| 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
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 22, 2002 | EMA | Amgen Europe B.V. | |
| Jan. 31, 2002 | FDA | AMGEN | |
| 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 | 26244.49 | 19.14 | 4732 | 81656 | 409 | 63402225 |
| Unintentional medical device removal | 25680.92 | 19.14 | 4772 | 81616 | 1343 | 63401291 |
| Wrong technique in product usage process | 15523.77 | 19.14 | 4979 | 81409 | 57361 | 63345273 |
| Device use error | 13647.65 | 19.14 | 2789 | 83599 | 2972 | 63399662 |
| Device malfunction | 11417.49 | 19.14 | 2978 | 83410 | 14879 | 63387755 |
| Accidental exposure to product | 7635.42 | 19.14 | 2393 | 83995 | 25012 | 63377622 |
| Device issue | 6063.35 | 19.14 | 1942 | 84446 | 21839 | 63380795 |
| Device occlusion | 4499.64 | 19.14 | 1188 | 85200 | 6199 | 63396435 |
| Application site haemorrhage | 3715.68 | 19.14 | 720 | 85668 | 404 | 63402230 |
| Drug dose omission by device | 2441.50 | 19.14 | 670 | 85718 | 4131 | 63398503 |
| Device physical property issue | 2429.53 | 19.14 | 561 | 85827 | 1451 | 63401183 |
| Device leakage | 2388.40 | 19.14 | 718 | 85670 | 6378 | 63396256 |
| Application site pain | 2329.19 | 19.14 | 627 | 85761 | 3555 | 63399079 |
| Occupational exposure to product | 2253.43 | 19.14 | 531 | 85857 | 1547 | 63401087 |
| Intercepted product preparation error | 1977.37 | 19.14 | 393 | 85995 | 304 | 63402330 |
| Bone pain | 1847.37 | 19.14 | 1064 | 85324 | 53577 | 63349057 |
| Febrile neutropenia | 1846.83 | 19.14 | 1423 | 84965 | 117026 | 63285608 |
| Application site discomfort | 1060.40 | 19.14 | 213 | 86175 | 185 | 63402449 |
| Neutropenia | 987.51 | 19.14 | 1202 | 85186 | 173803 | 63228831 |
| Underdose | 968.03 | 19.14 | 550 | 85838 | 26906 | 63375728 |
| Device power source issue | 967.44 | 19.14 | 211 | 86177 | 374 | 63402260 |
| Application site bruise | 833.88 | 19.14 | 169 | 86219 | 161 | 63402473 |
| Device electrical finding | 729.83 | 19.14 | 132 | 86256 | 10 | 63402624 |
| Investigation | 692.32 | 19.14 | 197 | 86191 | 1408 | 63401226 |
| Device failure | 682.73 | 19.14 | 270 | 86118 | 5741 | 63396893 |
| Product dose omission issue | 665.04 | 19.14 | 1163 | 85225 | 233150 | 63169484 |
| Incorrect disposal of product | 645.19 | 19.14 | 156 | 86232 | 523 | 63402111 |
| Drug ineffective | 529.50 | 19.14 | 393 | 85995 | 1044372 | 62358262 |
| Incorrect dose administered by device | 520.85 | 19.14 | 203 | 86185 | 4145 | 63398489 |
| Neutrophil count abnormal | 385.65 | 19.14 | 146 | 86242 | 2746 | 63399888 |
| Circumstance or information capable of leading to medication error | 351.11 | 19.14 | 148 | 86240 | 3722 | 63398912 |
| Device delivery system issue | 334.41 | 19.14 | 95 | 86293 | 674 | 63401960 |
| Off label use | 332.81 | 19.14 | 1797 | 84591 | 672665 | 62729969 |
| Aortitis | 327.13 | 19.14 | 101 | 86287 | 986 | 63401648 |
| Neutrophil count decreased | 316.42 | 19.14 | 387 | 86001 | 56019 | 63346615 |
| Arthropathy | 298.53 | 19.14 | 4 | 86384 | 234788 | 63167846 |
| Rheumatoid arthritis | 297.10 | 19.14 | 11 | 86377 | 253808 | 63148826 |
| Drug intolerance | 296.40 | 19.14 | 36 | 86352 | 308625 | 63094009 |
| Joint swelling | 287.36 | 19.14 | 50 | 86338 | 327616 | 63075018 |
| Chemotherapy | 282.41 | 19.14 | 99 | 86289 | 1480 | 63401154 |
| White blood cell count abnormal | 280.72 | 19.14 | 147 | 86241 | 6095 | 63396539 |
| Magnetic resonance imaging | 271.04 | 19.14 | 55 | 86333 | 53 | 63402581 |
| Condition aggravated | 257.12 | 19.14 | 113 | 86275 | 402104 | 63000530 |
| White blood cell count decreased | 246.29 | 19.14 | 568 | 85820 | 138536 | 63264098 |
| Maternal exposure during pregnancy | 246.13 | 19.14 | 13 | 86375 | 220049 | 63182585 |
| Treatment failure | 231.59 | 19.14 | 9 | 86379 | 199034 | 63203600 |
| Abdominal discomfort | 228.50 | 19.14 | 76 | 86312 | 320809 | 63081825 |
| Product use issue | 215.88 | 19.14 | 24 | 86364 | 220496 | 63182138 |
| Drug hypersensitivity | 211.92 | 19.14 | 79 | 86309 | 310608 | 63092026 |
| Hyperhidrosis | 206.07 | 19.14 | 454 | 85934 | 107382 | 63295252 |
| Drug delivery system malfunction | 194.44 | 19.14 | 69 | 86319 | 1071 | 63401563 |
| Weight increased | 194.14 | 19.14 | 57 | 86331 | 260735 | 63141899 |
| Hand deformity | 189.70 | 19.14 | 6 | 86382 | 159451 | 63243183 |
| Therapeutic product effect decreased | 189.14 | 19.14 | 21 | 86367 | 193166 | 63209468 |
| Swelling | 186.13 | 19.14 | 71 | 86317 | 275307 | 63127327 |
| Drug interaction | 186.00 | 19.14 | 42 | 86346 | 229089 | 63173545 |
| Sinusitis | 183.08 | 19.14 | 42 | 86346 | 226611 | 63176023 |
| Intercepted product administration error | 182.38 | 19.14 | 51 | 86337 | 339 | 63402295 |
| Needle issue | 181.75 | 19.14 | 134 | 86254 | 10242 | 63392392 |
| Hepatic enzyme increased | 181.39 | 19.14 | 29 | 86359 | 202299 | 63200335 |
| Pyrexia | 179.18 | 19.14 | 1173 | 85215 | 469305 | 62933329 |
| Exposure during pregnancy | 174.47 | 19.14 | 9 | 86379 | 155538 | 63247096 |
| Infusion related reaction | 173.22 | 19.14 | 59 | 86329 | 245462 | 63157172 |
| Toxicity to various agents | 166.65 | 19.14 | 64 | 86324 | 247186 | 63155448 |
| Pericarditis | 163.95 | 19.14 | 3 | 86385 | 131576 | 63271058 |
| Product communication issue | 162.56 | 19.14 | 53 | 86335 | 626 | 63402008 |
| Musculoskeletal stiffness | 162.06 | 19.14 | 28 | 86360 | 184590 | 63218044 |
| Application site erythema | 159.96 | 19.14 | 93 | 86295 | 4742 | 63397892 |
| Peripheral swelling | 158.58 | 19.14 | 82 | 86306 | 265860 | 63136774 |
| Hypertension | 155.20 | 19.14 | 94 | 86294 | 279209 | 63123425 |
| Glossodynia | 155.11 | 19.14 | 28 | 86360 | 178848 | 63223786 |
| Headache | 154.39 | 19.14 | 402 | 85986 | 632839 | 62769795 |
| Death | 153.85 | 19.14 | 952 | 85436 | 373429 | 63029205 |
| Colony stimulating factor therapy | 149.45 | 19.14 | 42 | 86346 | 285 | 63402349 |
| Intentional product use issue | 147.98 | 19.14 | 6 | 86382 | 127886 | 63274748 |
| Nasopharyngitis | 147.77 | 19.14 | 81 | 86307 | 254176 | 63148458 |
| Pruritus | 138.66 | 19.14 | 173 | 86215 | 361280 | 63041354 |
| Depression | 137.21 | 19.14 | 48 | 86340 | 196444 | 63206190 |
| Hospitalisation | 128.58 | 19.14 | 327 | 86061 | 84754 | 63317880 |
| Wound | 128.35 | 19.14 | 32 | 86356 | 163231 | 63239403 |
| Fall | 123.90 | 19.14 | 215 | 86173 | 392119 | 63010515 |
| Computerised tomogram thorax abnormal | 119.69 | 19.14 | 55 | 86333 | 1708 | 63400926 |
| Intercepted medication error | 118.95 | 19.14 | 41 | 86347 | 581 | 63402053 |
| Acute kidney injury | 118.85 | 19.14 | 110 | 86278 | 263305 | 63139329 |
| Pain | 115.22 | 19.14 | 568 | 85820 | 740060 | 62662574 |
| Blood pressure increased | 114.14 | 19.14 | 39 | 86349 | 162023 | 63240611 |
| Computerised tomogram | 109.23 | 19.14 | 20 | 86368 | 3 | 63402631 |
| Asthma | 108.35 | 19.14 | 21 | 86367 | 127540 | 63275094 |
| Intentional medical device removal by patient | 108.33 | 19.14 | 27 | 86361 | 106 | 63402528 |
| Rash | 106.18 | 19.14 | 399 | 85989 | 560472 | 62842162 |
| Psoriasis | 104.37 | 19.14 | 3 | 86385 | 86954 | 63315680 |
| Wrong technique in device usage process | 102.87 | 19.14 | 63 | 86325 | 3535 | 63399099 |
| Osteoarthritis | 99.53 | 19.14 | 8 | 86380 | 95335 | 63307299 |
| Therapeutic product effect incomplete | 99.28 | 19.14 | 24 | 86364 | 125032 | 63277602 |
| Arthralgia | 99.15 | 19.14 | 419 | 85969 | 569291 | 62833343 |
| Device alarm issue | 95.40 | 19.14 | 45 | 86343 | 1485 | 63401149 |
| Application site extravasation | 89.62 | 19.14 | 16 | 86372 | 0 | 63402634 |
| Discomfort | 89.22 | 19.14 | 59 | 86329 | 167315 | 63235319 |
| Fibromyalgia | 89.06 | 19.14 | 5 | 86383 | 80415 | 63322219 |
| Mucosal inflammation | 88.90 | 19.14 | 197 | 86191 | 46731 | 63355903 |
| Blister | 88.39 | 19.14 | 33 | 86355 | 129781 | 63272853 |
| Arteritis | 87.23 | 19.14 | 33 | 86355 | 619 | 63402015 |
| Arthritis | 84.96 | 19.14 | 26 | 86362 | 115895 | 63286739 |
| Dizziness | 83.78 | 19.14 | 302 | 86086 | 429623 | 62973011 |
| Computerised tomogram thorax | 83.56 | 19.14 | 29 | 86359 | 420 | 63402214 |
| Leukopenia | 83.38 | 19.14 | 263 | 86125 | 77027 | 63325607 |
| Contusion | 82.56 | 19.14 | 51 | 86337 | 149993 | 63252641 |
| Bronchitis | 81.38 | 19.14 | 34 | 86354 | 124901 | 63277733 |
| Product use in unapproved indication | 80.46 | 19.14 | 75 | 86313 | 179005 | 63223629 |
| Injury associated with device | 79.63 | 19.14 | 54 | 86334 | 3612 | 63399022 |
| Application site injury | 79.06 | 19.14 | 16 | 86372 | 15 | 63402619 |
| Folliculitis | 79.03 | 19.14 | 4 | 86384 | 70313 | 63332321 |
| Impaired healing | 78.84 | 19.14 | 21 | 86367 | 102521 | 63300113 |
| Hypersensitivity | 78.00 | 19.14 | 177 | 86211 | 292508 | 63110126 |
| Somnolence | 77.76 | 19.14 | 77 | 86311 | 178608 | 63224026 |
| Neutropenic sepsis | 75.18 | 19.14 | 102 | 86286 | 16336 | 63386298 |
| Leukocytosis | 74.86 | 19.14 | 130 | 86258 | 25805 | 63376829 |
| Application site mass | 74.71 | 19.14 | 17 | 86371 | 40 | 63402594 |
| COVID-19 | 71.73 | 19.14 | 32 | 86356 | 113071 | 63289563 |
| Irritable bowel syndrome | 71.18 | 19.14 | 13 | 86375 | 82399 | 63320235 |
| Product preparation error | 71.06 | 19.14 | 62 | 86326 | 6030 | 63396604 |
| Loss of personal independence in daily activities | 70.97 | 19.14 | 22 | 86366 | 97268 | 63305366 |
| Type 2 diabetes mellitus | 70.63 | 19.14 | 4 | 86384 | 63864 | 63338770 |
| Suicide attempt | 69.97 | 19.14 | 3 | 86385 | 60915 | 63341719 |
| Application site discolouration | 69.84 | 19.14 | 30 | 86358 | 791 | 63401843 |
| Atelectasis | 67.72 | 19.14 | 112 | 86276 | 21371 | 63381263 |
| Device material issue | 66.17 | 19.14 | 21 | 86367 | 226 | 63402408 |
| Migraine | 65.91 | 19.14 | 29 | 86359 | 103317 | 63299317 |
| Suicidal ideation | 65.81 | 19.14 | 5 | 86383 | 62416 | 63340218 |
| Application site swelling | 65.75 | 19.14 | 26 | 86362 | 552 | 63402082 |
| Device mechanical issue | 64.95 | 19.14 | 21 | 86367 | 241 | 63402393 |
| Palmar-plantar erythrodysaesthesia syndrome | 64.65 | 19.14 | 114 | 86274 | 22901 | 63379733 |
| Cardiac failure congestive | 63.76 | 19.14 | 23 | 86365 | 92410 | 63310224 |
| Confusional state | 62.91 | 19.14 | 143 | 86245 | 236237 | 63166397 |
| Myocardial infarction | 62.19 | 19.14 | 29 | 86359 | 99864 | 63302770 |
| Staphylococcal bacteraemia | 61.94 | 19.14 | 55 | 86333 | 5475 | 63397159 |
| Inappropriate schedule of product administration | 61.94 | 19.14 | 293 | 86095 | 103672 | 63298962 |
| Incorrect dose administered | 60.98 | 19.14 | 200 | 86188 | 59768 | 63342866 |
| White blood cell count increased | 60.62 | 19.14 | 174 | 86214 | 48387 | 63354247 |
| Cerebrovascular accident | 60.41 | 19.14 | 36 | 86352 | 107988 | 63294646 |
| Injury | 60.23 | 19.14 | 13 | 86375 | 73234 | 63329400 |
| Application site reaction | 59.21 | 19.14 | 26 | 86362 | 724 | 63401910 |
| Overdose | 58.09 | 19.14 | 43 | 86345 | 115035 | 63287599 |
| Device defective | 57.75 | 19.14 | 35 | 86353 | 1927 | 63400707 |
| Drug abuse | 57.38 | 19.14 | 14 | 86374 | 72504 | 63330130 |
| Platelet count decreased | 57.06 | 19.14 | 310 | 86078 | 115812 | 63286822 |
| Neuropathy peripheral | 56.91 | 19.14 | 305 | 86083 | 113362 | 63289272 |
| Bradycardia | 56.28 | 19.14 | 15 | 86373 | 73212 | 63329422 |
| Coma | 55.91 | 19.14 | 10 | 86378 | 64354 | 63338280 |
| Febrile bone marrow aplasia | 55.90 | 19.14 | 59 | 86329 | 7266 | 63395368 |
| Gastrooesophageal reflux disease | 54.72 | 19.14 | 31 | 86357 | 95608 | 63307026 |
| Wheezing | 54.67 | 19.14 | 31 | 86357 | 95564 | 63307070 |
| Alopecia areata | 54.65 | 19.14 | 32 | 86356 | 1653 | 63400981 |
| Gait disturbance | 54.47 | 19.14 | 104 | 86284 | 183074 | 63219560 |
| Anxiety | 54.38 | 19.14 | 136 | 86252 | 217405 | 63185229 |
| Sleep disorder due to general medical condition, insomnia type | 52.81 | 19.14 | 5 | 86383 | 52212 | 63350422 |
| Blood pressure systolic increased | 52.31 | 19.14 | 3 | 86385 | 47394 | 63355240 |
| Ill-defined disorder | 52.03 | 19.14 | 23 | 86365 | 81732 | 63320902 |
| Alopecia | 51.01 | 19.14 | 261 | 86127 | 337275 | 63065359 |
| Seizure | 50.20 | 19.14 | 64 | 86324 | 132570 | 63270064 |
| Cataract | 49.27 | 19.14 | 9 | 86379 | 57044 | 63345590 |
| Pneumonia | 47.77 | 19.14 | 395 | 85993 | 456372 | 62946262 |
| Heart rate abnormal | 47.24 | 19.14 | 45 | 86343 | 4902 | 63397732 |
| Heart rate decreased | 47.05 | 19.14 | 4 | 86384 | 45556 | 63357078 |
| Gastrointestinal haemorrhage | 46.89 | 19.14 | 26 | 86362 | 81150 | 63321484 |
| Application site haematoma | 46.87 | 19.14 | 10 | 86378 | 15 | 63402619 |
| Device monitoring procedure not performed | 46.44 | 19.14 | 9 | 86379 | 5 | 63402629 |
| Renal impairment | 45.91 | 19.14 | 32 | 86356 | 88323 | 63314311 |
| Application site irritation | 45.88 | 19.14 | 29 | 86359 | 1721 | 63400913 |
| Neutropenic colitis | 45.46 | 19.14 | 36 | 86352 | 3059 | 63399575 |
| Electrocardiogram QT prolonged | 44.24 | 19.14 | 13 | 86375 | 59517 | 63343117 |
| Stress | 44.18 | 19.14 | 18 | 86370 | 67149 | 63335485 |
| Abortion spontaneous | 44.01 | 19.14 | 6 | 86382 | 47189 | 63355445 |
| Lower respiratory tract infection | 43.97 | 19.14 | 70 | 86318 | 132237 | 63270397 |
| Amnesia | 43.45 | 19.14 | 11 | 86377 | 55574 | 63347060 |
| Mobility decreased | 43.27 | 19.14 | 61 | 86327 | 121098 | 63281536 |
| Hypoglycaemia | 43.06 | 19.14 | 14 | 86374 | 60051 | 63342583 |
| Blood glucose increased | 42.65 | 19.14 | 31 | 86357 | 83725 | 63318909 |
| Nasal congestion | 42.53 | 19.14 | 18 | 86370 | 65642 | 63336992 |
| Depressed level of consciousness | 41.88 | 19.14 | 16 | 86372 | 62062 | 63340572 |
| No adverse event | 41.77 | 19.14 | 4 | 86384 | 41401 | 63361233 |
| Oral pain | 41.68 | 19.14 | 108 | 86280 | 28286 | 63374348 |
| Sedation | 41.22 | 19.14 | 3 | 86385 | 38806 | 63363828 |
| Hair colour changes | 40.92 | 19.14 | 34 | 86354 | 3093 | 63399541 |
| Vision blurred | 40.67 | 19.14 | 39 | 86349 | 91885 | 63310749 |
| Ear infection | 40.45 | 19.14 | 3 | 86385 | 38210 | 63364424 |
| Injection site erythema | 39.54 | 19.14 | 33 | 86355 | 83141 | 63319493 |
| Application site pruritus | 39.49 | 19.14 | 37 | 86351 | 3947 | 63398687 |
| Injection site pruritus | 39.21 | 19.14 | 7 | 86381 | 45109 | 63357525 |
| Bursitis | 38.95 | 19.14 | 3 | 86385 | 37038 | 63365596 |
| International normalised ratio increased | 38.66 | 19.14 | 8 | 86380 | 46417 | 63356217 |
| Peripheral sensory neuropathy | 38.35 | 19.14 | 49 | 86339 | 7402 | 63395232 |
| C-reactive protein abnormal | 38.27 | 19.14 | 8 | 86380 | 46088 | 63356546 |
| Abdominal pain upper | 38.17 | 19.14 | 148 | 86240 | 206296 | 63196338 |
| Illness | 37.79 | 19.14 | 10 | 86378 | 49049 | 63353585 |
| Lymphadenitis | 37.53 | 19.14 | 33 | 86355 | 3242 | 63399392 |
| Femur fracture | 37.34 | 19.14 | 6 | 86382 | 41750 | 63360884 |
| Tremor | 36.80 | 19.14 | 78 | 86310 | 132161 | 63270473 |
| Memory impairment | 36.73 | 19.14 | 53 | 86335 | 104205 | 63298429 |
| Carotidynia | 36.71 | 19.14 | 12 | 86376 | 143 | 63402491 |
| Hypotension | 36.66 | 19.14 | 219 | 86169 | 272385 | 63130249 |
| Influenza | 36.62 | 19.14 | 57 | 86331 | 108665 | 63293969 |
| Blood pressure fluctuation | 36.52 | 19.14 | 9 | 86379 | 46308 | 63356326 |
| Delirium | 35.84 | 19.14 | 12 | 86376 | 50529 | 63352105 |
| Rhabdomyolysis | 35.73 | 19.14 | 8 | 86380 | 43943 | 63358691 |
| Cardiac arrest | 35.70 | 19.14 | 44 | 86344 | 92501 | 63310133 |
| Renal failure | 35.66 | 19.14 | 66 | 86322 | 117586 | 63285048 |
| Madarosis | 35.22 | 19.14 | 31 | 86357 | 3050 | 63399584 |
| Osteoporosis | 35.14 | 19.14 | 17 | 86371 | 57321 | 63345313 |
| Diabetes mellitus | 35.04 | 19.14 | 16 | 86372 | 55794 | 63346840 |
| Weight decreased | 34.32 | 19.14 | 228 | 86160 | 276570 | 63126064 |
| Pulmonary hypertension | 33.96 | 19.14 | 5 | 86383 | 37118 | 63365516 |
| Ultrasound scan | 33.61 | 19.14 | 6 | 86382 | 0 | 63402634 |
| Nephrolithiasis | 33.41 | 19.14 | 8 | 86380 | 41976 | 63360658 |
| Agitation | 33.28 | 19.14 | 20 | 86368 | 59737 | 63342897 |
| Metabolic acidosis | 33.20 | 19.14 | 10 | 86378 | 45059 | 63357575 |
| Thrombocytopenia | 32.74 | 19.14 | 332 | 86056 | 150825 | 63251809 |
| Device deployment issue | 32.61 | 19.14 | 33 | 86355 | 3869 | 63398765 |
| Drug ineffective for unapproved indication | 32.56 | 19.14 | 4 | 86384 | 34059 | 63368575 |
| Hair texture abnormal | 32.06 | 19.14 | 34 | 86354 | 4209 | 63398425 |
| Visual impairment | 31.68 | 19.14 | 41 | 86347 | 84405 | 63318229 |
| Dry mouth | 31.12 | 19.14 | 36 | 86352 | 77827 | 63324807 |
| Lactic acidosis | 31.06 | 19.14 | 7 | 86381 | 38280 | 63364354 |
| Hallucination | 31.02 | 19.14 | 18 | 86370 | 54799 | 63347835 |
| Herpes zoster | 30.98 | 19.14 | 40 | 86348 | 82422 | 63320212 |
| Chronic obstructive pulmonary disease | 30.88 | 19.14 | 24 | 86364 | 62662 | 63339972 |
| Respiratory arrest | 30.80 | 19.14 | 4 | 86384 | 32641 | 63369993 |
| Cardio-respiratory arrest | 30.77 | 19.14 | 22 | 86366 | 59937 | 63342697 |
| Balance disorder | 30.64 | 19.14 | 42 | 86346 | 84380 | 63318254 |
| Insomnia | 30.50 | 19.14 | 170 | 86218 | 215082 | 63187552 |
| Myalgia | 30.39 | 19.14 | 319 | 86069 | 146210 | 63256424 |
| Blood magnesium decreased | 30.35 | 19.14 | 60 | 86328 | 13138 | 63389496 |
| Product quality issue | 30.24 | 19.14 | 6 | 86382 | 35859 | 63366775 |
| Liver disorder | 29.85 | 19.14 | 18 | 86370 | 53669 | 63348965 |
| Product storage error | 29.69 | 19.14 | 64 | 86324 | 14892 | 63387742 |
| Pregnancy | 29.35 | 19.14 | 7 | 86381 | 36829 | 63365805 |
| Oedema peripheral | 28.89 | 19.14 | 146 | 86242 | 189365 | 63213269 |
| Radiotherapy | 28.83 | 19.14 | 13 | 86375 | 386 | 63402248 |
| Muscle spasms | 28.82 | 19.14 | 112 | 86276 | 156038 | 63246596 |
| Neutrophil count increased | 28.64 | 19.14 | 67 | 86321 | 16460 | 63386174 |
| Body temperature abnormal | 28.40 | 19.14 | 23 | 86365 | 2018 | 63400616 |
| Mastectomy | 28.39 | 19.14 | 21 | 86367 | 1612 | 63401022 |
| Recall phenomenon | 28.35 | 19.14 | 15 | 86373 | 635 | 63401999 |
| Joint range of motion decreased | 28.25 | 19.14 | 5 | 86383 | 32423 | 63370211 |
| Melaena | 27.99 | 19.14 | 4 | 86384 | 30361 | 63372273 |
| Premature delivery | 27.88 | 19.14 | 4 | 86384 | 30277 | 63372357 |
| Drug-induced liver injury | 27.74 | 19.14 | 10 | 86378 | 40212 | 63362422 |
| Hyperkalaemia | 27.67 | 19.14 | 20 | 86368 | 54183 | 63348451 |
| Basal ganglion degeneration | 27.39 | 19.14 | 13 | 86375 | 435 | 63402199 |
| Hepatitis | 27.26 | 19.14 | 10 | 86378 | 39778 | 63362856 |
| Red blood cell sedimentation rate increased | 27.01 | 19.14 | 13 | 86375 | 43969 | 63358665 |
| Tongue coated | 26.92 | 19.14 | 19 | 86369 | 1356 | 63401278 |
| Fluid retention | 26.78 | 19.14 | 25 | 86363 | 59661 | 63342973 |
| Infective aortitis | 26.71 | 19.14 | 6 | 86382 | 13 | 63402621 |
| Transient ischaemic attack | 26.70 | 19.14 | 9 | 86379 | 37744 | 63364890 |
| Dry eye | 26.68 | 19.14 | 11 | 86377 | 40750 | 63361884 |
| Application site warmth | 26.66 | 19.14 | 10 | 86378 | 183 | 63402451 |
| Alanine aminotransferase increased | 26.59 | 19.14 | 64 | 86324 | 103706 | 63298928 |
| Pancreatitis | 26.51 | 19.14 | 17 | 86371 | 49038 | 63353596 |
| Gastric disorder | 26.27 | 19.14 | 9 | 86379 | 37360 | 63365274 |
| Skin ulcer | 26.01 | 19.14 | 13 | 86375 | 43032 | 63359602 |
| Tissue infiltration | 25.98 | 19.14 | 14 | 86374 | 615 | 63402019 |
| Unresponsive to stimuli | 25.84 | 19.14 | 7 | 86381 | 33809 | 63368825 |
| Haematemesis | 25.82 | 19.14 | 5 | 86383 | 30407 | 63372227 |
| Upper respiratory tract infection | 25.78 | 19.14 | 45 | 86343 | 82002 | 63320632 |
| Left ventricular dysfunction | 25.78 | 19.14 | 53 | 86335 | 11935 | 63390699 |
| Dyskinesia | 25.66 | 19.14 | 6 | 86382 | 31996 | 63370638 |
| Vascular fragility | 25.58 | 19.14 | 9 | 86379 | 136 | 63402498 |
| Chronic kidney disease | 25.55 | 19.14 | 15 | 86373 | 45383 | 63357251 |
| Cardiac failure | 25.28 | 19.14 | 52 | 86336 | 89090 | 63313544 |
| Injection site swelling | 25.01 | 19.14 | 17 | 86371 | 47555 | 63355079 |
| Prescribed underdose | 24.96 | 19.14 | 5 | 86383 | 29684 | 63372950 |
| Orthostatic hypotension | 24.92 | 19.14 | 9 | 86379 | 36151 | 63366483 |
| Capillary leak syndrome | 24.88 | 19.14 | 22 | 86366 | 2178 | 63400456 |
| Oxygen saturation decreased | 24.85 | 19.14 | 52 | 86336 | 88533 | 63314101 |
| Acute febrile neutrophilic dermatosis | 24.57 | 19.14 | 25 | 86363 | 2949 | 63399685 |
| Vein discolouration | 24.46 | 19.14 | 10 | 86378 | 232 | 63402402 |
| Generalised tonic-clonic seizure | 24.16 | 19.14 | 5 | 86383 | 29011 | 63373623 |
| White blood cell disorder | 24.10 | 19.14 | 23 | 86365 | 2511 | 63400123 |
| Acute myocardial infarction | 23.90 | 19.14 | 7 | 86381 | 32117 | 63370517 |
| Disturbance in attention | 23.89 | 19.14 | 11 | 86377 | 38178 | 63364456 |
| Rectal haemorrhage | 23.86 | 19.14 | 19 | 86369 | 49011 | 63353623 |
| Vertigo | 23.59 | 19.14 | 28 | 86360 | 59859 | 63342775 |
| Pancytopenia | 23.48 | 19.14 | 218 | 86170 | 96715 | 63305919 |
| Intentional product misuse | 23.45 | 19.14 | 29 | 86359 | 60888 | 63341746 |
| Injection site reaction | 23.45 | 19.14 | 27 | 86361 | 58497 | 63344137 |
| Irritability | 23.41 | 19.14 | 7 | 86381 | 31687 | 63370947 |
| Aphasia | 23.11 | 19.14 | 8 | 86380 | 32992 | 63369642 |
| Splenic rupture | 22.80 | 19.14 | 17 | 86371 | 1321 | 63401313 |
| Colitis ulcerative | 22.77 | 19.14 | 4 | 86384 | 26087 | 63376547 |
| Lower limb fracture | 22.77 | 19.14 | 3 | 86385 | 24218 | 63378416 |
| Cholelithiasis | 22.69 | 19.14 | 16 | 86372 | 43909 | 63358725 |
| Respiratory depth decreased | 22.27 | 19.14 | 6 | 86382 | 34 | 63402600 |
| Road traffic accident | 22.23 | 19.14 | 11 | 86377 | 36621 | 63366013 |
| Infection | 22.19 | 19.14 | 202 | 86186 | 228971 | 63173663 |
| Medication error | 22.18 | 19.14 | 23 | 86365 | 52261 | 63350373 |
| Urticaria | 21.85 | 19.14 | 134 | 86254 | 165668 | 63236966 |
| Anaesthesia | 21.74 | 19.14 | 11 | 86377 | 424 | 63402210 |
| Blood creatine increased | 21.54 | 19.14 | 32 | 86356 | 5569 | 63397065 |
| Pneumonitis | 21.49 | 19.14 | 100 | 86288 | 35122 | 63367512 |
| Dysarthria | 21.49 | 19.14 | 16 | 86372 | 42695 | 63359939 |
| Renal disorder | 21.42 | 19.14 | 9 | 86379 | 32965 | 63369669 |
| Uterine enlargement | 21.36 | 19.14 | 16 | 86372 | 1252 | 63401382 |
| Frequent bowel movements | 21.29 | 19.14 | 3 | 86385 | 23019 | 63379615 |
| Drug resistance | 21.18 | 19.14 | 3 | 86385 | 22930 | 63379704 |
| Sleep disorder | 21.14 | 19.14 | 50 | 86338 | 81516 | 63321118 |
| Dyspepsia | 21.04 | 19.14 | 70 | 86318 | 102126 | 63300508 |
| Cardiac disorder | 20.84 | 19.14 | 23 | 86365 | 50793 | 63351841 |
| Joint stiffness | 20.66 | 19.14 | 16 | 86372 | 41853 | 63360781 |
| Osteomyelitis | 20.62 | 19.14 | 5 | 86383 | 26015 | 63376619 |
| Pneumocystis jirovecii pneumonia | 20.52 | 19.14 | 60 | 86328 | 16854 | 63385780 |
| Oral candidiasis | 20.51 | 19.14 | 73 | 86315 | 22725 | 63379909 |
| Application site urticaria | 20.38 | 19.14 | 9 | 86379 | 254 | 63402380 |
| Psychotic disorder | 20.26 | 19.14 | 5 | 86383 | 25707 | 63376927 |
| Aortic wall hypertrophy | 20.17 | 19.14 | 4 | 86384 | 3 | 63402631 |
| Gastroenteritis viral | 19.90 | 19.14 | 4 | 86384 | 23696 | 63378938 |
| Sciatica | 19.81 | 19.14 | 11 | 86377 | 34313 | 63368321 |
| Transaminases increased | 19.68 | 19.14 | 9 | 86379 | 31358 | 63371276 |
| Movement disorder | 19.62 | 19.14 | 3 | 86385 | 21658 | 63380976 |
| Blood creatinine increased | 19.61 | 19.14 | 58 | 86330 | 87786 | 63314848 |
| Haemorrhage | 19.60 | 19.14 | 33 | 86355 | 60989 | 63341645 |
| Hiatus hernia | 19.54 | 19.14 | 3 | 86385 | 21591 | 63381043 |
| Tooth disorder | 19.42 | 19.14 | 7 | 86381 | 28150 | 63374484 |
| Stevens-Johnson syndrome | 19.38 | 19.14 | 5 | 86383 | 24945 | 63377689 |
| Eczema | 19.14 | 19.14 | 10 | 86378 | 32281 | 63370353 |
| 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 | 14761.59 | 19.69 | 2588 | 39786 | 116 | 34914441 |
| Unintentional medical device removal | 13395.08 | 19.69 | 2388 | 39986 | 348 | 34914209 |
| Wrong technique in product usage process | 7577.66 | 19.69 | 2461 | 39913 | 33525 | 34881032 |
| Device use error | 7300.15 | 19.69 | 1402 | 40972 | 973 | 34913584 |
| Device malfunction | 5469.54 | 19.69 | 1451 | 40923 | 8970 | 34905587 |
| Device occlusion | 3342.30 | 19.69 | 893 | 41481 | 5652 | 34908905 |
| Device issue | 3009.48 | 19.69 | 898 | 41476 | 8879 | 34905678 |
| Accidental exposure to product | 2211.67 | 19.69 | 758 | 41616 | 12044 | 34902513 |
| Application site haemorrhage | 2036.41 | 19.69 | 371 | 42003 | 97 | 34914460 |
| Drug dose omission by device | 1651.94 | 19.69 | 410 | 41964 | 1829 | 34912728 |
| Device physical property issue | 1152.49 | 19.69 | 255 | 42119 | 594 | 34913963 |
| Application site pain | 1018.35 | 19.69 | 270 | 42104 | 1638 | 34912919 |
| Febrile neutropenia | 772.18 | 19.69 | 887 | 41487 | 135962 | 34778595 |
| Investigation | 719.46 | 19.69 | 177 | 42197 | 753 | 34913804 |
| Device power source issue | 656.06 | 19.69 | 139 | 42235 | 239 | 34914318 |
| Device leakage | 637.41 | 19.69 | 255 | 42119 | 6320 | 34908237 |
| Application site discomfort | 521.36 | 19.69 | 93 | 42281 | 11 | 34914546 |
| Product dose omission issue | 477.34 | 19.69 | 653 | 41721 | 119058 | 34795499 |
| Device failure | 418.53 | 19.69 | 143 | 42231 | 2233 | 34912324 |
| Incorrect disposal of product | 408.01 | 19.69 | 93 | 42281 | 260 | 34914297 |
| Device electrical finding | 381.23 | 19.69 | 68 | 42306 | 8 | 34914549 |
| Underdose | 369.53 | 19.69 | 222 | 42152 | 13558 | 34900999 |
| Intercepted product preparation error | 353.47 | 19.69 | 146 | 42228 | 3932 | 34910625 |
| Bone pain | 327.73 | 19.69 | 240 | 42134 | 20446 | 34894111 |
| Hyperhidrosis | 304.30 | 19.69 | 415 | 41959 | 75277 | 34839280 |
| Neutropenia | 286.50 | 19.69 | 604 | 41770 | 156174 | 34758383 |
| Application site bruise | 269.42 | 19.69 | 49 | 42325 | 12 | 34914545 |
| Incorrect dose administered by device | 255.37 | 19.69 | 93 | 42281 | 1765 | 34912792 |
| Occupational exposure to product | 228.59 | 19.69 | 59 | 42315 | 316 | 34914241 |
| Off label use | 212.35 | 19.69 | 1035 | 41339 | 418489 | 34496068 |
| Device delivery system issue | 211.65 | 19.69 | 59 | 42315 | 442 | 34914115 |
| Death | 205.66 | 19.69 | 988 | 41386 | 397061 | 34517496 |
| Hospitalisation | 200.37 | 19.69 | 293 | 42081 | 56609 | 34857948 |
| Circumstance or information capable of leading to medication error | 196.95 | 19.69 | 76 | 42298 | 1703 | 34912854 |
| Drug delivery system malfunction | 183.95 | 19.69 | 50 | 42324 | 337 | 34914220 |
| Chemotherapy | 172.59 | 19.69 | 53 | 42321 | 576 | 34913981 |
| Drug interaction | 171.74 | 19.69 | 33 | 42341 | 225913 | 34688644 |
| Toxicity to various agents | 159.34 | 19.69 | 26 | 42348 | 200336 | 34714221 |
| Magnetic resonance imaging | 154.36 | 19.69 | 27 | 42347 | 0 | 34914557 |
| Colony stimulating factor therapy | 143.34 | 19.69 | 35 | 42339 | 143 | 34914414 |
| Drug ineffective | 128.26 | 19.69 | 224 | 42150 | 456527 | 34458030 |
| Condition aggravated | 109.55 | 19.69 | 48 | 42326 | 192148 | 34722409 |
| Neutrophil count decreased | 107.36 | 19.69 | 209 | 42165 | 50895 | 34863662 |
| White blood cell count abnormal | 104.61 | 19.69 | 59 | 42315 | 3194 | 34911363 |
| Neutrophil count abnormal | 94.02 | 19.69 | 46 | 42328 | 1856 | 34912701 |
| Product communication issue | 85.12 | 19.69 | 28 | 42346 | 386 | 34914171 |
| Wrong technique in device usage process | 82.10 | 19.69 | 39 | 42335 | 1473 | 34913084 |
| Intercepted product administration error | 79.86 | 19.69 | 24 | 42350 | 241 | 34914316 |
| Needle issue | 72.49 | 19.69 | 60 | 42314 | 6105 | 34908452 |
| Depression | 71.92 | 19.69 | 15 | 42359 | 97083 | 34817474 |
| Device deployment issue | 70.04 | 19.69 | 20 | 42354 | 165 | 34914392 |
| Blood pressure increased | 68.67 | 19.69 | 12 | 42362 | 88090 | 34826467 |
| Device mechanical issue | 67.73 | 19.69 | 20 | 42354 | 188 | 34914369 |
| Intercepted medication error | 64.53 | 19.69 | 24 | 42350 | 484 | 34914073 |
| Application site extravasation | 62.88 | 19.69 | 11 | 42363 | 0 | 34914557 |
| Bradycardia | 61.64 | 19.69 | 9 | 42365 | 75409 | 34839148 |
| Hypertension | 59.43 | 19.69 | 47 | 42327 | 136396 | 34778161 |
| Acute kidney injury | 57.02 | 19.69 | 185 | 42189 | 304803 | 34609754 |
| Aortitis | 56.67 | 19.69 | 21 | 42353 | 419 | 34914138 |
| Weight increased | 56.57 | 19.69 | 21 | 42353 | 93012 | 34821545 |
| Myocardial infarction | 56.23 | 19.69 | 39 | 42335 | 121046 | 34793511 |
| Pyrexia | 56.07 | 19.69 | 633 | 41741 | 332380 | 34582177 |
| Intentional medical device removal by patient | 55.74 | 19.69 | 19 | 42355 | 294 | 34914263 |
| Device alarm issue | 55.60 | 19.69 | 23 | 42351 | 621 | 34913936 |
| Product use issue | 55.41 | 19.69 | 6 | 42368 | 63210 | 34851347 |
| Seizure | 55.37 | 19.69 | 29 | 42345 | 104828 | 34809729 |
| Dizziness | 55.04 | 19.69 | 114 | 42260 | 218407 | 34696150 |
| Intentional product use issue | 51.61 | 19.69 | 6 | 42368 | 59810 | 34854747 |
| Rash | 51.35 | 19.69 | 122 | 42252 | 222630 | 34691927 |
| Drug intolerance | 51.33 | 19.69 | 6 | 42368 | 59564 | 34854993 |
| Product preparation error | 51.13 | 19.69 | 33 | 42341 | 2284 | 34912273 |
| Renal impairment | 50.10 | 19.69 | 26 | 42348 | 94487 | 34820070 |
| Therapeutic procedure | 50.07 | 19.69 | 16 | 42358 | 200 | 34914357 |
| White blood cell count decreased | 48.82 | 19.69 | 237 | 42137 | 95208 | 34819349 |
| Somnolence | 48.72 | 19.69 | 38 | 42336 | 111078 | 34803479 |
| Drug hypersensitivity | 47.59 | 19.69 | 19 | 42355 | 80510 | 34834047 |
| Rhabdomyolysis | 47.53 | 19.69 | 12 | 42362 | 68151 | 34846406 |
| Hallucination | 47.47 | 19.69 | 4 | 42370 | 51494 | 34863063 |
| Hyperkalaemia | 46.90 | 19.69 | 13 | 42361 | 69376 | 34845181 |
| Overdose | 46.87 | 19.69 | 26 | 42348 | 91033 | 34823524 |
| Cardiac arrest | 45.93 | 19.69 | 30 | 42344 | 96129 | 34818428 |
| Blood creatinine increased | 44.87 | 19.69 | 30 | 42344 | 94946 | 34819611 |
| Cerebrovascular accident | 43.96 | 19.69 | 24 | 42350 | 84787 | 34829770 |
| Coronary artery disease | 43.86 | 19.69 | 4 | 42370 | 48301 | 34866256 |
| Confusional state | 43.66 | 19.69 | 67 | 42307 | 144093 | 34770464 |
| Cardiac failure congestive | 42.53 | 19.69 | 24 | 42350 | 83246 | 34831311 |
| Agitation | 42.21 | 19.69 | 9 | 42365 | 57390 | 34857167 |
| Inappropriate schedule of product administration | 41.96 | 19.69 | 168 | 42206 | 62128 | 34852429 |
| Febrile bone marrow aplasia | 40.69 | 19.69 | 50 | 42324 | 8159 | 34906398 |
| International normalised ratio increased | 40.20 | 19.69 | 5 | 42369 | 47322 | 34867235 |
| Application site injury | 40.02 | 19.69 | 7 | 42367 | 0 | 34914557 |
| Renal failure | 39.22 | 19.69 | 61 | 42313 | 130496 | 34784061 |
| Application site swelling | 38.42 | 19.69 | 14 | 42360 | 266 | 34914291 |
| Cardio-respiratory arrest | 38.02 | 19.69 | 10 | 42364 | 55263 | 34859294 |
| Weight decreased | 37.92 | 19.69 | 100 | 42274 | 176201 | 34738356 |
| Fall | 37.89 | 19.69 | 123 | 42251 | 202762 | 34711795 |
| Tremor | 37.79 | 19.69 | 27 | 42347 | 82560 | 34831997 |
| Blood creatine phosphokinase increased | 37.47 | 19.69 | 5 | 42369 | 44852 | 34869705 |
| Blood glucose increased | 37.41 | 19.69 | 17 | 42357 | 66701 | 34847856 |
| Alanine aminotransferase increased | 36.23 | 19.69 | 27 | 42347 | 80788 | 34833769 |
| Application site mass | 36.03 | 19.69 | 8 | 42366 | 19 | 34914538 |
| Psoriasis | 35.81 | 19.69 | 3 | 42371 | 38809 | 34875748 |
| Anxiety | 35.39 | 19.69 | 41 | 42333 | 99387 | 34815170 |
| Suicidal ideation | 34.96 | 19.69 | 4 | 42370 | 40384 | 34874173 |
| Neutropenic infection | 34.70 | 19.69 | 22 | 42352 | 1476 | 34913081 |
| Acute myocardial infarction | 34.59 | 19.69 | 11 | 42363 | 53708 | 34860849 |
| Therapeutic product effect incomplete | 33.17 | 19.69 | 10 | 42364 | 50531 | 34864026 |
| Expired device used | 32.69 | 19.69 | 9 | 42365 | 64 | 34914493 |
| Aspartate aminotransferase increased | 32.56 | 19.69 | 21 | 42353 | 67762 | 34846795 |
| Coma | 31.92 | 19.69 | 8 | 42366 | 45670 | 34868887 |
| Pruritus | 31.69 | 19.69 | 79 | 42295 | 141902 | 34772655 |
| Dyspnoea | 30.93 | 19.69 | 300 | 42074 | 376482 | 34538075 |
| Device defective | 30.48 | 19.69 | 16 | 42358 | 750 | 34913807 |
| Failure to anastomose | 30.43 | 19.69 | 11 | 42363 | 204 | 34914353 |
| Application site erythema | 30.13 | 19.69 | 24 | 42350 | 2312 | 34912245 |
| Pulmonary oedema | 30.13 | 19.69 | 10 | 42364 | 47519 | 34867038 |
| Foetal exposure during pregnancy | 30.09 | 19.69 | 5 | 42369 | 38096 | 34876461 |
| Gastritis bacterial | 30.04 | 19.69 | 11 | 42363 | 212 | 34914345 |
| Intentional product misuse | 29.98 | 19.69 | 9 | 42365 | 45602 | 34868955 |
| Neutropenic sepsis | 29.72 | 19.69 | 57 | 42317 | 13710 | 34900847 |
| Hypotension | 29.69 | 19.69 | 153 | 42221 | 221496 | 34693061 |
| Computerised tomogram | 29.63 | 19.69 | 7 | 42367 | 24 | 34914533 |
| Loss of consciousness | 29.51 | 19.69 | 34 | 42340 | 82633 | 34831924 |
| Headache | 28.88 | 19.69 | 135 | 42239 | 200500 | 34714057 |
| Lactic acidosis | 28.75 | 19.69 | 4 | 42370 | 34768 | 34879789 |
| Heart rate decreased | 27.84 | 19.69 | 3 | 42371 | 31742 | 34882815 |
| Phlebitis infective | 27.56 | 19.69 | 9 | 42365 | 121 | 34914436 |
| Gait disturbance | 27.29 | 19.69 | 38 | 42336 | 85102 | 34829455 |
| Febrile infection | 27.00 | 19.69 | 22 | 42352 | 2189 | 34912368 |
| Asthma | 26.99 | 19.69 | 9 | 42365 | 42647 | 34871910 |
| Joint swelling | 26.85 | 19.69 | 20 | 42354 | 59870 | 34854687 |
| Metabolic acidosis | 26.30 | 19.69 | 10 | 42364 | 43670 | 34870887 |
| Cardiac failure | 26.10 | 19.69 | 44 | 42330 | 91204 | 34823353 |
| Nasopharyngitis | 25.82 | 19.69 | 28 | 42346 | 69940 | 34844617 |
| Device difficult to use | 25.64 | 19.69 | 24 | 42350 | 2873 | 34911684 |
| Chronic kidney disease | 25.55 | 19.69 | 9 | 42365 | 41201 | 34873356 |
| Granulocytopenia neonatal | 25.30 | 19.69 | 6 | 42368 | 21 | 34914536 |
| Haematopoietic stem cell mobilisation | 25.04 | 19.69 | 9 | 42365 | 164 | 34914393 |
| Leukocytosis | 25.02 | 19.69 | 75 | 42299 | 23990 | 34890567 |
| Peripheral swelling | 24.69 | 19.69 | 34 | 42340 | 76507 | 34838050 |
| Arteritis | 24.56 | 19.69 | 11 | 42363 | 362 | 34914195 |
| Stress | 23.92 | 19.69 | 4 | 42370 | 30343 | 34884214 |
| Perihepatic abscess | 23.82 | 19.69 | 8 | 42366 | 118 | 34914439 |
| Haematuria | 23.38 | 19.69 | 16 | 42358 | 50050 | 34864507 |
| Diabetes mellitus | 23.23 | 19.69 | 14 | 42360 | 46859 | 34867698 |
| Haemorrhage | 23.22 | 19.69 | 17 | 42357 | 51353 | 34863204 |
| Gastrointestinal haemorrhage | 23.21 | 19.69 | 45 | 42329 | 88432 | 34826125 |
| Thrombocytopenia | 23.07 | 19.69 | 290 | 42084 | 155957 | 34758600 |
| Musculoskeletal stiffness | 23.05 | 19.69 | 14 | 42360 | 46666 | 34867891 |
| Wheezing | 22.51 | 19.69 | 11 | 42363 | 41391 | 34873166 |
| Hypoglycaemia | 22.31 | 19.69 | 20 | 42354 | 54620 | 34859937 |
| Abdominal discomfort | 22.02 | 19.69 | 24 | 42350 | 59811 | 34854746 |
| Hepatic enzyme increased | 21.83 | 19.69 | 10 | 42364 | 39070 | 34875487 |
| Device dislocation | 21.69 | 19.69 | 32 | 42342 | 6217 | 34908340 |
| Cataract | 21.68 | 19.69 | 3 | 42371 | 26183 | 34888374 |
| Disturbance in attention | 21.41 | 19.69 | 3 | 42371 | 25942 | 34888615 |
| Oedema peripheral | 21.40 | 19.69 | 74 | 42300 | 119738 | 34794819 |
| Mastitis | 21.08 | 19.69 | 8 | 42366 | 171 | 34914386 |
| Infusion related reaction | 20.98 | 19.69 | 20 | 42354 | 53037 | 34861520 |
| Depressed level of consciousness | 20.94 | 19.69 | 13 | 42361 | 42828 | 34871729 |
| Urticaria | 20.84 | 19.69 | 27 | 42347 | 62350 | 34852207 |
| Splenic rupture | 20.23 | 19.69 | 16 | 42358 | 1525 | 34913032 |
| Arthropathy | 20.23 | 19.69 | 4 | 42370 | 26903 | 34887654 |
| Angioedema | 20.21 | 19.69 | 10 | 42364 | 37364 | 34877193 |
| Application site discolouration | 20.13 | 19.69 | 9 | 42365 | 295 | 34914262 |
| Vision blurred | 19.77 | 19.69 | 16 | 42358 | 45947 | 34868610 |
| Jaundice | 19.70 | 19.69 | 7 | 42367 | 31875 | 34882682 |
| 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 | 37660.40 | 17.70 | 6666 | 94070 | 409 | 79643243 |
| Unintentional medical device removal | 33333.68 | 17.70 | 6093 | 94643 | 1619 | 79642033 |
| Wrong technique in product usage process | 18690.72 | 17.70 | 5867 | 94869 | 68008 | 79575644 |
| Device use error | 17519.34 | 17.70 | 3511 | 97225 | 3590 | 79640062 |
| Device malfunction | 15603.33 | 17.70 | 3904 | 96832 | 17544 | 79626108 |
| Device occlusion | 7601.19 | 17.70 | 1955 | 98781 | 9911 | 79633741 |
| Device issue | 7128.81 | 17.70 | 2227 | 98509 | 24881 | 79618771 |
| Accidental exposure to product | 6217.62 | 17.70 | 2079 | 98657 | 29243 | 79614409 |
| Application site haemorrhage | 4625.74 | 17.70 | 885 | 99851 | 508 | 79643144 |
| Drug dose omission by device | 3665.87 | 17.70 | 961 | 99775 | 5289 | 79638363 |
| Device physical property issue | 3244.81 | 17.70 | 736 | 100000 | 1894 | 79641758 |
| Application site pain | 2583.22 | 17.70 | 688 | 100048 | 4059 | 79639593 |
| Device leakage | 2388.54 | 17.70 | 780 | 99956 | 10076 | 79633576 |
| Febrile neutropenia | 1747.09 | 17.70 | 1783 | 98953 | 229216 | 79414436 |
| Intercepted product preparation error | 1655.80 | 17.70 | 456 | 100280 | 3104 | 79640548 |
| Device power source issue | 1509.58 | 17.70 | 328 | 100408 | 635 | 79643017 |
| Investigation | 1443.06 | 17.70 | 375 | 100361 | 1976 | 79641676 |
| Bone pain | 1320.69 | 17.70 | 842 | 99894 | 54900 | 79588752 |
| Application site discomfort | 1191.51 | 17.70 | 230 | 100506 | 148 | 79643504 |
| Device electrical finding | 1040.46 | 17.70 | 186 | 100550 | 16 | 79643636 |
| Application site bruise | 952.21 | 17.70 | 180 | 100556 | 85 | 79643567 |
| Product dose omission issue | 908.94 | 17.70 | 1327 | 99409 | 246210 | 79397442 |
| Incorrect disposal of product | 883.87 | 17.70 | 213 | 100523 | 772 | 79642880 |
| Underdose | 863.36 | 17.70 | 532 | 100204 | 32619 | 79611033 |
| Device failure | 846.64 | 17.70 | 313 | 100423 | 5948 | 79637704 |
| Neutropenia | 784.54 | 17.70 | 1346 | 99390 | 286364 | 79357288 |
| Incorrect dose administered by device | 702.61 | 17.70 | 257 | 100479 | 4732 | 79638920 |
| Drug ineffective | 480.25 | 17.70 | 399 | 100337 | 1080514 | 78563138 |
| Chemotherapy | 417.78 | 17.70 | 134 | 100602 | 1623 | 79642029 |
| Hospitalisation | 411.71 | 17.70 | 550 | 100186 | 93686 | 79549966 |
| Aortitis | 370.94 | 17.70 | 118 | 100618 | 1389 | 79642263 |
| Circumstance or information capable of leading to medication error | 362.25 | 17.70 | 149 | 100587 | 3799 | 79639853 |
| Magnetic resonance imaging | 354.08 | 17.70 | 69 | 100667 | 50 | 79643602 |
| Neutrophil count abnormal | 350.69 | 17.70 | 141 | 100595 | 3385 | 79640267 |
| Device delivery system issue | 346.15 | 17.70 | 95 | 100641 | 636 | 79643016 |
| Hyperhidrosis | 332.32 | 17.70 | 646 | 100090 | 150846 | 79492806 |
| Drug interaction | 318.60 | 17.70 | 68 | 100668 | 415115 | 79228537 |
| Toxicity to various agents | 317.50 | 17.70 | 72 | 100664 | 421468 | 79222184 |
| Death | 313.97 | 17.70 | 1480 | 99256 | 565034 | 79078618 |
| White blood cell count abnormal | 311.65 | 17.70 | 150 | 100586 | 5595 | 79638057 |
| Condition aggravated | 268.22 | 17.70 | 150 | 100586 | 500974 | 79142678 |
| Drug delivery system malfunction | 266.03 | 17.70 | 77 | 100659 | 640 | 79643012 |
| Neutrophil count decreased | 246.57 | 17.70 | 433 | 100303 | 93526 | 79550126 |
| Colony stimulating factor therapy | 243.04 | 17.70 | 67 | 100669 | 457 | 79643195 |
| Intercepted product administration error | 240.91 | 17.70 | 64 | 100672 | 372 | 79643280 |
| Needle issue | 240.73 | 17.70 | 169 | 100567 | 12899 | 79630753 |
| Rheumatoid arthritis | 224.28 | 17.70 | 9 | 100727 | 208461 | 79435191 |
| Drug intolerance | 220.17 | 17.70 | 35 | 100701 | 264084 | 79379568 |
| Product communication issue | 215.67 | 17.70 | 72 | 100664 | 997 | 79642655 |
| Arthropathy | 208.04 | 17.70 | 3 | 100733 | 177108 | 79466544 |
| Joint swelling | 200.47 | 17.70 | 58 | 100678 | 288588 | 79355064 |
| Drug hypersensitivity | 198.72 | 17.70 | 65 | 100671 | 298851 | 79344801 |
| Off label use | 197.28 | 17.70 | 1876 | 98860 | 905339 | 78738313 |
| White blood cell count decreased | 195.54 | 17.70 | 602 | 100134 | 187686 | 79455966 |
| Acute kidney injury | 194.49 | 17.70 | 222 | 100514 | 519182 | 79124470 |
| Hypertension | 182.86 | 17.70 | 95 | 100641 | 330897 | 79312755 |
| Wrong technique in device usage process | 182.35 | 17.70 | 93 | 100643 | 3935 | 79639717 |
| Product use issue | 178.97 | 17.70 | 26 | 100710 | 209796 | 79433856 |
| Treatment failure | 178 | 17.70 | 9 | 100727 | 170477 | 79473175 |
| Weight increased | 169.67 | 17.70 | 69 | 100667 | 277317 | 79366335 |
| Drug abuse | 159.62 | 17.70 | 12 | 100724 | 162679 | 79480973 |
| Intentional product use issue | 155.77 | 17.70 | 9 | 100727 | 152103 | 79491549 |
| Depression | 155.27 | 17.70 | 41 | 100695 | 216749 | 79426903 |
| Headache | 151.10 | 17.70 | 381 | 100355 | 653391 | 78990261 |
| Blood pressure increased | 147.57 | 17.70 | 42 | 100694 | 211318 | 79432334 |
| Pyrexia | 146.34 | 17.70 | 1402 | 99334 | 677307 | 78966345 |
| Intercepted medication error | 146.33 | 17.70 | 52 | 100684 | 877 | 79642775 |
| Fall | 142.12 | 17.70 | 249 | 100487 | 487380 | 79156272 |
| Pruritus | 137.73 | 17.70 | 178 | 100558 | 394470 | 79249182 |
| Hepatic enzyme increased | 135.67 | 17.70 | 32 | 100704 | 182578 | 79461074 |
| Peripheral swelling | 135.18 | 17.70 | 87 | 100649 | 269530 | 79374122 |
| Maternal exposure during pregnancy | 134.13 | 17.70 | 10 | 100726 | 136528 | 79507124 |
| Intentional medical device removal by patient | 132.29 | 17.70 | 39 | 100697 | 348 | 79643304 |
| Application site erythema | 130.38 | 17.70 | 81 | 100655 | 5029 | 79638623 |
| Sinusitis | 129.01 | 17.70 | 43 | 100693 | 195458 | 79448194 |
| Device mechanical issue | 126.31 | 17.70 | 38 | 100698 | 366 | 79643286 |
| Abdominal discomfort | 125.55 | 17.70 | 81 | 100655 | 250646 | 79393006 |
| Musculoskeletal stiffness | 125.49 | 17.70 | 33 | 100703 | 174975 | 79468677 |
| Infusion related reaction | 122.82 | 17.70 | 69 | 100667 | 230168 | 79413484 |
| Dizziness | 118.28 | 17.70 | 311 | 100425 | 526130 | 79117522 |
| Therapeutic product effect decreased | 115.41 | 17.70 | 32 | 100704 | 163831 | 79479821 |
| Nasopharyngitis | 115.34 | 17.70 | 91 | 100645 | 253790 | 79389862 |
| Occupational exposure to product | 113.37 | 17.70 | 40 | 100696 | 660 | 79642992 |
| Arteritis | 113.12 | 17.70 | 43 | 100693 | 884 | 79642768 |
| Product preparation error | 111.56 | 17.70 | 77 | 100659 | 5716 | 79637936 |
| Swelling | 111.26 | 17.70 | 68 | 100668 | 216643 | 79427009 |
| Computerised tomogram | 110.72 | 17.70 | 20 | 100716 | 3 | 79643649 |
| Pericarditis | 110.40 | 17.70 | 5 | 100731 | 104231 | 79539421 |
| Asthma | 110.06 | 17.70 | 19 | 100717 | 135076 | 79508576 |
| Bradycardia | 108.41 | 17.70 | 20 | 100716 | 135537 | 79508115 |
| Computerised tomogram thorax abnormal | 107.04 | 17.70 | 55 | 100681 | 2364 | 79641288 |
| Hand deformity | 106.84 | 17.70 | 6 | 100730 | 103913 | 79539739 |
| Rash | 106.80 | 17.70 | 374 | 100362 | 577984 | 79065668 |
| Application site extravasation | 105.05 | 17.70 | 19 | 100717 | 3 | 79643649 |
| Somnolence | 104.41 | 17.70 | 89 | 100647 | 238892 | 79404760 |
| Exposure during pregnancy | 103.48 | 17.70 | 6 | 100730 | 101126 | 79542526 |
| Therapeutic product effect incomplete | 102.90 | 17.70 | 26 | 100710 | 141619 | 79502033 |
| Myocardial infarction | 102.86 | 17.70 | 52 | 100684 | 184077 | 79459575 |
| Product use in unapproved indication | 100.21 | 17.70 | 101 | 100635 | 250258 | 79393394 |
| Coma | 97.09 | 17.70 | 8 | 100728 | 100641 | 79543011 |
| Overdose | 97.09 | 17.70 | 56 | 100680 | 184150 | 79459502 |
| Psoriasis | 95.86 | 17.70 | 4 | 100732 | 89583 | 79554069 |
| Confusional state | 95.64 | 17.70 | 159 | 100577 | 317838 | 79325814 |
| Suicide attempt | 91.16 | 17.70 | 3 | 100733 | 82929 | 79560723 |
| Cerebrovascular accident | 88.02 | 17.70 | 43 | 100693 | 155249 | 79488403 |
| Pain | 87.64 | 17.70 | 526 | 100210 | 703276 | 78940376 |
| Application site mass | 87.34 | 17.70 | 19 | 100717 | 37 | 79643615 |
| Osteoarthritis | 86.88 | 17.70 | 6 | 100730 | 87303 | 79556349 |
| Computerised tomogram thorax | 85.60 | 17.70 | 29 | 100707 | 421 | 79643231 |
| Device alarm issue | 85.28 | 17.70 | 45 | 100691 | 2044 | 79641608 |
| Cardiac failure congestive | 84.48 | 17.70 | 37 | 100699 | 142365 | 79501287 |
| Inappropriate schedule of product administration | 82.40 | 17.70 | 361 | 100375 | 133267 | 79510385 |
| Hypersensitivity | 81.76 | 17.70 | 128 | 100608 | 262111 | 79381541 |
| Cardiac arrest | 81.58 | 17.70 | 59 | 100677 | 172037 | 79471615 |
| Hypotension | 81.02 | 17.70 | 285 | 100451 | 440032 | 79203620 |
| Seizure | 80.43 | 17.70 | 72 | 100664 | 188762 | 79454890 |
| Blister | 79.28 | 17.70 | 26 | 100710 | 119450 | 79524202 |
| Arthritis | 78.01 | 17.70 | 24 | 100712 | 114856 | 79528796 |
| Anxiety | 77.76 | 17.70 | 121 | 100615 | 248391 | 79395261 |
| Renal impairment | 77.56 | 17.70 | 52 | 100684 | 157731 | 79485921 |
| Febrile bone marrow aplasia | 76.06 | 17.70 | 88 | 100648 | 12932 | 79630720 |
| Bronchitis | 75.84 | 17.70 | 35 | 100701 | 130609 | 79513043 |
| International normalised ratio increased | 75.79 | 17.70 | 9 | 100727 | 84712 | 79558940 |
| Helicobacter infection | 74.95 | 17.70 | 3 | 100733 | 69701 | 79573951 |
| Application site swelling | 74.49 | 17.70 | 30 | 100706 | 723 | 79642929 |
| Neuropathy peripheral | 73.33 | 17.70 | 363 | 100373 | 140942 | 79502710 |
| Cardio-respiratory arrest | 71.32 | 17.70 | 24 | 100712 | 108486 | 79535166 |
| Suicidal ideation | 71.11 | 17.70 | 7 | 100729 | 76333 | 79567319 |
| Rhabdomyolysis | 71.01 | 17.70 | 21 | 100715 | 103110 | 79540542 |
| Electrocardiogram QT prolonged | 70.85 | 17.70 | 14 | 100722 | 90372 | 79553280 |
| Heart rate decreased | 69.47 | 17.70 | 5 | 100731 | 70311 | 79573341 |
| Wound | 69.20 | 17.70 | 30 | 100706 | 116149 | 79527503 |
| Device defective | 68.99 | 17.70 | 38 | 100698 | 1882 | 79641770 |
| Renal failure | 68.62 | 17.70 | 92 | 100644 | 200876 | 79442776 |
| Fibromyalgia | 68.41 | 17.70 | 3 | 100733 | 64337 | 79579315 |
| Arthralgia | 68.16 | 17.70 | 433 | 100303 | 571370 | 79072282 |
| Wheezing | 68.11 | 17.70 | 31 | 100705 | 116633 | 79527019 |
| Impaired healing | 67.82 | 17.70 | 14 | 100722 | 87641 | 79556011 |
| Device material issue | 67.46 | 17.70 | 21 | 100715 | 229 | 79643423 |
| Hyperkalaemia | 67.41 | 17.70 | 30 | 100706 | 114368 | 79529284 |
| Agitation | 67.40 | 17.70 | 21 | 100715 | 99694 | 79543958 |
| Blood creatine phosphokinase increased | 67.37 | 17.70 | 4 | 100732 | 66086 | 79577566 |
| Alanine aminotransferase increased | 66.85 | 17.70 | 64 | 100672 | 162506 | 79481146 |
| Contusion | 66.68 | 17.70 | 54 | 100682 | 148722 | 79494930 |
| Coronary artery disease | 66.62 | 17.70 | 4 | 100732 | 65470 | 79578182 |
| Blood creatinine increased | 66.17 | 17.70 | 59 | 100677 | 154998 | 79488654 |
| Glossodynia | 65.95 | 17.70 | 24 | 100712 | 103313 | 79540339 |
| Device deployment issue | 64.95 | 17.70 | 44 | 100692 | 3168 | 79640484 |
| Application site discolouration | 63.95 | 17.70 | 28 | 100708 | 836 | 79642816 |
| Cardiac failure | 63.61 | 17.70 | 61 | 100675 | 154781 | 79488871 |
| Gastrointestinal haemorrhage | 63.29 | 17.70 | 56 | 100680 | 147663 | 79495989 |
| COVID-19 | 62.61 | 17.70 | 64 | 100672 | 157610 | 79486042 |
| Hypoglycaemia | 62.50 | 17.70 | 25 | 100711 | 101569 | 79542083 |
| Metabolic acidosis | 62.19 | 17.70 | 14 | 100722 | 82515 | 79561137 |
| Blood glucose increased | 61.93 | 17.70 | 34 | 100702 | 114941 | 79528711 |
| Hallucination | 61.76 | 17.70 | 16 | 100720 | 85729 | 79557923 |
| Gait disturbance | 60.28 | 17.70 | 106 | 100630 | 207400 | 79436252 |
| Type 2 diabetes mellitus | 59.64 | 17.70 | 3 | 100733 | 57119 | 79586533 |
| Depressed level of consciousness | 59.10 | 17.70 | 24 | 100712 | 96628 | 79547024 |
| Stress | 59.00 | 17.70 | 14 | 100722 | 79598 | 79564054 |
| Acute myocardial infarction | 58.18 | 17.70 | 13 | 100723 | 77023 | 79566629 |
| Blood pressure fluctuation | 57.96 | 17.70 | 8 | 100728 | 67137 | 79576515 |
| Application site injury | 57.13 | 17.70 | 12 | 100724 | 18 | 79643634 |
| Lactic acidosis | 57.06 | 17.70 | 10 | 100726 | 70349 | 79573303 |
| Injury | 56.70 | 17.70 | 14 | 100722 | 77482 | 79566170 |
| Migraine | 54.69 | 17.70 | 21 | 100715 | 87472 | 79556180 |
| Weight decreased | 54.45 | 17.70 | 247 | 100489 | 354951 | 79288701 |
| Alopecia areata | 54.19 | 17.70 | 32 | 100704 | 1811 | 79641841 |
| Tremor | 53.96 | 17.70 | 82 | 100654 | 170001 | 79473651 |
| Loss of personal independence in daily activities | 52.88 | 17.70 | 32 | 100704 | 102548 | 79541104 |
| Hepatotoxicity | 52.67 | 17.70 | 3 | 100733 | 51349 | 79592303 |
| Therapeutic procedure | 52.08 | 17.70 | 24 | 100712 | 810 | 79642842 |
| Folliculitis | 51.79 | 17.70 | 5 | 100731 | 55375 | 79588277 |
| Delirium | 51.77 | 17.70 | 21 | 100715 | 84606 | 79559046 |
| Atelectasis | 51.47 | 17.70 | 121 | 100615 | 32136 | 79611516 |
| Sedation | 50.39 | 17.70 | 4 | 100732 | 51891 | 79591761 |
| Drug reaction with eosinophilia and systemic symptoms | 50.24 | 17.70 | 10 | 100726 | 64234 | 79579418 |
| Neutropenic colitis | 50.22 | 17.70 | 48 | 100688 | 5659 | 79637993 |
| Intentional product misuse | 50.02 | 17.70 | 29 | 100707 | 95136 | 79548516 |
| Cataract | 50.01 | 17.70 | 9 | 100727 | 62111 | 79581541 |
| Expired device used | 49.92 | 17.70 | 19 | 100717 | 392 | 79643260 |
| Amnesia | 48.93 | 17.70 | 10 | 100726 | 63047 | 79580605 |
| Aspartate aminotransferase increased | 48.82 | 17.70 | 62 | 100674 | 138579 | 79505073 |
| Incorrect dose administered | 47.96 | 17.70 | 208 | 100528 | 76422 | 79567230 |
| Haemorrhage | 47.56 | 17.70 | 28 | 100708 | 91090 | 79552562 |
| Oedema peripheral | 47.20 | 17.70 | 162 | 100574 | 252126 | 79391526 |
| Device monitoring procedure not performed | 47.11 | 17.70 | 9 | 100727 | 5 | 79643647 |
| Neutropenic sepsis | 47.03 | 17.70 | 105 | 100631 | 26959 | 79616693 |
| Gastrooesophageal reflux disease | 46.50 | 17.70 | 38 | 100698 | 104208 | 79539444 |
| Treatment noncompliance | 45.66 | 17.70 | 6 | 100730 | 52262 | 79591390 |
| Pulmonary oedema | 44.83 | 17.70 | 28 | 100708 | 88226 | 79555426 |
| Leukopenia | 44.79 | 17.70 | 276 | 100460 | 116237 | 79527415 |
| Drug ineffective for unapproved indication | 44.47 | 17.70 | 6 | 100730 | 51232 | 79592420 |
| Vision blurred | 44.33 | 17.70 | 41 | 100695 | 105857 | 79537795 |
| Discomfort | 43.38 | 17.70 | 57 | 100679 | 125560 | 79518092 |
| Urticaria | 43.33 | 17.70 | 107 | 100629 | 185094 | 79458558 |
| Hepatitis | 42.90 | 17.70 | 9 | 100727 | 55718 | 79587934 |
| Platelet count decreased | 42.60 | 17.70 | 404 | 100332 | 194260 | 79449392 |
| Diabetes mellitus | 42.48 | 17.70 | 23 | 100713 | 78367 | 79565285 |
| Irritable bowel syndrome | 42.25 | 17.70 | 13 | 100723 | 62228 | 79581424 |
| Product prescribing error | 42.02 | 17.70 | 4 | 100732 | 44809 | 79598843 |
| Abdominal pain | 41.86 | 17.70 | 304 | 100432 | 389265 | 79254387 |
| Injection site pruritus | 41.79 | 17.70 | 3 | 100733 | 42280 | 79601372 |
| Drug resistance | 41.70 | 17.70 | 3 | 100733 | 42210 | 79601442 |
| Dyspnoea | 41.61 | 17.70 | 798 | 99938 | 856227 | 78787425 |
| Haematemesis | 41.15 | 17.70 | 8 | 100728 | 52256 | 79591396 |
| Respiratory arrest | 40.95 | 17.70 | 11 | 100725 | 57539 | 79586113 |
| Melaena | 40.83 | 17.70 | 13 | 100723 | 60877 | 79582775 |
| Psychotic disorder | 40.74 | 17.70 | 3 | 100733 | 41399 | 79602253 |
| Heart rate abnormal | 40.63 | 17.70 | 44 | 100692 | 6013 | 79637639 |
| Muscle spasms | 40.06 | 17.70 | 102 | 100634 | 174628 | 79469024 |
| Hyponatraemia | 39.87 | 17.70 | 105 | 100631 | 177743 | 79465909 |
| Madarosis | 39.81 | 17.70 | 31 | 100705 | 2771 | 79640881 |
| Abdominal pain upper | 39.68 | 17.70 | 147 | 100589 | 223672 | 79419980 |
| Hair texture abnormal | 39.50 | 17.70 | 34 | 100702 | 3500 | 79640152 |
| Drug-induced liver injury | 39.48 | 17.70 | 17 | 100719 | 66100 | 79577552 |
| Dysarthria | 39.42 | 17.70 | 18 | 100718 | 67604 | 79576048 |
| Rectal haemorrhage | 39.04 | 17.70 | 24 | 100712 | 76276 | 79567376 |
| Application site reaction | 38.31 | 17.70 | 19 | 100717 | 757 | 79642895 |
| Injection site erythema | 38.10 | 17.70 | 26 | 100710 | 78171 | 79565481 |
| Unresponsive to stimuli | 37.25 | 17.70 | 12 | 100724 | 55776 | 79587876 |
| Dry mouth | 36.93 | 17.70 | 34 | 100702 | 87985 | 79555667 |
| Carotidynia | 36.92 | 17.70 | 12 | 100724 | 152 | 79643500 |
| Oxygen saturation decreased | 36.49 | 17.70 | 67 | 100669 | 128980 | 79514672 |
| Application site haematoma | 36.30 | 17.70 | 10 | 100726 | 68 | 79643584 |
| Ill-defined disorder | 36.17 | 17.70 | 19 | 100717 | 65856 | 79577796 |
| Basal cell carcinoma | 35.96 | 17.70 | 3 | 100733 | 37372 | 79606280 |
| Transient ischaemic attack | 35.78 | 17.70 | 11 | 100725 | 52684 | 79590968 |
| Sleep disorder due to general medical condition, insomnia type | 35.74 | 17.70 | 6 | 100730 | 43550 | 79600102 |
| Atrial fibrillation | 35.71 | 17.70 | 129 | 100607 | 197757 | 79445895 |
| Mucosal inflammation | 35.58 | 17.70 | 189 | 100547 | 75391 | 79568261 |
| Loss of consciousness | 35.51 | 17.70 | 102 | 100634 | 167841 | 79475811 |
| Liver disorder | 35.39 | 17.70 | 24 | 100712 | 72393 | 79571259 |
| Application site pruritus | 35.35 | 17.70 | 33 | 100703 | 3777 | 79639875 |
| Upper respiratory tract infection | 35.06 | 17.70 | 38 | 100698 | 91130 | 79552522 |
| Dyskinesia | 34.95 | 17.70 | 7 | 100729 | 44766 | 79598886 |
| Liver function test abnormal | 34.81 | 17.70 | 19 | 100717 | 64456 | 79579196 |
| Nephrolithiasis | 34.64 | 17.70 | 12 | 100724 | 53279 | 79590373 |
| Memory impairment | 34.35 | 17.70 | 55 | 100681 | 111679 | 79531973 |
| Hair colour changes | 34.25 | 17.70 | 34 | 100702 | 4198 | 79639454 |
| Disease recurrence | 34.21 | 17.70 | 7 | 100729 | 44102 | 79599550 |
| Oral pain | 34.18 | 17.70 | 103 | 100633 | 31695 | 79611957 |
| Bursitis | 34.15 | 17.70 | 3 | 100733 | 35841 | 79607811 |
| Imaging procedure | 34.05 | 17.70 | 6 | 100730 | 0 | 79643652 |
| Accidental underdose | 33.58 | 17.70 | 18 | 100718 | 844 | 79642808 |
| Haematuria | 33.39 | 17.70 | 23 | 100713 | 68813 | 79574839 |
| Cardiac disorder | 33.21 | 17.70 | 21 | 100715 | 65736 | 79577916 |
| Application site irritation | 33.16 | 17.70 | 23 | 100713 | 1721 | 79641931 |
| Irritability | 33.03 | 17.70 | 6 | 100730 | 41138 | 79602514 |
| C-reactive protein abnormal | 33.01 | 17.70 | 10 | 100726 | 48357 | 79595295 |
| Colitis ulcerative | 32.85 | 17.70 | 3 | 100733 | 34739 | 79608913 |
| Visual impairment | 32.64 | 17.70 | 41 | 100695 | 92090 | 79551562 |
| Vertigo | 32.31 | 17.70 | 24 | 100712 | 69058 | 79574594 |
| White blood cell disorder | 32.25 | 17.70 | 29 | 100707 | 3163 | 79640489 |
| Disturbance in attention | 32.07 | 17.70 | 12 | 100724 | 50789 | 79592863 |
| Generalised tonic-clonic seizure | 31.99 | 17.70 | 8 | 100728 | 43902 | 79599750 |
| Nasal congestion | 31.61 | 17.70 | 30 | 100706 | 76522 | 79567130 |
| Pneumonia | 31.31 | 17.70 | 617 | 100119 | 659629 | 78984023 |
| Aphasia | 31.29 | 17.70 | 10 | 100726 | 46722 | 79596930 |
| Haematochezia | 31.05 | 17.70 | 39 | 100697 | 87606 | 79556046 |
| Body temperature abnormal | 31.01 | 17.70 | 25 | 100711 | 2350 | 79641302 |
| Influenza | 31.00 | 17.70 | 74 | 100662 | 129532 | 79514120 |
| Aortic wall hypertrophy | 30.99 | 17.70 | 6 | 100730 | 4 | 79643648 |
| Chronic kidney disease | 30.91 | 17.70 | 23 | 100713 | 66131 | 79577521 |
| Cholelithiasis | 30.72 | 17.70 | 14 | 100722 | 52650 | 79591002 |
| Hypervolaemia | 30.67 | 17.70 | 8 | 100728 | 42682 | 79600970 |
| Osteoporosis | 30.62 | 17.70 | 15 | 100721 | 54097 | 79589555 |
| Red blood cell sedimentation rate increased | 30.46 | 17.70 | 10 | 100726 | 45932 | 79597720 |
| Peripheral sensory neuropathy | 30.26 | 17.70 | 57 | 100679 | 12976 | 79630676 |
| Injection site swelling | 29.97 | 17.70 | 11 | 100725 | 47121 | 79596531 |
| Jaundice | 29.87 | 17.70 | 15 | 100721 | 53334 | 79590318 |
| Lymphadenitis | 29.81 | 17.70 | 33 | 100703 | 4622 | 79639030 |
| Transaminases increased | 29.80 | 17.70 | 14 | 100722 | 51729 | 79591923 |
| Tubulointerstitial nephritis | 29.80 | 17.70 | 6 | 100730 | 38229 | 79605423 |
| Medication error | 29.41 | 17.70 | 26 | 100710 | 68616 | 79575036 |
| Pulmonary hypertension | 29.29 | 17.70 | 12 | 100724 | 48068 | 79595584 |
| Fluid retention | 29.25 | 17.70 | 27 | 100709 | 69782 | 79573870 |
| Diarrhoea | 29.08 | 17.70 | 869 | 99867 | 879620 | 78764032 |
| Failure to anastomose | 28.99 | 17.70 | 11 | 100725 | 225 | 79643427 |
| Abdominal distension | 28.87 | 17.70 | 68 | 100668 | 119582 | 79524070 |
| Insomnia | 28.44 | 17.70 | 187 | 100549 | 244983 | 79398669 |
| Scan | 28.38 | 17.70 | 5 | 100731 | 0 | 79643652 |
| Ultrasound scan | 28.38 | 17.70 | 5 | 100731 | 0 | 79643652 |
| X-ray | 28.38 | 17.70 | 5 | 100731 | 0 | 79643652 |
| Pancreatitis | 28.17 | 17.70 | 27 | 100709 | 68548 | 79575104 |
| Cardiogenic shock | 28.01 | 17.70 | 9 | 100727 | 41905 | 79601747 |
| Ear infection | 27.69 | 17.70 | 5 | 100731 | 34427 | 79609225 |
| Acute hepatic failure | 27.43 | 17.70 | 3 | 100733 | 30110 | 79613542 |
| Chronic obstructive pulmonary disease | 27.25 | 17.70 | 41 | 100695 | 85378 | 79558274 |
| Hepatocellular injury | 27.22 | 17.70 | 13 | 100723 | 47580 | 79596072 |
| Cholestasis | 27.21 | 17.70 | 16 | 100720 | 52093 | 79591559 |
| Throat irritation | 27.00 | 17.70 | 9 | 100727 | 40937 | 79602715 |
| Injection site reaction | 26.98 | 17.70 | 18 | 100718 | 54767 | 79588885 |
| Lower respiratory tract infection | 26.94 | 17.70 | 79 | 100657 | 129141 | 79514511 |
| Orthostatic hypotension | 26.93 | 17.70 | 19 | 100717 | 56145 | 79587507 |
| Gastric disorder | 26.92 | 17.70 | 7 | 100729 | 37426 | 79606226 |
| Therapy non-responder | 26.92 | 17.70 | 47 | 100689 | 92258 | 79551394 |
| Muscular weakness | 26.91 | 17.70 | 108 | 100628 | 160621 | 79483031 |
| Blood urea increased | 26.90 | 17.70 | 14 | 100722 | 48776 | 79594876 |
| Angioedema | 26.76 | 17.70 | 34 | 100702 | 76001 | 79567651 |
| Frequent bowel movements | 26.76 | 17.70 | 3 | 100733 | 29536 | 79614116 |
| Palpitations | 26.69 | 17.70 | 77 | 100659 | 126533 | 79517119 |
| Vascular fragility | 26.67 | 17.70 | 9 | 100727 | 129 | 79643523 |
| No adverse event | 26.66 | 17.70 | 7 | 100729 | 37185 | 79606467 |
| Balance disorder | 26.48 | 17.70 | 53 | 100683 | 98804 | 79544848 |
| Leukocytosis | 26.46 | 17.70 | 117 | 100619 | 43338 | 79600314 |
| Femur fracture | 26.36 | 17.70 | 8 | 100728 | 38644 | 79605008 |
| Injection site pain | 25.90 | 17.70 | 81 | 100655 | 129757 | 79513895 |
| Toxic epidermal necrolysis | 25.77 | 17.70 | 12 | 100724 | 44569 | 79599083 |
| Acute febrile neutrophilic dermatosis | 25.75 | 17.70 | 28 | 100708 | 3844 | 79639808 |
| Oedema | 25.74 | 17.70 | 72 | 100664 | 119508 | 79524144 |
| Gait inability | 25.63 | 17.70 | 22 | 100714 | 58895 | 79584757 |
| Diabetic ketoacidosis | 25.28 | 17.70 | 6 | 100730 | 34116 | 79609536 |
| Product packaging issue | 25.19 | 17.70 | 17 | 100719 | 1216 | 79642436 |
| Product quality issue | 25.08 | 17.70 | 6 | 100730 | 33934 | 79609718 |
| Product storage error | 24.95 | 17.70 | 60 | 100676 | 16166 | 79627486 |
| Road traffic accident | 24.86 | 17.70 | 12 | 100724 | 43652 | 79600000 |
| Herpes zoster | 24.85 | 17.70 | 50 | 100686 | 93033 | 79550619 |
| Radiotherapy | 24.58 | 17.70 | 13 | 100723 | 593 | 79643059 |
| Splenic rupture | 24.41 | 17.70 | 22 | 100714 | 2407 | 79641245 |
| Obstructive airways disorder | 24.38 | 17.70 | 5 | 100731 | 31454 | 79612198 |
| Gastritis bacterial | 24.04 | 17.70 | 11 | 100725 | 365 | 79643287 |
| Vomiting | 24.01 | 17.70 | 649 | 100087 | 665179 | 78978473 |
| Accidental overdose | 23.91 | 17.70 | 10 | 100726 | 39571 | 79604081 |
| Therapy cessation | 23.50 | 17.70 | 9 | 100727 | 37553 | 79606099 |
| Tongue coated | 23.36 | 17.70 | 17 | 100719 | 1372 | 79642280 |
| White blood cell count increased | 23.36 | 17.70 | 168 | 100568 | 74465 | 79569187 |
| Cerebral haemorrhage | 23.35 | 17.70 | 23 | 100713 | 57650 | 79586002 |
| Multiple organ dysfunction syndrome | 23.30 | 17.70 | 76 | 100660 | 120170 | 79523482 |
| Illness | 23.28 | 17.70 | 15 | 100721 | 46496 | 79597156 |
| Disorientation | 23.22 | 17.70 | 27 | 100709 | 62749 | 79580903 |
| Blood magnesium decreased | 23.21 | 17.70 | 59 | 100677 | 16453 | 79627199 |
| Tissue infiltration | 22.99 | 17.70 | 13 | 100723 | 678 | 79642974 |
| Heart rate increased | 22.91 | 17.70 | 77 | 100659 | 120647 | 79523005 |
| Intercepted product selection error | 22.90 | 17.70 | 5 | 100731 | 10 | 79643642 |
| Angina pectoris | 22.89 | 17.70 | 19 | 100717 | 51713 | 79591939 |
| Haematopoietic stem cell mobilisation | 22.74 | 17.70 | 9 | 100727 | 207 | 79643445 |
| Respiratory depth decreased | 22.71 | 17.70 | 6 | 100730 | 34 | 79643618 |
| Nightmare | 22.51 | 17.70 | 3 | 100733 | 25858 | 79617794 |
| Basal ganglion degeneration | 22.21 | 17.70 | 11 | 100725 | 437 | 79643215 |
| Uterine enlargement | 22.17 | 17.70 | 14 | 100722 | 894 | 79642758 |
| Capillary leak syndrome | 22.04 | 17.70 | 26 | 100710 | 3899 | 79639753 |
| Sinus bradycardia | 21.81 | 17.70 | 3 | 100733 | 25244 | 79618408 |
| Vein discolouration | 21.49 | 17.70 | 10 | 100726 | 345 | 79643307 |
| Mastectomy | 21.45 | 17.70 | 15 | 100721 | 1137 | 79642515 |
| Pregnancy | 21.37 | 17.70 | 4 | 100732 | 26847 | 79616805 |
| Gastroenteritis viral | 21.33 | 17.70 | 3 | 100733 | 24828 | 79618824 |
| Rash pruritic | 21.32 | 17.70 | 36 | 100700 | 71593 | 79572059 |
| Body temperature decreased | 21.31 | 17.70 | 7 | 100729 | 32138 | 79611514 |
| Thrombocytopenia | 21.23 | 17.70 | 461 | 100275 | 264798 | 79378854 |
| Infective aortitis | 21.15 | 17.70 | 6 | 100730 | 46 | 79643606 |
| Diplopia | 20.96 | 17.70 | 8 | 100728 | 33458 | 79610194 |
| Blood bilirubin increased | 20.93 | 17.70 | 32 | 100704 | 66200 | 79577452 |
| Dyspepsia | 20.85 | 17.70 | 69 | 100667 | 108618 | 79535034 |
| Device placement issue | 20.82 | 17.70 | 15 | 100721 | 1192 | 79642460 |
| Perihepatic abscess | 20.80 | 17.70 | 8 | 100728 | 170 | 79643482 |
| Joint stiffness | 20.67 | 17.70 | 13 | 100723 | 40817 | 79602835 |
| Eczema | 20.66 | 17.70 | 13 | 100723 | 40805 | 79602847 |
| Speech disorder | 20.59 | 17.70 | 23 | 100713 | 54422 | 79589230 |
| Hepatic encephalopathy | 20.57 | 17.70 | 3 | 100733 | 24163 | 79619489 |
| Pneumonia aspiration | 20.54 | 17.70 | 33 | 100703 | 66934 | 79576718 |
| Prescribed underdose | 20.33 | 17.70 | 6 | 100730 | 29508 | 79614144 |
| Blood potassium increased | 20.07 | 17.70 | 6 | 100730 | 29269 | 79614383 |
| Tinnitus | 19.97 | 17.70 | 16 | 100720 | 44317 | 79599335 |
| Mobility decreased | 19.88 | 17.70 | 83 | 100653 | 122092 | 79521560 |
| Acne | 19.72 | 17.70 | 5 | 100731 | 27185 | 79616467 |
| Vaginal prolapse | 19.72 | 17.70 | 9 | 100727 | 297 | 79643355 |
| Application site warmth | 19.48 | 17.70 | 8 | 100728 | 203 | 79643449 |
| Ventricular fibrillation | 19.39 | 17.70 | 8 | 100728 | 31918 | 79611734 |
| Recall phenomenon | 19.32 | 17.70 | 14 | 100722 | 1123 | 79642529 |
| Crying | 19.30 | 17.70 | 3 | 100733 | 23040 | 79620612 |
| Palmar-plantar erythrodysaesthesia syndrome | 19.26 | 17.70 | 88 | 100648 | 33046 | 79610606 |
| Urinary retention | 19.23 | 17.70 | 26 | 100710 | 56604 | 79587048 |
| Renal disorder | 19.21 | 17.70 | 15 | 100721 | 42090 | 79601562 |
| Joint range of motion decreased | 19.18 | 17.70 | 9 | 100727 | 33273 | 79610379 |
| Stevens-Johnson syndrome | 19.11 | 17.70 | 13 | 100723 | 39153 | 79604499 |
| Ventricular tachycardia | 19.06 | 17.70 | 15 | 100721 | 41920 | 79601732 |
| Subdural haematoma | 18.90 | 17.70 | 8 | 100728 | 31426 | 79612226 |
| Therapy interrupted | 18.80 | 17.70 | 8 | 100728 | 31333 | 79612319 |
| Head injury | 18.78 | 17.70 | 12 | 100724 | 37357 | 79606295 |
| Posterior reversible encephalopathy syndrome | 18.74 | 17.70 | 5 | 100731 | 26276 | 79617376 |
| Interstitial lung disease | 18.65 | 17.70 | 221 | 100515 | 112379 | 79531273 |
| Spinal pain | 18.60 | 17.70 | 52 | 100684 | 15340 | 79628312 |
| Staphylococcal infection | 18.58 | 17.70 | 28 | 100708 | 58267 | 79585385 |
| Bronchiectasis | 18.55 | 17.70 | 3 | 100733 | 22383 | 79621269 |
| Diabetes mellitus inadequate control | 18.51 | 17.70 | 4 | 100732 | 24260 | 79619392 |
| Device dispensing error | 18.46 | 17.70 | 7 | 100729 | 143 | 79643509 |
| Cytomegalovirus infection | 18.45 | 17.70 | 16 | 100720 | 42628 | 79601024 |
| Drug eruption | 18.39 | 17.70 | 17 | 100719 | 43918 | 79599734 |
| Device dislocation | 18.20 | 17.70 | 73 | 100663 | 25897 | 79617755 |
| Hepatic function abnormal | 18.07 | 17.70 | 41 | 100695 | 73066 | 79570586 |
| Tendonitis | 18.03 | 17.70 | 4 | 100732 | 23826 | 79619826 |
| Movement disorder | 17.96 | 17.70 | 6 | 100730 | 27253 | 79616399 |
| Osteonecrosis of jaw | 17.77 | 17.70 | 17 | 100719 | 43209 | 79600443 |
| Anaesthesia | 17.76 | 17.70 | 10 | 100726 | 517 | 79643135 |
| Haemoptysis | 17.74 | 17.70 | 27 | 100709 | 55972 | 79587680 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L03AA13 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSTIMULANTS IMMUNOSTIMULANTS Colony stimulating factors |
| FDA CS | M0024695 | Granulocyte-Macrophage Colony-Stimulating Factor |
| FDA CS | M0024696 | Granulocyte Colony-Stimulating Factor |
| FDA PE | N0000009451 | Increased Myeloid Cell Production |
| FDA EPC | N0000175666 | Leukocyte Growth Factor |
| 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 |
| CHEMBL1201568 | ChEMBL_ID |
| 70683024 | PUBCHEM_CID |
| 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 |
| NYVEPRIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0324 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 30 sections |
| NYVEPRIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0324 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 30 sections |
| Neulasta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-190 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 31 sections |
| Neulasta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55513-190 | INJECTION | 6 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 | 26 sections |
| ZIEXTENZO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61314-866 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |
| STIMUFEND | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65219-371 | INJECTION, SOLUTION | 6 mg | SUBCUTANEOUS | BLA | 27 sections |
| Fulphila | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-833 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 27 sections |
| UDENYCA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70114-101 | 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 |
| FYLNETRA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70121-1627 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |
| FYLNETRA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70121-1627 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 26 sections |
| Fulphila | HUMAN PRESCRIPTION DRUG LABEL | 1 | 83257-005 | INJECTION | 6 mg | SUBCUTANEOUS | BLA | 27 sections |