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| Stem definition | Drug id | CAS RN |
|---|---|---|
| granulocyte colony stimulating factor (G-CSF) type substances | 4986 | 208265-92-3 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
pegylated (r-G-CSF) conjugated to polyethylene glycol for treatment of neutropenic patients with non-myeloid malignancies who are at high risk for infection
|
| Dose | Unit | Route |
|---|---|---|
| 0.30 | mg | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 31, 2002 | FDA | AMGEN | |
| Aug. 22, 2002 | EMA | Amgen Europe B.V. | |
| Sept. 26, 2014 | PMDA | Kyowa Hakko Kirin Co., Ltd. |
| 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 adhesion issue | 35418.92 | 19.35 | 6133 | 91906 | 558 | 90529850 |
| Unintentional medical device removal | 29761.87 | 19.35 | 5332 | 92707 | 1698 | 90528710 |
| Wrong technique in product usage process | 16580.32 | 19.35 | 5127 | 92912 | 66444 | 90463964 |
| Device use error | 15085.89 | 19.35 | 3030 | 95009 | 4191 | 90526217 |
| Device malfunction | 13829.99 | 19.35 | 3423 | 94616 | 17554 | 90512854 |
| Accidental exposure to product | 8589.00 | 19.35 | 2749 | 95290 | 39617 | 90490791 |
| Device issue | 7602.78 | 19.35 | 2302 | 95737 | 27235 | 90503173 |
| Device occlusion | 6745.86 | 19.35 | 1641 | 96398 | 7641 | 90522767 |
| Application site haemorrhage | 3975.41 | 19.35 | 739 | 97300 | 426 | 90529982 |
| Intercepted product preparation error | 3516.57 | 19.35 | 680 | 97359 | 640 | 90529768 |
| Drug dose omission by device | 3506.27 | 19.35 | 997 | 97042 | 9234 | 90521174 |
| Device physical property issue | 2996.35 | 19.35 | 677 | 97362 | 2099 | 90528309 |
| Occupational exposure to product | 2595.28 | 19.35 | 592 | 97447 | 1939 | 90528469 |
| Application site pain | 2526.93 | 19.35 | 654 | 97385 | 4066 | 90526342 |
| Device leakage | 2498.77 | 19.35 | 763 | 97276 | 9228 | 90521180 |
| Febrile neutropenia | 2419.50 | 19.35 | 1715 | 96324 | 156634 | 90373774 |
| Bone pain | 2044.27 | 19.35 | 1098 | 96941 | 60885 | 90469523 |
| Device electrical finding | 1184.92 | 19.35 | 208 | 97831 | 30 | 90530378 |
| Neutropenia | 1176.87 | 19.35 | 1329 | 96710 | 223575 | 90306833 |
| Application site discomfort | 1131.64 | 19.35 | 220 | 97819 | 218 | 90530190 |
| Device power source issue | 1120.61 | 19.35 | 245 | 97794 | 619 | 90529789 |
| Application site bruise | 884.50 | 19.35 | 174 | 97865 | 194 | 90530214 |
| Device failure | 761.05 | 19.35 | 285 | 97754 | 6612 | 90523796 |
| Underdose | 756.30 | 19.35 | 556 | 97483 | 53461 | 90476947 |
| Investigation | 738.01 | 19.35 | 197 | 97842 | 1400 | 90529008 |
| Product dose omission issue | 722.51 | 19.35 | 1200 | 96839 | 290487 | 90239921 |
| Incorrect disposal of product | 654.25 | 19.35 | 162 | 97877 | 816 | 90529592 |
| Incorrect dose administered by device | 625.48 | 19.35 | 235 | 97804 | 5502 | 90524906 |
| Product preparation error | 543.14 | 19.35 | 251 | 97788 | 10010 | 90520398 |
| Drug ineffective | 516.99 | 19.35 | 446 | 97593 | 1383852 | 89146556 |
| Aortitis | 459.59 | 19.35 | 131 | 97908 | 1219 | 90529189 |
| Intercepted product administration error | 420.75 | 19.35 | 112 | 97927 | 786 | 90529622 |
| Neutrophil count decreased | 397.57 | 19.35 | 437 | 97602 | 71095 | 90459313 |
| Neutrophil count abnormal | 381.71 | 19.35 | 150 | 97889 | 3978 | 90526430 |
| Arthropathy | 379.33 | 19.35 | 3 | 98036 | 366239 | 90164169 |
| Joint swelling | 376.32 | 19.35 | 50 | 97989 | 503250 | 90027158 |
| Drug intolerance | 358.27 | 19.35 | 35 | 98004 | 447556 | 90082852 |
| Circumstance or information capable of leading to medication error | 354.86 | 19.35 | 150 | 97889 | 4817 | 90525591 |
| Device delivery system issue | 353.35 | 19.35 | 114 | 97925 | 1664 | 90528744 |
| Rheumatoid arthritis | 339.16 | 19.35 | 12 | 98027 | 362602 | 90167806 |
| Condition aggravated | 327.37 | 19.35 | 118 | 97921 | 595427 | 89934981 |
| Maternal exposure during pregnancy | 326.37 | 19.35 | 15 | 98024 | 360048 | 90170360 |
| Chemotherapy | 318.14 | 19.35 | 106 | 97933 | 1721 | 90528687 |
| Needle issue | 306.71 | 19.35 | 190 | 97849 | 13744 | 90516664 |
| White blood cell count decreased | 297.88 | 19.35 | 597 | 97442 | 166512 | 90363896 |
| White blood cell count abnormal | 295.71 | 19.35 | 150 | 97889 | 7354 | 90523054 |
| Hand deformity | 291.23 | 19.35 | 6 | 98033 | 296356 | 90234052 |
| Abdominal discomfort | 288.15 | 19.35 | 80 | 97959 | 477248 | 90053160 |
| Treatment failure | 287.92 | 19.35 | 9 | 98030 | 303919 | 90226489 |
| Product communication issue | 285.12 | 19.35 | 93 | 97946 | 1408 | 90529000 |
| Hepatic enzyme increased | 283.93 | 19.35 | 30 | 98009 | 360706 | 90169702 |
| Magnetic resonance imaging | 276.09 | 19.35 | 56 | 97983 | 82 | 90530326 |
| Pericarditis | 275.93 | 19.35 | 3 | 98036 | 270148 | 90260260 |
| Weight increased | 275.79 | 19.35 | 58 | 97981 | 417869 | 90112539 |
| Drug hypersensitivity | 263.00 | 19.35 | 87 | 97952 | 463522 | 90066886 |
| Infusion related reaction | 254.98 | 19.35 | 68 | 97971 | 416712 | 90113696 |
| Glossodynia | 250.05 | 19.35 | 28 | 98011 | 321751 | 90208657 |
| Swelling | 247.76 | 19.35 | 73 | 97966 | 418985 | 90111423 |
| Product use issue | 243.49 | 19.35 | 34 | 98005 | 329885 | 90200523 |
| Sinusitis | 236.01 | 19.35 | 43 | 97996 | 343045 | 90187363 |
| Hypertension | 234.22 | 19.35 | 101 | 97938 | 457431 | 90072977 |
| Helicobacter infection | 229.49 | 19.35 | 3 | 98036 | 226847 | 90303561 |
| Musculoskeletal stiffness | 224.94 | 19.35 | 28 | 98011 | 296504 | 90233904 |
| Therapeutic product effect decreased | 223.80 | 19.35 | 21 | 98018 | 277550 | 90252858 |
| Wound | 221.75 | 19.35 | 32 | 98007 | 302948 | 90227460 |
| Peripheral swelling | 221.49 | 19.35 | 85 | 97954 | 413021 | 90117387 |
| Device placement issue | 220.70 | 19.35 | 83 | 97956 | 1947 | 90528461 |
| Nasopharyngitis | 219.53 | 19.35 | 83 | 97956 | 407021 | 90123387 |
| Exposure during pregnancy | 219.02 | 19.35 | 9 | 98030 | 238401 | 90292007 |
| Hyperhidrosis | 215.89 | 19.35 | 464 | 97575 | 135841 | 90394567 |
| Death | 206.37 | 19.35 | 1008 | 97031 | 455543 | 90074865 |
| Off label use | 204.51 | 19.35 | 1950 | 96089 | 1100302 | 89430106 |
| Folliculitis | 201.26 | 19.35 | 4 | 98035 | 204349 | 90326059 |
| Fibromyalgia | 199.39 | 19.35 | 5 | 98034 | 206264 | 90324144 |
| Drug delivery system malfunction | 196.97 | 19.35 | 69 | 97970 | 1312 | 90529096 |
| Pyrexia | 196.19 | 19.35 | 1303 | 96736 | 659182 | 89871226 |
| Asthma | 183.30 | 19.35 | 23 | 98016 | 242137 | 90288271 |
| Type 2 diabetes mellitus | 182.33 | 19.35 | 9 | 98030 | 203235 | 90327173 |
| Depression | 181.95 | 19.35 | 50 | 97989 | 300551 | 90229857 |
| Application site erythema | 181.89 | 19.35 | 96 | 97943 | 5112 | 90525296 |
| Colony stimulating factor therapy | 180.36 | 19.35 | 49 | 97990 | 375 | 90530033 |
| Impaired healing | 180.33 | 19.35 | 21 | 98018 | 234178 | 90296230 |
| Pruritus | 179.31 | 19.35 | 193 | 97846 | 541332 | 89989076 |
| Osteoarthritis | 177.74 | 19.35 | 8 | 98031 | 195722 | 90334686 |
| Intentional product use issue | 175.91 | 19.35 | 16 | 98023 | 216876 | 90313532 |
| Headache | 174.51 | 19.35 | 426 | 97613 | 862320 | 89668088 |
| Irritable bowel syndrome | 171.80 | 19.35 | 14 | 98025 | 207434 | 90322974 |
| Blister | 166.84 | 19.35 | 36 | 98003 | 254962 | 90275446 |
| Injury | 164.31 | 19.35 | 13 | 98026 | 197336 | 90333072 |
| Wheezing | 161.18 | 19.35 | 31 | 98008 | 238049 | 90292359 |
| Product use in unapproved indication | 152.67 | 19.35 | 87 | 97952 | 336149 | 90194259 |
| Computerised tomogram thorax abnormal | 145.67 | 19.35 | 62 | 97977 | 2025 | 90528383 |
| Psoriasis | 145.04 | 19.35 | 3 | 98036 | 147751 | 90382657 |
| Drug interaction | 142.97 | 19.35 | 60 | 97979 | 276393 | 90254015 |
| Toxicity to various agents | 140.22 | 19.35 | 68 | 97971 | 287778 | 90242630 |
| Joint range of motion decreased | 132.17 | 19.35 | 3 | 98036 | 135640 | 90394768 |
| Discomfort | 131.82 | 19.35 | 66 | 97973 | 274269 | 90256139 |
| Contusion | 129.13 | 19.35 | 55 | 97984 | 251161 | 90279247 |
| Bursitis | 127.94 | 19.35 | 3 | 98036 | 131651 | 90398757 |
| Pain | 127.53 | 19.35 | 600 | 97439 | 995741 | 89534667 |
| Rash | 126.63 | 19.35 | 440 | 97599 | 795660 | 89734748 |
| Intentional medical device removal by patient | 120.06 | 19.35 | 29 | 98010 | 129 | 90530279 |
| Computerised tomogram | 119.64 | 19.35 | 21 | 98018 | 3 | 90530405 |
| Mobility decreased | 119.44 | 19.35 | 61 | 97978 | 250673 | 90279735 |
| Sleep disorder due to general medical condition, insomnia type | 117.68 | 19.35 | 5 | 98034 | 128689 | 90401719 |
| Mucosal inflammation | 117.38 | 19.35 | 218 | 97821 | 57407 | 90473001 |
| Therapeutic product effect incomplete | 115.88 | 19.35 | 33 | 98006 | 193863 | 90336545 |
| Hypersensitivity | 114.13 | 19.35 | 198 | 97841 | 454479 | 90075929 |
| Arthralgia | 113.48 | 19.35 | 446 | 97593 | 778076 | 89752332 |
| Intercepted medication error | 113.47 | 19.35 | 41 | 97998 | 856 | 90529552 |
| Migraine | 112.68 | 19.35 | 33 | 98006 | 190359 | 90340049 |
| Ill-defined disorder | 111.36 | 19.35 | 31 | 98008 | 184860 | 90345548 |
| Neuropathy peripheral | 110.67 | 19.35 | 363 | 97676 | 136607 | 90393801 |
| Confusional state | 107.47 | 19.35 | 157 | 97882 | 386048 | 90144360 |
| C-reactive protein abnormal | 107.16 | 19.35 | 8 | 98031 | 127421 | 90402987 |
| Arthritis | 104.67 | 19.35 | 26 | 98013 | 167289 | 90363119 |
| Lower respiratory tract infection | 103.88 | 19.35 | 72 | 97967 | 250587 | 90279821 |
| Fall | 103.49 | 19.35 | 230 | 97809 | 481580 | 90048828 |
| Hospitalisation | 103.05 | 19.35 | 339 | 97700 | 127761 | 90402647 |
| Computerised tomogram thorax | 101.63 | 19.35 | 33 | 98006 | 492 | 90529916 |
| Blood pressure increased | 101.62 | 19.35 | 43 | 97996 | 197174 | 90333234 |
| Arteritis | 100.18 | 19.35 | 35 | 98004 | 660 | 90529748 |
| Leukopenia | 100.11 | 19.35 | 287 | 97752 | 100423 | 90429985 |
| Device alarm issue | 99.39 | 19.35 | 46 | 97993 | 1839 | 90528569 |
| Leukocytosis | 96.57 | 19.35 | 142 | 97897 | 30848 | 90499560 |
| Injury associated with device | 96.03 | 19.35 | 60 | 97979 | 4404 | 90526004 |
| Dry mouth | 95.04 | 19.35 | 40 | 97999 | 184019 | 90346389 |
| Application site extravasation | 93.29 | 19.35 | 16 | 98023 | 0 | 90530408 |
| Atelectasis | 92.71 | 19.35 | 123 | 97916 | 24286 | 90506122 |
| Prescribed overdose | 91.98 | 19.35 | 3 | 98036 | 97622 | 90432786 |
| Neutropenic sepsis | 90.82 | 19.35 | 105 | 97934 | 18025 | 90512383 |
| Dizziness | 90.68 | 19.35 | 330 | 97709 | 588954 | 89941454 |
| Sleep disorder | 90.16 | 19.35 | 51 | 97988 | 197979 | 90332429 |
| Gastrooesophageal reflux disease | 89.39 | 19.35 | 34 | 98005 | 166303 | 90364105 |
| Wrong technique in device usage process | 88.27 | 19.35 | 63 | 97976 | 5772 | 90524636 |
| Platelet count decreased | 86.63 | 19.35 | 335 | 97704 | 136634 | 90393774 |
| Facet joint syndrome | 86.20 | 19.35 | 5 | 98034 | 98384 | 90432024 |
| Application site injury | 82.72 | 19.35 | 16 | 98023 | 15 | 90530393 |
| Memory impairment | 82.59 | 19.35 | 56 | 97983 | 197188 | 90333220 |
| Amnesia | 80.39 | 19.35 | 11 | 98028 | 108494 | 90421914 |
| Acute kidney injury | 79.90 | 19.35 | 140 | 97899 | 320247 | 90210161 |
| Loss of personal independence in daily activities | 79.78 | 19.35 | 24 | 98015 | 136081 | 90394327 |
| Thrombocytopenia | 79.58 | 19.35 | 440 | 97599 | 208285 | 90322123 |
| Road traffic accident | 79.53 | 19.35 | 11 | 98028 | 107615 | 90422793 |
| Application site discolouration | 79.46 | 19.35 | 32 | 98007 | 906 | 90529502 |
| Application site mass | 78.89 | 19.35 | 17 | 98022 | 39 | 90530369 |
| Lower limb fracture | 78.74 | 19.35 | 3 | 98036 | 85010 | 90445398 |
| Palmar-plantar erythrodysaesthesia syndrome | 78.23 | 19.35 | 122 | 97917 | 27901 | 90502507 |
| Bronchitis | 76.16 | 19.35 | 35 | 98004 | 152892 | 90377516 |
| Device deployment issue | 74.26 | 19.35 | 53 | 97986 | 4856 | 90525552 |
| Sciatica | 73.43 | 19.35 | 11 | 98028 | 101371 | 90429037 |
| Application site swelling | 72.33 | 19.35 | 27 | 98012 | 620 | 90529788 |
| Anxiety | 72.23 | 19.35 | 141 | 97898 | 309631 | 90220777 |
| Liver disorder | 71.77 | 19.35 | 21 | 98018 | 121248 | 90409160 |
| Alopecia | 71.73 | 19.35 | 284 | 97755 | 494787 | 90035621 |
| Gait disturbance | 71.34 | 19.35 | 107 | 97932 | 260389 | 90270019 |
| Urticaria | 69.81 | 19.35 | 146 | 97893 | 312588 | 90217820 |
| Delirium | 69.72 | 19.35 | 14 | 98025 | 104345 | 90426063 |
| Gait inability | 69.16 | 19.35 | 36 | 98003 | 146420 | 90383988 |
| Abdominal pain upper | 68.77 | 19.35 | 162 | 97877 | 332512 | 90197896 |
| Suicide attempt | 68.69 | 19.35 | 3 | 98036 | 75396 | 90455012 |
| Device mechanical issue | 67.42 | 19.35 | 30 | 98009 | 1093 | 90529315 |
| Application site reaction | 65.80 | 19.35 | 27 | 98012 | 803 | 90529605 |
| Febrile bone marrow aplasia | 65.66 | 19.35 | 66 | 97973 | 9672 | 90520736 |
| Wound infection | 65.64 | 19.35 | 17 | 98022 | 106385 | 90424023 |
| Hypoaesthesia | 64.95 | 19.35 | 153 | 97886 | 314057 | 90216351 |
| Drug-induced liver injury | 64.95 | 19.35 | 10 | 98029 | 90308 | 90440100 |
| Overdose | 64.39 | 19.35 | 46 | 97993 | 157663 | 90372745 |
| Staphylococcal bacteraemia | 62.45 | 19.35 | 57 | 97982 | 7412 | 90522996 |
| Prescribed underdose | 62.25 | 19.35 | 5 | 98034 | 75014 | 90455394 |
| Inflammation | 61.96 | 19.35 | 61 | 97978 | 178531 | 90351877 |
| Dyspepsia | 61.76 | 19.35 | 74 | 97965 | 198086 | 90332322 |
| Product quality issue | 61.30 | 19.35 | 7 | 98032 | 79318 | 90451090 |
| Somnolence | 61.09 | 19.35 | 82 | 97957 | 209002 | 90321406 |
| Suicidal ideation | 61.07 | 19.35 | 5 | 98034 | 73850 | 90456558 |
| Muscle spasms | 61.04 | 19.35 | 112 | 97927 | 251771 | 90278637 |
| Aortic wall hypertrophy | 60.89 | 19.35 | 13 | 98026 | 28 | 90530380 |
| Oedema | 60.11 | 19.35 | 77 | 97962 | 200218 | 90330190 |
| Ear infection | 59.76 | 19.35 | 4 | 98035 | 69771 | 90460637 |
| Device material issue | 59.48 | 19.35 | 21 | 98018 | 409 | 90529999 |
| Obesity | 59.35 | 19.35 | 20 | 98019 | 105487 | 90424921 |
| Insomnia | 58.61 | 19.35 | 176 | 97863 | 333298 | 90197110 |
| Incorrect dose administered | 58.26 | 19.35 | 203 | 97836 | 78727 | 90451681 |
| Device defective | 58.24 | 19.35 | 40 | 97999 | 3446 | 90526962 |
| Application site haematoma | 57.85 | 19.35 | 12 | 98027 | 21 | 90530387 |
| Drug abuse | 57.24 | 19.35 | 10 | 98029 | 82337 | 90448071 |
| Epilepsy | 57.11 | 19.35 | 10 | 98029 | 82196 | 90448212 |
| Pneumonia | 56.61 | 19.35 | 431 | 97608 | 637628 | 89892780 |
| Osteoporosis | 56.60 | 19.35 | 17 | 98022 | 96514 | 90433894 |
| Alopecia areata | 56.15 | 19.35 | 32 | 98007 | 1983 | 90528425 |
| Pulmonary fibrosis | 56.06 | 19.35 | 23 | 98016 | 107480 | 90422928 |
| Oral pain | 56.03 | 19.35 | 115 | 97924 | 32568 | 90497840 |
| White blood cell count increased | 55.89 | 19.35 | 180 | 97859 | 67061 | 90463347 |
| Red blood cell sedimentation rate increased | 55.34 | 19.35 | 11 | 98028 | 82584 | 90447824 |
| Neutropenic colitis | 54.24 | 19.35 | 41 | 97998 | 4102 | 90526306 |
| Drug ineffective for unapproved indication | 53.77 | 19.35 | 5 | 98034 | 66639 | 90463769 |
| Autoimmune disorder | 51.88 | 19.35 | 10 | 98029 | 76734 | 90453674 |
| Blood pressure systolic increased | 51.00 | 19.35 | 3 | 98036 | 58342 | 90472066 |
| Infection | 50.96 | 19.35 | 210 | 97829 | 361884 | 90168524 |
| Product storage error | 50.86 | 19.35 | 84 | 97955 | 20157 | 90510251 |
| Cataract | 49.58 | 19.35 | 9 | 98030 | 72083 | 90458325 |
| Frequent bowel movements | 49.54 | 19.35 | 3 | 98036 | 56932 | 90473476 |
| COVID-19 | 49.54 | 19.35 | 66 | 97973 | 168777 | 90361631 |
| Anaemia | 49.33 | 19.35 | 591 | 97448 | 352211 | 90178197 |
| Application site irritation | 48.97 | 19.35 | 29 | 98010 | 1932 | 90528476 |
| Hair colour changes | 48.92 | 19.35 | 36 | 98003 | 3458 | 90526950 |
| Heart rate abnormal | 48.82 | 19.35 | 45 | 97994 | 5926 | 90524482 |
| Device monitoring procedure not performed | 48.50 | 19.35 | 9 | 98030 | 5 | 90530403 |
| Coma | 47.98 | 19.35 | 10 | 98029 | 72622 | 90457786 |
| Cerebrovascular accident | 47.90 | 19.35 | 38 | 98001 | 123495 | 90406913 |
| Pancytopenia | 47.46 | 19.35 | 256 | 97783 | 120007 | 90410401 |
| Inappropriate schedule of product administration | 47.41 | 19.35 | 301 | 97738 | 149632 | 90380776 |
| Colitis ulcerative | 47.37 | 19.35 | 5 | 98034 | 60261 | 90470147 |
| Cardiac failure congestive | 46.98 | 19.35 | 24 | 98015 | 98670 | 90431738 |
| Pneumocystis jirovecii pneumonia | 46.82 | 19.35 | 84 | 97955 | 21532 | 90508876 |
| Myalgia | 45.51 | 19.35 | 335 | 97704 | 174790 | 90355618 |
| Muscular weakness | 44.82 | 19.35 | 98 | 97941 | 206568 | 90323840 |
| Application site pruritus | 44.79 | 19.35 | 37 | 98002 | 4210 | 90526198 |
| Liver function test increased | 44.50 | 19.35 | 18 | 98021 | 84837 | 90445571 |
| Pregnancy | 44.32 | 19.35 | 7 | 98032 | 62040 | 90468368 |
| Hepatitis | 44.21 | 19.35 | 11 | 98028 | 70728 | 90459680 |
| Peripheral sensory neuropathy | 43.71 | 19.35 | 52 | 97987 | 9198 | 90521210 |
| Bradycardia | 43.62 | 19.35 | 18 | 98021 | 83829 | 90446579 |
| Nasal congestion | 43.25 | 19.35 | 18 | 98021 | 83396 | 90447012 |
| Myocardial infarction | 43.13 | 19.35 | 31 | 98008 | 105941 | 90424467 |
| Weight decreased | 42.57 | 19.35 | 239 | 97800 | 379671 | 90150737 |
| Electrocardiogram QT prolonged | 42.05 | 19.35 | 13 | 98026 | 72443 | 90457965 |
| Lung disorder | 41.56 | 19.35 | 61 | 97978 | 149822 | 90380586 |
| Stress | 41.50 | 19.35 | 18 | 98021 | 81377 | 90449031 |
| Nail bed inflammation | 40.75 | 19.35 | 25 | 98014 | 1776 | 90528632 |
| Heart rate decreased | 40.65 | 19.35 | 5 | 98034 | 53500 | 90476908 |
| Sedation | 40.56 | 19.35 | 3 | 98036 | 48168 | 90482240 |
| Seizure | 40.51 | 19.35 | 64 | 97975 | 152565 | 90377843 |
| Joint stiffness | 40.20 | 19.35 | 17 | 98022 | 78025 | 90452383 |
| Visual impairment | 39.58 | 19.35 | 51 | 97988 | 132314 | 90398094 |
| Carotidynia | 39.57 | 19.35 | 12 | 98027 | 141 | 90530267 |
| Rectal haemorrhage | 39.56 | 19.35 | 20 | 98019 | 82724 | 90447684 |
| Illness | 38.91 | 19.35 | 20 | 98019 | 81949 | 90448459 |
| Treatment noncompliance | 38.89 | 19.35 | 5 | 98034 | 51722 | 90478686 |
| Abortion spontaneous | 38.83 | 19.35 | 6 | 98033 | 54050 | 90476358 |
| Upper respiratory tract infection | 38.83 | 19.35 | 49 | 97990 | 128269 | 90402139 |
| Night sweats | 38.11 | 19.35 | 50 | 97989 | 128716 | 90401692 |
| Renal impairment | 37.73 | 19.35 | 35 | 98004 | 105386 | 90425022 |
| Nasal mucosal disorder | 37.54 | 19.35 | 24 | 98015 | 1833 | 90528575 |
| Lymphadenitis | 37.41 | 19.35 | 33 | 98006 | 4104 | 90526304 |
| Streptococcal sepsis | 37.33 | 19.35 | 31 | 98008 | 3553 | 90526855 |
| Sleep disorder due to a general medical condition | 37.06 | 19.35 | 3 | 98036 | 44735 | 90485673 |
| Madarosis | 36.99 | 19.35 | 31 | 98008 | 3598 | 90526810 |
| Fluid retention | 36.87 | 19.35 | 25 | 98014 | 88066 | 90442342 |
| Gastrointestinal disorder | 36.63 | 19.35 | 148 | 97891 | 256539 | 90273869 |
| Injection site reaction | 36.10 | 19.35 | 28 | 98011 | 92052 | 90438356 |
| Hair texture abnormal | 35.78 | 19.35 | 34 | 98005 | 4653 | 90525755 |
| Dehydration | 35.65 | 19.35 | 344 | 97695 | 194103 | 90336305 |
| Therapy non-responder | 35.64 | 19.35 | 58 | 97981 | 136646 | 90393762 |
| Pneumonitis | 35.58 | 19.35 | 117 | 97922 | 44053 | 90486355 |
| Medication error | 35.46 | 19.35 | 24 | 98015 | 84628 | 90445780 |
| Influenza | 35.46 | 19.35 | 60 | 97979 | 139204 | 90391204 |
| Foetal exposure during pregnancy | 35.28 | 19.35 | 3 | 98036 | 42972 | 90487436 |
| Ultrasound scan | 34.98 | 19.35 | 6 | 98033 | 0 | 90530408 |
| Hypoglycaemia | 34.74 | 19.35 | 16 | 98023 | 69832 | 90460576 |
| Injection site pruritus | 34.37 | 19.35 | 8 | 98031 | 53826 | 90476582 |
| Pseudomonal sepsis | 34.36 | 19.35 | 32 | 98007 | 4270 | 90526138 |
| Neutrophil count increased | 34.15 | 19.35 | 69 | 97970 | 19321 | 90511087 |
| Blood magnesium decreased | 34.01 | 19.35 | 61 | 97978 | 15632 | 90514776 |
| Pancreatitis | 33.20 | 19.35 | 17 | 98022 | 69809 | 90460599 |
| Depressed level of consciousness | 32.74 | 19.35 | 19 | 98020 | 72765 | 90457643 |
| Injection site erythema | 32.62 | 19.35 | 35 | 98004 | 98467 | 90431941 |
| Dry eye | 32.54 | 19.35 | 11 | 98028 | 57920 | 90472488 |
| Blood glucose increased | 32.49 | 19.35 | 33 | 98006 | 95213 | 90435195 |
| Vision blurred | 32.46 | 19.35 | 43 | 97996 | 110250 | 90420158 |
| Metabolic acidosis | 32.29 | 19.35 | 10 | 98029 | 55666 | 90474742 |
| Vasculitis | 32.21 | 19.35 | 74 | 97965 | 22619 | 90507789 |
| Radiotherapy | 31.98 | 19.35 | 17 | 98022 | 918 | 90529490 |
| Intentional product misuse | 31.77 | 19.35 | 30 | 98009 | 89574 | 90440834 |
| Interstitial lung disease | 31.75 | 19.35 | 165 | 97874 | 76240 | 90454168 |
| Lactic acidosis | 31.24 | 19.35 | 8 | 98031 | 50455 | 90479953 |
| Sepsis | 30.96 | 19.35 | 314 | 97725 | 179500 | 90350908 |
| Disability | 30.49 | 19.35 | 4 | 98035 | 40741 | 90489667 |
| Nephrolithiasis | 29.97 | 19.35 | 8 | 98031 | 49077 | 90481331 |
| Pulmonary hypertension | 29.91 | 19.35 | 5 | 98034 | 42518 | 90487890 |
| Unevaluable event | 29.77 | 19.35 | 128 | 97911 | 54720 | 90475688 |
| Cystitis haemorrhagic | 29.42 | 19.35 | 33 | 98006 | 5480 | 90524928 |
| Left ventricular dysfunction | 29.24 | 19.35 | 55 | 97984 | 14614 | 90515794 |
| Femur fracture | 29.12 | 19.35 | 7 | 98032 | 46075 | 90484333 |
| Capillary leak syndrome | 28.96 | 19.35 | 24 | 98015 | 2743 | 90527665 |
| Hypersensitivity pneumonitis | 28.93 | 19.35 | 28 | 98011 | 3920 | 90526488 |
| Hallucination | 28.58 | 19.35 | 18 | 98021 | 65941 | 90464467 |
| Premature delivery | 28.54 | 19.35 | 4 | 98035 | 38758 | 90491650 |
| Poor quality device used | 28.50 | 19.35 | 22 | 98017 | 2271 | 90528137 |
| Oedema peripheral | 28.46 | 19.35 | 163 | 97876 | 257752 | 90272656 |
| Neutropenic infection | 28.45 | 19.35 | 20 | 98019 | 1789 | 90528619 |
| Body temperature abnormal | 28.03 | 19.35 | 23 | 98016 | 2592 | 90527816 |
| Mastectomy | 27.99 | 19.35 | 21 | 98018 | 2078 | 90528330 |
| Recall phenomenon | 27.82 | 19.35 | 15 | 98024 | 834 | 90529574 |
| Gastrointestinal haemorrhage | 27.79 | 19.35 | 34 | 98005 | 90214 | 90440194 |
| Walking aid user | 27.77 | 19.35 | 3 | 98036 | 35503 | 90494905 |
| Diabetes mellitus | 27.70 | 19.35 | 18 | 98021 | 64857 | 90465551 |
| Blood pressure fluctuation | 27.67 | 19.35 | 11 | 98028 | 52402 | 90478006 |
| Tongue coated | 27.08 | 19.35 | 19 | 98020 | 1694 | 90528714 |
| Chronic obstructive pulmonary disease | 27.03 | 19.35 | 24 | 98015 | 73805 | 90456603 |
| Hepatotoxicity | 27.00 | 19.35 | 8 | 98031 | 45834 | 90484574 |
| Vascular device infection | 26.60 | 19.35 | 47 | 97992 | 11905 | 90518503 |
| International normalised ratio increased | 26.55 | 19.35 | 9 | 98030 | 47307 | 90483101 |
| Injection site haemorrhage | 26.49 | 19.35 | 79 | 97960 | 28239 | 90502169 |
| Taste disorder | 26.38 | 19.35 | 17 | 98022 | 61529 | 90468879 |
| Therapeutic procedure | 26.30 | 19.35 | 15 | 98024 | 931 | 90529477 |
| Laryngitis | 26.23 | 19.35 | 11 | 98028 | 50742 | 90479666 |
| Tremor | 26.05 | 19.35 | 82 | 97957 | 153091 | 90377317 |
| Splenic rupture | 25.95 | 19.35 | 17 | 98022 | 1354 | 90529054 |
| Acute febrile neutrophilic dermatosis | 25.71 | 19.35 | 25 | 98014 | 3520 | 90526888 |
| White blood cell disorder | 25.53 | 19.35 | 23 | 98016 | 2941 | 90527467 |
| Application site warmth | 25.52 | 19.35 | 10 | 98029 | 263 | 90530145 |
| Basal ganglion degeneration | 25.51 | 19.35 | 11 | 98028 | 371 | 90530037 |
| Cardiac arrest | 25.09 | 19.35 | 47 | 97992 | 104888 | 90425520 |
| Melaena | 24.68 | 19.35 | 4 | 98035 | 34793 | 90495615 |
| Immunodeficiency | 24.65 | 19.35 | 8 | 98031 | 43226 | 90487182 |
| Stomatitis | 24.55 | 19.35 | 185 | 97854 | 274513 | 90255895 |
| Hyperleukocytosis | 24.49 | 19.35 | 14 | 98025 | 873 | 90529535 |
| Breast cancer metastatic | 24.48 | 19.35 | 52 | 97987 | 15080 | 90515328 |
| Vascular fragility | 24.14 | 19.35 | 9 | 98030 | 206 | 90530202 |
| Vein discolouration | 24.01 | 19.35 | 10 | 98029 | 309 | 90530099 |
| Infective aortitis | 23.94 | 19.35 | 6 | 98033 | 32 | 90530376 |
| Endoscopic retrograde cholangiopancreatography | 23.89 | 19.35 | 9 | 98030 | 212 | 90530196 |
| Metastases to central nervous system | 23.58 | 19.35 | 56 | 97983 | 17486 | 90512922 |
| Refusal of treatment by patient | 23.48 | 19.35 | 30 | 98009 | 5708 | 90524700 |
| Anaesthesia | 23.46 | 19.35 | 11 | 98028 | 453 | 90529955 |
| Application site cellulitis | 23.32 | 19.35 | 4 | 98035 | 0 | 90530408 |
| Respiratory arrest | 23.25 | 19.35 | 4 | 98035 | 33307 | 90497101 |
| Agitation | 23.16 | 19.35 | 23 | 98016 | 67075 | 90463333 |
| Disturbance in attention | 23.10 | 19.35 | 11 | 98028 | 47098 | 90483310 |
| Transient ischaemic attack | 22.89 | 19.35 | 9 | 98030 | 43167 | 90487241 |
| Balance disorder | 22.76 | 19.35 | 44 | 97995 | 97036 | 90433372 |
| Generalised tonic-clonic seizure | 22.65 | 19.35 | 5 | 98034 | 34898 | 90495510 |
| Respiratory disorder | 22.63 | 19.35 | 22 | 98017 | 64794 | 90465614 |
| Aphasia | 22.58 | 19.35 | 9 | 98030 | 42803 | 90487605 |
| Application site urticaria | 22.47 | 19.35 | 9 | 98030 | 251 | 90530157 |
| Injection site swelling | 22.45 | 19.35 | 19 | 98020 | 59820 | 90470588 |
| Metastases to lymph nodes | 22.28 | 19.35 | 43 | 97996 | 11646 | 90518762 |
| Sinus disorder | 22.23 | 19.35 | 5 | 98034 | 34442 | 90495966 |
| Varicose vein | 22.00 | 19.35 | 33 | 98006 | 7294 | 90523114 |
| Lymphadenopathy | 21.97 | 19.35 | 103 | 97936 | 45672 | 90484736 |
| Blood creatine increased | 21.81 | 19.35 | 32 | 98007 | 6935 | 90523473 |
| Eye irritation | 21.79 | 19.35 | 5 | 98034 | 33973 | 90496435 |
| Orthostatic hypotension | 21.72 | 19.35 | 9 | 98030 | 41818 | 90488590 |
| Hypotension | 21.72 | 19.35 | 236 | 97803 | 325161 | 90205247 |
| Haematemesis | 21.55 | 19.35 | 5 | 98034 | 33721 | 90496687 |
| Device dislocation | 21.54 | 19.35 | 79 | 97960 | 31403 | 90499005 |
| Movement disorder | 21.35 | 19.35 | 3 | 98036 | 29016 | 90501392 |
| Drug reaction with eosinophilia and systemic symptoms | 20.95 | 19.35 | 10 | 98029 | 42748 | 90487660 |
| Acne | 20.85 | 19.35 | 3 | 98036 | 28504 | 90501904 |
| Rhabdomyolysis | 20.85 | 19.35 | 15 | 98024 | 51241 | 90479167 |
| Abdominal distension | 20.77 | 19.35 | 72 | 97967 | 130529 | 90399879 |
| Hypervolaemia | 20.65 | 19.35 | 5 | 98034 | 32752 | 90497656 |
| Cholelithiasis | 20.54 | 19.35 | 16 | 98023 | 52490 | 90477918 |
| Dyskinesia | 20.41 | 19.35 | 7 | 98032 | 36527 | 90493881 |
| Therapy interrupted | 19.94 | 19.35 | 15 | 98024 | 50093 | 90480315 |
| Skin ulcer | 19.92 | 19.35 | 15 | 98024 | 50060 | 90480348 |
| Tissue infiltration | 19.49 | 19.35 | 12 | 98027 | 858 | 90529550 |
| Respiratory depth decreased | 19.45 | 19.35 | 5 | 98034 | 30 | 90530378 |
| Hyperkalaemia | 19.45 | 19.35 | 25 | 98014 | 64939 | 90465469 |
| 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 adhesion issue | 19743.82 | 19.50 | 3441 | 46178 | 193 | 42571523 |
| Unintentional medical device removal | 15240.82 | 19.50 | 2711 | 46908 | 480 | 42571236 |
| Wrong technique in product usage process | 7580.70 | 19.50 | 2543 | 47076 | 40092 | 42531624 |
| Device use error | 7525.00 | 19.50 | 1500 | 48119 | 1697 | 42570019 |
| Device malfunction | 6273.01 | 19.50 | 1661 | 47958 | 10666 | 42561050 |
| Device occlusion | 4622.72 | 19.50 | 1207 | 48412 | 7243 | 42564473 |
| Device issue | 3459.73 | 19.50 | 1067 | 48552 | 12442 | 42559274 |
| Accidental exposure to product | 2374.01 | 19.50 | 892 | 48727 | 19501 | 42552215 |
| Application site haemorrhage | 2113.48 | 19.50 | 382 | 49237 | 98 | 42571618 |
| Drug dose omission by device | 2111.76 | 19.50 | 604 | 49015 | 5282 | 42566434 |
| Device physical property issue | 1283.91 | 19.50 | 307 | 49312 | 1187 | 42570529 |
| Application site pain | 1003.40 | 19.50 | 276 | 49343 | 2053 | 42569663 |
| Febrile neutropenia | 863.19 | 19.50 | 1069 | 48550 | 184634 | 42387082 |
| Investigation | 725.57 | 19.50 | 177 | 49442 | 758 | 42570958 |
| Intercepted product preparation error | 704.52 | 19.50 | 280 | 49339 | 7109 | 42564607 |
| Device power source issue | 695.90 | 19.50 | 158 | 49461 | 456 | 42571260 |
| Device electrical finding | 620.74 | 19.50 | 112 | 49507 | 27 | 42571689 |
| Device leakage | 587.01 | 19.50 | 271 | 49348 | 10014 | 42561702 |
| Application site discomfort | 542.87 | 19.50 | 97 | 49522 | 17 | 42571699 |
| Device failure | 450.19 | 19.50 | 155 | 49464 | 2588 | 42569128 |
| Incorrect disposal of product | 426.87 | 19.50 | 99 | 49520 | 323 | 42571393 |
| Product dose omission issue | 411.19 | 19.50 | 683 | 48936 | 153682 | 42418034 |
| Underdose | 346.24 | 19.50 | 225 | 49394 | 16441 | 42555275 |
| Incorrect dose administered by device | 328.86 | 19.50 | 123 | 49496 | 2633 | 42569083 |
| Bone pain | 319.43 | 19.50 | 246 | 49373 | 23546 | 42548170 |
| Neutropenia | 308.03 | 19.50 | 701 | 48918 | 198730 | 42372986 |
| Product preparation error | 298.09 | 19.50 | 134 | 49485 | 4644 | 42567072 |
| Application site bruise | 283.68 | 19.50 | 51 | 49568 | 11 | 42571705 |
| Hyperhidrosis | 276.91 | 19.50 | 427 | 49192 | 90085 | 42481631 |
| Occupational exposure to product | 250.81 | 19.50 | 65 | 49554 | 372 | 42571344 |
| Device delivery system issue | 231.82 | 19.50 | 74 | 49545 | 963 | 42570753 |
| Device placement issue | 222.37 | 19.50 | 46 | 49573 | 70 | 42571646 |
| Drug ineffective | 203.11 | 19.50 | 263 | 49356 | 629934 | 41941782 |
| Drug interaction | 187.52 | 19.50 | 41 | 49578 | 266958 | 42304758 |
| Circumstance or information capable of leading to medication error | 187.21 | 19.50 | 80 | 49539 | 2448 | 42569268 |
| Death | 185.50 | 19.50 | 1054 | 48565 | 470131 | 42101585 |
| Toxicity to various agents | 173.98 | 19.50 | 29 | 49590 | 229107 | 42342609 |
| Drug delivery system malfunction | 173.17 | 19.50 | 50 | 49569 | 451 | 42571265 |
| Magnetic resonance imaging | 169.86 | 19.50 | 30 | 49589 | 3 | 42571713 |
| Hospitalisation | 167.51 | 19.50 | 306 | 49313 | 74024 | 42497692 |
| Intercepted product administration error | 163.77 | 19.50 | 49 | 49570 | 506 | 42571210 |
| Chemotherapy | 161.70 | 19.50 | 53 | 49566 | 754 | 42570962 |
| Colony stimulating factor therapy | 160.58 | 19.50 | 39 | 49580 | 163 | 42571553 |
| Condition aggravated | 148.53 | 19.50 | 59 | 49560 | 260695 | 42311021 |
| Neutrophil count decreased | 129.08 | 19.50 | 250 | 49369 | 63165 | 42508551 |
| Needle issue | 123.15 | 19.50 | 93 | 49526 | 8634 | 42563082 |
| Product communication issue | 109.06 | 19.50 | 43 | 49576 | 1066 | 42570650 |
| White blood cell count abnormal | 104.64 | 19.50 | 61 | 49558 | 3664 | 42568052 |
| Neutrophil count abnormal | 101.41 | 19.50 | 54 | 49565 | 2717 | 42568999 |
| Off label use | 99.65 | 19.50 | 1156 | 48463 | 637179 | 41934537 |
| Aortitis | 95.84 | 19.50 | 34 | 49585 | 622 | 42571094 |
| Device deployment issue | 92.10 | 19.50 | 33 | 49586 | 622 | 42571094 |
| Hypertension | 78.28 | 19.50 | 49 | 49570 | 167155 | 42404561 |
| Depression | 78.24 | 19.50 | 17 | 49602 | 111346 | 42460370 |
| Blood pressure increased | 74.85 | 19.50 | 14 | 49605 | 101914 | 42469802 |
| Bradycardia | 74.02 | 19.50 | 7 | 49612 | 85477 | 42486239 |
| Acute kidney injury | 68.78 | 19.50 | 210 | 49409 | 367127 | 42204589 |
| Drug intolerance | 68.55 | 19.50 | 7 | 49612 | 80417 | 42491299 |
| Rash | 67.66 | 19.50 | 138 | 49481 | 276816 | 42294900 |
| Somnolence | 66.52 | 19.50 | 41 | 49578 | 141064 | 42430652 |
| Device mechanical issue | 65.88 | 19.50 | 30 | 49589 | 1071 | 42570645 |
| Intercepted medication error | 65.25 | 19.50 | 24 | 49595 | 489 | 42571227 |
| Application site extravasation | 63.33 | 19.50 | 11 | 49608 | 0 | 42571716 |
| Wrong technique in device usage process | 61.62 | 19.50 | 39 | 49580 | 2718 | 42568998 |
| Arteritis | 61.44 | 19.50 | 23 | 49596 | 493 | 42571223 |
| Dizziness | 61.03 | 19.50 | 124 | 49495 | 249130 | 42322586 |
| Seizure | 58.26 | 19.50 | 34 | 49585 | 120527 | 42451189 |
| Renal impairment | 57.80 | 19.50 | 28 | 49591 | 110200 | 42461516 |
| Pyrexia | 57.74 | 19.50 | 706 | 48913 | 393336 | 42178380 |
| Intentional medical device removal by patient | 57.69 | 19.50 | 21 | 49598 | 415 | 42571301 |
| Intentional product use issue | 56.91 | 19.50 | 8 | 49611 | 71825 | 42499891 |
| Device alarm issue | 55.18 | 19.50 | 24 | 49595 | 767 | 42570949 |
| Weight increased | 54.27 | 19.50 | 29 | 49590 | 107954 | 42463762 |
| Neutropenic sepsis | 54.01 | 19.50 | 79 | 49540 | 15867 | 42555849 |
| Therapeutic procedure | 53.61 | 19.50 | 18 | 49601 | 277 | 42571439 |
| Hallucination | 51.72 | 19.50 | 4 | 49615 | 57503 | 42514213 |
| Confusional state | 51.49 | 19.50 | 72 | 49547 | 167525 | 42404191 |
| Pruritus | 51.40 | 19.50 | 88 | 49531 | 188683 | 42383033 |
| Rhabdomyolysis | 50.71 | 19.50 | 14 | 49605 | 78005 | 42493711 |
| Cerebrovascular accident | 50.45 | 19.50 | 25 | 49594 | 97135 | 42474581 |
| Cardiac arrest | 49.82 | 19.50 | 33 | 49586 | 109287 | 42462429 |
| Drug hypersensitivity | 49.50 | 19.50 | 27 | 49592 | 99362 | 42472354 |
| Therapeutic product effect incomplete | 49.46 | 19.50 | 11 | 49608 | 70928 | 42500788 |
| Myocardial infarction | 49.39 | 19.50 | 43 | 49576 | 123966 | 42447750 |
| Tremor | 48.75 | 19.50 | 26 | 49593 | 96903 | 42474813 |
| Product use in unapproved indication | 48.40 | 19.50 | 88 | 49531 | 184368 | 42387348 |
| Weight decreased | 47.91 | 19.50 | 107 | 49512 | 207841 | 42363875 |
| Hyperkalaemia | 47.72 | 19.50 | 17 | 49602 | 80441 | 42491275 |
| Overdose | 47.66 | 19.50 | 32 | 49587 | 105232 | 42466484 |
| Leukocytosis | 47.36 | 19.50 | 106 | 49513 | 29602 | 42542114 |
| Anxiety | 47.35 | 19.50 | 41 | 49578 | 118519 | 42453197 |
| Agitation | 46.85 | 19.50 | 9 | 49610 | 64305 | 42507411 |
| Fall | 46.77 | 19.50 | 130 | 49489 | 234390 | 42337326 |
| White blood cell count decreased | 45.68 | 19.50 | 251 | 49368 | 110145 | 42461571 |
| Coronary artery disease | 44.94 | 19.50 | 5 | 49614 | 53715 | 42518001 |
| Psoriasis | 44.80 | 19.50 | 3 | 49616 | 48601 | 42523115 |
| Intentional product misuse | 44.38 | 19.50 | 9 | 49610 | 61891 | 42509825 |
| Blood creatinine increased | 43.98 | 19.50 | 38 | 49581 | 109965 | 42461751 |
| Bone marrow necrosis | 41.70 | 19.50 | 15 | 49604 | 286 | 42571430 |
| Fat embolism syndrome | 41.58 | 19.50 | 11 | 49608 | 69 | 42571647 |
| International normalised ratio increased | 41.54 | 19.50 | 4 | 49615 | 48164 | 42523552 |
| Suicidal ideation | 41.53 | 19.50 | 4 | 49615 | 48157 | 42523559 |
| Headache | 41.12 | 19.50 | 142 | 49477 | 239227 | 42332489 |
| Application site injury | 40.30 | 19.50 | 7 | 49612 | 0 | 42571716 |
| Cardiac failure congestive | 40.14 | 19.50 | 25 | 49594 | 85577 | 42486139 |
| Febrile bone marrow aplasia | 39.76 | 19.50 | 54 | 49565 | 10127 | 42561589 |
| Application site swelling | 39.75 | 19.50 | 15 | 49604 | 329 | 42571387 |
| Blood glucose increased | 39.74 | 19.50 | 18 | 49601 | 73681 | 42498035 |
| Dyspnoea | 38.58 | 19.50 | 330 | 49289 | 442291 | 42129425 |
| Coma | 37.95 | 19.50 | 8 | 49611 | 53546 | 42518170 |
| Renal failure | 37.30 | 19.50 | 69 | 49550 | 143657 | 42428059 |
| Stress | 37.28 | 19.50 | 4 | 49615 | 44208 | 42527508 |
| Asthma | 37.23 | 19.50 | 13 | 49606 | 62301 | 42509415 |
| Cardio-respiratory arrest | 37.22 | 19.50 | 11 | 49608 | 58625 | 42513091 |
| Blood creatine phosphokinase increased | 36.87 | 19.50 | 6 | 49613 | 48332 | 42523384 |
| Application site mass | 36.35 | 19.50 | 8 | 49611 | 19 | 42571697 |
| Foetal exposure during pregnancy | 35.80 | 19.50 | 6 | 49613 | 47305 | 42524411 |
| Neutropenic infection | 35.75 | 19.50 | 24 | 49595 | 1849 | 42569867 |
| Device defective | 35.55 | 19.50 | 23 | 49596 | 1665 | 42570051 |
| Application site erythema | 35.43 | 19.50 | 27 | 49592 | 2539 | 42569177 |
| Computerised tomogram | 34.99 | 19.50 | 8 | 49611 | 24 | 42571692 |
| Cardiac failure | 34.74 | 19.50 | 44 | 49575 | 106812 | 42464904 |
| Drug ineffective for unapproved indication | 34.61 | 19.50 | 6 | 49613 | 46157 | 42525559 |
| Wheezing | 33.47 | 19.50 | 11 | 49608 | 54770 | 42516946 |
| Gait disturbance | 33.28 | 19.50 | 39 | 49580 | 97961 | 42473755 |
| Musculoskeletal stiffness | 32.91 | 19.50 | 13 | 49606 | 57752 | 42513964 |
| Abdominal discomfort | 32.58 | 19.50 | 24 | 49595 | 75231 | 42496485 |
| Metabolic acidosis | 32.42 | 19.50 | 10 | 49609 | 51848 | 42519868 |
| Pulmonary oedema | 32.02 | 19.50 | 11 | 49608 | 53261 | 42518455 |
| Diabetes mellitus | 31.89 | 19.50 | 15 | 49604 | 60072 | 42511644 |
| Heart rate decreased | 31.59 | 19.50 | 3 | 49616 | 36529 | 42535187 |
| Product use issue | 31.30 | 19.50 | 26 | 49593 | 76725 | 42494991 |
| Failure to anastomose | 30.57 | 19.50 | 11 | 49608 | 210 | 42571506 |
| Nasopharyngitis | 30.09 | 19.50 | 32 | 49587 | 83964 | 42487752 |
| Thrombocytopenia | 29.97 | 19.50 | 346 | 49273 | 189933 | 42381783 |
| Lactic acidosis | 29.63 | 19.50 | 8 | 49611 | 45253 | 42526463 |
| Joint swelling | 29.05 | 19.50 | 22 | 49597 | 68000 | 42503716 |
| Loss of consciousness | 29.02 | 19.50 | 39 | 49580 | 92315 | 42479401 |
| Peripheral swelling | 28.48 | 19.50 | 38 | 49581 | 90232 | 42481484 |
| Phlebitis infective | 27.92 | 19.50 | 9 | 49610 | 121 | 42571595 |
| Hypotension | 27.66 | 19.50 | 181 | 49438 | 257450 | 42314266 |
| Haematochezia | 27.48 | 19.50 | 17 | 49602 | 58419 | 42513297 |
| Febrile infection | 27.39 | 19.50 | 24 | 49595 | 2747 | 42568969 |
| Haematuria | 26.93 | 19.50 | 17 | 49602 | 57782 | 42513934 |
| Palpitations | 26.47 | 19.50 | 13 | 49606 | 50784 | 42520932 |
| Chronic kidney disease | 26.31 | 19.50 | 11 | 49608 | 47230 | 42524486 |
| Tubulointerstitial nephritis | 26.22 | 19.50 | 3 | 49616 | 31545 | 42540171 |
| Gastrointestinal haemorrhage | 26.16 | 19.50 | 46 | 49573 | 97680 | 42474036 |
| Treatment noncompliance | 25.94 | 19.50 | 6 | 49613 | 37666 | 42534050 |
| Granulocytopenia neonatal | 25.54 | 19.50 | 6 | 49613 | 21 | 42571695 |
| Gastritis bacterial | 25.54 | 19.50 | 11 | 49608 | 343 | 42571373 |
| Haemorrhage | 25.33 | 19.50 | 20 | 49599 | 60543 | 42511173 |
| Oedema peripheral | 25.22 | 19.50 | 78 | 49541 | 135998 | 42435718 |
| Cataract | 25.22 | 19.50 | 3 | 49616 | 30601 | 42541115 |
| Myeloblast count increased | 25.12 | 19.50 | 6 | 49613 | 23 | 42571693 |
| Expired device used | 25.10 | 19.50 | 9 | 49610 | 170 | 42571546 |
| Drug reaction with eosinophilia and systemic symptoms | 24.75 | 19.50 | 9 | 49610 | 42066 | 42529650 |
| Hypoglycaemia | 24.74 | 19.50 | 20 | 49599 | 59834 | 42511882 |
| Ventricular fibrillation | 24.70 | 19.50 | 3 | 49616 | 30120 | 42541596 |
| Disturbance in attention | 24.43 | 19.50 | 3 | 49616 | 29863 | 42541853 |
| Perihepatic abscess | 24.26 | 19.50 | 8 | 49611 | 116 | 42571600 |
| Loss of personal independence in daily activities | 24.12 | 19.50 | 14 | 49605 | 49802 | 42521914 |
| Cardiogenic shock | 23.90 | 19.50 | 6 | 49613 | 35634 | 42536082 |
| Urticaria | 23.52 | 19.50 | 31 | 49588 | 74005 | 42497711 |
| Neuropathy peripheral | 22.67 | 19.50 | 199 | 49420 | 101654 | 42470062 |
| Arthralgia | 22.62 | 19.50 | 143 | 49476 | 205095 | 42366621 |
| COVID-19 | 22.53 | 19.50 | 65 | 49554 | 115883 | 42455833 |
| Depressed level of consciousness | 22.49 | 19.50 | 14 | 49605 | 47956 | 42523760 |
| Eczema | 22.36 | 19.50 | 6 | 49613 | 34080 | 42537636 |
| Angioedema | 21.93 | 19.50 | 11 | 49608 | 42466 | 42529250 |
| Arthropathy | 21.85 | 19.50 | 4 | 49615 | 29593 | 42542123 |
| Abdominal distension | 21.82 | 19.50 | 31 | 49588 | 71704 | 42500012 |
| Alanine aminotransferase increased | 21.57 | 19.50 | 44 | 49575 | 88362 | 42483354 |
| Multiple organ dysfunction syndrome | 21.45 | 19.50 | 51 | 49568 | 96984 | 42474732 |
| Drug-induced liver injury | 21.17 | 19.50 | 9 | 49610 | 38264 | 42533452 |
| Dry mouth | 21.09 | 19.50 | 10 | 49609 | 39869 | 42531847 |
| Jaundice | 21.03 | 19.50 | 7 | 49612 | 34582 | 42537134 |
| Dysarthria | 21.02 | 19.50 | 10 | 49609 | 39797 | 42531919 |
| Vision blurred | 20.91 | 19.50 | 19 | 49600 | 53680 | 42518036 |
| Mastitis | 20.85 | 19.50 | 8 | 49611 | 184 | 42571532 |
| Cardiac disorder | 20.67 | 19.50 | 16 | 49603 | 48916 | 42522800 |
| Hyponatraemia | 20.36 | 19.50 | 56 | 49563 | 101406 | 42470310 |
| Pancytopenia | 20.29 | 19.50 | 218 | 49401 | 117525 | 42454191 |
| Rectal haemorrhage | 19.98 | 19.50 | 17 | 49602 | 49589 | 42522127 |
| Sleep disorder | 19.97 | 19.50 | 16 | 49603 | 48079 | 42523637 |
| Acute myocardial infarction | 19.90 | 19.50 | 23 | 49596 | 58142 | 42513574 |
| Splenic rupture | 19.87 | 19.50 | 16 | 49603 | 1631 | 42570085 |
| Migraine | 19.73 | 19.50 | 3 | 49616 | 25411 | 42546305 |
| Blister | 19.69 | 19.50 | 4 | 49615 | 27486 | 42544230 |
| Prostate cancer | 19.62 | 19.50 | 14 | 49605 | 44629 | 42527087 |
| Angiodysplasia | 19.51 | 19.50 | 12 | 49607 | 795 | 42570921 |
| 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 adhesion issue | 51136.33 | 18.06 | 8782 | 109317 | 528 | 110470672 |
| Unintentional medical device removal | 38890.28 | 18.06 | 6921 | 111178 | 2002 | 110469198 |
| Wrong technique in product usage process | 19577.60 | 18.06 | 6083 | 112016 | 81265 | 110389935 |
| Device use error | 19161.41 | 18.06 | 3834 | 114265 | 5255 | 110465945 |
| Device malfunction | 18401.39 | 18.06 | 4464 | 113635 | 21094 | 110450106 |
| Device occlusion | 11070.16 | 18.06 | 2683 | 115416 | 12502 | 110458698 |
| Device issue | 9019.61 | 18.06 | 2714 | 115385 | 31821 | 110439379 |
| Accidental exposure to product | 7039.99 | 18.06 | 2460 | 115639 | 47548 | 110423652 |
| Drug dose omission by device | 5059.48 | 18.06 | 1429 | 116670 | 13087 | 110458113 |
| Application site haemorrhage | 4881.71 | 18.06 | 912 | 117187 | 584 | 110470616 |
| Device physical property issue | 3937.96 | 18.06 | 894 | 117205 | 2900 | 110468300 |
| Intercepted product preparation error | 3186.97 | 18.06 | 846 | 117253 | 5974 | 110465226 |
| Application site pain | 2745.69 | 18.06 | 719 | 117380 | 4780 | 110466420 |
| Device leakage | 2410.46 | 18.06 | 830 | 117269 | 15218 | 110455982 |
| Febrile neutropenia | 2272.23 | 18.06 | 2200 | 115899 | 314567 | 110156633 |
| Device electrical finding | 1721.38 | 18.06 | 302 | 117797 | 47 | 110471153 |
| Device power source issue | 1716.08 | 18.06 | 376 | 117723 | 981 | 110470219 |
| Investigation | 1508.52 | 18.06 | 375 | 117724 | 1957 | 110469243 |
| Bone pain | 1415.43 | 18.06 | 876 | 117223 | 64257 | 110406943 |
| Application site discomfort | 1264.52 | 18.06 | 240 | 117859 | 187 | 110471013 |
| Application site bruise | 991.91 | 18.06 | 187 | 117912 | 134 | 110471066 |
| Neutropenia | 964.58 | 18.06 | 1557 | 116542 | 373063 | 110098137 |
| Device failure | 941.01 | 18.06 | 336 | 117763 | 6871 | 110464329 |
| Incorrect disposal of product | 916.64 | 18.06 | 225 | 117874 | 1103 | 110470097 |
| Product dose omission issue | 878.39 | 18.06 | 1374 | 116725 | 320408 | 110150792 |
| Incorrect dose administered by device | 872.03 | 18.06 | 313 | 117786 | 6501 | 110464699 |
| Product preparation error | 853.99 | 18.06 | 350 | 117749 | 10529 | 110460671 |
| Underdose | 652.92 | 18.06 | 542 | 117557 | 63012 | 110408188 |
| Intercepted product administration error | 572.86 | 18.06 | 142 | 117957 | 730 | 110470470 |
| Drug ineffective | 553.43 | 18.06 | 489 | 117610 | 1520051 | 108951149 |
| Aortitis | 523.07 | 18.06 | 158 | 117941 | 1857 | 110469343 |
| Chemotherapy | 446.34 | 18.06 | 142 | 117957 | 2004 | 110469196 |
| Needle issue | 420.60 | 18.06 | 253 | 117846 | 17587 | 110453613 |
| Device placement issue | 393.52 | 18.06 | 124 | 117975 | 1693 | 110469507 |
| Device delivery system issue | 386.01 | 18.06 | 127 | 117972 | 2006 | 110469194 |
| Magnetic resonance imaging | 368.45 | 18.06 | 72 | 118027 | 77 | 110471123 |
| Condition aggravated | 367.21 | 18.06 | 163 | 117936 | 734673 | 109736527 |
| Neutrophil count abnormal | 361.95 | 18.06 | 153 | 117946 | 4979 | 110466221 |
| Circumstance or information capable of leading to medication error | 359.07 | 18.06 | 153 | 117946 | 5080 | 110466120 |
| Product communication issue | 350.56 | 18.06 | 123 | 117976 | 2383 | 110468817 |
| Death | 346.78 | 18.06 | 1570 | 116529 | 697299 | 109773901 |
| Hyperhidrosis | 340.90 | 18.06 | 670 | 117429 | 186628 | 110284572 |
| Neutrophil count decreased | 334.07 | 18.06 | 520 | 117579 | 120421 | 110350779 |
| Hospitalisation | 327.76 | 18.06 | 564 | 117535 | 141929 | 110329271 |
| White blood cell count abnormal | 321.39 | 18.06 | 154 | 117945 | 6755 | 110464445 |
| Drug intolerance | 306.68 | 18.06 | 37 | 118062 | 406475 | 110064725 |
| Colony stimulating factor therapy | 291.98 | 18.06 | 78 | 118021 | 564 | 110470636 |
| Joint swelling | 289.77 | 18.06 | 60 | 118039 | 442785 | 110028415 |
| Toxicity to various agents | 287.16 | 18.06 | 79 | 118020 | 480476 | 109990724 |
| Drug interaction | 282.93 | 18.06 | 91 | 118008 | 500092 | 109971108 |
| Rheumatoid arthritis | 275.71 | 18.06 | 10 | 118089 | 299603 | 110171597 |
| Hypertension | 274.36 | 18.06 | 101 | 117998 | 509983 | 109961217 |
| Drug hypersensitivity | 256.10 | 18.06 | 83 | 118016 | 454007 | 110017193 |
| Treatment failure | 255.97 | 18.06 | 9 | 118090 | 277225 | 110193975 |
| Drug delivery system malfunction | 250.90 | 18.06 | 77 | 118022 | 958 | 110470242 |
| Weight increased | 250.65 | 18.06 | 69 | 118030 | 419575 | 110051625 |
| Contraindicated product administered | 248.97 | 18.06 | 3 | 118096 | 248264 | 110222936 |
| Maternal exposure during pregnancy | 223.02 | 18.06 | 12 | 118087 | 254871 | 110216329 |
| White blood cell count decreased | 221.22 | 18.06 | 641 | 117458 | 228749 | 110242451 |
| Hepatic enzyme increased | 217.15 | 18.06 | 40 | 118059 | 320852 | 110150348 |
| Pericarditis | 209.99 | 18.06 | 5 | 118094 | 219109 | 110252091 |
| Depression | 207.48 | 18.06 | 43 | 118056 | 317292 | 110153908 |
| Hand deformity | 205.60 | 18.06 | 6 | 118093 | 218500 | 110252700 |
| Abdominal discomfort | 200.16 | 18.06 | 85 | 118014 | 393773 | 110077427 |
| Peripheral swelling | 196.24 | 18.06 | 93 | 118006 | 403941 | 110067259 |
| Headache | 195.68 | 18.06 | 406 | 117693 | 881971 | 109589229 |
| Musculoskeletal stiffness | 195.63 | 18.06 | 32 | 118067 | 279790 | 110191410 |
| Pruritus | 189.57 | 18.06 | 205 | 117894 | 581355 | 109889845 |
| Swelling | 189.49 | 18.06 | 69 | 118030 | 350972 | 110120228 |
| Infusion related reaction | 189.35 | 18.06 | 85 | 118014 | 381077 | 110090123 |
| Product use in unapproved indication | 188.39 | 18.06 | 123 | 117976 | 447254 | 110023946 |
| Intentional product use issue | 188.26 | 18.06 | 22 | 118077 | 247884 | 110223316 |
| Sinusitis | 186.29 | 18.06 | 44 | 118055 | 296644 | 110174556 |
| Asthma | 185.69 | 18.06 | 24 | 118075 | 250267 | 110220933 |
| Nasopharyngitis | 180.70 | 18.06 | 98 | 118001 | 394263 | 110076937 |
| Helicobacter infection | 178.87 | 18.06 | 3 | 118096 | 181874 | 110289326 |
| Wheezing | 174.42 | 18.06 | 31 | 118068 | 255199 | 110216001 |
| Product use issue | 170.37 | 18.06 | 60 | 118039 | 311635 | 110159565 |
| Pyrexia | 169.86 | 18.06 | 1581 | 116518 | 896684 | 109574516 |
| Osteoarthritis | 168.29 | 18.06 | 6 | 118093 | 182617 | 110288583 |
| Fibromyalgia | 167.33 | 18.06 | 3 | 118096 | 170906 | 110300294 |
| Arteritis | 164.01 | 18.06 | 57 | 118042 | 1072 | 110470128 |
| Therapeutic product effect decreased | 161.98 | 18.06 | 32 | 118067 | 244284 | 110226916 |
| Impaired healing | 161.07 | 18.06 | 13 | 118086 | 196704 | 110274496 |
| Glossodynia | 158.30 | 18.06 | 24 | 118075 | 221980 | 110249220 |
| Wound | 156.91 | 18.06 | 30 | 118069 | 234407 | 110236793 |
| Type 2 diabetes mellitus | 156.10 | 18.06 | 8 | 118091 | 177224 | 110293976 |
| Acute kidney injury | 154.98 | 18.06 | 276 | 117823 | 635154 | 109836046 |
| Folliculitis | 152.79 | 18.06 | 6 | 118093 | 167647 | 110303553 |
| Exposure during pregnancy | 152.55 | 18.06 | 6 | 118093 | 167418 | 110303782 |
| Blister | 150.28 | 18.06 | 30 | 118069 | 227346 | 110243854 |
| Drug abuse | 150.18 | 18.06 | 10 | 118089 | 177401 | 110293799 |
| Wrong technique in device usage process | 150.18 | 18.06 | 93 | 118006 | 6808 | 110464392 |
| Application site erythema | 149.13 | 18.06 | 86 | 118013 | 5524 | 110465676 |
| Blood pressure increased | 147.74 | 18.06 | 46 | 118053 | 258327 | 110212873 |
| Neuropathy peripheral | 145.69 | 18.06 | 472 | 117627 | 178805 | 110292395 |
| Intentional medical device removal by patient | 145.58 | 18.06 | 43 | 118056 | 465 | 110470735 |
| Rash | 141.95 | 18.06 | 429 | 117670 | 820535 | 109650665 |
| Intercepted medication error | 141.19 | 18.06 | 52 | 118047 | 1164 | 110470036 |
| Fall | 140.16 | 18.06 | 270 | 117829 | 603212 | 109867988 |
| Injury | 138.97 | 18.06 | 14 | 118085 | 177251 | 110293949 |
| Confusional state | 138.93 | 18.06 | 178 | 117921 | 468502 | 110002698 |
| Therapeutic product effect incomplete | 136.94 | 18.06 | 35 | 118064 | 223770 | 110247430 |
| Device deployment issue | 134.29 | 18.06 | 73 | 118026 | 4180 | 110467020 |
| Device mechanical issue | 131.69 | 18.06 | 57 | 118042 | 1967 | 110469233 |
| Dizziness | 131.58 | 18.06 | 350 | 117749 | 697843 | 109773357 |
| Psoriasis | 131.11 | 18.06 | 4 | 118095 | 139989 | 110331211 |
| Computerised tomogram thorax abnormal | 129.08 | 18.06 | 62 | 118037 | 2733 | 110468467 |
| Irritable bowel syndrome | 126.09 | 18.06 | 14 | 118085 | 164201 | 110306999 |
| Computerised tomogram | 125.74 | 18.06 | 22 | 118077 | 3 | 110471197 |
| Bursitis | 120.63 | 18.06 | 4 | 118095 | 129914 | 110341286 |
| Hypersensitivity | 117.06 | 18.06 | 156 | 117943 | 403842 | 110067358 |
| Pain | 116.75 | 18.06 | 574 | 117525 | 954381 | 109516819 |
| Occupational exposure to product | 112.85 | 18.06 | 40 | 118059 | 799 | 110470401 |
| Contusion | 109.76 | 18.06 | 56 | 118043 | 233305 | 110237895 |
| Anxiety | 109.71 | 18.06 | 124 | 117975 | 344954 | 110126246 |
| Migraine | 108.61 | 18.06 | 25 | 118074 | 171627 | 110299573 |
| Dry mouth | 108.35 | 18.06 | 39 | 118060 | 199909 | 110271291 |
| Application site extravasation | 108.24 | 18.06 | 19 | 118080 | 3 | 110471197 |
| Somnolence | 105.79 | 18.06 | 97 | 118002 | 297352 | 110173848 |
| Arthritis | 104.86 | 18.06 | 25 | 118074 | 167561 | 110303639 |
| C-reactive protein abnormal | 102.29 | 18.06 | 10 | 118089 | 129685 | 110341515 |
| Computerised tomogram thorax | 101.98 | 18.06 | 33 | 118066 | 493 | 110470707 |
| Bradycardia | 99.69 | 18.06 | 22 | 118077 | 155495 | 110315705 |
| Arthralgia | 99.65 | 18.06 | 461 | 117638 | 779171 | 109692029 |
| Urticaria | 98.73 | 18.06 | 117 | 117982 | 318740 | 110152460 |
| Overdose | 98.70 | 18.06 | 64 | 118035 | 233730 | 110237470 |
| Joint range of motion decreased | 97.13 | 18.06 | 9 | 118090 | 121823 | 110349377 |
| Suicide attempt | 96.65 | 18.06 | 3 | 118096 | 103391 | 110367809 |
| Coma | 95.89 | 18.06 | 8 | 118091 | 117861 | 110353339 |
| Application site mass | 90.86 | 18.06 | 19 | 118080 | 36 | 110471164 |
| Facet joint syndrome | 89.83 | 18.06 | 3 | 118096 | 96825 | 110374375 |
| Triple negative breast cancer | 89.57 | 18.06 | 30 | 118069 | 502 | 110470698 |
| Sleep disorder due to general medical condition, insomnia type | 89.26 | 18.06 | 6 | 118093 | 105637 | 110365563 |
| Gastrooesophageal reflux disease | 87.95 | 18.06 | 41 | 118058 | 179935 | 110291265 |
| Lip dry | 86.61 | 18.06 | 5 | 118094 | 100078 | 110371122 |
| Febrile bone marrow aplasia | 84.93 | 18.06 | 99 | 118000 | 17366 | 110453834 |
| Discomfort | 83.73 | 18.06 | 64 | 118035 | 214643 | 110256557 |
| Cerebrovascular accident | 83.03 | 18.06 | 45 | 118054 | 181239 | 110289961 |
| Sleep disorder | 82.99 | 18.06 | 55 | 118044 | 198589 | 110272611 |
| Device alarm issue | 82.88 | 18.06 | 44 | 118055 | 2402 | 110468798 |
| Application site swelling | 81.59 | 18.06 | 32 | 118067 | 855 | 110470345 |
| Lower respiratory tract infection | 80.96 | 18.06 | 84 | 118015 | 243022 | 110228178 |
| Hypercholesterolaemia | 80.29 | 18.06 | 4 | 118095 | 90833 | 110380367 |
| Gait inability | 80.25 | 18.06 | 23 | 118076 | 136353 | 110334847 |
| Amnesia | 78.40 | 18.06 | 10 | 118089 | 105398 | 110365802 |
| Memory impairment | 77.70 | 18.06 | 58 | 118041 | 196886 | 110274314 |
| Gait disturbance | 76.96 | 18.06 | 111 | 117988 | 278097 | 110193103 |
| Prescribed overdose | 76.95 | 18.06 | 4 | 118095 | 87577 | 110383623 |
| Muscle spasms | 76.93 | 18.06 | 111 | 117988 | 278046 | 110193154 |
| Drug-induced liver injury | 76.92 | 18.06 | 17 | 118082 | 120050 | 110351150 |
| Liver disorder | 76.62 | 18.06 | 28 | 118071 | 142215 | 110328985 |
| Neutropenic sepsis | 76.32 | 18.06 | 126 | 117973 | 30620 | 110440580 |
| Drug ineffective for unapproved indication | 75.90 | 18.06 | 10 | 118089 | 102828 | 110368372 |
| Mobility decreased | 75.77 | 18.06 | 85 | 118014 | 237337 | 110233863 |
| Road traffic accident | 75.65 | 18.06 | 12 | 118087 | 107386 | 110363814 |
| Aortic wall hypertrophy | 75.30 | 18.06 | 16 | 118083 | 34 | 110471166 |
| Loss of personal independence in daily activities | 75.14 | 18.06 | 33 | 118066 | 149987 | 110321213 |
| Bronchitis | 74.85 | 18.06 | 37 | 118062 | 156995 | 110314205 |
| Suicidal ideation | 74.72 | 18.06 | 7 | 118092 | 93930 | 110377270 |
| Seizure | 74.13 | 18.06 | 76 | 118023 | 221109 | 110250091 |
| Myocardial infarction | 73.95 | 18.06 | 58 | 118041 | 192025 | 110279175 |
| Electrocardiogram QT prolonged | 72.76 | 18.06 | 14 | 118085 | 108946 | 110362254 |
| Renal impairment | 72.43 | 18.06 | 57 | 118042 | 188388 | 110282812 |
| Delirium | 72.02 | 18.06 | 27 | 118072 | 134998 | 110336202 |
| Ill-defined disorder | 70.29 | 18.06 | 40 | 118059 | 156813 | 110314387 |
| Weight decreased | 70.15 | 18.06 | 260 | 117839 | 467797 | 110003403 |
| Cardiac arrest | 70.12 | 18.06 | 64 | 118035 | 196689 | 110274511 |
| Cardiac failure congestive | 69.85 | 18.06 | 37 | 118062 | 150963 | 110320237 |
| Grip strength decreased | 69.39 | 18.06 | 4 | 118095 | 80170 | 110391030 |
| Stress | 69.37 | 18.06 | 14 | 118085 | 105334 | 110365866 |
| Heart rate decreased | 69.04 | 18.06 | 5 | 118094 | 82751 | 110388449 |
| Oedema | 68.29 | 18.06 | 74 | 118025 | 209902 | 110261298 |
| Thrombocytopenia | 68.08 | 18.06 | 619 | 117480 | 348266 | 110122934 |
| Device defective | 67.10 | 18.06 | 45 | 118054 | 3777 | 110467423 |
| Off label use | 66.88 | 18.06 | 2083 | 116016 | 1498102 | 108973098 |
| Therapeutic procedure | 66.72 | 18.06 | 29 | 118070 | 1011 | 110470189 |
| Colitis ulcerative | 66.53 | 18.06 | 4 | 118095 | 77359 | 110393841 |
| Application site discolouration | 66.48 | 18.06 | 29 | 118070 | 1020 | 110470180 |
| Hepatitis | 65.88 | 18.06 | 9 | 118090 | 90045 | 110381155 |
| Intentional product misuse | 65.36 | 18.06 | 30 | 118069 | 132874 | 110338326 |
| Obesity | 65.08 | 18.06 | 20 | 118079 | 113331 | 110357869 |
| Lower limb fracture | 64.48 | 18.06 | 4 | 118095 | 75344 | 110395856 |
| Metabolic acidosis | 64.14 | 18.06 | 14 | 118085 | 99730 | 110371470 |
| Atelectasis | 63.88 | 18.06 | 129 | 117970 | 36583 | 110434617 |
| Sciatica | 63.57 | 18.06 | 11 | 118088 | 92388 | 110378812 |
| Frequent bowel movements | 63.56 | 18.06 | 3 | 118096 | 71387 | 110399813 |
| Platelet count decreased | 63.09 | 18.06 | 442 | 117657 | 230001 | 110241199 |
| International normalised ratio increased | 62.71 | 18.06 | 9 | 118090 | 86763 | 110384437 |
| Abdominal pain upper | 61.91 | 18.06 | 180 | 117919 | 348931 | 110122269 |
| Hallucination | 61.76 | 18.06 | 16 | 118083 | 101416 | 110369784 |
| Neutropenic colitis | 61.24 | 18.06 | 58 | 118041 | 8007 | 110463193 |
| Coronary artery disease | 60.77 | 18.06 | 4 | 118095 | 71686 | 110399514 |
| Rectal haemorrhage | 60.58 | 18.06 | 26 | 118073 | 119807 | 110351393 |
| Agitation | 59.63 | 18.06 | 23 | 118076 | 113028 | 110358172 |
| Application site injury | 59.14 | 18.06 | 12 | 118087 | 18 | 110471182 |
| Sedation | 58.74 | 18.06 | 4 | 118095 | 69679 | 110401521 |
| Muscular weakness | 58.58 | 18.06 | 110 | 117989 | 248358 | 110222842 |
| Product quality issue | 58.30 | 18.06 | 7 | 118092 | 77292 | 110393908 |
| Hypoaesthesia | 57.94 | 18.06 | 159 | 117940 | 314064 | 110157136 |
| Cardiac failure | 57.88 | 18.06 | 69 | 118030 | 187557 | 110283643 |
| Therapy non-responder | 57.45 | 18.06 | 50 | 118049 | 157257 | 110313943 |
| Leukocytosis | 57.27 | 18.06 | 156 | 117943 | 53672 | 110417528 |
| Insomnia | 56.86 | 18.06 | 196 | 117903 | 360394 | 110110806 |
| Hypotension | 56.53 | 18.06 | 328 | 117771 | 523521 | 109947679 |
| Device material issue | 56.24 | 18.06 | 21 | 118078 | 489 | 110470711 |
| Hypoglycaemia | 55.87 | 18.06 | 27 | 118072 | 116077 | 110355123 |
| Lactic acidosis | 55.82 | 18.06 | 15 | 118084 | 92796 | 110378404 |
| Lung disorder | 55.77 | 18.06 | 66 | 118033 | 179981 | 110291219 |
| Cataract | 55.71 | 18.06 | 9 | 118090 | 79476 | 110391724 |
| Rhabdomyolysis | 54.96 | 18.06 | 30 | 118069 | 120371 | 110350829 |
| Blood glucose increased | 54.91 | 18.06 | 37 | 118062 | 132459 | 110338741 |
| Hyperkalaemia | 54.85 | 18.06 | 39 | 118060 | 135757 | 110335443 |
| Cardio-respiratory arrest | 54.14 | 18.06 | 28 | 118071 | 115808 | 110355392 |
| Alopecia areata | 54.10 | 18.06 | 32 | 118067 | 2155 | 110469045 |
| Depressed level of consciousness | 52.69 | 18.06 | 27 | 118072 | 112251 | 110358949 |
| Red blood cell sedimentation rate increased | 52.41 | 18.06 | 10 | 118089 | 78292 | 110392908 |
| Mucosal inflammation | 51.16 | 18.06 | 221 | 117878 | 95920 | 110375280 |
| Tremor | 50.85 | 18.06 | 86 | 118013 | 202146 | 110269054 |
| Osteoporosis | 50.72 | 18.06 | 15 | 118084 | 87137 | 110384063 |
| Wound infection | 50.26 | 18.06 | 20 | 118079 | 96445 | 110374755 |
| Dyspepsia | 50.08 | 18.06 | 79 | 118020 | 190886 | 110280314 |
| Oedema peripheral | 49.58 | 18.06 | 182 | 117917 | 328478 | 110142722 |
| Treatment noncompliance | 49.54 | 18.06 | 9 | 118090 | 72981 | 110398219 |
| Blood pressure fluctuation | 49.14 | 18.06 | 10 | 118089 | 74814 | 110396386 |
| Ear infection | 49.03 | 18.06 | 5 | 118094 | 62727 | 110408473 |
| Prescribed underdose | 48.91 | 18.06 | 6 | 118093 | 65168 | 110406032 |
| Epilepsy | 48.68 | 18.06 | 23 | 118076 | 100186 | 110371014 |
| Device monitoring procedure not performed | 48.62 | 18.06 | 9 | 118090 | 5 | 110471195 |
| COVID-19 | 48.22 | 18.06 | 120 | 117979 | 244940 | 110226260 |
| Inflammation | 47.83 | 18.06 | 83 | 118016 | 193155 | 110278045 |
| Leukopenia | 47.75 | 18.06 | 297 | 117802 | 148494 | 110322706 |
| Blood creatinine increased | 47.64 | 18.06 | 76 | 118023 | 182813 | 110288387 |
| Medication error | 47.02 | 18.06 | 27 | 118072 | 105339 | 110365861 |
| Application site haematoma | 46.99 | 18.06 | 12 | 118087 | 71 | 110471129 |
| Autoimmune disorder | 46.84 | 18.06 | 7 | 118092 | 65476 | 110405724 |
| Gastrointestinal haemorrhage | 46.79 | 18.06 | 65 | 118034 | 165453 | 110305747 |
| Liver function test increased | 46.73 | 18.06 | 18 | 118081 | 88530 | 110382670 |
| Expired device used | 46.71 | 18.06 | 20 | 118079 | 672 | 110470528 |
| Renal failure | 46.12 | 18.06 | 109 | 117990 | 226465 | 110244735 |
| Aggression | 45.56 | 18.06 | 5 | 118094 | 59205 | 110411995 |
| Injection site reaction | 45.54 | 18.06 | 19 | 118080 | 89051 | 110382149 |
| Blood creatine phosphokinase increased | 45.51 | 18.06 | 11 | 118088 | 73066 | 110398134 |
| Inappropriate schedule of product administration | 45.28 | 18.06 | 372 | 117727 | 203265 | 110267935 |
| Product storage error | 44.74 | 18.06 | 82 | 118017 | 21646 | 110449554 |
| Abdominal distension | 44.45 | 18.06 | 74 | 118025 | 175029 | 110296171 |
| Diabetes mellitus | 43.59 | 18.06 | 26 | 118073 | 99355 | 110371845 |
| Pancytopenia | 42.95 | 18.06 | 376 | 117723 | 209237 | 110261963 |
| Application site reaction | 42.83 | 18.06 | 20 | 118079 | 827 | 110470373 |
| Drug resistance | 42.77 | 18.06 | 5 | 118094 | 56369 | 110414831 |
| Psychotic disorder | 42.71 | 18.06 | 3 | 118096 | 50934 | 110420266 |
| Dyspnoea | 41.88 | 18.06 | 883 | 117216 | 1105989 | 109365211 |
| Abdominal pain | 41.63 | 18.06 | 349 | 117750 | 512640 | 109958560 |
| Pulmonary fibrosis | 41.61 | 18.06 | 29 | 118070 | 102013 | 110369187 |
| Drug reaction with eosinophilia and systemic symptoms | 41.19 | 18.06 | 18 | 118081 | 82077 | 110389123 |
| Hair texture abnormal | 41.15 | 18.06 | 34 | 118065 | 3920 | 110467280 |
| Upper respiratory tract infection | 40.82 | 18.06 | 48 | 118051 | 131280 | 110339920 |
| Nail bed inflammation | 40.76 | 18.06 | 26 | 118073 | 2004 | 110469196 |
| Hepatotoxicity | 40.56 | 18.06 | 9 | 118090 | 63391 | 110407809 |
| Injection site pruritus | 40.29 | 18.06 | 4 | 118095 | 51254 | 110419946 |
| Heart rate abnormal | 40.26 | 18.06 | 44 | 118055 | 7194 | 110464006 |
| Pregnancy | 40.10 | 18.06 | 4 | 118095 | 51063 | 110420137 |
| Haemorrhage | 40.07 | 18.06 | 33 | 118066 | 106659 | 110364541 |
| Nasal mucosal disorder | 40.02 | 18.06 | 25 | 118074 | 1858 | 110469342 |
| Fat embolism syndrome | 39.88 | 18.06 | 12 | 118087 | 139 | 110471061 |
| Visual impairment | 39.81 | 18.06 | 51 | 118048 | 134377 | 110336823 |
| Application site pruritus | 39.64 | 18.06 | 34 | 118065 | 4126 | 110467074 |
| Poor quality device used | 39.30 | 18.06 | 29 | 118070 | 2834 | 110468366 |
| Pulmonary oedema | 39.23 | 18.06 | 30 | 118069 | 100629 | 110370571 |
| Vision blurred | 39.20 | 18.06 | 48 | 118051 | 128974 | 110342226 |
| Carotidynia | 38.62 | 18.06 | 12 | 118087 | 156 | 110471044 |
| Sleep disorder due to a general medical condition | 38.61 | 18.06 | 5 | 118094 | 52107 | 110419093 |
| Madarosis | 38.61 | 18.06 | 31 | 118068 | 3432 | 110467768 |
| Oral pain | 38.32 | 18.06 | 107 | 117992 | 37337 | 110433863 |
| Hair colour changes | 37.99 | 18.06 | 35 | 118064 | 4666 | 110466534 |
| Melaena | 37.93 | 18.06 | 13 | 118086 | 68744 | 110402456 |
| Nasal congestion | 37.41 | 18.06 | 30 | 118069 | 98252 | 110372948 |
| Basal cell carcinoma | 37.01 | 18.06 | 3 | 118096 | 45267 | 110425933 |
| Haematemesis | 36.60 | 18.06 | 9 | 118090 | 59099 | 110412101 |
| Pancreatitis | 36.30 | 18.06 | 28 | 118071 | 93505 | 110377695 |
| Nephrolithiasis | 35.71 | 18.06 | 13 | 118086 | 66199 | 110405001 |
| Fluid retention | 35.63 | 18.06 | 29 | 118070 | 94278 | 110376922 |
| Injection site erythema | 35.53 | 18.06 | 29 | 118070 | 94147 | 110377053 |
| Influenza | 35.49 | 18.06 | 80 | 118019 | 169021 | 110302179 |
| Transient ischaemic attack | 35.47 | 18.06 | 12 | 118087 | 63970 | 110407230 |
| Alanine aminotransferase increased | 35.36 | 18.06 | 91 | 118008 | 183682 | 110287518 |
| Obstructive airways disorder | 35.25 | 18.06 | 4 | 118095 | 46145 | 110425055 |
| Incorrect dose administered | 35.22 | 18.06 | 210 | 117889 | 103431 | 110367769 |
| Imaging procedure | 35.06 | 18.06 | 6 | 118093 | 0 | 110471200 |
| Vertigo | 35.01 | 18.06 | 25 | 118074 | 86845 | 110384355 |
| Cardiogenic shock | 34.99 | 18.06 | 9 | 118090 | 57329 | 110413871 |
| Joint stiffness | 34.93 | 18.06 | 14 | 118085 | 67229 | 110403971 |
| Serotonin syndrome | 34.75 | 18.06 | 10 | 118089 | 59143 | 110412057 |
| Generalised tonic-clonic seizure | 34.50 | 18.06 | 8 | 118091 | 54672 | 110416528 |
| Application site irritation | 34.47 | 18.06 | 23 | 118076 | 1914 | 110469286 |
| Bone marrow necrosis | 34.27 | 18.06 | 14 | 118085 | 417 | 110470783 |
| Dysarthria | 34.17 | 18.06 | 24 | 118075 | 84097 | 110387103 |
| Pneumonia | 34.11 | 18.06 | 696 | 117403 | 876018 | 109595182 |
| Haematochezia | 34.03 | 18.06 | 44 | 118055 | 115480 | 110355720 |
| Disturbance in attention | 33.72 | 18.06 | 12 | 118087 | 61983 | 110409217 |
| Anaemia | 33.39 | 18.06 | 792 | 117307 | 546294 | 109924906 |
| Lupus-like syndrome | 32.54 | 18.06 | 3 | 118096 | 40789 | 110430411 |
| Injection site haemorrhage | 32.45 | 18.06 | 93 | 118006 | 32935 | 110438265 |
| Irritability | 32.22 | 18.06 | 6 | 118093 | 47803 | 110423397 |
| Tubulointerstitial nephritis | 32.22 | 18.06 | 9 | 118090 | 54275 | 110416925 |
| Respiratory arrest | 32.20 | 18.06 | 11 | 118088 | 58288 | 110412912 |
| Unresponsive to stimuli | 31.98 | 18.06 | 14 | 118085 | 63776 | 110407424 |
| Joint injury | 31.75 | 18.06 | 3 | 118096 | 39991 | 110431209 |
| White blood cell disorder | 31.71 | 18.06 | 29 | 118070 | 3830 | 110467370 |
| Angioedema | 31.70 | 18.06 | 35 | 118064 | 98465 | 110372735 |
| Cholelithiasis | 31.67 | 18.06 | 14 | 118085 | 63408 | 110407792 |
| Dyskinesia | 31.54 | 18.06 | 8 | 118091 | 51438 | 110419762 |
| Infection | 31.40 | 18.06 | 242 | 117857 | 361958 | 110109242 |
| Unevaluable event | 31.39 | 18.06 | 136 | 117963 | 59091 | 110412109 |
| Hallucination, visual | 31.36 | 18.06 | 3 | 118096 | 39602 | 110431598 |
| Aphasia | 31.12 | 18.06 | 12 | 118087 | 58985 | 110412215 |
| Cholestasis | 31.04 | 18.06 | 15 | 118084 | 64503 | 110406697 |
| Loss of consciousness | 30.72 | 18.06 | 107 | 117992 | 196199 | 110275001 |
| Chronic obstructive pulmonary disease | 30.71 | 18.06 | 43 | 118056 | 109115 | 110362085 |
| Peripheral sensory neuropathy | 30.69 | 18.06 | 60 | 118039 | 16620 | 110454580 |
| Palmar-plantar erythrodysaesthesia syndrome | 30.61 | 18.06 | 105 | 117994 | 40920 | 110430280 |
| Hyponatraemia | 30.57 | 18.06 | 124 | 117975 | 217529 | 110253671 |
| Failure to anastomose | 30.52 | 18.06 | 11 | 118088 | 231 | 110470969 |
| Streptococcal sepsis | 30.26 | 18.06 | 32 | 118067 | 5040 | 110466160 |
| Product packaging issue | 30.12 | 18.06 | 20 | 118079 | 1651 | 110469549 |
| Lymphadenitis | 29.87 | 18.06 | 33 | 118066 | 5460 | 110465740 |
| General physical health deterioration | 29.87 | 18.06 | 300 | 117799 | 424995 | 110046205 |
| Neutropenic infection | 29.87 | 18.06 | 26 | 118073 | 3219 | 110467981 |
| Throat irritation | 29.76 | 18.06 | 10 | 118089 | 53542 | 110417658 |
| Gastrointestinal disorder | 29.67 | 18.06 | 145 | 117954 | 241807 | 110229393 |
| Accidental underdose | 29.45 | 18.06 | 18 | 118081 | 1287 | 110469913 |
| Refusal of treatment by patient | 29.27 | 18.06 | 43 | 118056 | 9451 | 110461749 |
| Rash pruritic | 29.25 | 18.06 | 37 | 118062 | 98032 | 110373168 |
| Oxygen saturation decreased | 29.24 | 18.06 | 79 | 118020 | 156903 | 110314297 |
| Scan | 29.22 | 18.06 | 5 | 118094 | 0 | 110471200 |
| X-ray | 29.22 | 18.06 | 5 | 118094 | 0 | 110471200 |
| Ultrasound scan | 29.22 | 18.06 | 5 | 118094 | 0 | 110471200 |
| Illness | 28.94 | 18.06 | 27 | 118072 | 82144 | 110389056 |
| Body temperature abnormal | 28.79 | 18.06 | 25 | 118074 | 3084 | 110468116 |
| Injection site swelling | 28.78 | 18.06 | 15 | 118084 | 61775 | 110409425 |
| Haematuria | 28.39 | 18.06 | 28 | 118071 | 82977 | 110388223 |
| Palpitations | 28.26 | 18.06 | 82 | 118017 | 159130 | 110312070 |
| Accidental overdose | 28.25 | 18.06 | 10 | 118089 | 51824 | 110419376 |
| Nightmare | 28.15 | 18.06 | 4 | 118095 | 38859 | 110432341 |
| Orthostatic hypotension | 28.12 | 18.06 | 18 | 118081 | 66231 | 110404969 |
| Disease recurrence | 27.95 | 18.06 | 15 | 118084 | 60769 | 110410431 |
| Pseudomonal sepsis | 27.93 | 18.06 | 41 | 118058 | 9005 | 110462195 |
| Product prescribing error | 27.81 | 18.06 | 10 | 118089 | 51321 | 110419879 |
| Hepatic cytolysis | 27.73 | 18.06 | 12 | 118087 | 55041 | 110416159 |
| Cardiac disorder | 26.94 | 18.06 | 25 | 118074 | 76255 | 110394945 |
| Respiratory disorder | 26.90 | 18.06 | 22 | 118077 | 71360 | 110399840 |
| Dry eye | 26.80 | 18.06 | 13 | 118086 | 55780 | 110415420 |
| Jaundice | 26.68 | 18.06 | 15 | 118084 | 59221 | 110411979 |
| Pulmonary hypertension | 26.32 | 18.06 | 13 | 118086 | 55207 | 110415993 |
| Splenic rupture | 26.04 | 18.06 | 22 | 118077 | 2615 | 110468585 |
| Pneumonitis | 25.96 | 18.06 | 155 | 117944 | 76376 | 110394824 |
| Myeloblast count increased | 25.92 | 18.06 | 7 | 118092 | 53 | 110471147 |
| Bronchiectasis | 25.87 | 18.06 | 4 | 118095 | 36489 | 110434711 |
| Pain in extremity | 25.62 | 18.06 | 366 | 117733 | 486752 | 109984448 |
| Rash erythematous | 25.33 | 18.06 | 30 | 118069 | 81802 | 110389398 |
| Eye irritation | 25.30 | 18.06 | 3 | 118096 | 33449 | 110437751 |
| Application site laceration | 25.28 | 18.06 | 5 | 118094 | 6 | 110471194 |
| Femur fracture | 25.25 | 18.06 | 8 | 118091 | 44461 | 110426739 |
| Metastases to central nervous system | 25.14 | 18.06 | 67 | 118032 | 22750 | 110448450 |
| Interstitial lung disease | 25.02 | 18.06 | 243 | 117856 | 139091 | 110332109 |
| Radiotherapy | 24.88 | 18.06 | 17 | 118082 | 1471 | 110469729 |
| Therapy interrupted | 24.87 | 18.06 | 11 | 118088 | 49811 | 110421389 |
| Chronic kidney disease | 24.67 | 18.06 | 27 | 118072 | 76264 | 110394936 |
| Basal ganglion degeneration | 24.25 | 18.06 | 11 | 118088 | 425 | 110470775 |
| Capillary leak syndrome | 24.16 | 18.06 | 28 | 118071 | 4880 | 110466320 |
| Vascular fragility | 24.09 | 18.06 | 9 | 118090 | 210 | 110470990 |
| Acute febrile neutrophilic dermatosis | 24.03 | 18.06 | 28 | 118071 | 4908 | 110466292 |
| Hepatocellular injury | 24.02 | 18.06 | 12 | 118087 | 50630 | 110420570 |
| Taste disorder | 23.61 | 18.06 | 21 | 118078 | 65366 | 110405834 |
| Endoscopic retrograde cholangiopancreatography | 23.51 | 18.06 | 9 | 118090 | 225 | 110470975 |
| Laryngitis | 23.43 | 18.06 | 8 | 118091 | 42403 | 110428797 |
| Blood magnesium decreased | 23.35 | 18.06 | 60 | 118039 | 19936 | 110451264 |
| Uterine enlargement | 23.29 | 18.06 | 14 | 118085 | 971 | 110470229 |
| Toxic epidermal necrolysis | 23.29 | 18.06 | 16 | 118083 | 56711 | 110414489 |
| Diabetic ketoacidosis | 23.12 | 18.06 | 8 | 118091 | 42050 | 110429150 |
| Balance disorder | 22.97 | 18.06 | 57 | 118042 | 116503 | 110354697 |
| Breast cancer metastatic | 22.77 | 18.06 | 42 | 118057 | 11139 | 110460061 |
| Heart rate increased | 22.77 | 18.06 | 78 | 118021 | 143756 | 110327444 |
| Liver function test abnormal | 22.74 | 18.06 | 24 | 118075 | 68926 | 110402274 |
| Acute myocardial infarction | 22.58 | 18.06 | 34 | 118065 | 83743 | 110387457 |
| Therapeutic response decreased | 22.48 | 18.06 | 43 | 118056 | 96456 | 110374744 |
| Night sweats | 22.35 | 18.06 | 71 | 118028 | 133912 | 110337288 |
| Swollen tongue | 22.26 | 18.06 | 19 | 118080 | 60343 | 110410857 |
| Therapy cessation | 22.24 | 18.06 | 10 | 118089 | 44847 | 110426353 |
| Perihepatic abscess | 22.15 | 18.06 | 8 | 118091 | 169 | 110471031 |
| Blood urea increased | 21.90 | 18.06 | 16 | 118083 | 54941 | 110416259 |
| Hypervolaemia | 21.60 | 18.06 | 13 | 118086 | 49447 | 110421753 |
| White blood cell count increased | 21.56 | 18.06 | 177 | 117922 | 96665 | 110374535 |
| Neck pain | 21.43 | 18.06 | 64 | 118035 | 123066 | 110348134 |
| Onychomadesis | 21.39 | 18.06 | 11 | 118088 | 45652 | 110425548 |
| Cystitis haemorrhagic | 21.36 | 18.06 | 43 | 118056 | 12166 | 110459034 |
| Gastritis bacterial | 21.34 | 18.06 | 11 | 118088 | 565 | 110470635 |
| Diplopia | 21.31 | 18.06 | 9 | 118090 | 41885 | 110429315 |
| Tongue coated | 21.20 | 18.06 | 17 | 118082 | 1879 | 110469321 |
| Tinnitus | 21.19 | 18.06 | 20 | 118079 | 60520 | 110410680 |
| Intercepted product selection error | 21.19 | 18.06 | 5 | 118094 | 20 | 110471180 |
| Hyperleukocytosis | 21.06 | 18.06 | 22 | 118077 | 3417 | 110467783 |
| Atrial fibrillation | 21.05 | 18.06 | 151 | 117948 | 229491 | 110241709 |
| Vein discolouration | 20.90 | 18.06 | 10 | 118089 | 437 | 110470763 |
| Gastroenteritis viral | 20.87 | 18.06 | 4 | 118095 | 31222 | 110439978 |
| Anaesthesia | 20.85 | 18.06 | 11 | 118088 | 593 | 110470607 |
| Ventricular fibrillation | 20.82 | 18.06 | 9 | 118090 | 41304 | 110429896 |
| Paraesthesia | 20.69 | 18.06 | 192 | 117907 | 276329 | 110194871 |
| Eosinophilia | 20.45 | 18.06 | 19 | 118080 | 57917 | 110413283 |
| Body temperature decreased | 20.35 | 18.06 | 7 | 118092 | 36928 | 110434272 |
| Premature delivery | 20.31 | 18.06 | 4 | 118095 | 30628 | 110440572 |
| Pneumocystis jirovecii pneumonia | 20.30 | 18.06 | 95 | 118004 | 42640 | 110428560 |
| Hepatic encephalopathy | 20.25 | 18.06 | 3 | 118096 | 28253 | 110442947 |
| Mastectomy | 20.06 | 18.06 | 15 | 118084 | 1496 | 110469704 |
| Tissue infiltration | 20.06 | 18.06 | 13 | 118086 | 1030 | 110470170 |
| Acute hepatic failure | 19.94 | 18.06 | 7 | 118092 | 36461 | 110434739 |
| Injury associated with device | 19.89 | 18.06 | 24 | 118075 | 4365 | 110466835 |
| Transaminases increased | 19.87 | 18.06 | 23 | 118076 | 63367 | 110407833 |
| Disorientation | 19.72 | 18.06 | 28 | 118071 | 70643 | 110400557 |
| Stevens-Johnson syndrome | 19.56 | 18.06 | 13 | 118086 | 46888 | 110424312 |
| Respiratory depth decreased | 19.52 | 18.06 | 5 | 118094 | 30 | 110471170 |
| Diabetes mellitus inadequate control | 19.51 | 18.06 | 4 | 118095 | 29771 | 110441429 |
| Hyperlipidaemia | 19.39 | 18.06 | 7 | 118092 | 35841 | 110435359 |
| Posterior reversible encephalopathy syndrome | 19.39 | 18.06 | 6 | 118093 | 33855 | 110437345 |
| Transposition of the great vessels | 19.38 | 18.06 | 6 | 118093 | 77 | 110471123 |
| Device dislocation | 19.32 | 18.06 | 76 | 118023 | 31628 | 110439572 |
| Ischaemic stroke | 19.24 | 18.06 | 10 | 118089 | 41253 | 110429947 |
| Sinus bradycardia | 19.24 | 18.06 | 4 | 118095 | 29479 | 110441721 |
| Nail bed tenderness | 19.21 | 18.06 | 9 | 118090 | 375 | 110470825 |
| Angina pectoris | 19.11 | 18.06 | 23 | 118076 | 62272 | 110408928 |
| Acne | 19.08 | 18.06 | 6 | 118093 | 33514 | 110437686 |
| Labelled drug-drug interaction medication error | 19.07 | 18.06 | 4 | 118095 | 29298 | 110441902 |
| Urinary retention | 19.06 | 18.06 | 28 | 118071 | 69655 | 110401545 |
| Erythema | 19.05 | 18.06 | 209 | 117890 | 291238 | 110179962 |
| Cytomegalovirus infection | 19.04 | 18.06 | 18 | 118081 | 54426 | 110416774 |
| Spinal pain | 19.04 | 18.06 | 53 | 118046 | 18462 | 110452738 |
| Adverse drug reaction | 19.00 | 18.06 | 54 | 118045 | 105505 | 110365695 |
| Vaginal prolapse | 18.99 | 18.06 | 9 | 118090 | 385 | 110470815 |
| Infective aortitis | 18.97 | 18.06 | 6 | 118093 | 83 | 110471117 |
| Cerebral haemorrhage | 18.87 | 18.06 | 25 | 118074 | 64943 | 110406257 |
| Recall phenomenon | 18.85 | 18.06 | 14 | 118085 | 1382 | 110469818 |
| Blood potassium increased | 18.84 | 18.06 | 6 | 118093 | 33243 | 110437957 |
| Vascular device infection | 18.72 | 18.06 | 49 | 118050 | 16463 | 110454737 |
| Flatulence | 18.53 | 18.06 | 17 | 118082 | 52132 | 110419068 |
| Movement disorder | 18.23 | 18.06 | 8 | 118091 | 36396 | 110434804 |
| Eye pain | 18.19 | 18.06 | 16 | 118083 | 50083 | 110421117 |
| Renal tubular necrosis | 18.18 | 18.06 | 5 | 118094 | 30470 | 110440730 |
| Haematopoietic stem cell mobilisation | 18.18 | 18.06 | 9 | 118090 | 424 | 110470776 |
| Application site warmth | 18.11 | 18.06 | 8 | 118091 | 290 | 110470910 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L03AA13 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSTIMULANTS IMMUNOSTIMULANTS Colony stimulating factors |
| FDA CS | M0024696 | Granulocyte Colony-Stimulating Factor |
| FDA PE | N0000009451 | Increased Myeloid Cell Production |
| FDA EPC | N0000175666 | Leukocyte Growth Factor |
| CHEBI has role | CHEBI:35441 | antiinfective agent |
| CHEBI has role | CHEBI:35526 | hypoglycemic agent |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chemotherapy-induced neutropenia | indication | 425229001 | |
| Allogeneic peripheral blood stem cell transplant | indication | 425843001 |
None
None
None
None
None
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Granulocyte colony-stimulating factor receptor | Membrane receptor | ACTIVATOR | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 3A58010674 | UNII |
| D06889 | KEGG_DRUG |
| 4021293 | VUID |
| N0000148730 | NUI |
| 4021293 | VANDF |
| 4037680 | VANDF |
| C1136535 | UMLSCUI |
| CHEBI:749426 | CHEBI |
| CHEMBL1201568 | ChEMBL_ID |
| DB00019 | DRUGBANK_ID |
| 8114 | INN_ID |
| C455861 | MESH_SUPPLEMENTAL_RECORD_UI |
| 6969 | IUPHAR_LIGAND_ID |
| 2048018 | RXNORM |
| 16343 | MMSL |
| 284537 | MMSL |
| 34517 | MMSL |
| 42757 | MMSL |
| d04790 | MMSL |
| 009564 | NDDF |
| 017594 | NDDF |
| 385544005 | SNOMEDCT_US |
| 388379009 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| NYVEPRIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0324 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 30 sections |
| Neulasta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-099 | SOLUTION | 4 mg | SUBCUTANEOUS | BLA | 31 sections |
| Neulasta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-190 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 31 sections |
| ZIEXTENZO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61314-866 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 25 sections |
| STIMUFEND | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65219-371 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 28 sections |
| UDENYCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69448-025 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |
| UDENYCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69448-026 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |
| UDENYCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69448-027 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |
| UDENYCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70114-101 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |
| UDENYCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70114-120 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |
| UDENYCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70114-130 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |
| FYLNETRA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70121-1627 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 27 sections |
| ARMLUPEG | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70748-273 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 25 sections |
| STIMUFEND | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72603-402 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 28 sections |
| Fulphila | HUMAN PRESCRIPTION DRUG LABEL | 1 | 83257-005 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |