887 |
| Bradycardia | 113.30 | 24.54 | 26 | 112353 | 135531 | 79496478 |
| Dysphonia | 112.41 | 24.54 | 248 | 112131 | 56624 | 79575385 |
| Needle issue | 112.28 | 24.54 | 114 | 112265 | 12954 | 79619055 |
| Muscle disorder | 111.85 | 24.54 | 80 | 112299 | 5627 | 79626382 |
| Injection site indentation | 111.53 | 24.54 | 30 | 112349 | 162 | 79631847 |
| Neutrophil count decreased | 111.10 | 24.54 | 5 | 112374 | 93954 | 79538055 |
| Stent placement | 111.10 | 24.54 | 84 | 112295 | 6436 | 79625573 |
| Abdominal pain | 110.83 | 24.54 | 240 | 112139 | 389329 | 79242680 |
| Respiratory tract congestion | 108.11 | 24.54 | 137 | 112242 | 19817 | 79612192 |
| Deep vein thrombosis | 105.54 | 24.54 | 21 | 112358 | 120898 | 79511111 |
| Low density lipoprotein abnormal | 105.34 | 24.54 | 35 | 112344 | 424 | 79631585 |
| Delirium | 105.27 | 24.54 | 3 | 112376 | 84624 | 79547385 |
| Cardio-respiratory arrest | 103.17 | 24.54 | 15 | 112364 | 108495 | 79523514 |
| Cardiac operation | 102.25 | 24.54 | 72 | 112307 | 4940 | 79627069 |
| Blood creatinine increased | 100.97 | 24.54 | 46 | 112333 | 155011 | 79476998 |
| Wound | 99.69 | 24.54 | 21 | 112358 | 116158 | 79515851 |
| Hypoacusis | 94.70 | 24.54 | 160 | 112219 | 29990 | 79602019 |
| Drug hypersensitivity | 94.56 | 24.54 | 173 | 112206 | 298743 | 79333266 |
| Adverse reaction | 94.50 | 24.54 | 89 | 112290 | 9225 | 79622784 |
| Somnolence | 93.16 | 24.54 | 120 | 112259 | 238861 | 79393148 |
| Oedema | 90.35 | 24.54 | 28 | 112351 | 119552 | 79512457 |
| International normalised ratio increased | 89.82 | 24.54 | 8 | 112371 | 84713 | 79547296 |
| Syncope | 88.09 | 24.54 | 74 | 112305 | 179375 | 79452634 |
| Muscular weakness | 87.72 | 24.54 | 453 | 111926 | 160276 | 79471733 |
| Ascites | 86.24 | 24.54 | 5 | 112374 | 75557 | 79556452 |
| Device delivery system issue | 85.92 | 24.54 | 34 | 112345 | 697 | 79631312 |
| Mobility decreased | 85.40 | 24.54 | 370 | 112009 | 121805 | 79510204 |
| Alanine aminotransferase increased | 84.89 | 24.54 | 63 | 112316 | 162507 | 79469502 |
| Injection site injury | 84.77 | 24.54 | 34 | 112345 | 723 | 79631286 |
| Injection site reaction | 84.55 | 24.54 | 217 | 112162 | 54568 | 79577441 |
| Adverse event | 84.29 | 24.54 | 230 | 112149 | 59984 | 79572025 |
| Joint swelling | 83.56 | 24.54 | 176 | 112203 | 288470 | 79343539 |
| Medication error | 83.35 | 24.54 | 3 | 112376 | 68639 | 79563370 |
| Intentional product misuse | 83.16 | 24.54 | 309 | 112070 | 94856 | 79537153 |
| Lactic acidosis | 82.35 | 24.54 | 4 | 112375 | 70355 | 79561654 |
| Lower respiratory tract infection | 81.56 | 24.54 | 40 | 112339 | 129180 | 79502829 |
| Death | 80.36 | 24.54 | 469 | 111910 | 566045 | 79065964 |
| Renal impairment | 80.02 | 24.54 | 63 | 112316 | 157720 | 79474289 |
| Upper-airway cough syndrome | 79.30 | 24.54 | 90 | 112289 | 11603 | 79620406 |
| Rash pruritic | 78.68 | 24.54 | 251 | 112128 | 71378 | 79560631 |
| Glossodynia | 78.42 | 24.54 | 24 | 112355 | 103313 | 79528696 |
| Helicobacter infection | 78.38 | 24.54 | 5 | 112374 | 69699 | 79562310 |
| Encephalopathy | 78.35 | 24.54 | 4 | 112375 | 67393 | 79564616 |
| Constipation | 77.48 | 24.54 | 178 | 112201 | 282872 | 79349137 |
| Pneumonia aspiration | 74.72 | 24.54 | 5 | 112374 | 66962 | 79565047 |
| Application site swelling | 74.68 | 24.54 | 31 | 112348 | 722 | 79631287 |
| Aspartate aminotransferase increased | 74.64 | 24.54 | 52 | 112327 | 138589 | 79493420 |
| Hypoglycaemia | 74.60 | 24.54 | 25 | 112354 | 101569 | 79530440 |
| Application site mass | 74.41 | 24.54 | 17 | 112362 | 39 | 79631970 |
| Agitation | 74.17 | 24.54 | 24 | 112355 | 99691 | 79532318 |
| Psoriatic arthropathy | 73.64 | 24.54 | 11 | 112368 | 77988 | 79554021 |
| Pulmonary oedema | 73.59 | 24.54 | 17 | 112362 | 88237 | 79543772 |
| Therapeutic product effect decreased | 71.69 | 24.54 | 75 | 112304 | 163788 | 79468221 |
| Blood bilirubin increased | 70.90 | 24.54 | 6 | 112373 | 66226 | 79565783 |
| Muscle tightness | 70.49 | 24.54 | 89 | 112290 | 12825 | 79619184 |
| Haematocrit decreased | 70.14 | 24.54 | 4 | 112375 | 61308 | 79570701 |
| Lack of injection site rotation | 69.65 | 24.54 | 27 | 112352 | 523 | 79631486 |
| Melaena | 69.58 | 24.54 | 4 | 112375 | 60886 | 79571123 |
| Mental status changes | 69.19 | 24.54 | 7 | 112372 | 66952 | 79565057 |
| Atrial fibrillation | 67.60 | 24.54 | 109 | 112270 | 197777 | 79434232 |
| Pneumonitis | 66.58 | 24.54 | 5 | 112374 | 60855 | 79571154 |
| Rhabdomyolysis | 66.50 | 24.54 | 31 | 112348 | 103100 | 79528909 |
| Injury | 66.49 | 24.54 | 14 | 112365 | 77482 | 79554527 |
| Rash maculo-papular | 66.24 | 24.54 | 3 | 112376 | 56075 | 79575934 |
| Arthropathy | 65.88 | 24.54 | 92 | 112287 | 177019 | 79454990 |
| Hepatitis | 65.76 | 24.54 | 3 | 112376 | 55724 | 79576285 |
| Bone pain | 65.53 | 24.54 | 200 | 112179 | 55542 | 79576467 |
| Product dispensing error | 63.97 | 24.54 | 86 | 112293 | 13177 | 79618832 |
| Neck pain | 63.49 | 24.54 | 242 | 112137 | 75175 | 79556834 |
| Musculoskeletal disorder | 62.35 | 24.54 | 110 | 112269 | 21338 | 79610671 |
| Blood cholesterol abnormal | 61.19 | 24.54 | 45 | 112334 | 3305 | 79628704 |
| Suicidal ideation | 61.13 | 24.54 | 16 | 112363 | 76324 | 79555685 |
| Haematemesis | 61.07 | 24.54 | 3 | 112376 | 52261 | 79579748 |
| Loss of consciousness | 60.72 | 24.54 | 89 | 112290 | 167854 | 79464155 |
| Sedation | 60.57 | 24.54 | 3 | 112376 | 51892 | 79580117 |
| High density lipoprotein decreased | 60.16 | 24.54 | 51 | 112328 | 4604 | 79627405 |
| Cellulitis | 59.91 | 24.54 | 40 | 112339 | 109020 | 79522989 |
| Acute respiratory failure | 59.55 | 24.54 | 7 | 112372 | 59534 | 79572475 |
| Application site haemorrhage | 59.29 | 24.54 | 32 | 112347 | 1361 | 79630648 |
| Injection site irritation | 58.40 | 24.54 | 46 | 112333 | 3744 | 79628265 |
| Anaphylactic reaction | 57.44 | 24.54 | 23 | 112356 | 83720 | 79548289 |
| Hepatic function abnormal | 57.26 | 24.54 | 16 | 112363 | 73091 | 79558918 |
| White blood cell count increased | 57.23 | 24.54 | 17 | 112362 | 74616 | 79557393 |
| Unresponsive to stimuli | 57.21 | 24.54 | 6 | 112373 | 55782 | 79576227 |
| Haematochezia | 57.04 | 24.54 | 26 | 112353 | 87619 | 79544390 |
| Injection site warmth | 56.68 | 24.54 | 86 | 112293 | 14721 | 79617288 |
| Drug ineffective for unapproved indication | 56.65 | 24.54 | 4 | 112375 | 51234 | 79580775 |
| Device physical property issue | 56.50 | 24.54 | 39 | 112340 | 2591 | 79629418 |
| Hepatic enzyme increased | 55.67 | 24.54 | 108 | 112271 | 182502 | 79449507 |
| Blood alkaline phosphatase increased | 55.66 | 24.54 | 11 | 112368 | 63653 | 79568356 |
| Rectal haemorrhage | 55.63 | 24.54 | 19 | 112360 | 76281 | 79555728 |
| Impaired healing | 55.51 | 24.54 | 27 | 112352 | 87628 | 79544381 |
| Orthostatic hypotension | 55.19 | 24.54 | 7 | 112372 | 56157 | 79575852 |
| Hallucination | 54.93 | 24.54 | 26 | 112353 | 85719 | 79546290 |
| Headache | 54.72 | 24.54 | 1255 | 111124 | 652517 | 78979492 |
| Red blood cell count decreased | 54.55 | 24.54 | 8 | 112371 | 57505 | 79574504 |
| Throat irritation | 53.94 | 24.54 | 153 | 112226 | 40793 | 79591216 |
| Injection site paraesthesia | 53.49 | 24.54 | 23 | 112356 | 586 | 79631423 |
| Dysarthria | 52.59 | 24.54 | 15 | 112364 | 67607 | 79564402 |
| Pulmonary hypertension | 52.46 | 24.54 | 4 | 112375 | 48076 | 79583933 |
| Haematuria | 52.20 | 24.54 | 16 | 112363 | 68820 | 79563189 |
| Folliculitis | 51.84 | 24.54 | 8 | 112371 | 55372 | 79576637 |
| Hepatocellular injury | 51.81 | 24.54 | 4 | 112375 | 47589 | 79584420 |
| Musculoskeletal discomfort | 51.66 | 24.54 | 97 | 112282 | 19738 | 79612271 |
| Jaundice | 51.58 | 24.54 | 7 | 112372 | 53342 | 79578667 |
| Liver injury | 51.17 | 24.54 | 9 | 112370 | 56605 | 79575404 |
| Gamma-glutamyltransferase increased | 50.96 | 24.54 | 8 | 112371 | 54672 | 79577337 |
| Multiple sclerosis relapse | 50.41 | 24.54 | 4 | 112375 | 46529 | 79585480 |
| Back disorder | 49.74 | 24.54 | 71 | 112308 | 11507 | 79620502 |
| Depression | 49.63 | 24.54 | 149 | 112230 | 216641 | 79415368 |
| Swelling | 49.57 | 24.54 | 149 | 112230 | 216562 | 79415447 |
| Osteoarthritis | 49.34 | 24.54 | 31 | 112348 | 87278 | 79544731 |
| Leukocytosis | 49.21 | 24.54 | 3 | 112376 | 43452 | 79588557 |
| Respiratory distress | 49.11 | 24.54 | 11 | 112368 | 58328 | 79573681 |
| Colitis | 48.88 | 24.54 | 21 | 112358 | 73286 | 79558723 |
| Liver function test abnormal | 48.87 | 24.54 | 15 | 112364 | 64460 | 79567549 |
| Cerebral haemorrhage | 48.30 | 24.54 | 11 | 112368 | 57662 | 79574347 |
| Therapy cessation | 48.16 | 24.54 | 139 | 112240 | 37423 | 79594586 |
| Respiratory arrest | 48.15 | 24.54 | 11 | 112368 | 57539 | 79574470 |
| Nervousness | 48.12 | 24.54 | 129 | 112250 | 33286 | 79598723 |
| Cardiac failure congestive | 48.10 | 24.54 | 79 | 112300 | 142323 | 79489686 |
| Dyspnoea | 47.74 | 24.54 | 886 | 111493 | 856139 | 78775870 |
| Limb discomfort | 47.49 | 24.54 | 127 | 112252 | 32723 | 79599286 |
| Application site pain | 47.47 | 24.54 | 45 | 112334 | 4702 | 79627307 |
| Drug-induced liver injury | 47.28 | 24.54 | 17 | 112362 | 66100 | 79565909 |
| Plasma cell myeloma | 46.99 | 24.54 | 9 | 112370 | 53250 | 79578759 |
| Altered state of consciousness | 46.82 | 24.54 | 4 | 112375 | 43818 | 79588191 |
| Psychotic disorder | 46.46 | 24.54 | 3 | 112376 | 41399 | 79590610 |
| Blood cholesterol increased | 46.36 | 24.54 | 237 | 112142 | 83483 | 79548526 |
| Aggression | 46.27 | 24.54 | 8 | 112371 | 50950 | 79581059 |
| Injection site hypoaesthesia | 46.00 | 24.54 | 20 | 112359 | 524 | 79631485 |
| Pruritus | 45.82 | 24.54 | 796 | 111583 | 393852 | 79238157 |
| Epilepsy | 45.73 | 24.54 | 3 | 112376 | 40857 | 79591152 |
| Inflammation | 45.57 | 24.54 | 39 | 112340 | 93714 | 79538295 |
| Blood pressure systolic increased | 44.97 | 24.54 | 19 | 112360 | 66967 | 79565042 |
| Haemorrhage | 44.17 | 24.54 | 38 | 112341 | 91080 | 79540929 |
| Drug level increased | 44.12 | 24.54 | 3 | 112376 | 39648 | 79592361 |
| Chronic kidney disease | 44.03 | 24.54 | 19 | 112360 | 66135 | 79565874 |
| Shock | 43.85 | 24.54 | 5 | 112374 | 43543 | 79588466 |
| Blood lactate dehydrogenase increased | 43.48 | 24.54 | 3 | 112376 | 39167 | 79592842 |
| Coronary artery bypass | 43.40 | 24.54 | 48 | 112331 | 6014 | 79625995 |
| Gait disturbance | 42.77 | 24.54 | 464 | 111915 | 207042 | 79424967 |
| Hypervolaemia | 42.74 | 24.54 | 5 | 112374 | 42685 | 79589324 |
| Fatigue | 42.14 | 24.54 | 1654 | 110725 | 928073 | 78703936 |
| Acute respiratory distress syndrome | 42.09 | 24.54 | 6 | 112373 | 44061 | 79587948 |
| Transaminases increased | 41.13 | 24.54 | 11 | 112368 | 51732 | 79580277 |
| Wheezing | 41.02 | 24.54 | 63 | 112316 | 116601 | 79515408 |
| Increased tendency to bruise | 40.37 | 24.54 | 61 | 112318 | 10403 | 79621606 |
| Emotional distress | 39.23 | 24.54 | 5 | 112374 | 39964 | 79592045 |
| Haemoptysis | 39.03 | 24.54 | 15 | 112364 | 55984 | 79576025 |
| Angioedema | 38.99 | 24.54 | 30 | 112349 | 76005 | 79556004 |
| Basal cell carcinoma | 38.37 | 24.54 | 4 | 112375 | 37371 | 79594638 |
| Pericardial effusion | 38.36 | 24.54 | 9 | 112370 | 46228 | 79585781 |
| Stevens-Johnson syndrome | 38.20 | 24.54 | 5 | 112374 | 39161 | 79592848 |
| No adverse event | 38.13 | 24.54 | 4 | 112375 | 37188 | 79594821 |
| Treatment noncompliance | 38.13 | 24.54 | 13 | 112366 | 52255 | 79579754 |
| Clostridium difficile infection | 38.11 | 24.54 | 7 | 112372 | 42678 | 79589331 |
| Red blood cell sedimentation rate increased | 38.00 | 24.54 | 9 | 112370 | 45933 | 79586076 |
| Pulmonary fibrosis | 37.78 | 24.54 | 8 | 112371 | 44104 | 79587905 |
| Disease recurrence | 37.77 | 24.54 | 8 | 112371 | 44101 | 79587908 |
| Injection site haematoma | 37.67 | 24.54 | 40 | 112339 | 4787 | 79627222 |
| Drug resistance | 37.52 | 24.54 | 7 | 112372 | 42206 | 79589803 |
| Sluggishness | 37.00 | 24.54 | 46 | 112333 | 6526 | 79625483 |
| Asthma | 36.89 | 24.54 | 85 | 112294 | 135010 | 79496999 |
| Blood pressure fluctuation | 36.37 | 24.54 | 25 | 112354 | 67120 | 79564889 |
| Dizziness | 36.35 | 24.54 | 985 | 111394 | 525456 | 79106553 |
| Circulatory collapse | 36.28 | 24.54 | 5 | 112374 | 37663 | 79594346 |
| Thrombosis | 36.20 | 24.54 | 39 | 112340 | 84061 | 79547948 |
| Laboratory test abnormal | 36.16 | 24.54 | 104 | 112275 | 27944 | 79604065 |
| Pallor | 35.58 | 24.54 | 13 | 112366 | 50049 | 79581960 |
| Hypertension | 35.51 | 24.54 | 297 | 112082 | 330695 | 79301314 |
| Head discomfort | 35.40 | 24.54 | 69 | 112310 | 14433 | 79617576 |
| Osteoporosis | 35.29 | 24.54 | 16 | 112363 | 54096 | 79577913 |
| Blister | 35.25 | 24.54 | 72 | 112307 | 119404 | 79512605 |
| Cardiogenic shock | 35.09 | 24.54 | 8 | 112371 | 41906 | 79590103 |
| Bacteraemia | 35.06 | 24.54 | 3 | 112376 | 32821 | 79599188 |
| Ejection fraction decreased | 34.74 | 24.54 | 4 | 112375 | 34573 | 79597436 |
| Intentional self-injury | 34.53 | 24.54 | 3 | 112376 | 32416 | 79599593 |
| Hyperglycaemia | 34.50 | 24.54 | 29 | 112350 | 70306 | 79561703 |
| Body temperature increased | 34.27 | 24.54 | 10 | 112369 | 44410 | 79587599 |
| Aphonia | 34.08 | 24.54 | 56 | 112323 | 10256 | 79621753 |
| Staphylococcal infection | 33.91 | 24.54 | 20 | 112359 | 58275 | 79573734 |
| Blood calcium decreased | 33.74 | 24.54 | 3 | 112376 | 31816 | 79600193 |
| Obstructive airways disorder | 33.26 | 24.54 | 3 | 112376 | 31456 | 79600553 |
| Haematoma | 33.16 | 24.54 | 16 | 112363 | 52179 | 79579830 |
| Blood glucose abnormal | 33.08 | 24.54 | 56 | 112323 | 10510 | 79621499 |
| Obesity | 33.05 | 24.54 | 5 | 112374 | 35120 | 79596889 |
| Nausea | 32.83 | 24.54 | 1064 | 111315 | 956132 | 78675877 |
| Injection site scab | 32.62 | 24.54 | 14 | 112365 | 355 | 79631654 |
| Candida infection | 32.58 | 24.54 | 7 | 112372 | 38207 | 79593802 |
| Neuropathy peripheral | 32.41 | 24.54 | 97 | 112282 | 141208 | 79490801 |
| Urinary retention | 32.14 | 24.54 | 20 | 112359 | 56610 | 79575399 |
| Proteinuria | 32.06 | 24.54 | 4 | 112375 | 32498 | 79599511 |
| Drug delivery system malfunction | 32 | 24.54 | 17 | 112362 | 700 | 79631309 |
| Coagulopathy | 31.94 | 24.54 | 6 | 112373 | 36000 | 79596009 |
| Drug eruption | 31.92 | 24.54 | 11 | 112368 | 43924 | 79588085 |
| Urinary tract infection | 31.90 | 24.54 | 241 | 112138 | 274271 | 79357738 |
| Lung disorder | 31.82 | 24.54 | 40 | 112339 | 80517 | 79551492 |
| High density lipoprotein increased | 31.82 | 24.54 | 20 | 112359 | 1134 | 79630875 |
| Myelodysplastic syndrome | 31.74 | 24.54 | 3 | 112376 | 30298 | 79601711 |
| Blood pressure diastolic decreased | 31.63 | 24.54 | 3 | 112376 | 30213 | 79601796 |
| Full blood count abnormal | 31.43 | 24.54 | 9 | 112370 | 40465 | 79591544 |
| Anxiety | 31.38 | 24.54 | 213 | 112166 | 248299 | 79383710 |
| Chronic obstructive pulmonary disease | 31.12 | 24.54 | 45 | 112334 | 85374 | 79546635 |
| Intestinal obstruction | 30.86 | 24.54 | 11 | 112368 | 43009 | 79589000 |
| Abortion spontaneous | 30.70 | 24.54 | 3 | 112376 | 29504 | 79602505 |
| Hepatic cirrhosis | 30.58 | 24.54 | 6 | 112373 | 34900 | 79597109 |
| Neutrophil count increased | 30.56 | 24.54 | 3 | 112376 | 29393 | 79602616 |
| Abnormal behaviour | 30.39 | 24.54 | 7 | 112372 | 36414 | 79595595 |
| Spinal operation | 30.33 | 24.54 | 46 | 112333 | 7871 | 79624138 |
| Osteonecrosis | 30.25 | 24.54 | 4 | 112375 | 31091 | 79600918 |
| COVID-19 | 30.21 | 24.54 | 117 | 112262 | 157557 | 79474452 |
| Injection site laceration | 29.96 | 24.54 | 10 | 112369 | 123 | 79631886 |
| Heart rate decreased | 29.83 | 24.54 | 33 | 112346 | 70283 | 79561726 |
| Liver disorder | 29.62 | 24.54 | 35 | 112344 | 72382 | 79559627 |
| Dyskinesia | 29.57 | 24.54 | 13 | 112366 | 44760 | 79587249 |
| Blood urea increased | 29.44 | 24.54 | 16 | 112363 | 48774 | 79583235 |
| Device leakage | 29.41 | 24.54 | 54 | 112325 | 10802 | 79621207 |
| Coronary artery occlusion | 29.36 | 24.54 | 66 | 112313 | 15249 | 79616760 |
| Pain | 29.24 | 24.54 | 1241 | 111138 | 702561 | 78929448 |
| Muscle injury | 29.19 | 24.54 | 16 | 112363 | 48545 | 79583464 |
| Psoriasis | 29.05 | 24.54 | 51 | 112328 | 89536 | 79542473 |
| Ventricular fibrillation | 29.01 | 24.54 | 5 | 112374 | 31921 | 79600088 |
| Sinus congestion | 28.84 | 24.54 | 77 | 112302 | 19819 | 79612190 |
| Burning sensation | 28.39 | 24.54 | 160 | 112219 | 58472 | 79573537 |
| Ischaemic stroke | 28.39 | 24.54 | 6 | 112373 | 33125 | 79598884 |
| Osteomyelitis | 28.06 | 24.54 | 6 | 112373 | 32859 | 79599150 |
| Gastrointestinal disorder | 27.94 | 24.54 | 84 | 112295 | 122121 | 79509888 |
| Vascular graft | 27.79 | 24.54 | 23 | 112356 | 2008 | 79630001 |
| Small intestinal obstruction | 27.79 | 24.54 | 3 | 112376 | 27269 | 79604740 |
| Lacrimation increased | 27.68 | 24.54 | 82 | 112297 | 22395 | 79609614 |
| Diabetic ketoacidosis | 27.60 | 24.54 | 7 | 112372 | 34115 | 79597894 |
| Atelectasis | 27.32 | 24.54 | 6 | 112373 | 32251 | 79599758 |
| Withdrawal syndrome | 27.25 | 24.54 | 3 | 112376 | 26851 | 79605158 |
| Hemiparesis | 27.14 | 24.54 | 7 | 112372 | 33726 | 79598283 |
| Urosepsis | 26.78 | 24.54 | 3 | 112376 | 26492 | 79605517 |
| Pneumothorax | 26.72 | 24.54 | 4 | 112375 | 28319 | 79603690 |
| Haemorrhage intracranial | 26.39 | 24.54 | 3 | 112376 | 26190 | 79605819 |
| Type 2 diabetes mellitus | 26.28 | 24.54 | 25 | 112354 | 57097 | 79574912 |
| Discomfort | 26.18 | 24.54 | 90 | 112289 | 125527 | 79506482 |
| Device dislocation | 26.10 | 24.54 | 3 | 112376 | 25967 | 79606042 |
| Femur fracture | 25.88 | 24.54 | 11 | 112368 | 38641 | 79593368 |
| Iron deficiency anaemia | 25.71 | 24.54 | 3 | 112376 | 25669 | 79606340 |
| COVID-19 pneumonia | 25.18 | 24.54 | 5 | 112374 | 28844 | 79603165 |
| Lipids increased | 25.14 | 24.54 | 20 | 112359 | 1651 | 79630358 |
| Skin lesion | 24.85 | 24.54 | 14 | 112365 | 41830 | 79590179 |
| Bronchospasm | 24.66 | 24.54 | 3 | 112376 | 24856 | 79607153 |
| Blood triglycerides decreased | 24.58 | 24.54 | 10 | 112369 | 221 | 79631788 |
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 | D000924 | Anticholesteremic Agents |
| MeSH PA | D000963 | Antimetabolites |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D000960 | Hypolipidemic Agents |
| MeSH PA | D057847 | Lipid Regulating Agents |
| MeSH PA | D000091362 | PCSK9 Inhibitors |
| MeSH PA | D011480 | Protease Inhibitors |
| MeSH PA | D015842 | Serine Proteinase Inhibitors |
| FDA MoA | N0000191730 | PCSK9 Inhibitors |
| FDA EPC | N0000191731 | PCSK9 Inhibitor |
| 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 |
| 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 | 55513-750 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-750 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-750 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-760 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-760 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-760 | 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 | 72511-750 | 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 |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72511-760 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |
| REPATHA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72511-760 | INJECTION, SOLUTION | 140 mg | SUBCUTANEOUS | BLA | 33 sections |