cytarabine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives 770 147-94-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cytarabine hydrochloride
  • cytarabine
  • arabinocytosine
  • Arabinoside C
  • aracytidine
  • cyclocide
  • cytarabin
  • cytarabinoside
  • cytosine beta-D-arabinofuranoside
  • cytarabine liposome
  • cytarabine HCl
A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)
  • Molecular weight: 243.22
  • Formula: C9H13N3O5
  • CLOGP: -2.19
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 4
  • TPSA: 128.61
  • ALOGS: -0.74
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 11 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 11.10 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 20 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.67 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 41.67 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.87 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.17 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.723 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 6.839 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.750 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.288 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 89.850 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 90.480 % High 1
herg hERG pIC50 3.218 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 0.859 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.350 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 82.150 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PRKDC,TEK 20
kinase-selectivity-class GRK2,MAP2K6 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.582 High 0.81
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.300 High 1
mh-clint Mouse hepatocyte intrinsic clearance 0.593 High 1
mppb Mouse plasma protein binding (% unbound) 94.940 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.019 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 94.550 % High 1
rat-kpuu-brain Rat brain Kpuu 0.006 % High 0.81
rh-clint Rat hepatocyte intrinsic clearance 1.462 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 96.390 % High 1
rppb Rat plasma protein binding (% unbound) 93.170 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 868.960 uM High 1

Approvals:

DateAgencyCompanyOrphan
Aug. 21, 2020 PMDA Nippon Shinyaku Co., Ltd.
June 17, 1969 FDA
July 11, 2001 EMA PACIRA LIMITED

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 5270.83 19.93 2524 67750 155825 90402348
Myelosuppression 1330.00 19.93 703 69571 52888 90505285
Neutropenia 1181.40 19.93 1140 69134 223764 90334409
Mucosal inflammation 950.95 19.93 579 69695 57046 90501127
Pancytopenia 866.23 19.93 729 69545 119534 90438639
Bone marrow failure 862.76 19.93 445 69829 31776 90526397
Thrombocytopenia 822.03 19.93 907 69367 207818 90350355
Disease progression 817.76 19.93 792 69482 155823 90402350
Septic shock 769.65 19.93 587 69687 83573 90474600
Sepsis 754.29 19.93 808 69466 179006 90379167
Febrile bone marrow aplasia 728.92 19.93 277 69997 9461 90548712
Venoocclusive liver disease 668.53 19.93 229 70045 5764 90552409
Haematotoxicity 598.09 19.93 258 70016 12277 90545896
Acute myeloid leukaemia 517.87 19.93 273 70001 20367 90537806
Neurotoxicity 488.27 19.93 266 70008 21201 90536972
Multiple organ dysfunction syndrome 464.43 19.93 401 69873 67935 90490238
Acute myeloid leukaemia recurrent 457.04 19.93 133 70141 1924 90556249
Neutropenic colitis 422.23 19.93 148 70126 3995 90554178
Posterior reversible encephalopathy syndrome 421.77 19.93 245 70029 22094 90536079
Arthralgia 409.59 19.93 59 70215 778463 89779710
Myelodysplastic syndrome 399.28 19.93 231 70043 20672 90537501
Diffuse large B-cell lymphoma recurrent 398.19 19.93 136 70138 3390 90554783
Pyrexia 393.23 19.93 1263 69011 659222 89898951
Pain 379.49 19.93 150 70124 996191 89561982
Joint swelling 364.54 19.93 5 70269 503295 90054878
Bronchopulmonary aspergillosis 353.55 19.93 174 70100 11224 90546949
Bacteraemia 349.52 19.93 217 70057 22083 90536090
Acute lymphocytic leukaemia recurrent 347.01 19.93 115 70159 2606 90555567
Platelet count decreased 339.19 19.93 472 69802 136497 90421676
Fatigue 332.90 19.93 247 70027 1153776 89404397
Aplasia 322.13 19.93 120 70154 3871 90554302
Leukoencephalopathy 309.27 19.93 123 70151 4750 90553423
Off label use 302.02 19.93 1661 68613 1100591 89457582
Myelopathy 298.04 19.93 109 70165 3335 90554838
Cytokine release syndrome 284.16 19.93 208 70066 27765 90530408
Neutrophil count decreased 279.37 19.93 310 69964 71222 90486951
Cytopenia 276.49 19.93 171 70103 17278 90540895
Pneumonia fungal 275.24 19.93 126 70148 6905 90551268
Aspergillus infection 273.84 19.93 144 70130 10679 90547494
Hypofibrinogenaemia 271.16 19.93 81 70193 1289 90556884
Neoplasm recurrence 270.41 19.93 100 70174 3159 90555014
Mucormycosis 269.09 19.93 104 70170 3717 90554456
Abdominal discomfort 268.11 19.93 29 70245 477299 90080874
Systemic lupus erythematosus 264.55 19.93 3 70271 361893 90196280
Haemophagocytic lymphohistiocytosis 264.17 19.93 159 70115 15300 90542873
Fungaemia 264.08 19.93 99 70175 3251 90554922
Second primary malignancy 259.51 19.93 137 70137 10241 90547932
Alopecia 256.55 19.93 39 70235 495032 90063141
Enterococcal infection 252.98 19.93 133 70141 9858 90548315
Nasopharyngitis 252.60 19.93 16 70258 407088 90151085
Arthropathy 251.61 19.93 7 70267 366235 90191938
Escherichia bacteraemia 247.44 19.93 110 70164 5625 90552548
Hyperbilirubinaemia 245.05 19.93 146 70128 13790 90544383
Peripheral swelling 234.76 19.93 24 70250 413082 90145091
Diffuse large B-cell lymphoma refractory 229.23 19.93 76 70198 1724 90556449
Tumour lysis syndrome 225.68 19.93 128 70146 11024 90547149
Colitis 224.41 19.93 274 70000 69668 90488505
Graft versus host disease 216.46 19.93 112 70162 8032 90550141
Wound 215.02 19.93 4 70270 302976 90255197
Blood culture positive 214.71 19.93 96 70178 4976 90553197
Acute respiratory distress syndrome 214.61 19.93 178 70096 28508 90529665
Neutropenic sepsis 214.58 19.93 148 70126 17982 90540191
Fall 212.04 19.93 56 70218 481754 90076419
Leukaemia recurrent 211.33 19.93 68 70206 1399 90556774
Malaise 210.06 19.93 96 70178 585890 89972283
Product dose omission issue 206.39 19.93 4 70270 291683 90266490
Drug hypersensitivity 205.69 19.93 53 70221 463556 90094617
Swelling 201.73 19.93 40 70234 419018 90139155
Dizziness 199.89 19.93 104 70170 589180 89968993
Fusarium infection 192.80 19.93 59 70215 1023 90557150
Infusion related reaction 192.00 19.93 44 70230 416736 90141437
Venoocclusive disease 191.51 19.93 72 70202 2383 90555790
Respiratory failure 188.24 19.93 333 69941 118085 90440088
Insomnia 185.26 19.93 21 70253 333453 90224720
Human herpesvirus 6 infection 184.81 19.93 77 70197 3355 90554818
Neoplasm progression 184.43 19.93 199 70075 44287 90513886
Cytomegalovirus infection 182.41 19.93 157 70117 26445 90531728
Cardiotoxicity 181.41 19.93 112 70162 11277 90546896
White blood cell count decreased 179.84 19.93 399 69875 166710 90391463
Musculoskeletal stiffness 174.32 19.93 15 70259 296517 90261656
Acute graft versus host disease 174.13 19.93 85 70189 5383 90552790
Asthma 172.61 19.93 3 70271 242157 90316016
Staphylococcal sepsis 169.40 19.93 100 70174 9283 90548890
Geotrichum infection 169.18 19.93 47 70227 569 90557604
Discomfort 166.51 19.93 12 70262 274323 90283850
Pseudomonas infection 165.76 19.93 117 70157 14748 90543425
Lower respiratory tract infection 164.35 19.93 7 70267 250652 90307521
Hypersensitivity 163.59 19.93 74 70200 454603 90103570
Bacterial infection 162.04 19.93 139 70135 23305 90534868
Dyspnoea 161.84 19.93 272 70002 880683 89677490
Pulmonary haemorrhage 159.52 19.93 91 70183 7922 90550251
Acute graft versus host disease in skin 157.68 19.93 76 70198 4680 90553493
Drug intolerance 156.16 19.93 76 70198 447515 90110658
Impaired healing 155.36 19.93 6 70268 234193 90323980
Therapeutic product effect decreased 150.39 19.93 19 70255 277552 90280621
Weight increased 150.36 19.93 68 70206 417859 90140314
Hypertriglyceridaemia 150.13 19.93 87 70187 7802 90550371
Urticaria 150.13 19.93 30 70244 312704 90245469
Drug resistance 149.22 19.93 149 70125 30300 90527873
Duodenal ulcer perforation 149.11 19.93 5 70269 221283 90336890
Therapy partial responder 148.91 19.93 129 70145 21914 90536259
Muscle spasms 147.32 19.93 13 70261 251870 90306303
Disease recurrence 146.64 19.93 163 70111 37490 90520683
Wheezing 142.80 19.93 11 70263 238069 90320104
Disseminated intravascular coagulation 141.38 19.93 124 70150 21414 90536759
Agranulocytosis 140.59 19.93 154 70120 34848 90523325
Blood lactate dehydrogenase increased 140.36 19.93 134 70140 25798 90532375
Sleep disorder 138.91 19.93 3 70271 198027 90360146
Blood cholesterol increased 135.72 19.93 6 70268 208006 90350167
Anxiety 134.28 19.93 37 70237 309735 90248438
Ejection fraction decreased 133.34 19.93 131 70143 26122 90532051
Alpha haemolytic streptococcal infection 131.60 19.93 50 70224 1704 90556469
Clostridium difficile colitis 131.45 19.93 131 70143 26575 90531598
Sinusitis 131.12 19.93 51 70223 343037 90215136
Klebsiella sepsis 130.86 19.93 50 70224 1731 90556442
Cardiomyopathy 129.97 19.93 115 70159 20091 90538082
Blister 127.64 19.93 22 70252 254976 90303197
Depression 126.43 19.93 38 70236 300563 90257610
Pneumatosis intestinalis 126.43 19.93 59 70215 3378 90554795
Product use in unapproved indication 126.41 19.93 556 69718 335680 90222493
Pharyngeal inflammation 124.05 19.93 42 70232 1018 90557155
Pruritus 123.41 19.93 143 70131 541382 90016791
Herpes simplex 122.57 19.93 84 70190 10097 90548076
Cystitis haemorrhagic 121.68 19.93 67 70207 5446 90552727
Injury 121.57 19.93 8 70266 197341 90360832
Condition aggravated 121.52 19.93 171 70103 595374 89962799
Osteoarthritis 120.37 19.93 8 70266 195722 90362451
Lymphoma 117.93 19.93 92 70182 13499 90544674
Pericarditis 117.58 19.93 32 70242 270119 90288054
Systemic candida 117.04 19.93 63 70211 4896 90553277
Hepatotoxicity 116.35 19.93 160 70114 45682 90512491
Mobility decreased 116.31 19.93 26 70248 250708 90307465
Enterobacter infection 116.12 19.93 51 70223 2532 90555641
Abdominal pain upper 115.19 19.93 57 70217 332617 90225556
Malignant neoplasm progression 114.70 19.93 255 70019 106615 90451558
Graft versus host disease in skin 114.08 19.93 57 70217 3796 90554377
Hepatocellular injury 113.86 19.93 126 70148 28832 90529341
Granulocyte count decreased 112.13 19.93 49 70225 2403 90555770
Weight decreased 111.94 19.93 79 70195 379831 90178342
Mantle cell lymphoma recurrent 111.45 19.93 31 70243 377 90557796
Escherichia infection 111.39 19.93 95 70179 15800 90542373
Staphylococcal infection 111.00 19.93 161 70113 48278 90509895
Contusion 110.76 19.93 29 70245 251187 90306986
Folliculitis 110.64 19.93 14 70260 204339 90353834
Hepatic enzyme increased 110.31 19.93 72 70202 360664 90197509
Rhinovirus infection 108.82 19.93 64 70210 5899 90552274
Encephalopathy 108.81 19.93 156 70118 46288 90511885
Bacterial sepsis 108.76 19.93 60 70214 4895 90553278
Pleural effusion 107.81 19.93 256 70018 111735 90446438
Staphylococcal bacteraemia 107.78 19.93 69 70205 7400 90550773
Fungal infection 106.92 19.93 148 70126 42513 90515660
Gene mutation 105.39 19.93 45 70229 2085 90556088
Alanine aminotransferase increased 104.85 19.93 262 70012 118076 90440097
Enterococcal bacteraemia 104.17 19.93 44 70230 1984 90556189
Malignant transformation 103.76 19.93 32 70242 570 90557603
Dry mouth 103.65 19.93 11 70263 184048 90374125
Blood bilirubin increased 103.29 19.93 147 70127 43323 90514850
Pseudomonal sepsis 102.50 19.93 55 70219 4247 90553926
Feeling abnormal 102.35 19.93 7 70267 167228 90390945
Graft versus host disease in gastrointestinal tract 101.48 19.93 55 70219 4333 90553840
Differentiation syndrome 100.07 19.93 38 70236 1293 90556880
Neutropenic infection 98.80 19.93 41 70233 1768 90556405
Memory impairment 98.73 19.93 17 70257 197227 90360946
Hypoalbuminaemia 97.34 19.93 88 70186 15809 90542364
Escherichia sepsis 97.24 19.93 59 70215 5757 90552416
Psoriasis 97.24 19.93 4 70270 147750 90410423
Arthritis 96.83 19.93 9 70265 167306 90390867
Leukopenia 96.70 19.93 230 70044 100480 90457693
Headache 93.63 19.93 349 69925 862397 89695776
Chest pain 93.44 19.93 67 70207 319578 90238595
Immune effector cell-associated neurotoxicity syndrome 92.56 19.93 57 70217 5711 90552462
Aplastic anaemia 92.36 19.93 79 70195 13190 90544983
Stem cell transplant 91.91 19.93 41 70233 2113 90556060
Systemic mycosis 91.48 19.93 37 70237 1493 90556680
Hypoxia 90.68 19.93 184 70090 72215 90485958
Quadriplegia 90.53 19.93 41 70233 2190 90555983
Vasogenic cerebral oedema 90.44 19.93 35 70239 1255 90556918
Thrombotic microangiopathy 90.26 19.93 84 70190 15659 90542514
Hypogammaglobulinaemia 89.90 19.93 71 70203 10603 90547570
Inappropriate schedule of product administration 89.68 19.93 7 70267 149926 90408247
Human bocavirus infection 89.50 19.93 27 70247 445 90557728
Neuropathy peripheral 89.25 19.93 271 70003 136699 90421474
Streptococcal bacteraemia 87.44 19.93 40 70234 2187 90555986
Bone marrow disorder 87.25 19.93 44 70230 2988 90555185
Dyspepsia 87.10 19.93 23 70251 198137 90360036
Stenotrophomonas infection 85.62 19.93 41 70233 2488 90555685
C-reactive protein abnormal 85.39 19.93 3 70271 127426 90430747
Musculoskeletal pain 85.18 19.93 15 70259 171236 90386937
Pneumocystis jirovecii pneumonia 84.88 19.93 94 70180 21522 90536651
Polyneuropathy 84.53 19.93 89 70185 19252 90538921
Candida infection 83.62 19.93 117 70157 33940 90524233
Pain in extremity 83.49 19.93 138 70136 450391 90107782
Cytarabine syndrome 83.37 19.93 17 70257 43 90558130
Blood lactate dehydrogenase abnormal 82.37 19.93 25 70249 421 90557752
Confusional state 81.58 19.93 108 70166 386097 90172076
Bronchitis 81.51 19.93 11 70263 152916 90405257
Klebsiella infection 81.41 19.93 66 70208 10231 90547942
Type 2 diabetes mellitus 81.34 19.93 28 70246 203216 90354957
Anaemia 80.38 19.93 508 69766 352294 90205879
Overdose 80.24 19.93 13 70261 157696 90400477
Blood pressure increased 79.22 19.93 27 70247 197190 90360983
Hospitalisation 76.55 19.93 6 70268 128094 90430079
Capillary leak syndrome 76.26 19.93 39 70235 2728 90555445
Device related infection 76.22 19.93 97 70177 25689 90532484
Left ventricular dysfunction 75.98 19.93 74 70200 14595 90543578
Arachnoiditis 75.65 19.93 25 70249 561 90557612
Adenovirus infection 75.00 19.93 46 70228 4576 90553597
Epstein-Barr virus infection 72.84 19.93 62 70212 10282 90547891
Pericardial effusion 72.41 19.93 114 70160 36719 90521454
Acute lymphocytic leukaemia 72.34 19.93 38 70236 2810 90555363
Chloroma 72.15 19.93 20 70254 240 90557933
Loss of personal independence in daily activities 72.04 19.93 10 70264 136095 90422078
Chronic graft versus host disease 71.81 19.93 43 70231 4096 90554077
Upper respiratory fungal infection 71.51 19.93 19 70255 192 90557981
Hepatic failure 71.33 19.93 118 70156 39610 90518563
Renal failure 69.79 19.93 242 70032 130765 90427408
Venous thrombosis 69.78 19.93 47 70227 5490 90552683
Streptococcal sepsis 69.46 19.93 40 70234 3544 90554629
Central nervous system leukaemia 68.24 19.93 19 70255 232 90557941
Amnesia 68.00 19.93 4 70270 108501 90449672
Hepatosplenic candidiasis 67.32 19.93 20 70254 312 90557861
Enterobacter bacteraemia 67.26 19.93 25 70249 801 90557372
Hypoaesthesia 67.22 19.93 87 70187 314123 90244050
Gastroenteritis norovirus 66.97 19.93 34 70240 2342 90555831
Lung infiltration 66.21 19.93 70 70204 15212 90542961
Sciatica 65.86 19.93 3 70271 101379 90456794
Obesity 65.78 19.93 4 70270 105503 90452670
Paraparesis 65.65 19.93 36 70238 2902 90555271
Hepatitis B reactivation 65.63 19.93 40 70234 3934 90554239
Palmar-plantar erythrodysaesthesia syndrome 65.44 19.93 94 70180 27929 90530244
Toxic erythema of chemotherapy 64.93 19.93 18 70256 216 90557957
Rhinocerebral mucormycosis 64.01 19.93 24 70250 788 90557385
Philadelphia chromosome positive 63.64 19.93 21 70253 469 90557704
Bacillus infection 63.63 19.93 25 70249 934 90557239
Candida sepsis 62.74 19.93 29 70245 1624 90556549
Night sweats 62.48 19.93 12 70262 128754 90429419
Central nervous system lymphoma 62.47 19.93 31 70243 2034 90556139
Osteoporosis 62.24 19.93 3 70271 96528 90461645
White matter lesion 62.23 19.93 33 70241 2488 90555685
Pyomyositis 62.08 19.93 20 70254 413 90557760
Pathogen resistance 62.02 19.93 51 70223 8064 90550109
Acute kidney injury 61.94 19.93 443 69831 319944 90238229
Charles Bonnet syndrome 61.64 19.93 13 70261 41 90558132
Secondary immunodeficiency 61.61 19.93 31 70243 2095 90556078
Klebsiella bacteraemia 61.37 19.93 33 70241 2559 90555614
Progressive multifocal leukoencephalopathy 61.33 19.93 68 70206 15587 90542586
Cytomegalovirus viraemia 60.77 19.93 49 70225 7537 90550636
Injection site erythema 60.62 19.93 4 70270 98498 90459675
Ascites 60.57 19.93 122 70152 47618 90510555
Prescribed overdose 59.97 19.93 4 70270 97621 90460552
Leukoerythroblastosis 59.93 19.93 18 70256 292 90557881
Treatment failure 59.18 19.93 90 70184 303838 90254335
Urinary tract infection 59.04 19.93 91 70183 305541 90252632
Cerebellar syndrome 58.94 19.93 37 70237 3835 90554338
Gait inability 58.89 19.93 20 70254 146436 90411737
Rash 58.87 19.93 369 69905 795731 89762442
Perineal necrosis 58.83 19.93 15 70259 127 90558046
Neurological symptom 58.64 19.93 46 70228 6801 90551372
Adverse drug reaction 58.51 19.93 10 70264 116691 90441482
Nephropathy toxic 58.34 19.93 60 70214 12628 90545545
Central nervous system haemorrhage 58.27 19.93 17 70257 248 90557925
Peripheral sensory neuropathy 58.20 19.93 52 70222 9198 90548975
Cardiac failure 58.08 19.93 202 70072 109294 90448879
Paraplegia 58.04 19.93 35 70239 3377 90554796
Pseudomonas test positive 57.70 19.93 23 70251 893 90557280
Pneumonia 57.65 19.93 751 69523 637308 89920865
Cytomegalovirus infection reactivation 57.49 19.93 48 70226 7752 90550421
Gastrointestinal inflammation 57.38 19.93 45 70229 6651 90551522
Haemoglobin abnormal 57.17 19.93 46 70228 7054 90551119
Enteritis 57.11 19.93 54 70220 10267 90547906
White blood cell count abnormal 57.02 19.93 47 70227 7457 90550716
Hypercholesterolaemia 56.86 19.93 6 70268 100886 90457287
Retinitis viral 56.47 19.93 17 70257 278 90557895
Ill-defined disorder 56.33 19.93 37 70237 184854 90373319
Trichosporon infection 56.27 19.93 18 70256 363 90557810
Post transplant lymphoproliferative disorder 55.91 19.93 45 70229 6904 90551269
Subacute combined cord degeneration 55.39 19.93 16 70258 225 90557948
Hemiparesis 55.11 19.93 93 70181 31726 90526447
Hidradenitis 55.02 19.93 37 70237 4310 90553863
Pulmonary oedema 54.49 19.93 137 70137 61943 90496230
Clostridium test positive 54.46 19.93 40 70234 5361 90552812
Coagulopathy 54.21 19.93 78 70196 23211 90534962
Toxic skin eruption 54.16 19.93 64 70210 15710 90542463
Perineal infection 54.11 19.93 15 70259 180 90557993
Minimal residual disease 53.97 19.93 18 70256 416 90557757
Hyperglycaemia 53.96 19.93 121 70153 50849 90507324
Gastrooesophageal reflux disease 53.85 19.93 31 70243 166306 90391867
Superior sagittal sinus thrombosis 53.43 19.93 21 70253 785 90557388
Hepatic infarction 53.07 19.93 20 70254 666 90557507
Guillain-Barre syndrome 53.04 19.93 37 70237 4575 90553598
Platelet count abnormal 52.73 19.93 36 70238 4299 90553874
Enterocolitis 52.62 19.93 52 70222 10438 90547735
Alternaria infection 52.41 19.93 17 70257 359 90557814
Maternal exposure during pregnancy 52.32 19.93 127 70147 359936 90198237
Cytomegalovirus chorioretinitis 52.29 19.93 29 70245 2390 90555783
Toxic leukoencephalopathy 52.28 19.93 21 70253 832 90557341
Retinal haemorrhage 52.14 19.93 40 70234 5724 90552449
Cerebral haemorrhage 52.13 19.93 95 70179 34427 90523746
Intentional product use issue 51.80 19.93 55 70219 216837 90341336
Intentional product misuse 51.35 19.93 5 70269 89599 90468574
Respiratory distress 51.17 19.93 101 70173 38845 90519328
Toxic epidermal necrolysis 51.02 19.93 91 70183 32437 90525736
Skin toxicity 50.55 19.93 42 70232 6737 90551436
Subclavian vein thrombosis 50.26 19.93 27 70247 2089 90556084
Left atrial hypertrophy 50.12 19.93 11 70263 44 90558129
Stenotrophomonas bacteraemia 49.98 19.93 13 70261 120 90558053
Systemic inflammatory response syndrome 49.90 19.93 41 70233 6475 90551698
Haemoglobin decreased 49.21 19.93 252 70022 161704 90396469
Adverse event 49.04 19.93 15 70259 117403 90440770
Seizure 48.85 19.93 241 70033 152388 90405785
Encephalitis 48.23 19.93 51 70223 11083 90547090
Metastases to bone marrow 47.72 19.93 18 70256 601 90557572
Inflammation 47.65 19.93 41 70233 178551 90379622
Soft tissue infection 47.43 19.93 29 70245 2868 90555305
Diffuse large B-cell lymphoma 47.40 19.93 45 70229 8600 90549573
Enterovirus infection 47.19 19.93 23 70251 1451 90556722
Toxic encephalopathy 47.16 19.93 45 70229 8654 90549519
Transaminases increased 47.12 19.93 95 70179 37097 90521076
Gastrointestinal necrosis 47.05 19.93 30 70244 3195 90554978
Sinusitis fungal 46.48 19.93 25 70249 1939 90556234
Appendicitis 46.35 19.93 48 70226 10183 90547990
Incorrect dose administered 46.32 19.93 4 70270 78926 90479247
Gastrointestinal disorder 45.31 19.93 81 70193 256606 90301567
Cholestasis 45.14 19.93 92 70182 36207 90521966
Palpitations 44.95 19.93 25 70249 136703 90421470
Enterovirus test positive 44.92 19.93 13 70261 184 90557989
Protothecosis 44.85 19.93 16 70258 455 90557718
Hypokalaemia 44.81 19.93 211 70063 130905 90427268
Chronic graft versus host disease in skin 44.72 19.93 21 70253 1219 90556954
Aspartate aminotransferase increased 44.65 19.93 178 70096 102759 90455414
Foetal anaemia 44.41 19.93 12 70262 130 90558043
Nervous system disorder 44.06 19.93 68 70206 21525 90536648
Hepatomegaly 44.00 19.93 53 70221 13273 90544900
Product quality issue 43.98 19.93 5 70269 79320 90478853
Meningitis bacterial 43.87 19.93 23 70251 1694 90556479
Wrong technique in product usage process 43.76 19.93 3 70271 71568 90486605
Peripheral motor neuropathy 43.60 19.93 24 70250 1949 90556224
Myeloid leukaemia 43.33 19.93 16 70258 503 90557670
Respiratory tract infection fungal 43.12 19.93 16 70258 510 90557663
Acute graft versus host disease in liver 43.11 19.93 18 70256 788 90557385
Blast crisis in myelogenous leukaemia 43.04 19.93 17 70257 644 90557529
Back pain 42.89 19.93 116 70158 317059 90241114
Pulmonary fibrosis 42.67 19.93 15 70259 107488 90450685
Gait disturbance 42.65 19.93 86 70188 260410 90297763
Ear infection 42.45 19.93 3 70271 69772 90488401
Blast cells present 42.37 19.93 16 70258 536 90557637
Antithrombin III decreased 42.23 19.93 13 70261 230 90557943
Acute febrile neutrophilic dermatosis 42.08 19.93 29 70245 3516 90554657
Subdural haematoma 42.08 19.93 58 70216 16587 90541586
Jugular vein thrombosis 41.82 19.93 29 70245 3552 90554621
Drug clearance decreased 41.70 19.93 23 70251 1875 90556298
Dry skin 41.08 19.93 9 70265 88064 90470109
Ileus 40.85 19.93 57 70217 16489 90541684
Pneumonia bacterial 40.82 19.93 50 70224 12740 90545433
Lower respiratory tract infection fungal 40.70 19.93 13 70261 261 90557912
Feeling hot 40.65 19.93 6 70268 78002 90480171
Hyperhidrosis 40.54 19.93 28 70246 136277 90421896
Cerebral fungal infection 40.46 19.93 13 70261 266 90557907
Hypertension 40.31 19.93 200 70074 457332 90100841
Fluid intake reduced 40.18 19.93 30 70244 4122 90554051
Primary hypogonadism 40.16 19.93 12 70262 191 90557982
Chronic obstructive pulmonary disease 40.08 19.93 5 70269 73824 90484349
Myocardial infarction 40.02 19.93 16 70258 105956 90452217
B-cell lymphoma recurrent 39.54 19.93 15 70259 509 90557664
Chemotherapeutic drug level increased 39.43 19.93 12 70262 204 90557969
Blast cell count increased 39.40 19.93 15 70259 514 90557659
Gastroenteritis adenovirus 39.16 19.93 13 70261 296 90557877
Asthenia 39.06 19.93 248 70026 533503 90024670
Oedema peripheral 39.02 19.93 89 70185 257826 90300347
Areflexia 38.99 19.93 28 70246 3625 90554548
Leukaemia cutis 38.87 19.93 11 70263 143 90558030
Cryptosporidiosis infection 38.79 19.93 14 70260 412 90557761
Haemorrhage intracranial 38.58 19.93 53 70221 15109 90543064
Epstein-Barr viraemia 38.44 19.93 20 70254 1450 90556723
Parainfluenzae virus infection 38.24 19.93 25 70249 2778 90555395
Granulocytopenia 38.15 19.93 35 70239 6406 90551767
Engraftment syndrome 38.14 19.93 16 70258 709 90557464
Antithrombin III 37.99 19.93 11 70263 156 90558017
Paraesthesia 37.37 19.93 87 70187 250239 90307934
Hepatic function abnormal 37.37 19.93 99 70175 46189 90511984
Neck pain 37.22 19.93 21 70253 113942 90444231
Cardiac dysfunction 37.09 19.93 27 70247 3570 90554603
Acute graft versus host disease in intestine 37.07 19.93 22 70252 2061 90556112
Visual impairment 37.02 19.93 29 70245 132336 90425837
Paralysis 36.84 19.93 45 70229 11433 90546740
Pregnancy 36.80 19.93 3 70271 62044 90496129
JC virus infection 36.48 19.93 24 70250 2695 90555478
Subdural hygroma 36.45 19.93 12 70262 266 90557907
Pulmonary alveolar haemorrhage 36.32 19.93 33 70241 5965 90552208
Pneumonia klebsiella 36.16 19.93 25 70249 3047 90555126
Pericoronitis 36.00 19.93 10 70264 121 90558052
Hypotension 35.86 19.93 398 69876 324999 90233174
Angiokeratoma 35.55 19.93 10 70264 127 90558046
Colitis ulcerative 35.51 19.93 3 70271 60263 90497910
Enterocolitis haemorrhagic 35.36 19.93 20 70254 1712 90556461
Leukaemia 35.31 19.93 30 70244 4962 90553211
Klebsiella test positive 35.20 19.93 19 70255 1484 90556689
Cerebellar stroke 35.14 19.93 13 70261 411 90557762
Hot flush 34.94 19.93 3 70271 59485 90498688
Pulse waveform abnormal 34.91 19.93 9 70265 80 90558093
Metastases to diaphragm 34.84 19.93 8 70266 41 90558132
Ankle brachial index decreased 34.81 19.93 9 70265 81 90558092
Dedifferentiated liposarcoma 34.68 19.93 8 70266 42 90558131
Glioma 34.64 19.93 13 70261 428 90557745
Enterococcus test positive 34.52 19.93 18 70256 1311 90556862
Cardiac arrest 34.50 19.93 167 70107 104768 90453405
Periventricular leukomalacia 34.47 19.93 11 70263 220 90557953
Brain oedema 34.43 19.93 54 70220 17331 90540842
Acute promyelocytic leukaemia 34.30 19.93 17 70257 1112 90557061
Congestive cardiomyopathy 34.22 19.93 35 70239 7319 90550854
Glioblastoma multiforme 34.18 19.93 16 70258 922 90557251
Blood pressure systolic increased 34.11 19.93 3 70271 58342 90499831
Tachycardia 33.96 19.93 224 70050 157449 90400724
Metastases to meninges 33.96 19.93 26 70248 3709 90554464
Enterococcal sepsis 33.91 19.93 19 70255 1597 90556576
Intracranial hypotension 33.84 19.93 12 70262 335 90557838
BK virus infection 33.81 19.93 28 70246 4470 90553703
Cystitis bacterial 33.71 19.93 12 70262 339 90557834
Mucocutaneous ulceration 33.58 19.93 11 70263 240 90557933
Pneumonia moraxella 33.49 19.93 8 70266 50 90558123
Refractoriness to platelet transfusion 33.36 19.93 8 70266 51 90558122
Carotid intima-media thickness increased 33.35 19.93 9 70265 97 90558076
Viraemia 33.34 19.93 19 70255 1650 90556523
Live birth 33.22 19.93 10 70264 79097 90479076
Tonsillar haemorrhage 32.99 19.93 11 70263 254 90557919
Shock haemorrhagic 32.98 19.93 44 70230 12201 90545972
Ataxia 32.94 19.93 54 70220 17988 90540185
Acute respiratory failure 32.84 19.93 90 70184 42828 90515345
Cystitis 32.82 19.93 6 70268 66712 90491461
Therapeutic response delayed 32.54 19.93 15 70259 835 90557338
Oophoritis 32.48 19.93 10 70264 177 90557996
Hyperpyrexia 32.43 19.93 28 70246 4733 90553440
Cataract 32.36 19.93 8 70266 72084 90486089
Hepatic infection fungal 32.35 19.93 8 70266 59 90558114
Intussusception 32.25 19.93 16 70258 1049 90557124
Intermittent positive pressure breathing 32.23 19.93 8 70266 60 90558113
Mucosal toxicity 32.12 19.93 12 70262 390 90557783
Stomatococcal infection 32.09 19.93 9 70265 113 90558060
Myalgia 32.05 19.93 54 70220 175071 90383102
Myelitis 31.99 19.93 20 70254 2058 90556115
Cerebral venous sinus thrombosis 31.95 19.93 21 70253 2355 90555818
Autoimmune disorder 31.69 19.93 10 70264 76734 90481439
Neutrophil count abnormal 31.67 19.93 26 70248 4102 90554071
Hepatitis B 31.64 19.93 27 70247 4492 90553681
Ventricular hypokinesia 31.59 19.93 29 70245 5312 90552861
Inappropriate antidiuretic hormone secretion 31.14 19.93 55 70219 19450 90538723
Bone marrow necrosis 31.06 19.93 9 70265 128 90558045
Underdose 30.99 19.93 3 70271 54014 90504159
Blood fibrinogen decreased 30.83 19.93 16 70258 1154 90557019
Hyperammonaemia 30.46 19.93 31 70243 6444 90551729
Lung consolidation 30.04 19.93 27 70247 4813 90553360
Granulicatella infection 29.91 19.93 9 70265 147 90558026
Enterocolitis infectious 29.76 19.93 19 70255 2028 90556145
Encephalitis fungal 29.74 19.93 8 70266 85 90558088
Escherichia test positive 29.73 19.93 21 70253 2649 90555524
Fungal sepsis 29.33 19.93 17 70257 1524 90556649
Lineage switch leukaemia 29.27 19.93 7 70267 44 90558129
Influenza like illness 29.11 19.93 13 70261 80598 90477575
Blood glucose increased 29.08 19.93 19 70255 95227 90462946
Sweat gland tumour 29.04 19.93 9 70265 163 90558010
Varicella zoster virus infection 28.87 19.93 24 70250 3853 90554320
Exposure during pregnancy 28.73 19.93 92 70182 238318 90319855
Paraspinal abscess 28.69 19.93 10 70264 265 90557908
Procalcitonin abnormal 28.67 19.93 6 70268 18 90558155
Human rhinovirus test positive 28.64 19.93 14 70260 889 90557284
Ureaplasma infection 28.61 19.93 14 70260 891 90557282
Lymphopenia 28.46 19.93 58 70216 22823 90535350
Immune reconstitution inflammatory syndrome 28.38 19.93 31 70243 6988 90551185
Ovarian failure 28.32 19.93 17 70257 1626 90556547
Haemodynamic instability 28.32 19.93 40 70234 11699 90546474
Cytogenetic abnormality 28.31 19.93 12 70262 546 90557627
Quadriparesis 28.27 19.93 20 70254 2529 90555644
Acute pulmonary oedema 28.25 19.93 36 70238 9544 90548629
Hepatic lesion 28.23 19.93 28 70246 5645 90552528
Postictal state 28.21 19.93 16 70258 1377 90556796
Dysplasia 28.20 19.93 16 70258 1378 90556795
Suicidal ideation 28.14 19.93 11 70263 73844 90484329
Device related bacteraemia 28.07 19.93 11 70263 408 90557765
Cardiogenic shock 28.07 19.93 60 70214 24408 90533765
Sinusitis aspergillus 28.06 19.93 8 70266 107 90558066
Continuous haemodiafiltration 28.06 19.93 14 70260 929 90557244
Ototoxicity 27.98 19.93 18 70256 1946 90556227
Genotoxicity 27.97 19.93 6 70268 21 90558152
Sensorimotor disorder 27.89 19.93 13 70261 742 90557431
Intra-abdominal haemorrhage 27.49 19.93 20 70254 2642 90555531
Cardiopulmonary failure 27.26 19.93 24 70250 4164 90554009
Liver function test increased 27.19 19.93 16 70258 84839 90473334
Eosinophilic cystitis 27.07 19.93 7 70267 63 90558110
Myelomalacia 27.07 19.93 7 70267 63 90558110
Gastrointestinal toxicity 27.01 19.93 35 70239 9432 90548741
Enterobacter sepsis 26.85 19.93 10 70264 322 90557851
Vocal cord paralysis 26.79 19.93 19 70255 2411 90555762
Blood stem cell transplant failure 26.66 19.93 9 70265 216 90557957
Hepatic cirrhosis 26.55 19.93 8 70266 63245 90494928
Laryngeal inflammation 26.45 19.93 8 70266 133 90558040
Abscess fungal 26.41 19.93 7 70267 70 90558103
Nasal congestion 26.35 19.93 16 70258 83398 90474775
Bone marrow transplant 26.28 19.93 13 70261 847 90557326
Strongyloidiasis 26.14 19.93 16 70258 1586 90556587
Breast cancer 26.09 19.93 5 70269 53756 90504417
Nausea 26.08 19.93 659 69615 1109657 89448516
General physical health deterioration 25.94 19.93 165 70109 354950 90203223
Upper respiratory tract infection 25.93 19.93 37 70237 128281 90429892
Platelet transfusion 25.79 19.93 14 70260 1106 90557067
Generalised oedema 25.74 19.93 50 70224 19003 90539170
Overgrowth fungal 25.71 19.93 8 70266 147 90558026
Hypernatraemia 25.69 19.93 34 70240 9353 90548820
Constipation 25.58 19.93 121 70153 280274 90277899
Electrocardiogram PR shortened 25.35 19.93 11 70263 530 90557643
Peritoneal mesothelioma malignant 25.33 19.93 5 70269 10 90558163
Leukaemic lymphoma 25.33 19.93 7 70267 83 90558090
Brain herniation 25.22 19.93 23 70251 4177 90553996
Meningitis 25.21 19.93 32 70242 8449 90549724
Leukaemic infiltration 25.19 19.93 6 70268 37 90558136
Hypophosphataemia 25.17 19.93 43 70231 14811 90543362
Facial paralysis 25.06 19.93 44 70230 15490 90542683
Chest discomfort 25.00 19.93 43 70231 138322 90419851
Pneumonia cytomegaloviral 24.72 19.93 20 70254 3091 90555082
Treatment noncompliance 24.71 19.93 5 70269 51722 90506451
Myeloblast percentage decreased 24.66 19.93 6 70268 41 90558132
Portal vein embolism 24.60 19.93 7 70267 93 90558080
Aspergilloma 24.46 19.93 9 70265 280 90557893
Sedation 24.42 19.93 4 70270 48167 90510006
Sinoatrial block 24.37 19.93 13 70261 992 90557181
Abdominal wall wound 24.33 19.93 7 70267 97 90558076
Cardiomyopathy acute 24.25 19.93 9 70265 287 90557886
Cytomegalovirus test positive 24.22 19.93 21 70253 3570 90554603
Tachypnoea 24.15 19.93 52 70222 21257 90536916
Chronic myeloid leukaemia recurrent 24.08 19.93 9 70265 293 90557880
Splenomegaly 24.02 19.93 39 70235 12885 90545288
Lower gastrointestinal haemorrhage 24.02 19.93 32 70242 8860 90549313
Intracranial pressure increased 23.99 19.93 28 70246 6783 90551390
Cryptococcal fungaemia 23.94 19.93 7 70267 103 90558070
Disseminated trichosporonosis 23.81 19.93 7 70267 105 90558068
Encopresis 23.81 19.93 7 70267 105 90558068
Depressed mood 23.69 19.93 5 70269 50217 90507956
Intestinal haematoma 23.63 19.93 7 70267 108 90558065
Electrolyte imbalance 23.61 19.93 55 70219 23690 90534483
Infection reactivation 23.33 19.93 16 70258 1924 90556249
Pleuroparenchymal fibroelastosis 23.32 19.93 8 70266 202 90557971
Ileus paralytic 23.29 19.93 24 70250 5061 90553112
Anal squamous cell carcinoma 23.24 19.93 11 70263 650 90557523
Hepatosplenomegaly 23.18 19.93 19 70255 2990 90555183
Rash scarlatiniform 23.17 19.93 8 70266 206 90557967
Chronic myeloid leukaemia 23.04 19.93 18 70256 2646 90555527
Skin maceration 23.03 19.93 8 70266 210 90557963
Drug eruption 22.98 19.93 70 70204 35337 90522836
Ear pain 22.98 19.93 8 70266 57694 90500479
Somnolence 22.93 19.93 84 70190 209000 90349173
Haemodialysis 22.90 19.93 31 70243 8716 90549457
Infusion site eschar 22.78 19.93 5 70269 20 90558153
Dysbiosis 22.78 19.93 15 70259 1687 90556486
Balance disorder 22.74 19.93 25 70249 97055 90461118
Haematocolpos 22.73 19.93 6 70268 59 90558114
Lipase increased 22.68 19.93 35 70239 11076 90547097
Acute myeloid leukaemia refractory 22.63 19.93 7 70267 126 90558047
Febrile infection 22.40 19.93 16 70258 2053 90556120
Penetrating aortic ulcer 22.40 19.93 5 70269 22 90558151
Metastases to spleen 22.34 19.93 8 70266 230 90557943
Encephalitis cytomegalovirus 22.32 19.93 11 70263 711 90557462
Product use issue 22.24 19.93 157 70117 329762 90228411
Axonal neuropathy 22.12 19.93 13 70261 1196 90556977
Perirectal abscess 22.07 19.93 12 70262 951 90557222
Mouth haemorrhage 22.06 19.93 30 70244 8471 90549702
T-cell type acute leukaemia 21.84 19.93 7 70267 142 90558031
Gallbladder enlargement 21.84 19.93 12 70262 971 90557202
Transformation to acute myeloid leukaemia 21.64 19.93 9 70265 390 90557783
Skin ulcer 21.63 19.93 6 70268 50069 90508104
Mental status changes 21.61 19.93 80 70194 44599 90513574
Procalcitonin increased 21.46 19.93 14 70260 1550 90556623
Central nervous system lesion 21.45 19.93 35 70239 11611 90546562
Acquired gene mutation 21.45 19.93 13 70261 1266 90556907
Splenic infection fungal 21.40 19.93 5 70269 28 90558145
Hydrocephalus 21.38 19.93 25 70249 6069 90552104
Necrosis 21.35 19.93 26 70248 6584 90551589
Hepatitis E 21.29 19.93 15 70259 1884 90556289
Endophthalmitis 21.26 19.93 22 70252 4663 90553510
Epstein Barr virus positive mucocutaneous ulcer 21.21 19.93 10 70264 586 90557587
Acute monocytic leukaemia 21.19 19.93 7 70267 157 90558016
Unevaluable event 21.17 19.93 8 70266 54840 90503333
Delirium 21.17 19.93 30 70244 104329 90453844
VIth nerve paresis 21.13 19.93 6 70268 79 90558094
Acute lymphocytic leukaemia refractory 21.06 19.93 6 70268 80 90558093
Osmotic demyelination syndrome 21.06 19.93 12 70262 1042 90557131
Sinus tachycardia 21.03 19.93 59 70215 28454 90529719
Multiple-drug resistance 21.03 19.93 28 70246 7748 90550425
Renal replacement therapy 21.00 19.93 6 70268 81 90558092
Cough 20.95 19.93 184 70090 368778 90189395
Metapneumovirus infection 20.93 19.93 13 70261 1322 90556851
Hepatic cytolysis 20.90 19.93 62 70212 30854 90527319
Petechiae 20.89 19.93 41 70233 15700 90542473
Swollen tongue 20.82 19.93 5 70269 45951 90512222
Streptococcal infection 20.75 19.93 27 70247 7306 90550867
Leukaemic infiltration extramedullary 20.74 19.93 7 70267 168 90558005
Throat irritation 20.73 19.93 6 70268 48689 90509484
Subarachnoid haemorrhage 20.65 19.93 44 70230 17860 90540313
Pseudomonal bacteraemia 20.63 19.93 15 70259 1979 90556194
Hepatitis G 20.60 19.93 6 70268 87 90558086
Adenoviral hepatitis 20.56 19.93 9 70265 443 90557730
Porphyria non-acute 20.46 19.93 8 70266 295 90557878
Monoparesis 20.41 19.93 15 70259 2012 90556161
Lennox-Gastaut syndrome 20.41 19.93 8 70266 297 90557876
Heart rate decreased 20.33 19.93 8 70266 53497 90504676
Influenza 20.29 19.93 49 70225 139215 90418958
Fluid retention 20.29 19.93 23 70251 88068 90470105
Cerebral haemangioma 20.05 19.93 6 70268 96 90558077
Hemianopia 20.05 19.93 15 70259 2067 90556106

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 4535.98 14.65 3584 93916 182119 42341716
Myelosuppression 1927.38 14.65 1182 96318 39279 42484556
Neutropenia 882.08 14.65 1609 95891 197822 42326013
Bone marrow failure 829.31 14.65 652 96848 32441 42491394
Mucosal inflammation 815.47 14.65 766 96734 48608 42475227
Disease progression 797.82 14.65 1283 96217 142373 42381462
Venoocclusive liver disease 765.46 14.65 403 97097 9899 42513936
Haematotoxicity 634.74 14.65 364 97136 10621 42513214
Pancytopenia 609.10 14.65 1019 96481 116724 42407111
Thrombocytopenia 597.21 14.65 1332 96168 188947 42334888
Febrile bone marrow aplasia 552.76 14.65 324 97176 9857 42513978
Acute myeloid leukaemia recurrent 543.09 14.65 228 97272 3284 42520551
Septic shock 505.67 14.65 817 96683 90855 42432980
Pyrexia 489.50 14.65 1985 95515 392057 42131778
Acute myeloid leukaemia 457.60 14.65 391 97109 21865 42501970
Leukoencephalopathy 405.87 14.65 207 97293 4747 42519088
Fatigue 402.35 14.65 251 97249 435390 42088445
Myelodysplastic syndrome 398.57 14.65 365 97135 22380 42501455
Sepsis 397.76 14.65 1177 96323 198157 42325678
Neutropenic colitis 381.46 14.65 192 97308 4278 42519557
Diffuse large B-cell lymphoma recurrent 356.81 14.65 189 97311 4697 42519138
Myelopathy 337.49 14.65 154 97346 2737 42521098
Bronchopulmonary aspergillosis 334.98 14.65 309 97191 19120 42504715
Fungal infection 331.02 14.65 309 97191 19413 42504422
Off label use 326.75 14.65 2530 94970 635805 41888030
Product dose omission issue 319.29 14.65 7 97493 154358 42369477
Tumour lysis syndrome 307.00 14.65 313 97187 21918 42501917
Neoplasm progression 292.21 14.65 346 97154 28654 42495181
Aplasia 286.46 14.65 163 97337 4680 42519155
Aspergillus infection 281.04 14.65 256 97244 15581 42508254
Neurotoxicity 278.63 14.65 306 97194 23345 42500490
Dizziness 275.37 14.65 113 97387 249141 42274694
Dyspnoea 271.18 14.65 371 97129 442250 42081585
Second primary malignancy 268.84 14.65 202 97298 9373 42514462
Fall 266.13 14.65 102 97398 234418 42289417
Venoocclusive disease 262.23 14.65 143 97357 3772 42520063
Leukaemia recurrent 260.95 14.65 113 97387 1763 42522072
Posterior reversible encephalopathy syndrome 250.81 14.65 219 97281 12602 42511233
Pneumonia fungal 248.04 14.65 189 97311 8957 42514878
Cytopenia 237.30 14.65 244 97256 17253 42506582
Acute lymphocytic leukaemia recurrent 220.38 14.65 125 97375 3566 42520269
Hyperbilirubinaemia 219.18 14.65 253 97247 20382 42503453
Blood lactate dehydrogenase increased 215.92 14.65 282 97218 25799 42498036
Malaise 205.44 14.65 115 97385 212041 42311794
Completed suicide 200.87 14.65 4 97496 96461 42427374
Arthralgia 200.53 14.65 110 97390 205128 42318707
Bacteraemia 199.95 14.65 266 97234 24774 42499061
Graft versus host disease 198.78 14.65 193 97307 12732 42511103
Neutropenic sepsis 197.73 14.65 212 97288 15734 42508101
Insomnia 186.29 14.65 25 97475 118228 42405607
Inappropriate schedule of product administration 185.12 14.65 8 97492 95894 42427941
Pain 183.46 14.65 174 97326 244674 42279161
Multiple organ dysfunction syndrome 182.63 14.65 562 96938 96473 42427362
Stomatitis 178.58 14.65 371 97129 49958 42473877
Neoplasm recurrence 178.30 14.65 98 97402 2626 42521209
Depression 174.33 14.65 24 97476 111339 42412496
Hypogammaglobulinaemia 172.51 14.65 172 97328 11719 42512116
Cytokine release syndrome 171.97 14.65 340 97160 44187 42479648
Infection 168.88 14.65 602 96898 111466 42412369
Peripheral swelling 166.42 14.65 10 97490 90260 42433575
Cytomegalovirus infection reactivation 162.74 14.65 162 97338 11016 42512819
Mucormycosis 162.27 14.65 133 97367 7010 42516825
Platelet count decreased 158.94 14.65 683 96817 137898 42385937
Myocardial infarction 157.98 14.65 44 97456 123965 42399870
Product use in unapproved indication 155.69 14.65 832 96668 183624 42340211
Granulocyte count decreased 153.50 14.65 74 97426 1496 42522339
Colitis 153.30 14.65 333 97167 46239 42477596
Cystitis haemorrhagic 153.10 14.65 130 97370 7199 42516636
Overdose 144.44 14.65 32 97468 105232 42418603
Hypertriglyceridaemia 144.19 14.65 145 97355 9981 42513854
Blood bilirubin increased 142.37 14.65 305 97195 41947 42481888
Diffuse large B-cell lymphoma refractory 142.28 14.65 76 97424 1921 42521914
Neutrophil count decreased 141.07 14.65 390 97110 63025 42460810
Blood culture positive 140.50 14.65 106 97394 4947 42518888
Acute graft versus host disease 140.29 14.65 130 97370 8085 42515750
Weight decreased 137.55 14.65 164 97336 207784 42316051
Acute graft versus host disease in skin 135.60 14.65 122 97378 7302 42516533
Anxiety 131.93 14.65 53 97447 118507 42405328
Hypofibrinogenaemia 129.39 14.65 71 97429 1896 42521939
Hepatotoxicity 128.63 14.65 217 97283 24950 42498885
Somnolence 127.36 14.65 83 97417 141022 42382813
Nasopharyngitis 127.05 14.65 20 97480 83976 42439859
Joint swelling 127.01 14.65 7 97493 68015 42455820
Respiratory failure 126.31 14.65 604 96896 127528 42396307
Skin toxicity 124.33 14.65 110 97390 6439 42517396
Constipation 123.00 14.65 114 97386 162177 42361658
Clostridium difficile colitis 120.44 14.65 192 97308 21060 42502775
Muscle spasms 120.40 14.65 25 97475 86019 42437816
Mantle cell lymphoma recurrent 117.85 14.65 54 97446 969 42522866
Haemophagocytic lymphohistiocytosis 117.84 14.65 175 97325 18047 42505788
Death 117.77 14.65 617 96883 470568 42053267
Blood pressure increased 117.66 14.65 43 97457 101885 42421950
Asthma 117.64 14.65 6 97494 62308 42461527
Escherichia infection 116.45 14.65 137 97363 11259 42512576
Chronic obstructive pulmonary disease 116.29 14.65 7 97493 63107 42460728
Escherichia sepsis 116.09 14.65 100 97400 5647 42518188
Systemic candida 114.50 14.65 96 97404 5223 42518612
Hospitalisation 114.01 14.65 17 97483 74313 42449522
Arachnoiditis 112.62 14.65 40 97460 354 42523481
Intentional product misuse 110.71 14.65 8 97492 61892 42461943
Disease recurrence 107.85 14.65 221 97279 29457 42494378
Injection site pain 107.74 14.65 6 97494 57792 42466043
Malignant transformation 107.59 14.65 50 97450 928 42522907
Candida infection 107.36 14.65 184 97316 21426 42502409
Lymphoid tissue hypoplasia 106.36 14.65 48 97452 830 42523005
Feeling abnormal 104.67 14.65 17 97483 69769 42454066
Lymphadenopathy 104.61 14.65 234 97266 33131 42490704
Thymus hypoplasia 104.03 14.65 47 97453 815 42523020
Fusarium infection 102.64 14.65 57 97443 1559 42522276
Enterococcal infection 102.46 14.65 132 97368 11907 42511928
Bacterial sepsis 100.05 14.65 97 97403 6385 42517450
Chest pain 99.93 14.65 103 97397 139427 42384408
Asthenia 99.90 14.65 320 97180 280473 42243362
Systemic mycosis 99.00 14.65 64 97436 2323 42521512
Therapy partial responder 98.84 14.65 170 97330 19851 42503984
Immune effector cell-associated neurotoxicity syndrome 98.77 14.65 115 97385 9346 42514489
Chronic graft versus host disease 98.37 14.65 93 97407 5932 42517903
Cytomegalovirus infection 97.30 14.65 223 97277 32083 42491752
Incorrect dose administered 97.22 14.65 6 97494 52968 42470867
Abdominal discomfort 97.12 14.65 26 97474 75229 42448606
Pruritus 95.52 14.65 179 97321 188592 42335243
Rash 95.49 14.65 320 97180 276634 42247201
Cardiac failure congestive 94.02 14.65 39 97461 85563 42438272
Differentiation syndrome 93.92 14.65 56 97444 1757 42522078
Staphylococcal infection 93.26 14.65 241 97259 37402 42486433
Suicidal ideation 92.97 14.65 4 97496 48157 42475678
Cytomegalovirus chorioretinitis 92.66 14.65 80 97420 4531 42519304
Suicide attempt 91.83 14.65 3 97497 46097 42477738
Escherichia bacteraemia 90.87 14.65 83 97417 5066 42518769
Wheezing 90.10 14.65 10 97490 54771 42469064
Device related infection 89.56 14.65 164 97336 20115 42503720
Musculoskeletal stiffness 89.07 14.65 13 97487 57752 42466083
Hyperhidrosis 87.57 14.65 49 97451 90463 42433372
Nervous system disorder 87.51 14.65 148 97352 17047 42506788
Pain in extremity 87.08 14.65 131 97369 150473 42373362
Sleep disorder 86.62 14.65 6 97494 48089 42475746
Transformation to acute myeloid leukaemia 84.24 14.65 44 97456 1061 42522774
Graft versus host disease in skin 84.23 14.65 80 97420 5132 42518703
Stenotrophomonas infection 84.20 14.65 69 97431 3635 42520200
Arthritis 82.87 14.65 3 97497 42062 42481773
Viral haemorrhagic cystitis 82.59 14.65 52 97448 1802 42522033
Staphylococcal bacteraemia 82.47 14.65 114 97386 11007 42512828
Drug interaction 82.43 14.65 323 97177 266676 42257159
Geotrichum infection 81.05 14.65 35 97465 542 42523293
Chloroma 81.05 14.65 35 97465 542 42523293
Stem cell transplant 80.89 14.65 59 97441 2613 42521222
Urticaria 80.86 14.65 34 97466 74002 42449833
White blood cell count decreased 79.15 14.65 477 97023 109919 42413916
Rhabdomyolysis 78.75 14.65 40 97460 77979 42445856
Cardiotoxicity 78.56 14.65 91 97409 7354 42516481
Myalgia 78.20 14.65 63 97437 96017 42427818
Post transplant lymphoproliferative disorder 77.62 14.65 100 97400 9020 42514815
B-cell lymphoma recurrent 76.41 14.65 38 97462 824 42523011
Tremor 75.88 14.65 66 97434 96863 42426972
Bacterial infection 75.87 14.65 185 97315 27694 42496141
Hyperkalaemia 75.77 14.65 45 97455 80413 42443422
Disseminated aspergillosis 75.76 14.65 48 97452 1682 42522153
Dehydration 75.66 14.65 130 97370 141637 42382198
Klebsiella infection 74.95 14.65 110 97390 11222 42512613
Staphylococcal sepsis 74.34 14.65 110 97390 11304 42512531
Syncope 73.88 14.65 71 97429 99335 42424500
Agranulocytosis 72.77 14.65 193 97307 30419 42493416
Drug hypersensitivity 72.69 14.65 72 97428 99317 42424518
Plasma cell myeloma 72.68 14.65 11 97489 47567 42476268
Cerebrovascular accident 72.67 14.65 69 97431 97091 42426744
Psoriasis 72.52 14.65 12 97488 48592 42475243
Oedema peripheral 72.41 14.65 125 97375 135951 42387884
Pulmonary haemorrhage 70.19 14.65 107 97393 11290 42512545
Superior sagittal sinus thrombosis 69.32 14.65 27 97473 316 42523519
Blood fibrinogen decreased 69.01 14.65 44 97456 1559 42522276
Graft versus host disease in gastrointestinal tract 68.41 14.65 71 97429 5072 42518763
Drug resistance 67.75 14.65 202 97298 34046 42489789
Lymphopenia 67.32 14.65 151 97349 21412 42502423
Wrong technique in product usage process 67.13 14.65 9 97491 42626 42481209
Lymphoma 66.01 14.65 118 97382 14203 42509632
Glioma 65.57 14.65 29 97471 477 42523358
Capillary leak syndrome 64.85 14.65 52 97448 2655 42521180
Cytomegalovirus viraemia 64.72 14.65 98 97402 10279 42513556
Cerebellar syndrome 64.51 14.65 53 97447 2802 42521033
Dyspepsia 64.46 14.65 9 97491 41343 42482492
Thrombosis 63.55 14.65 39 97461 68472 42455363
Aggression 63.50 14.65 12 97488 44151 42479684
Acute respiratory distress syndrome 62.82 14.65 181 97319 29927 42493908
Central nervous system leukaemia 62.38 14.65 26 97474 367 42523468
Swelling 61.90 14.65 24 97476 54861 42468974
Therapy non-responder 61.82 14.65 264 97236 53095 42470740
Dry skin 61.79 14.65 17 97483 48321 42475514
Osteonecrosis 61.04 14.65 121 97379 15744 42508091
Loss of personal independence in daily activities 60.97 14.65 19 97481 49797 42474038
Stomatococcal infection 60.57 14.65 22 97478 209 42523626
Adenovirus infection 60.05 14.65 76 97424 6733 42517102
Minimal residual disease 59.90 14.65 29 97471 592 42523243
Coronary artery disease 59.74 14.65 24 97476 53696 42470139
Condition aggravated 59.68 14.65 351 97149 260403 42263432
Diabetes mellitus 58.87 14.65 32 97468 60055 42463780
Loss of consciousness 58.69 14.65 75 97425 92279 42431556
Weight increased 57.61 14.65 99 97401 107884 42415951
Leukopenia 57.44 14.65 329 97171 74417 42449418
Encephalopathy 57.07 14.65 216 97284 41117 42482718
Hypertension 56.98 14.65 194 97306 167010 42356825
Hypersensitivity 56.97 14.65 49 97451 72321 42451514
Epstein-Barr virus infection 56.71 14.65 89 97411 9629 42514206
Sweat gland tumour 56.59 14.65 25 97475 410 42523425
Memory impairment 56.57 14.65 22 97478 50200 42473635
Back pain 56.53 14.65 153 97347 141623 42382212
Prostate cancer 56.51 14.65 16 97484 44627 42479208
Alanine aminotransferase increased 56.49 14.65 371 97129 88035 42435800
Parainfluenzae virus infection 55.25 14.65 54 97446 3589 42520246
Acute promyelocytic leukaemia 55.23 14.65 29 97471 707 42523128
Cytarabine syndrome 55.19 14.65 14 97486 30 42523805
Malignant neoplasm progression 54.84 14.65 430 97070 107970 42415865
Abdominal pain upper 54.68 14.65 65 97435 82544 42441291
Klebsiella sepsis 54.55 14.65 47 97453 2654 42521181
Blood glucose increased 54.33 14.65 53 97447 73646 42450189
Acute graft versus host disease in intestine 53.37 14.65 55 97445 3896 42519939
Pseudomonal bacteraemia 53.14 14.65 44 97456 2352 42521483
Gastrointestinal toxicity 53.05 14.65 55 97445 3924 42519911
Hyperpyrexia 52.81 14.65 52 97448 3488 42520347
Drug clearance decreased 52.52 14.65 42 97458 2136 42521699
Central nervous system fungal infection 52.46 14.65 24 97476 429 42523406
Hepatosplenic candidiasis 52.38 14.65 20 97480 221 42523614
Fungaemia 52.33 14.65 49 97451 3087 42520748
Medication error 52.19 14.65 7 97493 33147 42490688
Adverse drug reaction 52.09 14.65 11 97489 37423 42486412
Aplastic anaemia 51.98 14.65 98 97402 12286 42511549
Toxicity to various agents 51.58 14.65 310 97190 228826 42295009
Dry mouth 51.02 14.65 14 97486 39865 42483970
Hallucination 50.26 14.65 35 97465 57472 42466363
Gastrooesophageal reflux disease 50.25 14.65 20 97480 45003 42478832
Streptococcal bacteraemia 50.24 14.65 45 97455 2677 42521158
Unevaluable event 49.98 14.65 9 97491 34279 42489556
Enterocolitis 49.91 14.65 85 97415 9844 42513991
Disseminated intravascular coagulation 49.75 14.65 147 97353 24647 42499188
Arthropathy 49.70 14.65 5 97495 29592 42494243
Progressive multifocal leukoencephalopathy 49.30 14.65 92 97408 11444 42512391
Enterococcal bacteraemia 49.04 14.65 44 97456 2623 42521212
Chest discomfort 48.95 14.65 44 97456 63572 42460263
Treatment noncompliance 48.62 14.65 13 97487 37659 42486176
Pneumonia aspiration 48.58 14.65 27 97473 50051 42473784
Blood creatine phosphokinase increased 48.44 14.65 25 97475 48313 42475522
Paraplegia 48.38 14.65 48 97452 3249 42520586
Nephropathy toxic 48.25 14.65 114 97386 16724 42507111
Glioblastoma multiforme 47.67 14.65 28 97472 854 42522981
Central nervous system lymphoma 47.50 14.65 33 97467 1352 42522483
Cerebellar tumour 47.47 14.65 16 97484 119 42523716
Acute myeloid leukaemia refractory 47.24 14.65 16 97484 121 42523714
Transient ischaemic attack 46.77 14.65 10 97490 33729 42490106
Alpha haemolytic streptococcal infection 46.56 14.65 37 97463 1865 42521970
Pneumocystis jirovecii pneumonia 46.50 14.65 145 97355 25036 42498799
Cytogenetic abnormality 46.27 14.65 28 97472 903 42522932
Pulmonary embolism 46.24 14.65 131 97369 119481 42404354
Clostridium bacteraemia 45.81 14.65 18 97482 216 42523619
Herpes simplex 45.66 14.65 68 97432 7027 42516808
Haematochezia 45.46 14.65 40 97460 58396 42465439
Blood stem cell transplant failure 45.35 14.65 22 97478 451 42523384
Acute lymphocytic leukaemia 44.98 14.65 47 97453 3384 42520451
Hepatopulmonary syndrome 44.81 14.65 15 97485 109 42523726
Diarrhoea 44.66 14.65 764 96736 460085 42063750
Heart rate decreased 44.58 14.65 14 97486 36518 42487317
Gallbladder oedema 44.52 14.65 18 97482 234 42523601
Intracranial pressure increased 44.15 14.65 54 97446 4620 42519215
Osteoarthritis 44.07 14.65 3 97497 24402 42499433
Blood pressure fluctuation 44.02 14.65 5 97495 26903 42496932
Decreased appetite 43.60 14.65 261 97239 192876 42330959
Autoimmune lymphoproliferative syndrome 43.57 14.65 17 97483 200 42523635
Eczema 43.54 14.65 12 97488 34074 42489761
Lower respiratory tract infection 43.28 14.65 20 97480 41186 42482649
Trichosporon infection 43.15 14.65 27 97473 925 42522910
Sinusitis fungal 43.05 14.65 25 97475 746 42523089
Hypoglycaemia 43.02 14.65 44 97456 59810 42464025
Lower respiratory tract infection fungal 42.96 14.65 23 97477 584 42523251
Neutropenic infection 42.80 14.65 35 97465 1838 42521997
Erectile dysfunction 42.38 14.65 4 97496 24909 42498926
Epstein-Barr virus infection reactivation 41.84 14.65 40 97460 2587 42521248
Contusion 41.65 14.65 22 97478 41963 42481872
Blood pressure systolic increased 41.51 14.65 7 97493 27961 42495874
Acute graft versus host disease in liver 41.44 14.65 35 97465 1923 42521912
Multiple-drug resistance 41.27 14.65 66 97434 7256 42516579
Angina pectoris 41.24 14.65 12 97488 32884 42490951
Human rhinovirus test positive 41.21 14.65 18 97482 287 42523548
Diffuse large B-cell lymphoma 41.16 14.65 76 97424 9378 42514457
Bacillus infection 41.16 14.65 24 97476 722 42523113
Influenza like illness 41.06 14.65 11 97489 31829 42492006
Bradycardia 40.64 14.65 84 97416 85400 42438435
Pneumonia escherichia 40.58 14.65 23 97477 655 42523180
Acute febrile neutrophilic dermatosis 40.54 14.65 34 97466 1850 42521985
Engraftment syndrome 40.52 14.65 30 97470 1360 42522475
Hepatitis B reactivation 40.22 14.65 51 97449 4527 42519308
Hepatitis B 39.91 14.65 62 97438 6649 42517186
Illness 39.87 14.65 5 97495 24925 42498910
Scedosporium infection 39.62 14.65 31 97469 1527 42522308
Serotonin syndrome 39.41 14.65 6 97494 25839 42497996
Toxic leukoencephalopathy 39.08 14.65 23 97477 704 42523131
Pseudostroke 39.01 14.65 13 97487 93 42523742
Gait disturbance 38.86 14.65 106 97394 97894 42425941
Vertigo 38.75 14.65 15 97485 34332 42489503
Respiratory moniliasis 38.69 14.65 17 97483 275 42523560
Cardiac disorder 38.66 14.65 33 97467 48899 42474936
Musculoskeletal pain 38.56 14.65 14 97486 33326 42490509
Epstein-Barr virus associated lymphoproliferative disorder 38.53 14.65 37 97463 2406 42521429
Pseudomonal sepsis 38.38 14.65 48 97452 4201 42519634
Aeromonas infection 38.35 14.65 18 97482 342 42523493
Dysphonia 38.29 14.65 9 97491 28441 42495394
Acute myocardial infarction 38.24 14.65 46 97454 58119 42465716
Clostridium difficile infection 37.78 14.65 126 97374 22533 42501302
Candida sepsis 37.29 14.65 29 97471 1416 42522419
Gastrointestinal wall thickening 37.14 14.65 32 97468 1807 42522028
Bronchitis 37.09 14.65 32 97468 47169 42476666
Nausea 37.06 14.65 662 96838 396137 42127698
Dyspnoea exertional 37.03 14.65 36 97464 50112 42473723
Confusional state 37.02 14.65 228 97272 167369 42356466
Dysgeusia 36.84 14.65 16 97484 34173 42489662
Acute monocytic leukaemia 36.33 14.65 18 97482 387 42523448
Neurological decompensation 36.16 14.65 44 97456 3745 42520090
Leukaemic infiltration 36.01 14.65 14 97486 163 42523672
Cerebral venous sinus thrombosis 35.82 14.65 22 97478 729 42523106
Colitis ulcerative 35.79 14.65 8 97492 26167 42497668
Central nervous system neoplasm 35.52 14.65 12 97488 90 42523745
Pseudomonas infection 35.44 14.65 98 97402 15825 42508010
Enterococcus test positive 35.42 14.65 30 97470 1655 42522180
Retinal haemorrhage 35.28 14.65 54 97446 5716 42518119
Drug withdrawal syndrome 35.26 14.65 4 97496 21545 42502290
Haematopoietic stem cell mobilisation 35.20 14.65 17 97483 345 42523490
Escherichia test positive 35.15 14.65 27 97473 1294 42522541
Cataract 35.14 14.65 13 97487 30591 42493244
Blast cells present 35.08 14.65 19 97481 494 42523341
Cough 34.97 14.65 251 97249 177852 42345983
Febrile infection 34.62 14.65 37 97463 2734 42521101
Depressed mood 34.38 14.65 6 97494 23378 42500457
Accidental overdose 34.31 14.65 11 97489 28319 42495516
Mobility decreased 34.29 14.65 19 97481 35287 42488548
Respiratory tract infection fungal 34.07 14.65 22 97478 797 42523038
Contraindicated product administered 34.00 14.65 8 97492 25264 42498571
Therapeutic product effect decreased 33.98 14.65 24 97476 39126 42484709
Cerebral venous thrombosis 33.83 14.65 24 97476 1017 42522818
Gout 33.79 14.65 11 97489 28044 42495791
Psoriatic arthropathy 33.40 14.65 8 97492 24959 42498876
Nephrolithiasis 32.73 14.65 22 97478 36808 42487027
Meningitis chemical 32.50 14.65 11 97489 83 42523752
Guillain-Barre syndrome 32.39 14.65 59 97441 7204 42516631
Pneumonia klebsiella 32.33 14.65 44 97456 4185 42519650
Diabetic ketoacidosis 32.32 14.65 6 97494 22361 42501474
Hot flush 32.29 14.65 6 97494 22345 42501490
Swollen tongue 32.21 14.65 5 97495 21226 42502609
Aspergillus test positive 32.08 14.65 20 97480 681 42523154
Lung infiltration 32.03 14.65 87 97413 13902 42509933
Angioedema 31.94 14.65 30 97470 42447 42481388
Urinary tract infection 31.92 14.65 118 97382 99166 42424669
Pleural effusion 31.72 14.65 351 97149 96815 42427020
Refractory cancer 31.61 14.65 13 97487 177 42523658
BK virus infection 31.41 14.65 65 97435 8719 42515116
Influenza 31.35 14.65 59 97441 62116 42461719
Bone marrow disorder 31.17 14.65 30 97470 1956 42521879
Obstructive airways disorder 31.10 14.65 9 97491 24750 42499085
Gastrointestinal mucormycosis 31.04 14.65 16 97484 375 42523460
Adverse event 30.80 14.65 8 97492 23632 42500203
Sleep apnoea syndrome 30.79 14.65 6 97494 21602 42502233
Respiratory distress 30.76 14.65 182 97318 41638 42482197
Blood HIV RNA increased 30.75 14.65 27 97473 1564 42522271
Coagulopathy 30.73 14.65 116 97384 22046 42501789
Migraine 30.55 14.65 10 97490 25404 42498431
Hepatic infection fungal 30.51 14.65 14 97486 252 42523583
Hydrocephalus 30.50 14.65 52 97448 6026 42517809
Blast crisis in myelogenous leukaemia 30.47 14.65 19 97481 647 42523188
Quadriparesis 30.46 14.65 32 97468 2318 42521517
Injury 30.15 14.65 7 97493 22309 42501526
Pneumonia cytomegaloviral 30.14 14.65 42 97458 4084 42519751
Eosinophilia 30.12 14.65 19 97481 32880 42490955
Pathogen resistance 30.11 14.65 75 97425 11375 42512460
Graft versus host disease in liver 30.06 14.65 27 97473 1612 42522223
Cystitis viral 30.06 14.65 24 97476 1218 42522617
Toxic erythema of chemotherapy 29.82 14.65 12 97488 154 42523681
Metastases to spleen 29.74 14.65 17 97483 492 42523343
Refractory anaemia with an excess of blasts 29.68 14.65 15 97485 337 42523498
Encephalitis 29.56 14.65 65 97435 9093 42514742
Large intestine infection 29.51 14.65 30 97470 2091 42521744
B-cell lymphoma refractory 29.49 14.65 13 97487 212 42523623
Fibrinous bronchitis 29.27 14.65 11 97489 116 42523719
Haematopoietic neoplasm 29.24 14.65 9 97491 48 42523787
Vena cava thrombosis 29.19 14.65 26 97474 1535 42522300
Adenoviral haemorrhagic cystitis 28.72 14.65 17 97483 526 42523309
Frequent bowel movements 28.36 14.65 7 97493 21400 42502435
Accidental exposure to product 28.35 14.65 6 97494 20387 42503448
Chronic kidney disease 28.34 14.65 40 97460 47201 42476634
Neuropathy peripheral 27.99 14.65 356 97144 101497 42422338
Vision blurred 27.93 14.65 50 97450 53649 42470186
Arteriosclerosis 27.84 14.65 4 97496 17985 42505850
International normalised ratio increased 27.70 14.65 42 97458 48126 42475709
Palpitations 27.60 14.65 46 97454 50751 42473084
Burning sensation 27.59 14.65 7 97493 21006 42502829
Antithrombin III deficiency 27.49 14.65 11 97489 139 42523696
Meningeal neoplasm 27.44 14.65 10 97490 96 42523739
Capnocytophaga infection 27.42 14.65 11 97489 140 42523695
Rib fracture 27.30 14.65 3 97497 16568 42507267
Chromosome analysis abnormal 27.21 14.65 12 97488 196 42523639
Vasogenic cerebral oedema 27.19 14.65 21 97479 1015 42522820
Dyskinesia 27.17 14.65 12 97488 25378 42498457
Device related thrombosis 26.89 14.65 24 97476 1421 42522414
Rectal haemorrhage 26.88 14.65 45 97455 49561 42474274
Gastrointestinal inflammation 26.72 14.65 42 97458 4550 42519285
Agitation 26.68 14.65 68 97432 64246 42459589
Pseudomonas test positive 26.63 14.65 24 97476 1439 42522396
Chronic graft versus host disease in skin 26.62 14.65 25 97475 1581 42522254
Lentigo 26.58 14.65 19 97481 815 42523020
Disease susceptibility 26.13 14.65 9 97491 72 42523763
Cerebral candidiasis 26.13 14.65 9 97491 72 42523763
Philadelphia chromosome positive 26.13 14.65 17 97483 624 42523211
Interstitial lung disease 26.04 14.65 92 97408 78370 42445465
Abnormal behaviour 26.03 14.65 14 97486 26437 42497398
Bladder cancer 25.89 14.65 4 97496 17043 42506792
Enterobacter sepsis 25.74 14.65 20 97480 975 42522860
Haemoglobin abnormal 25.62 14.65 43 97457 4921 42518914
Aspartate aminotransferase increased 25.30 14.65 279 97221 76884 42446951
Steatohepatitis 25.23 14.65 15 97485 468 42523367
Labelled drug-drug interaction medication error 25.23 14.65 3 97497 15579 42508256
Psychotic disorder 25.22 14.65 18 97482 29190 42494645
Intestinal atresia 25.21 14.65 9 97491 81 42523754
Human herpesvirus 6 infection 25.20 14.65 30 97470 2495 42521340
Klebsiella bacteraemia 25.12 14.65 29 97471 2335 42521500
Balance disorder 25.10 14.65 44 97456 47601 42476234
Blood cholesterol increased 25.10 14.65 15 97485 26726 42497109
Hidradenitis 24.91 14.65 25 97475 1716 42522119
Facial paralysis 24.74 14.65 74 97426 12489 42511346
Meningitis aseptic 24.71 14.65 40 97460 4442 42519393
Blast cell count increased 24.71 14.65 21 97479 1164 42522671
Streptococcal sepsis 24.54 14.65 26 97474 1902 42521933
Hypoalbuminaemia 24.44 14.65 85 97415 15525 42508310
Acute lymphocytic leukaemia refractory 24.39 14.65 10 97490 135 42523700
Loss of CAR T-cell persistence 24.38 14.65 7 97493 28 42523807
General physical health deterioration 24.25 14.65 225 97275 151021 42372814
Transaminases increased 24.10 14.65 143 97357 32742 42491093
Lung neoplasm malignant 23.97 14.65 7 97493 19140 42504695
Amnesia 23.94 14.65 18 97482 28419 42495416
Noninfectious myelitis 23.93 14.65 6 97494 12 42523823
Heart rate increased 23.91 14.65 54 97446 53201 42470634
Recurrent cancer 23.89 14.65 24 97476 1649 42522186
Cytomegalovirus hepatitis 23.87 14.65 15 97485 518 42523317
Enterovirus test positive 23.85 14.65 9 97491 96 42523739
Congenital pneumonia 23.85 14.65 9 97491 96 42523739
Full blood count abnormal 23.78 14.65 20 97480 29856 42493979
Flatulence 23.76 14.65 14 97486 25138 42498697
Feeling hot 23.74 14.65 12 97488 23470 42500365
Hypothyroidism 23.72 14.65 23 97477 32061 42491774
Platelet transfusion 23.64 14.65 24 97476 1670 42522165
Metastases to bone 23.61 14.65 3 97497 14806 42509029
Septic embolus 23.53 14.65 22 97478 1383 42522452
Tinnitus 23.49 14.65 19 97481 28919 42494916
Central nervous system enteroviral infection 23.45 14.65 8 97492 62 42523773
Respiratory depression 23.44 14.65 7 97493 18861 42504974
Product quality issue 23.40 14.65 6 97494 17876 42505959
Ileus paralytic 23.28 14.65 53 97447 7588 42516247
Hypertensive hydrocephalus 23.23 14.65 8 97492 64 42523771
Staphylococcus test positive 23.21 14.65 35 97465 3657 42520178
Hippocampal sclerosis 23.21 14.65 10 97490 154 42523681
Haemodynamic instability 22.90 14.65 72 97428 12485 42511350
Foetal exposure during pregnancy 22.89 14.65 46 97454 47265 42476570
Hepatomegaly 22.81 14.65 69 97431 11716 42512119
Body temperature decreased 22.79 14.65 3 97497 14410 42509425
Productive cough 22.58 14.65 53 97447 51514 42472321
Enterobacter infection 22.58 14.65 31 97469 2973 42520862
Palmar-plantar erythrodysaesthesia syndrome 22.42 14.65 100 97400 20482 42503353
Ill-defined disorder 22.35 14.65 85 97415 16211 42507624
Central nervous system haemorrhage 22.33 14.65 9 97491 116 42523719
Vascular access complication 22.21 14.65 13 97487 394 42523441
Spinal cord disorder 22.06 14.65 18 97482 942 42522893
Personality change due to a general medical condition 22.05 14.65 7 97493 42 42523793
Metastatic lymphoma 22.03 14.65 13 97487 400 42523435
Metastases to testicle 22.02 14.65 8 97492 76 42523759
Osteonecrosis of jaw 22.02 14.65 8 97492 19041 42504794
Emotional distress 21.84 14.65 5 97495 16088 42507747
Mental disorder 21.83 14.65 7 97493 18022 42505813
Sertoli-cell-only syndrome 21.78 14.65 7 97493 44 42523791
Restlessness 21.59 14.65 21 97479 29228 42494607
Abscess fungal 21.48 14.65 12 97488 332 42523503
Hallucination, auditory 21.45 14.65 4 97496 14860 42508975
Periorbital infection 21.35 14.65 10 97490 189 42523646
Bacillus test positive 21.31 14.65 8 97492 84 42523751
Peripheral motor neuropathy 21.13 14.65 26 97474 2238 42521597
Procalcitonin increased 21.02 14.65 26 97474 2250 42521585
Leukaemia 20.98 14.65 43 97457 5729 42518106
Hepatosplenomegaly 20.97 14.65 38 97462 4622 42519213
Type 2 diabetes mellitus 20.95 14.65 8 97492 18463 42505372
Pyomyositis 20.88 14.65 11 97489 270 42523565
Candida endophthalmitis 20.80 14.65 9 97491 140 42523695
Atypical haemolytic uraemic syndrome 20.78 14.65 14 97486 545 42523290
Pneumonia viral 20.71 14.65 36 97464 4238 42519597
Chronic myeloid leukaemia 20.70 14.65 27 97473 2465 42521370
Premature ageing 20.67 14.65 8 97492 92 42523743
Skin discolouration 20.64 14.65 11 97489 20879 42502956
Pleuroparenchymal fibroelastosis 20.57 14.65 9 97491 144 42523691
Cardiogenic shock 20.57 14.65 31 97469 35609 42488226
Lower motor neurone lesion 20.55 14.65 7 97493 54 42523781
Gamma-glutamyltransferase increased 20.51 14.65 136 97364 32361 42491474
Diabetes mellitus inadequate control 20.45 14.65 5 97495 15385 42508450
Papilloedema 20.44 14.65 31 97469 3255 42520580
Lip swelling 20.39 14.65 9 97491 19044 42504791
Limb injury 20.32 14.65 4 97496 14301 42509534
Hyperlipidaemia 20.29 14.65 12 97488 21504 42502331
Meningeal thickening 20.29 14.65 5 97495 9 42523826
Sopor 20.28 14.65 3 97497 13199 42510636
Engraft failure 20.25 14.65 14 97486 569 42523266
Septal panniculitis 20.22 14.65 7 97493 57 42523778
Superior mesenteric artery syndrome 20.21 14.65 8 97492 98 42523737
Urethral obstruction 20.18 14.65 10 97490 215 42523620
Blood glucose decreased 20.15 14.65 4 97496 14215 42509620
Wound 20.11 14.65 7 97493 17110 42506725
Systemic inflammatory response syndrome 20.06 14.65 49 97451 7341 42516494
Fungal sepsis 20.02 14.65 18 97482 1076 42522759
Enterococcal sepsis 19.93 14.65 24 97476 2020 42521815
Cranial nerve disorder 19.87 14.65 14 97486 587 42523248
Therapy cessation 19.86 14.65 11 97489 20439 42503396
Combined immunodeficiency 19.72 14.65 8 97492 105 42523730
Infusion related reaction 19.71 14.65 72 97428 60734 42463101
Intracranial tumour haemorrhage 19.69 14.65 12 97488 392 42523443
Blood test abnormal 19.67 14.65 3 97497 12903 42510932
Leukaemic infiltration pulmonary 19.62 14.65 5 97495 11 42523824
Juvenile chronic myelomonocytic leukaemia 19.49 14.65 6 97494 32 42523803
Cerebral toxoplasmosis 19.43 14.65 24 97476 2074 42521761
Enterovirus infection 19.30 14.65 19 97481 1274 42522561
Haemorrhagic pneumonia 19.17 14.65 9 97491 171 42523664
Metastases to muscle 19.15 14.65 10 97490 241 42523594
Aphasia 19.14 14.65 107 97393 23976 42499859
Gallbladder empyema 19.13 14.65 7 97493 68 42523767
Blast cell crisis 19.13 14.65 8 97492 114 42523721
Anorectal cellulitis 19.05 14.65 6 97494 35 42523800
Swelling face 18.96 14.65 21 97479 27533 42496302
Blister 18.86 14.65 21 97479 27469 42496366
Morphoea 18.85 14.65 10 97490 249 42523586
Arrhythmia 18.83 14.65 40 97460 40277 42483558
Mucosal infection 18.82 14.65 10 97490 250 42523585
Laboratory test abnormal 18.76 14.65 15 97485 22963 42500872
Nasal congestion 18.68 14.65 24 97476 29477 42494358
Bacillus bacteraemia 18.62 14.65 9 97491 183 42523652
Miosis 18.60 14.65 4 97496 13442 42510393
Cytomegalovirus colitis 18.60 14.65 33 97467 3948 42519887
Anaemia 18.58 14.65 801 96699 279477 42244358
Stenotrophomonas sepsis 18.58 14.65 9 97491 184 42523651
Infection in an immunocompromised host 18.57 14.65 17 97483 1040 42522795
Diffuse large B-cell lymphoma stage IV 18.55 14.65 13 97487 540 42523295
Proteus test positive 18.53 14.65 10 97490 258 42523577
Central nervous system necrosis 18.50 14.65 10 97490 259 42523576
Encephalitis enteroviral 18.44 14.65 9 97491 187 42523648
Xanthogranuloma 18.44 14.65 7 97493 76 42523759
Metastases to retroperitoneum 18.39 14.65 10 97490 262 42523573
Autoimmune neutropenia 18.39 14.65 11 97489 347 42523488
Eccrine squamous syringometaplasia 18.37 14.65 6 97494 40 42523795
Meningitis tuberculous 18.34 14.65 14 97486 665 42523170
Visual impairment 18.33 14.65 45 97455 43068 42480767
Arteriosclerosis coronary artery 18.21 14.65 10 97490 18667 42505168
Ejection fraction decreased 18.13 14.65 99 97401 21988 42501847
Encephalitis cytomegalovirus 18.11 14.65 18 97482 1221 42522614
Blood fibrinogen abnormal 18.10 14.65 4 97496 3 42523832
Gastrointestinal haemorrhage 18.07 14.65 140 97360 97586 42426249
Ataxia 18.06 14.65 79 97421 16046 42507789
Nocturia 18.04 14.65 3 97497 12109 42511726
Hypothalamo-pituitary disorder 17.99 14.65 17 97483 1083 42522752
Precursor T-lymphoblastic lymphoma/leukaemia 17.99 14.65 6 97494 43 42523792
Cerebral fungal infection 17.92 14.65 11 97489 364 42523471
Enteritis 17.90 14.65 60 97440 10756 42513079
Rhinitis 17.77 14.65 3 97497 11974 42511861
Anger 17.75 14.65 4 97496 13014 42510821
Splenic candidiasis 17.67 14.65 7 97493 86 42523749
Blood pressure decreased 17.66 14.65 71 97429 58261 42465574
Peripheral sensory neuropathy 17.62 14.65 52 97448 8710 42515125
Headache 17.62 14.65 415 97085 238954 42284881
Hepatic failure 17.54 14.65 148 97352 37952 42485883
Hypoxia 17.53 14.65 240 97260 69546 42454289
Blindness cortical 17.48 14.65 12 97488 482 42523353
Areflexia 17.45 14.65 31 97469 3712 42520123
Pneumonia adenoviral 17.45 14.65 11 97489 382 42523453
Bone marrow necrosis 17.45 14.65 10 97490 291 42523544
Head injury 17.36 14.65 13 97487 20569 42503266
Rhinovirus infection 17.33 14.65 43 97457 6505 42517330
Cardiac murmur 17.27 14.65 4 97496 12771 42511064
Limb discomfort 17.26 14.65 4 97496 12763 42511072
Peripheral blood stem cell apheresis 17.24 14.65 8 97492 148 42523687
Disturbance in attention 17.21 14.65 26 97474 29840 42493995
Ichthyosis 17.19 14.65 8 97492 149 42523686
Peritoneal lesion 17.14 14.65 8 97492 150 42523685
Bronchiectasis 17.06 14.65 10 97490 18009 42505826
Radiculopathy 17.02 14.65 28 97472 3152 42520683
Localised infection 17.01 14.65 13 97487 20360 42503475
Pericardial effusion 16.98 14.65 120 97380 29155 42494680
Intussusception 16.96 14.65 14 97486 745 42523090
Lethargy 16.92 14.65 53 97447 46837 42476998
Chronic myelomonocytic leukaemia 16.90 14.65 14 97486 749 42523086
Haemoptysis 16.78 14.65 52 97448 46115 42477720
Enamel anomaly 16.69 14.65 9 97491 232 42523603
Cytomegalovirus test positive 16.68 14.65 33 97467 4286 42519549
Candida pneumonia 16.53 14.65 14 97486 772 42523063
Atrioventricular block complete 16.52 14.65 3 97497 11361 42512474
Skin candida 16.48 14.65 13 97487 648 42523187
Posturing 16.46 14.65 12 97488 531 42523304
Oxygen saturation decreased 16.43 14.65 84 97416 64603 42459232
Arthritis fungal 16.41 14.65 7 97493 105 42523730
Joint stiffness 16.38 14.65 4 97496 12318 42511517
B precursor type acute leukaemia 16.38 14.65 9 97491 241 42523594
Orthostatic hypotension 16.31 14.65 28 97472 30542 42493293
Drug reaction with eosinophilia and systemic symptoms 16.30 14.65 46 97454 42029 42481806
Interleukin level decreased 16.30 14.65 4 97496 7 42523828
CSF cell count decreased 16.30 14.65 4 97496 7 42523828
CSF lactate decreased 16.30 14.65 4 97496 7 42523828
Metastases to bone marrow 16.28 14.65 12 97488 540 42523295
Plasma cells decreased 16.25 14.65 6 97494 60 42523775
Drug-induced liver injury 16.23 14.65 146 97354 38127 42485708
Device related bacteraemia 16.17 14.65 13 97487 666 42523169
Hepatic calcification 16.16 14.65 10 97490 336 42523499
Adenoviral hepatitis 16.15 14.65 12 97488 547 42523288
Skin laceration 16.09 14.65 6 97494 14052 42509783
Tooth hypoplasia 16.05 14.65 9 97491 251 42523584
Cerebrosclerosis 16.04 14.65 5 97495 28 42523807
Adenomatous polyposis coli 15.98 14.65 8 97492 176 42523659
Sinusitis bacterial 15.98 14.65 12 97488 556 42523279
Hepatitis E 15.97 14.65 27 97473 3107 42520728
Hernia 15.93 14.65 3 97497 11070 42512765
Blood bilirubin unconjugated increased 15.91 14.65 13 97487 682 42523153
Throat irritation 15.90 14.65 5 97495 13031 42510804
Nephritis allergic 15.89 14.65 13 97487 683 42523152
Gastroenteritis sapovirus 15.86 14.65 8 97492 179 42523656
Raoultella ornithinolytica infection 15.82 14.65 6 97494 65 42523770
Hyponatraemia 15.79 14.65 152 97348 101310 42422525
Irritability 15.72 14.65 25 97475 28103 42495732
Human herpesvirus 6 infection reactivation 15.72 14.65 11 97489 456 42523379
Fear 15.72 14.65 3 97497 10962 42512873
Cavernous sinus thrombosis 15.70 14.65 8 97492 183 42523652
Skin exfoliation 15.68 14.65 46 97454 41507 42482328
Movement disorder 15.64 14.65 7 97493 14691 42509144
Multiple lentigines syndrome 15.61 14.65 5 97495 31 42523804
Bronchospasm 15.61 14.65 5 97495 12880 42510955
Human polyomavirus infection 15.58 14.65 17 97483 1286 42522549
Disseminated toxoplasmosis 15.58 14.65 9 97491 266 42523569
Micturition urgency 15.55 14.65 4 97496 11894 42511941
Apoptosis 15.52 14.65 12 97488 581 42523254
Gastrointestinal fungal infection 15.52 14.65 9 97491 268 42523567
Pulmonary mass 15.50 14.65 76 97424 16189 42507646
Congenital cardiovascular anomaly 15.46 14.65 8 97492 189 42523646
Dystonia 15.43 14.65 5 97495 12785 42511050
Dystrophic calcification 15.35 14.65 5 97495 33 42523802
Eosinophil count increased 15.31 14.65 3 97497 10760 42513075
Bilirubin conjugated increased 15.31 14.65 29 97471 3648 42520187
Squamous cell carcinoma of skin 15.31 14.65 5 97495 12721 42511114
Rhinorrhoea 15.30 14.65 31 97469 31763 42492072
Candida test positive 15.30 14.65 11 97489 476 42523359
Deep vein thrombosis 15.30 14.65 108 97392 76849 42446986
Human herpesvirus 8 infection 15.30 14.65 18 97482 1479 42522356
Erythema 15.28 14.65 167 97333 108626 42415209
Interferon gamma level increased 15.25 14.65 3 97497 0 42523835
Acral lentiginous melanoma 15.22 14.65 5 97495 34 42523801
Cardiac ventricular disorder 15.22 14.65 9 97491 278 42523557
Mood altered 15.22 14.65 3 97497 10715 42513120
Post procedural fistula 15.21 14.65 7 97493 127 42523708
Acute myelomonocytic leukaemia 15.16 14.65 8 97492 197 42523638
Stevens-Johnson syndrome 15.15 14.65 17 97483 22161 42501674
Hyperthyroidism 15.00 14.65 7 97493 14334 42509501
Immunosuppression 14.98 14.65 48 97452 8405 42515430
Hepatic angiosarcoma 14.98 14.65 6 97494 76 42523759
Catheter site infection 14.98 14.65 26 97474 3057 42520778
Spinal cord injury thoracic 14.96 14.65 7 97493 132 42523703
5q minus syndrome 14.91 14.65 7 97493 133 42523702
Atrial fibrillation 14.91 14.65 227 97273 139366 42384469
Troponin increased 14.88 14.65 13 97487 19049 42504786
Pulmonary veno-occlusive disease 14.88 14.65 12 97488 618 42523217
Bone marrow transplant 14.85 14.65 16 97484 1193 42522642
Pneumonia 14.85 14.65 1139 96361 421010 42102825
Chemotherapeutic drug level increased 14.82 14.65 9 97491 292 42523543
Petechiae 14.78 14.65 55 97445 10380 42513455
Flushing 14.70 14.65 40 97460 36988 42486847
Neck pain 14.67 14.65 29 97471 29985 42493850
Body mass index decreased 14.66 14.65 9 97491 298 42523537

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 9332.75 16.64 5673 148771 311094 110123761
Myelosuppression 3034.01 16.64 1795 152649 92545 110342310
Neutropenia 1910.08 16.64 2477 151967 372143 110062712
Bone marrow failure 1690.89 16.64 1036 153408 56812 110378043
Mucosal inflammation 1581.66 16.64 1207 153237 94934 110339921
Thrombocytopenia 1382.05 16.64 2044 152400 346841 110088014
Pancytopenia 1309.60 16.64 1537 152907 208076 110226779
Disease progression 1226.50 16.64 1604 152840 242430 110192425
Septic shock 1197.73 16.64 1280 153164 156248 110278607
Haematotoxicity 1140.53 16.64 567 153877 20515 110414340
Sepsis 1090.20 16.64 1771 152673 325575 110109280
Venoocclusive liver disease 1054.20 16.64 485 153959 14722 110420133
Acute myeloid leukaemia recurrent 956.18 16.64 334 154110 4805 110430050
Acute myeloid leukaemia 954.05 16.64 619 153825 37491 110397364
Febrile bone marrow aplasia 892.59 16.64 452 153992 17013 110417842
Pyrexia 879.26 16.64 2999 151445 895266 109539589
Neutropenic colitis 752.51 16.64 317 154127 7748 110427107
Myelodysplastic syndrome 752.33 16.64 531 153913 36953 110397902
Bronchopulmonary aspergillosis 744.84 16.64 484 153960 29379 110405476
Myelopathy 713.20 16.64 275 154169 5301 110429554
Fatigue 702.37 16.64 416 154028 1215542 109219313
Neurotoxicity 693.69 16.64 530 153914 41677 110393178
Leukoencephalopathy 690.14 16.64 310 154134 8885 110425970
Arthralgia 638.40 16.64 153 154291 779479 109655376
Posterior reversible encephalopathy syndrome 632.04 16.64 459 153985 33402 110401453
Aspergillus infection 623.75 16.64 409 154035 25207 110409648
Pain 610.87 16.64 286 154158 954669 109480186
Multiple organ dysfunction syndrome 603.61 16.64 892 153552 150818 110284037
Diffuse large B-cell lymphoma recurrent 599.10 16.64 251 154193 6048 110428807
Off label use 575.72 16.64 3814 150630 1496371 108938484
Joint swelling 560.34 16.64 12 154432 442833 109992022
Aplasia 545.31 16.64 251 154193 7622 110427233
Tumour lysis syndrome 535.39 16.64 400 154044 30401 110404454
Second primary malignancy 523.46 16.64 322 154122 17746 110417109
Pneumonia fungal 510.98 16.64 295 154149 14459 110420396
Acute lymphocytic leukaemia recurrent 505.21 16.64 217 154227 5570 110429285
Bacteraemia 502.25 16.64 440 154004 41950 110392905
Platelet count decreased 483.51 16.64 1023 153421 229420 110205435
Malaise 472.95 16.64 174 154270 671645 109763210
Dizziness 469.81 16.64 194 154250 697999 109736856
Fall 464.02 16.64 134 154310 603348 109831507
Fungal infection 460.09 16.64 454 153990 50352 110384503
Cytopenia 457.47 16.64 361 154083 29755 110405100
Leukaemia recurrent 449.43 16.64 168 154276 2963 110431892
Peripheral swelling 444.23 16.64 31 154413 404003 110030852
Cytokine release syndrome 443.92 16.64 519 153925 69787 110365068
Nasopharyngitis 428.56 16.64 32 154412 394329 110040526
Venoocclusive disease 407.38 16.64 192 154252 6158 110428697
Product dose omission issue 405.82 16.64 9 154435 321773 110113082
Hyperbilirubinaemia 405.40 16.64 339 154105 30332 110404523
Dyspnoea 397.34 16.64 583 153861 1106289 109328566
Graft versus host disease 397.33 16.64 275 154169 18531 110416324
Neoplasm progression 393.15 16.64 468 153976 64127 110370728
Bacterial infection 390.39 16.64 397 154047 45639 110389216
Neutrophil count decreased 382.20 16.64 640 153804 120301 110314554
Mucormycosis 380.06 16.64 217 154227 10411 110424444
Neoplasm recurrence 378.69 16.64 172 154272 5060 110429795
Abdominal discomfort 371.51 16.64 54 154390 393804 110041051
Insomnia 365.52 16.64 39 154405 360551 110074304
Clostridium difficile colitis 363.00 16.64 373 154071 43405 110391450
Arthropathy 362.72 16.64 8 154436 287514 110147341
Drug hypersensitivity 350.38 16.64 100 154344 453990 109980865
Neutropenic sepsis 349.94 16.64 312 154132 30434 110404421
Haemophagocytic lymphohistiocytosis 337.07 16.64 309 154135 31250 110403605
Colitis 323.97 16.64 542 153902 101781 110333074
Completed suicide 317.11 16.64 4 154440 242377 110192478
Asthma 315.55 16.64 7 154437 250284 110184571
Respiratory failure 313.26 16.64 829 153615 214503 110220352
Swelling 311.20 16.64 57 154387 350984 110083871
Contraindicated product administered 305.23 16.64 9 154435 248258 110186597
Fusarium infection 302.91 16.64 122 154322 2649 110432206
Musculoskeletal stiffness 300.26 16.64 24 154420 279798 110155057
Product use in unapproved indication 299.73 16.64 1328 153116 446049 109988806
Human herpesvirus 6 infection 295 16.64 156 154288 6425 110428430
Cytomegalovirus infection 293.36 16.64 371 154073 54073 110380782
Enterococcal infection 291.95 16.64 236 154208 20130 110414725
Hypersensitivity 291.88 16.64 100 154344 403898 110030957
Blood culture positive 291.07 16.64 172 154272 8804 110426051
Acute graft versus host disease 290.21 16.64 196 154248 12685 110422170
Blood lactate dehydrogenase increased 289.39 16.64 333 154111 44001 110390854
Wound 282.85 16.64 10 154434 234427 110200428
Wheezing 282.11 16.64 19 154425 255211 110179644
Escherichia bacteraemia 281.38 16.64 176 154268 9988 110424867
Secondary immunodeficiency 280.48 16.64 135 154309 4541 110430314
Muscle spasms 279.50 16.64 31 154413 278126 110156729
Fungaemia 272.05 16.64 144 154300 5942 110428913
Depression 271.82 16.64 56 154388 317279 110117576
Cystitis haemorrhagic 270.83 16.64 184 154260 12025 110422830
Hypertriglyceridaemia 270.07 16.64 205 154239 15949 110418906
Alopecia 267.46 16.64 88 154356 364665 110070190
Urticaria 265.52 16.64 60 154384 318797 110116058
Infusion related reaction 260.73 16.64 103 154341 381059 110053796
White blood cell count decreased 260.63 16.64 808 153636 228582 110206273
Granulocyte count decreased 257.52 16.64 121 154323 3853 110431002
Acute graft versus host disease in skin 255.38 16.64 169 154275 10571 110424284
Lower respiratory tract infection 254.92 16.64 23 154421 243083 110191772
Thymus hypoplasia 254.90 16.64 94 154350 1593 110433262
Psoriatic arthropathy 249.99 16.64 5 154439 196756 110238099
Lymphoid tissue hypoplasia 248.72 16.64 92 154352 1573 110433282
Disease recurrence 246.70 16.64 361 154083 60423 110374432
Anxiety 244.79 16.64 88 154356 344990 110089865
Blood bilirubin increased 243.89 16.64 405 154039 75567 110359288
Geotrichum infection 241.80 16.64 83 154361 1129 110433726
Cardiotoxicity 238.56 16.64 194 154250 16687 110418168
Sleep disorder 237.80 16.64 9 154435 198635 110236220
Acute respiratory distress syndrome 236.56 16.64 330 154114 52868 110381987
Cytomegalovirus infection reactivation 234.77 16.64 199 154245 18134 110416721
Systemic candida 232.46 16.64 155 154289 9819 110425036
Malignant neoplasm progression 231.75 16.64 650 153794 173917 110260938
Inappropriate schedule of product administration 231.52 16.64 13 154431 203624 110231231
Therapeutic product effect decreased 231.42 16.64 33 154411 244283 110190572
Cytomegalovirus chorioretinitis 226.98 16.64 135 154309 6993 110427862
Arachnoiditis 225.96 16.64 76 154368 968 110433887
Weight increased 225.51 16.64 155 154289 419489 110015366
Pruritus 224.41 16.64 290 154154 581270 109853585
Pseudomonal sepsis 221.55 16.64 145 154299 8901 110425954
Duodenal ulcer perforation 220.02 16.64 6 154438 177694 110257161
Agranulocytosis 219.74 16.64 345 154099 61415 110373440
Staphylococcal infection 219.36 16.64 369 154075 69575 110365280
Weight decreased 216.30 16.64 201 154243 467856 109966999
Mobility decreased 215.92 16.64 36 154408 237386 110197469
Helicobacter infection 215.14 16.64 9 154435 181868 110252987
Diffuse large B-cell lymphoma refractory 215.02 16.64 93 154351 2428 110432427
Injection site pain 213.18 16.64 8 154436 177914 110256941
Hepatotoxicity 212.98 16.64 345 154099 63055 110371800
Osteoarthritis 212.85 16.64 10 154434 182613 110252242
Pulmonary haemorrhage 211.49 16.64 179 154265 16277 110418578
Immune effector cell-associated neurotoxicity syndrome 211.25 16.64 171 154273 14611 110420244
Parainfluenzae virus infection 208.92 16.64 127 154317 6847 110428008
Bacterial sepsis 207.50 16.64 147 154297 10279 110424576
Pain in extremity 207.02 16.64 225 154219 486893 109947962
Abdominal pain upper 206.89 16.64 115 154329 348996 110085859
Escherichia infection 206.66 16.64 208 154236 23608 110411247
Contusion 206.51 16.64 38 154406 233323 110201532
Therapy partial responder 205.14 16.64 256 154188 36805 110398050
Cytomegalovirus viraemia 203.59 16.64 181 154263 17583 110417272
Hypogammaglobulinaemia 201.69 16.64 190 154254 19886 110414969
Migraine 201.35 16.64 9 154435 171643 110263212
Blister 201.26 16.64 37 154407 227339 110207516
Hypofibrinogenaemia 199.26 16.64 88 154356 2419 110432436
Dry mouth 199.03 16.64 23 154421 199925 110234930
Malignant transformation 197.83 16.64 76 154368 1449 110433406
Candida infection 197.53 16.64 287 154157 47722 110387133
Injury 196.43 16.64 13 154431 177252 110257603
Blood cholesterol increased 195.01 16.64 17 154427 184768 110250087
Drug resistance 192.41 16.64 309 154135 56065 110378790
Discomfort 192.06 16.64 34 154410 214673 110220182
Staphylococcal bacteraemia 191.18 16.64 170 154274 16518 110418337
Escherichia sepsis 191.07 16.64 139 154305 10133 110424722
Staphylococcal sepsis 190.48 16.64 173 154271 17281 110417574
Arthritis 189.57 16.64 11 154433 167575 110267280
Chest pain 189.25 16.64 149 154295 376226 110058629
Systemic mycosis 186.60 16.64 96 154348 3733 110431122
Blood pressure increased 183.00 16.64 66 154378 258307 110176548
Overdose 182.93 16.64 50 154394 233744 110201111
Stenotrophomonas infection 181.47 16.64 109 154335 5749 110429106
Condition aggravated 180.19 16.64 483 153961 734353 109700502
Differentiation syndrome 179.90 16.64 87 154357 2957 110431898
Feeling abnormal 179.33 16.64 21 154423 180690 110254165
Impaired healing 178.48 16.64 30 154414 196687 110238168
Skin toxicity 176.24 16.64 140 154304 11643 110423212
Drug intolerance 175.76 16.64 185 154259 406327 110028528
Enterobacter infection 174.53 16.64 106 154338 5705 110429150
Human bocavirus infection 170.97 16.64 63 154381 1065 110433790
Musculoskeletal pain 168.08 16.64 27 154417 182996 110251859
Rhinovirus infection 167.67 16.64 136 154308 11653 110423202
Dyspepsia 167.02 16.64 32 154412 190933 110243922
Chronic graft versus host disease 164.71 16.64 123 154321 9334 110425521
Device related infection 163.67 16.64 237 154207 39282 110395573
Graft versus host disease in skin 163.39 16.64 116 154328 8138 110426717
Memory impairment 162.01 16.64 38 154406 196906 110237949
Pseudomonas infection 161.56 16.64 197 154247 27656 110407199
Folliculitis 160.26 16.64 22 154422 167631 110267224
Klebsiella infection 159.57 16.64 167 154277 19842 110415013
C-reactive protein abnormal 158.28 16.64 5 154439 129690 110305165
Mantle cell lymphoma recurrent 158.09 16.64 58 154386 968 110433887
Encephalopathy 155.08 16.64 347 154097 80708 110354147
Herpes simplex 154.17 16.64 147 154297 15617 110419238
Chloroma 153.47 16.64 54 154390 794 110434061
Type 2 diabetes mellitus 152.26 16.64 31 154413 177201 110257654
Stem cell transplant 151.90 16.64 88 154356 4339 110430516
Cerebellar syndrome 151.86 16.64 100 154344 6202 110428653
Klebsiella sepsis 151.72 16.64 86 154358 4067 110430788
Neuropathy peripheral 151.29 16.64 572 153872 178705 110256150
Psoriasis 150.13 16.64 12 154432 139981 110294874
Intentional product misuse 149.47 16.64 9 154435 132895 110301960
Disseminated intravascular coagulation 148.75 16.64 232 154212 41054 110393801
Leukopenia 147.10 16.64 500 153944 148291 110286564
Rash 145.04 16.64 622 153822 820342 109614513
Aplastic anaemia 144.37 16.64 174 154270 24134 110410721
Pneumatosis intestinalis 144.25 16.64 109 154335 8420 110426435
Joint range of motion decreased 144.16 16.64 6 154438 121826 110313029
Obesity 143.48 16.64 3 154441 113348 110321507
Pathogen resistance 141.83 16.64 148 154296 17524 110417331
Pleural effusion 141.77 16.64 557 153887 177152 110257703
Pneumocystis jirovecii pneumonia 141.41 16.64 231 154213 42504 110392351
Enterococcal bacteraemia 140.77 16.64 84 154360 4377 110430478
Adenovirus infection 140.07 16.64 119 154325 10875 110423980
Graft versus host disease in gastrointestinal tract 139.40 16.64 109 154335 8859 110425996
Maternal exposure during pregnancy 135.69 16.64 95 154349 254788 110180067
Headache 135.63 16.64 703 153741 881674 109553181
Road traffic accident 135.32 16.64 3 154441 107395 110327460
Alanine aminotransferase increased 133.88 16.64 560 153884 183213 110251642
Hospitalisation 133.15 16.64 20 154424 142473 110292382
Alpha haemolytic streptococcal infection 132.87 16.64 75 154369 3518 110431337
Neutropenic infection 131.67 16.64 72 154372 3173 110431682
Ejection fraction decreased 131.26 16.64 218 154226 40662 110394193
Cystitis bacterial 129.53 16.64 53 154391 1200 110433655
Viraemia 128.82 16.64 77 154367 4025 110430830
Sinusitis 127.08 16.64 136 154308 296552 110138303
Hepatic enzyme increased 125.70 16.64 158 154286 320734 110114121
Cytarabine syndrome 125.30 16.64 30 154414 92 110434763
Loss of personal independence in daily activities 125.27 16.64 28 154416 149992 110284863
Lymphopenia 124.70 16.64 211 154233 39959 110394896
Streptococcal bacteraemia 124.60 16.64 79 154365 4590 110430265
Mycobacterium chelonae infection 124.45 16.64 68 154376 2992 110431863
Gastrooesophageal reflux disease 122.36 16.64 49 154395 179927 110254928
Minimal residual disease 121.86 16.64 47 154397 906 110433949
Lip dry 121.62 16.64 4 154440 100079 110334776
Myocardial infarction 121.57 16.64 58 154386 192025 110242830
Norovirus test positive 121.05 16.64 47 154397 923 110433932
Epstein-Barr virus infection 121.00 16.64 140 154304 18598 110416257
Nervous system disorder 120.95 16.64 183 154261 31538 110403317
Asthenia 120.39 16.64 524 153920 688475 109746380
Lymphoma 119.16 16.64 144 154300 20027 110414828
Post transplant lymphoproliferative disorder 118.62 16.64 127 154317 15486 110419369
Enteritis 118.50 16.64 140 154304 19016 110415839
Disseminated aspergillosis 117.46 16.64 61 154383 2419 110432436
Capillary leak syndrome 116.13 16.64 77 154367 4831 110430024
Pneumonia 116.00 16.64 1792 152652 874922 109559933
Paraplegia 113.28 16.64 83 154361 6117 110428738
Chronic obstructive pulmonary disease 112.59 16.64 11 154433 109147 110325708
Bronchitis 111.35 16.64 40 154404 156992 110277863
Infection 111.34 16.64 876 153568 361324 110073531
Hypertension 111.23 16.64 354 154090 509730 109925125
Nephropathy toxic 111.18 16.64 163 154281 27315 110407540
Incorrect dose administered 110.80 16.64 9 154435 103632 110331223
Myelodysplastic syndrome transformation 110.59 16.64 42 154402 775 110434080
Injection site erythema 110.23 16.64 5 154439 94171 110340684
Superior sagittal sinus thrombosis 109.82 16.64 46 154398 1107 110433748
Pericarditis 109.74 16.64 87 154357 219027 110215828
Acute lymphocytic leukaemia 109.48 16.64 79 154365 5686 110429169
Central nervous system leukaemia 108.35 16.64 38 154406 553 110434302
Hepatosplenic candidiasis 107.64 16.64 39 154405 627 110434228
Encephalitis 107.24 16.64 132 154312 18707 110416148
Glioma 107.19 16.64 42 154402 846 110434009
Transformation to acute myeloid leukaemia 106.85 16.64 49 154395 1474 110433381
B-cell lymphoma recurrent 106.29 16.64 45 154399 1113 110433742
Vasogenic cerebral oedema 105.40 16.64 55 154389 2203 110432652
Confusional state 105.19 16.64 321 154123 468359 109966496
Somnolence 104.89 16.64 158 154286 297291 110137564
Trichosporon infection 104.51 16.64 46 154398 1254 110433601
Progressive multifocal leukoencephalopathy 102.37 16.64 149 154295 24807 110410048
Viral haemorrhagic cystitis 102.08 16.64 62 154382 3337 110431518
Enterocolitis 101.84 16.64 129 154315 18820 110416035
Hepatitis B reactivation 101.53 16.64 84 154360 7400 110427455
Hypoaesthesia 101.34 16.64 177 154267 314046 110120809
Myalgia 100.84 16.64 97 154347 222284 110212571
Urinary tract infection 100.58 16.64 189 154255 326093 110108762
Anaemia 100.13 16.64 1186 153258 545900 109888955
Prescribed overdose 98.27 16.64 6 154438 87575 110347280
Lymphadenopathy 97.02 16.64 250 154194 63585 110371270
Constipation 97.01 16.64 223 154221 357563 110077292
Hyperhidrosis 96.81 16.64 72 154372 187226 110247629
Wound infection 96.21 16.64 11 154433 96454 110338401
Oedema peripheral 95.59 16.64 197 154247 328463 110106392
Cardiomyopathy 94.80 16.64 169 154275 33356 110401499
Retinal haemorrhage 93.68 16.64 89 154355 9412 110425443
Night sweats 93.52 16.64 35 154409 133948 110300907
Sciatica 93.51 16.64 10 154434 92389 110342466
Pharyngeal inflammation 92.37 16.64 46 154398 1668 110433187
Adverse drug reaction 91.62 16.64 18 154426 105541 110329314
Illness 91.09 16.64 6 154438 82165 110352690
Lung infiltration 90.96 16.64 140 154304 24488 110410367
Acute graft versus host disease in intestine 90.82 16.64 70 154374 5569 110429286
Sweat gland tumour 90.49 16.64 33 154411 541 110434314
Exposure during pregnancy 89.61 16.64 62 154382 167362 110267493
Adverse event 89.45 16.64 21 154423 108788 110326067
Philadelphia chromosome positive 89.41 16.64 37 154407 863 110433992
Glioblastoma multiforme 89.31 16.64 43 154401 1447 110433408
Toxic erythema of chemotherapy 89.20 16.64 30 154414 382 110434473
Back pain 89.12 16.64 246 154198 370750 110064105
Drug clearance decreased 88.76 16.64 61 154383 4061 110430794
Hypoalbuminaemia 88.35 16.64 151 154293 28823 110406032
Dry skin 88.06 16.64 21 154423 107632 110327223
Acute promyelocytic leukaemia 87.98 16.64 46 154398 1850 110433005
Stomatococcal infection 86.97 16.64 29 154415 359 110434496
Gene mutation 86.51 16.64 56 154388 3373 110431482
Toxic leukoencephalopathy 85.97 16.64 43 154401 1574 110433281
Inflammation 85.63 16.64 86 154358 193152 110241703
Suicide attempt 84.91 16.64 20 154424 103374 110331481
Wrong technique in product usage process 84.56 16.64 11 154433 87337 110347518
Nausea 84.52 16.64 1217 153227 1234473 109200382
Lower respiratory tract infection fungal 84.35 16.64 35 154409 822 110434033
Suicidal ideation 83.70 16.64 15 154429 93922 110340933
Blood fibrinogen decreased 83.45 16.64 50 154394 2625 110432230
Bone marrow disorder 82.78 16.64 59 154385 4164 110430691
Hepatic failure 82.50 16.64 247 154197 68492 110366363
Cytogenetic abnormality 82.23 16.64 38 154406 1164 110433691
Gait inability 82.06 16.64 44 154400 136332 110298523
Blood pressure systolic increased 81.44 16.64 10 154434 82981 110351874
Blood pressure fluctuation 81.38 16.64 6 154438 74818 110360037
Palmar-plantar erythrodysaesthesia syndrome 81.12 16.64 178 154266 40847 110394008
Acute febrile neutrophilic dermatosis 81.09 16.64 62 154382 4874 110429981
Pseudomonal bacteraemia 80.96 16.64 59 154385 4312 110430543
Guillain-Barre syndrome 80.93 16.64 87 154357 10657 110424198
Hidradenitis 80.60 16.64 63 154381 5117 110429738
Central nervous system lymphoma 79.98 16.64 51 154393 2993 110431862
Frequent bowel movements 79.77 16.64 5 154439 71385 110363470
Neck pain 79.72 16.64 36 154408 123094 110311761
Product quality issue 79.17 16.64 8 154436 77291 110357564
Sinusitis fungal 77.56 16.64 48 154396 2672 110432183
Joint stiffness 77.31 16.64 4 154440 67239 110367616
Gastrointestinal inflammation 77.24 16.64 80 154364 9389 110425466
Venous thrombosis 76.95 16.64 76 154368 8429 110426426
Hypoxia 76.52 16.64 371 154073 129144 110305711
Candida sepsis 76.28 16.64 49 154395 2912 110431943
Hepatitis B 76.24 16.64 80 154364 9532 110425323
Amnesia 76.18 16.64 26 154418 105382 110329473
Feeling hot 76.06 16.64 17 154427 91089 110343766
Klebsiella bacteraemia 75.29 16.64 59 154385 4810 110430045
Quadriplegia 74.84 16.64 55 154389 4072 110430783
Hyperpyrexia 74.68 16.64 73 154371 7996 110426859
Pyomyositis 74.67 16.64 31 154413 729 110434126
Sedation 74.63 16.64 6 154438 69677 110365178
Bacillus infection 74.44 16.64 39 154405 1575 110433280
Osteonecrosis 74.35 16.64 153 154291 33588 110401267
Burning sensation 74.01 16.64 6 154438 69206 110365649
Hypercholesterolaemia 73.75 16.64 18 154426 90819 110344036
BK virus infection 73.26 16.64 91 154353 13015 110421840
Chest discomfort 72.96 16.64 81 154363 173767 110261088
Respiratory tract infection fungal 72.73 16.64 36 154408 1288 110433567
Blast crisis in myelogenous leukaemia 72.51 16.64 33 154411 975 110433880
Thrombotic microangiopathy 72.44 16.64 139 154305 29010 110405845
Colitis ulcerative 71.94 16.64 11 154433 77352 110357503
Prescribed underdose 71.54 16.64 5 154439 65169 110369686
Palpitations 71.52 16.64 70 154374 159142 110275713
Left ventricular dysfunction 71.06 16.64 122 154322 23371 110411484
Streptococcal sepsis 71.05 16.64 58 154386 5014 110429841
Pneumonia klebsiella 70.92 16.64 65 154379 6567 110428288
Pseudomonas test positive 70.85 16.64 43 154401 2311 110432544
Cerebellar tumour 70.74 16.64 21 154423 172 110434683
Peripheral sensory neuropathy 70.47 16.64 101 154343 16579 110418276
Hyperkalaemia 70.42 16.64 52 154392 135744 110299111
Diffuse large B-cell lymphoma 69.73 16.64 98 154346 15800 110419055
Renal failure 69.56 16.64 548 153896 226026 110208829
Underdose 69.40 16.64 5 154439 63549 110371306
Coagulopathy 69.30 16.64 167 154277 40744 110394111
Abscess bacterial 68.43 16.64 31 154413 906 110433949
Respiratory distress 67.63 16.64 231 154213 68643 110366212
Enterococcus test positive 67.36 16.64 45 154399 2859 110431996
Systemic inflammatory response syndrome 67.27 16.64 87 154357 12956 110421899
Hot flush 67.20 16.64 7 154437 66029 110368826
Central nervous system haemorrhage 67.13 16.64 25 154419 436 110434419
Aspartate aminotransferase increased 66.82 16.64 417 154027 159519 110275336
Live birth 66.66 16.64 9 154435 69475 110365380
Pericardial effusion 66.22 16.64 203 154241 57014 110377841
Transaminases increased 65.24 16.64 216 154228 63174 110371681
Intracranial pressure increased 65.17 16.64 77 154367 10458 110424397
Enterovirus infection 64.43 16.64 43 154401 2727 110432128
Dehydration 64.40 16.64 189 154255 279322 110155533
Injection site reaction 64.31 16.64 22 154422 89048 110345807
Peripheral motor neuropathy 64.24 16.64 50 154394 4036 110430819
Leukaemia 64.01 16.64 65 154379 7453 110427402
Gait disturbance 63.46 16.64 189 154255 278019 110156836
Polyneuropathy 63.41 16.64 139 154305 31873 110402982
Multiple-drug resistance 63.19 16.64 85 154359 13150 110421705
Gastrointestinal disorder 63.00 16.64 154 154290 241798 110193057
Blood stem cell transplant failure 62.92 16.64 27 154417 691 110434164
Pulmonary fibrosis 62.75 16.64 32 154412 102010 110332845
Febrile infection 62.59 16.64 51 154393 4397 110430458
Ataxia 62.23 16.64 133 154311 29975 110404880
Acute myeloid leukaemia refractory 62.18 16.64 21 154423 271 110434584
Quadriparesis 62.13 16.64 52 154392 4655 110430200
Leukaemic infiltration 62.03 16.64 19 154425 175 110434680
Hepatomegaly 61.90 16.64 109 154335 21305 110413550
Syncope 61.78 16.64 118 154326 202418 110232437
Hepatocellular injury 61.74 16.64 183 154261 50459 110384396
Hydrocephalus 61.17 16.64 74 154370 10301 110424554
Subacute combined cord degeneration 61.16 16.64 22 154422 346 110434509
Acute graft versus host disease in liver 60.68 16.64 39 154405 2320 110432535
Influenza like illness 60.19 16.64 24 154420 88388 110346467
Acute kidney injury 59.67 16.64 1231 153213 634199 109800656
Clostridium difficile infection 59.45 16.64 184 154260 51945 110382910
Medication error 59.11 16.64 37 154407 105329 110329526
Pregnancy 58.83 16.64 3 154441 51064 110383791
Osteoporosis 58.78 16.64 24 154420 87128 110347727
Gastrointestinal toxicity 58.50 16.64 75 154369 11073 110423782
Ear infection 58.15 16.64 9 154435 62723 110372132
Dysphonia 57.95 16.64 17 154427 75912 110358943
Blast cells present 57.94 16.64 28 154416 950 110433905
Enterobacter sepsis 57.56 16.64 31 154413 1325 110433530
Pneumonia cytomegaloviral 57.17 16.64 59 154385 6895 110427960
Heart rate decreased 57.11 16.64 22 154422 82734 110352121
Cerebral haemorrhage 57.01 16.64 210 154234 64758 110370097
Chronic graft versus host disease in skin 56.97 16.64 39 154405 2580 110432275
General physical health deterioration 56.42 16.64 355 154089 424940 110009915
Cerebral venous sinus thrombosis 55.72 16.64 40 154404 2855 110432000
Swollen tongue 55.18 16.64 9 154435 60353 110374502
Epstein-Barr virus associated lymphoproliferative disorder 55.16 16.64 49 154395 4753 110430102
Loss of consciousness 55.09 16.64 120 154324 196186 110238669
Cataract 55.07 16.64 21 154423 79464 110355391
Diarrhoea 54.87 16.64 1194 153250 1138311 109296544
Enterovirus test positive 54.83 16.64 20 154424 328 110434527
Tremor 54.81 16.64 126 154318 202106 110232749
Blast cell count increased 54.73 16.64 32 154412 1605 110433250
Clostridium bacteraemia 54.69 16.64 22 154422 476 110434379
Treatment noncompliance 54.51 16.64 17 154427 72973 110361882
Autoimmune lymphoproliferative syndrome 54.26 16.64 18 154426 219 110434636
Blood glucose increased 54.21 16.64 63 154381 132433 110302422
Human rhinovirus test positive 54.09 16.64 29 154415 1228 110433627
Viral infection 53.74 16.64 180 154264 52959 110381896
Facial paralysis 53.58 16.64 110 154334 24104 110410751
Depressed mood 53.55 16.64 10 154434 60799 110374056
Acute monocytic leukaemia 53.51 16.64 23 154421 591 110434264
Product prescribing error 53.39 16.64 5 154439 51326 110383529
Paraparesis 53.27 16.64 47 154397 4519 110430336
Central nervous system fungal infection 53.26 16.64 23 154421 598 110434257
Pseudostroke 53.21 16.64 17 154427 182 110434673
Areflexia 53.08 16.64 56 154388 6713 110428142
Cough 53.02 16.64 402 154042 461239 109973616
Bone erosion 52.56 16.64 3 154441 46368 110388487
Metastases to spleen 52.54 16.64 25 154419 819 110434036
Scedosporium infection 52.04 16.64 36 154408 2422 110432433
Myelitis 52.00 16.64 40 154404 3173 110431682
Nasal congestion 51.78 16.64 37 154407 98245 110336610
Drug dependence 51.68 16.64 5 154439 50015 110384840
Charles Bonnet syndrome 51.63 16.64 13 154431 52 110434803
Paraesthesia 51.46 16.64 205 154239 276316 110158539
Upper respiratory fungal infection 50.85 16.64 20 154424 407 110434448
Vertigo 50.84 16.64 29 154415 86841 110348014
Gastroenteritis adenovirus 50.31 16.64 20 154424 419 110434436
Decreased appetite 50.20 16.64 424 154020 475422 109959433
Cerebral fungal infection 50.15 16.64 23 154421 692 110434163
Engraftment syndrome 49.84 16.64 32 154412 1900 110432955
Seizure 49.82 16.64 500 153944 220685 110214170
Accidental exposure to product 49.13 16.64 6 154438 50002 110384853
Therapy interrupted 48.89 16.64 6 154438 49816 110385039
Neurological decompensation 48.82 16.64 54 154390 6829 110428026
Influenza 48.59 16.64 102 154342 168999 110265856
Hepatic infection fungal 47.96 16.64 18 154426 321 110434534
Fungal sepsis 47.92 16.64 33 154411 2204 110432651
Diffuse alveolar damage 47.90 16.64 42 154402 4005 110430850
Unevaluable event 47.56 16.64 12 154432 59215 110375640
Aspergillus test positive 47.37 16.64 25 154419 1025 110433830
JC virus infection 47.36 16.64 47 154397 5243 110429612
Ill-defined disorder 47.29 16.64 92 154352 156761 110278094
Laryngitis 47.29 16.64 3 154441 42408 110392447
Balance disorder 47.06 16.64 56 154388 116504 110318351
Chemotherapeutic drug level increased 46.97 16.64 20 154424 502 110434353
Stenotrophomonas bacteraemia 46.94 16.64 17 154427 273 110434582
Soft tissue infection 46.88 16.64 46 154398 5061 110429794
Hepatosplenomegaly 46.88 16.64 53 154391 6866 110427989
Enterobacter bacteraemia 46.87 16.64 28 154416 1462 110433393
Throat irritation 46.75 16.64 9 154435 53543 110381312
Diabetes mellitus 46.62 16.64 42 154402 99339 110335516
Ileus paralytic 46.58 16.64 69 154375 11668 110423187
Rhinocerebral mucormycosis 46.40 16.64 28 154416 1489 110433366
Rhabdomyolysis 46.36 16.64 60 154384 120341 110314514
Perineal necrosis 45.87 16.64 15 154429 174 110434681
Brain oedema 45.41 16.64 120 154324 30978 110403877
Metastases to meninges 44.87 16.64 45 154399 5083 110429772
Intussusception 44.69 16.64 28 154416 1593 110433262
Angioedema 44.59 16.64 43 154401 98457 110336398
Enterococcal sepsis 44.57 16.64 37 154407 3275 110431580
Autoimmune disorder 44.21 16.64 18 154426 65465 110369390
Transient ischaemic attack 44.16 16.64 17 154427 63965 110370890
Epstein-Barr viraemia 44.09 16.64 38 154406 3541 110431314
Bone marrow transplant 44.08 16.64 28 154416 1632 110433223
Drug interaction 44.07 16.64 466 153978 499717 109935138
Escherichia test positive 44.04 16.64 38 154406 3546 110431309
Visual impairment 43.96 16.64 75 154369 134353 110300502
Angina pectoris 43.92 16.64 16 154428 62279 110372576
Pneumonia escherichia 43.78 16.64 25 154419 1199 110433656
Bone marrow necrosis 43.77 16.64 18 154426 413 110434442
Therapy non-responder 43.69 16.64 372 154072 156935 110277920
Cardiac failure congestive 43.45 16.64 91 154353 150909 110283946
Ileus 43.28 16.64 117 154327 30612 110404243
Pleuroparenchymal fibroelastosis 43.22 16.64 17 154427 346 110434509
Lip swelling 43.21 16.64 9 154435 50658 110384197
Hypothyroidism 43.15 16.64 24 154420 72875 110361980
Subclavian vein thrombosis 43.11 16.64 34 154410 2798 110432057
Plasma cell myeloma 42.98 16.64 17 154427 62919 110371936
Abscess fungal 42.79 16.64 18 154426 438 110434417
Appendicitis 42.75 16.64 111 154333 28353 110406502
Cardiac dysfunction 42.73 16.64 48 154396 6175 110428680
Hepatitis E 42.50 16.64 41 154403 4418 110430437
Eczema 42.50 16.64 24 154420 72269 110362586
Granulocytopenia 42.42 16.64 69 154375 12646 110422209
Respiratory moniliasis 42.34 16.64 18 154426 450 110434405
Breast cancer 42.17 16.64 3 154441 38539 110396316
Meningitis bacterial 42.10 16.64 35 154409 3104 110431751
Chronic myeloid leukaemia 42.07 16.64 40 154404 4233 110430622
Leukaemia cutis 42.05 16.64 15 154429 230 110434625
Hemiparesis 42.01 16.64 146 154298 43757 110391098
Rectal haemorrhage 41.87 16.64 64 154380 119769 110315086
Cellulitis 41.56 16.64 310 154134 125706 110309149
Recurrent cancer 41.47 16.64 36 154408 3387 110431468
Stomatitis 41.31 16.64 567 153877 269675 110165180
Left atrial hypertrophy 41.21 16.64 11 154433 58 110434797
Cytomegalovirus colitis 41.04 16.64 50 154394 7011 110427844
Limb injury 40.98 16.64 3 154441 37633 110397222
Platelet transfusion 40.83 16.64 33 154411 2813 110432042
Meningitis aseptic 40.58 16.64 59 154385 9811 110425044
Acute lymphocytic leukaemia refractory 40.55 16.64 14 154430 194 110434661
Antithrombin III decreased 40.51 16.64 18 154426 502 110434353
Encephalitis cytomegalovirus 40.50 16.64 28 154416 1882 110432973
Haemorrhage intracranial 40.50 16.64 110 154334 28859 110405996
Haematopoietic stem cell mobilisation 40.32 16.64 17 154427 416 110434439
Refractory cancer 40.25 16.64 15 154429 262 110434593
Mucosal infection 40.25 16.64 18 154426 510 110434345
Body temperature decreased 40.06 16.64 3 154441 36932 110397923
Ascites 40.02 16.64 244 154200 92564 110342291
Aeromonas infection 39.96 16.64 18 154426 519 110434336
Hippocampal sclerosis 39.84 16.64 14 154430 205 110434650
Metastases to bone marrow 39.77 16.64 22 154422 992 110433863
Sopor 39.54 16.64 3 154441 36543 110398312
Haemodynamic instability 39.37 16.64 94 154350 22794 110412061
Retinitis viral 39.37 16.64 17 154427 442 110434413
Hepatic function abnormal 39.29 16.64 236 154208 89059 110345796
Spinal cord disorder 39.20 16.64 29 154415 2169 110432686
Coronary artery disease 39.08 16.64 26 154418 71664 110363191
Clostridium test positive 38.93 16.64 61 154383 10832 110424023
Drug withdrawal syndrome 38.81 16.64 4 154440 38050 110396805
Hallucination 38.58 16.64 51 154393 101381 110333474
Lung disorder 38.44 16.64 126 154318 179921 110254934
Device related bacteraemia 38.39 16.64 23 154421 1207 110433648
Procedural pain 38.26 16.64 3 154441 35562 110399293
Procalcitonin increased 38.11 16.64 37 154407 4019 110430836
Ocular hyperaemia 37.90 16.64 5 154439 39281 110395574
Epstein-Barr virus infection reactivation 37.89 16.64 37 154407 4047 110430808
Subdural hygroma 37.88 16.64 18 154426 588 110434267
Gastroenteritis norovirus 37.85 16.64 35 154409 3576 110431279
Cholestasis 37.50 16.64 184 154260 64334 110370521
Liver function test increased 37.42 16.64 41 154403 88507 110346348
Gastrointestinal mucormycosis 37.33 16.64 19 154425 722 110434133
Nervousness 37.25 16.64 4 154440 36847 110398008
Cerebrovascular accident 37.24 16.64 129 154315 181155 110253700
Gastrointestinal necrosis 36.95 16.64 46 154398 6594 110428261
Cerebral venous thrombosis 36.90 16.64 33 154411 3229 110431626
Myeloid leukaemia 36.50 16.64 20 154424 885 110433970
Candida pneumonia 36.50 16.64 21 154423 1022 110433833
Brain herniation 36.47 16.64 53 154391 8810 110426045
Hepatopulmonary syndrome 36.46 16.64 13 154431 199 110434656
Pulmonary oedema 36.29 16.64 253 154191 100406 110334449
Graft versus host disease in liver 36.25 16.64 29 154415 2436 110432419
Chromosome analysis abnormal 36.24 16.64 14 154430 271 110434584
Lentigo 36.23 16.64 19 154425 769 110434086
Cardiac failure 36.11 16.64 411 154033 187215 110247640
Aggression 35.76 16.64 19 154425 59191 110375664
Platelet count abnormal 35.73 16.64 44 154400 6238 110428617
Adenoviral haemorrhagic cystitis 35.56 16.64 18 154426 676 110434179
Limb discomfort 35.38 16.64 7 154437 40847 110394008
Enterocolitis infectious 35.37 16.64 33 154411 3411 110431444
Pneumonia bacterial 35.01 16.64 98 154346 26163 110408692
Stenotrophomonas sepsis 35.00 16.64 13 154431 225 110434630
Sleep apnoea syndrome 34.88 16.64 7 154437 40440 110394415
Cytomegalovirus test positive 34.84 16.64 46 154398 6990 110427865
Paralysis 34.67 16.64 71 154373 15529 110419326
Chromosomal deletion 34.58 16.64 12 154432 169 110434686
Perineal infection 34.52 16.64 19 154425 848 110434007
Klebsiella test positive 34.32 16.64 28 154416 2418 110432437
Infection reactivation 34.23 16.64 35 154409 4046 110430809
Hypoglycaemia 34.22 16.64 69 154375 116035 110318820
Flatulence 34.14 16.64 15 154429 52134 110382721
Toxic skin eruption 34.08 16.64 100 154344 27415 110407440
Petechiae 34.07 16.64 90 154354 23227 110411628
Retinitis 34.02 16.64 3 154441 32324 110402531
Hepatic lesion 33.80 16.64 50 154394 8443 110426412
Oesophageal candidiasis 33.71 16.64 59 154385 11475 110423380
Leukoerythroblastosis 33.65 16.64 14 154430 331 110434524
Muscle spasticity 33.64 16.64 5 154439 35910 110398945
Ureaplasma infection 33.57 16.64 23 154421 1523 110433332
Swelling face 33.53 16.64 48 154396 92273 110342582
Rib fracture 33.30 16.64 4 154440 33766 110401089
Heart rate increased 33.30 16.64 97 154347 143737 110291118
Haematopoietic neoplasm 33.25 16.64 10 154434 86 110434769
Large intestine infection 33.18 16.64 36 154408 4456 110430399
Protothecosis 33.16 16.64 16 154428 541 110434314
Upper respiratory tract infection 33.07 16.64 85 154359 131243 110303612
Encephalitis enteroviral 33.03 16.64 13 154431 265 110434590
Subdural haematoma 32.96 16.64 119 154325 36335 110398520
Metastases to bone 32.77 16.64 3 154441 31369 110403486
Blood HIV RNA increased 32.73 16.64 26 154418 2162 110432693
Meningitis chemical 32.71 16.64 14 154430 356 110434499
Engraft failure 32.61 16.64 18 154426 808 110434047
Restlessness 32.61 16.64 19 154425 56240 110378615
Anorectal cellulitis 32.56 16.64 10 154434 93 110434762
Fibrinous bronchitis 32.36 16.64 11 154433 145 110434710
Dyspnoea exertional 32.27 16.64 60 154384 104000 110330855
Ear pain 32.26 16.64 17 154427 53209 110381646
Streptococcal infection 32.21 16.64 56 154388 10834 110424021
Cystitis viral 32.19 16.64 22 154422 1451 110433404
Aphasia 32.00 16.64 165 154279 58832 110376023
Sinusitis aspergillus 31.95 16.64 13 154431 290 110434565
Flushing 31.94 16.64 61 154383 104675 110330180
Lineage switch leukaemia 31.80 16.64 9 154435 61 110434794
Transfusion reaction 31.67 16.64 25 154419 2060 110432795
Necrosis 31.60 16.64 57 154387 11349 110423506
Gamma-glutamyltransferase increased 31.56 16.64 169 154275 61140 110373715
Papilloedema 31.50 16.64 45 154399 7364 110427491
Blindness 31.45 16.64 117 154327 36242 110398613
Carotid intima-media thickness increased 31.39 16.64 10 154434 106 110434749
Central nervous system lesion 31.33 16.64 68 154376 15485 110419370
Septic embolus 31.33 16.64 26 154418 2300 110432555
Delirium 31.30 16.64 91 154353 134934 110299921
Haematochezia 31.27 16.64 72 154372 115452 110319403
Diffuse large B-cell lymphoma stage IV 31.21 16.64 18 154426 880 110433975
Intracranial hypotension 31.10 16.64 16 154428 622 110434233
Pulmonary mucormycosis 31.06 16.64 25 154419 2118 110432737
Cytomegalovirus hepatitis 31.06 16.64 18 154426 888 110433967
Sneezing 31.02 16.64 4 154440 31980 110402875
Primary hypogonadism 30.98 16.64 12 154432 234 110434621
Therapy cessation 30.82 16.64 12 154432 44845 110390010
Accidental overdose 30.77 16.64 17 154427 51817 110383038
Necrotising fasciitis 30.66 16.64 45 154399 7546 110427309
Eye irritation 30.55 16.64 5 154439 33447 110401408
Cerebral candidiasis 30.50 16.64 9 154435 72 110434783
Metapneumovirus infection 30.21 16.64 26 154418 2418 110432437
Inappropriate antidiuretic hormone secretion 30.18 16.64 110 154334 33741 110401114
Bacillus test positive 30.18 16.64 11 154433 180 110434675
Central nervous system neoplasm 30.12 16.64 11 154433 181 110434674
Bacillus bacteraemia 30.12 16.64 12 154432 253 110434602
Cytotoxic oedema 30.11 16.64 14 154430 435 110434420
Capnocytophaga infection 30.01 16.64 11 154433 183 110434672
Renal replacement therapy 29.79 16.64 11 154433 187 110434668
Ventricular hypokinesia 29.76 16.64 55 154389 11159 110423696
Jugular vein thrombosis 29.70 16.64 37 154407 5308 110429547
Erythema 29.67 16.64 262 154182 291185 110143670
Fluid retention 29.58 16.64 54 154390 94253 110340602
Mucosal toxicity 29.57 16.64 16 154428 690 110434165
Productive cough 29.54 16.64 73 154371 114232 110320623
Heart rate irregular 29.41 16.64 6 154438 34268 110400587
Ankle brachial index decreased 29.37 16.64 9 154435 83 110434772
Pulse waveform abnormal 29.37 16.64 9 154435 83 110434772
Diabetic ketoacidosis 29.32 16.64 11 154433 42047 110392808
Alternaria infection 29.21 16.64 18 154426 994 110433861
Thrombosis 29.19 16.64 68 154376 108594 110326261
Obstructive airways disorder 29.08 16.64 14 154430 46135 110388720
Xanthogranuloma 28.90 16.64 9 154435 88 110434767
Serum ferritin increased 28.83 16.64 56 154388 11791 110423064
Femur fracture 28.78 16.64 13 154431 44456 110390399
International normalised ratio increased 28.75 16.64 48 154396 86724 110348131
Orthostatic hypotension 28.75 16.64 30 154414 66219 110368636
Streptococcus test positive 28.70 16.64 26 154418 2588 110432267
Brain abscess 28.59 16.64 41 154403 6733 110428122
Skin ulcer 28.55 16.64 28 154416 63617 110371238
Hypersomnia 28.48 16.64 3 154441 28058 110406797
Vision blurred 28.44 16.64 89 154355 128933 110305922
Splenomegaly 28.42 16.64 87 154357 24411 110410444
Gastric disorder 28.29 16.64 6 154438 33351 110401504
Bilirubin conjugated increased 28.24 16.64 39 154405 6185 110428670
Diabetes mellitus inadequate control 28.22 16.64 4 154440 29771 110405084
Metastatic lymphoma 28.16 16.64 15 154429 627 110434228
Disseminated trichosporonosis 28.14 16.64 11 154433 220 110434635
Meningitis 28.09 16.64 55 154389 11647 110423208
Anaphylactic reaction 28.00 16.64 75 154369 114225 110320630
Antithrombin III deficiency 27.94 16.64 10 154434 155 110434700
Central nervous system enteroviral infection 27.87 16.64 9 154435 100 110434755
Pericoronitis 27.70 16.64 10 154434 159 110434696
Labelled drug-drug interaction medication error 27.63 16.64 4 154440 29298 110405557
Nephrolithiasis 27.60 16.64 31 154413 66181 110368674
Granulicatella infection 27.53 16.64 10 154434 162 110434693
Gastrointestinal protozoal infection 27.47 16.64 9 154435 105 110434750
Refractoriness to platelet transfusion 27.39 16.64 11 154433 237 110434618
Pulmonary mass 27.39 16.64 114 154330 37187 110397668
Lung consolidation 27.32 16.64 51 154393 10425 110424430
B-cell lymphoma refractory 27.31 16.64 10 154434 166 110434689
Cryptosporidiosis infection 27.21 16.64 18 154426 1125 110433730
Hepatic infarction 27.18 16.64 17 154427 964 110433891
Metastases to diaphragm 27.11 16.64 8 154436 64 110434791
Intestinal atresia 27.11 16.64 8 154436 64 110434791
Clostridium colitis 27.02 16.64 28 154416 3287 110431568
Refractory anaemia with an excess of blasts 26.86 16.64 16 154428 831 110434024
Leukaemic infiltration extramedullary 26.83 16.64 12 154432 340 110434515
Central nervous system infection 26.81 16.64 21 154423 1711 110433144
Atelectasis 26.80 16.64 112 154332 36600 110398255
Skin laceration 26.79 16.64 7 154437 33746 110401109
Hepatic cirrhosis 26.76 16.64 33 154411 67593 110367262
Toxic encephalopathy 26.73 16.64 63 154381 15151 110419704
Adenoviral hepatitis 26.70 16.64 17 154427 995 110433860
Cerebral haemangioma 26.59 16.64 9 154435 117 110434738
Therapeutic product effect incomplete 26.56 16.64 193 154251 223612 110211243
Movement disorder 26.26 16.64 9 154435 36395 110398460
Haemorrhagic pneumonia 26.26 16.64 10 154434 186 110434669
Immune reconstitution inflammatory syndrome 26.16 16.64 65 154379 16161 110418694
Bradycardia 26.03 16.64 120 154324 155397 110279458
Device related thrombosis 26.01 16.64 28 154416 3434 110431421
Oxygen saturation decreased 25.76 16.64 122 154322 156860 110277995
Head injury 25.69 16.64 14 154430 43003 110391852
Noninfectious myelitis 25.68 16.64 6 154438 16 110434839
Neurological symptom 25.67 16.64 63 154381 15545 110419310
Blood glucose decreased 25.64 16.64 5 154439 29483 110405372
Osmotic demyelination syndrome 25.61 16.64 22 154422 2041 110432814
Sinus disorder 25.58 16.64 7 154437 32721 110402134
Abortion spontaneous 25.57 16.64 8 154436 34274 110400581
Coronavirus infection 25.56 16.64 47 154397 9498 110425357
Arthritis fungal 25.54 16.64 10 154434 201 110434654
Myeloblast percentage increased 25.53 16.64 5 154439 3 110434852
Precursor T-lymphoblastic lymphoma/leukaemia 25.41 16.64 9 154435 135 110434720
Leukaemic infiltration pulmonary 25.41 16.64 6 154438 17 110434838
Candida endophthalmitis 25.40 16.64 10 154434 204 110434651
Human herpesvirus 8 infection 25.38 16.64 21 154423 1850 110433005
Human herpesvirus 7 infection 25.31 16.64 10 154434 206 110434649
Angiokeratoma 25.27 16.64 10 154434 207 110434648
Oophoritis 25.17 16.64 9 154435 139 110434716
Lung neoplasm malignant 25.06 16.64 8 154436 33834 110401021
Splenic candidiasis 24.93 16.64 8 154436 87 110434768
Enterocolitis haemorrhagic 24.93 16.64 24 154420 2580 110432275
Drug ineffective 24.84 16.64 2454 151990 1518086 108916769
Hypokalaemia 24.77 16.64 375 154069 182073 110252782
Cerebral toxoplasmosis 24.65 16.64 26 154418 3116 110431739
Blood creatine phosphokinase increased 24.60 16.64 40 154404 73037 110361818
Staphylococcus test positive 24.59 16.64 40 154404 7330 110427525
Atypical haemolytic uraemic syndrome 24.55 16.64 19 154425 1521 110433334
Peripheral blood stem cell apheresis 24.54 16.64 9 154435 150 110434705
Blood test abnormal 24.50 16.64 5 154439 28549 110406306
Liver abscess 24.48 16.64 41 154403 7698 110427157
Lower motor neurone lesion 24.42 16.64 7 154437 50 110434805
Subileus 24.34 16.64 37 154407 6400 110428455
Eosinophilic cystitis 24.06 16.64 9 154435 159 110434696
Marrow hyperplasia 24.03 16.64 20 154424 1776 110433079
Withdrawal syndrome 23.99 16.64 7 154437 31373 110403482
Premature ageing 23.92 16.64 8 154436 100 110434755
Skin discolouration 23.88 16.64 20 154424 49026 110385829
Loss of CAR T-cell persistence 23.83 16.64 6 154438 24 110434831
Pneumonia respiratory syncytial viral 23.83 16.64 24 154420 2725 110432130
Apoptosis 23.77 16.64 14 154430 712 110434143
T-cell type acute leukaemia 23.74 16.64 11 154433 339 110434516
Anti-platelet antibody positive 23.74 16.64 11 154433 339 110434516
Cardiac ventricular disorder 23.71 16.64 11 154433 340 110434515
Cardiac disorder 23.64 16.64 44 154400 76236 110358619
Cerebellar stroke 23.57 16.64 15 154429 877 110433978
Dysplasia 23.53 16.64 20 154424 1828 110433027
Clostridial infection 23.52 16.64 36 154408 6266 110428589
Proteus test positive 23.38 16.64 14 154430 734 110434121
Human herpesvirus 6 encephalitis 23.38 16.64 16 154428 1058 110433797
Bone marrow leukaemic cell infiltration 23.36 16.64 8 154436 108 110434747
Pneumonia aspiration 23.32 16.64 49 154395 81184 110353671
Treatment failure 23.30 16.64 261 154183 276973 110157882
Serotonin syndrome 23.26 16.64 29 154415 59124 110375731
Varicella zoster virus infection 23.23 16.64 36 154408 6332 110428523
Oral herpes 23.23 16.64 106 154338 35974 110398881
Cytogenetic analysis abnormal 23.21 16.64 17 154427 1252 110433603
Eosinophilia 23.21 16.64 28 154416 57908 110376947
Herpes simplex reactivation 23.16 16.64 18 154426 1450 110433405
Paraesthesia oral 23.15 16.64 9 154435 33662 110401193
Sinus tachycardia 23.14 16.64 123 154321 44370 110390485
CSF cell count decreased 23.11 16.64 5 154439 8 110434847
Intentional product use issue 23.02 16.64 228 154216 247678 110187177
Facial paresis 22.92 16.64 35 154409 6078 110428777
CSF protein increased 22.91 16.64 18 154426 1473 110433382
Abnormal behaviour 22.89 16.64 13 154431 39026 110395829
Cranial nerve disorder 22.88 16.64 17 154427 1280 110433575
Temporal lobe epilepsy 22.87 16.64 12 154432 486 110434369
Prostate cancer 22.85 16.64 12 154432 37629 110397226
Intracardiac thrombus 22.84 16.64 29 154415 4239 110430616
Combined immunodeficiency 22.75 16.64 9 154435 186 110434669
Meningeal thickening 22.74 16.64 5 154439 9 110434846
Atypical pneumonia 22.70 16.64 40 154404 7822 110427033
Tachypnoea 22.64 16.64 112 154332 39283 110395572
Electrocardiogram PR shortened 22.61 16.64 11 154433 379 110434476
Rhinorrhoea 22.50 16.64 71 154373 102595 110332260
Blood pressure diastolic decreased 22.44 16.64 11 154433 35874 110398981
Immunosuppression 22.43 16.64 65 154379 17694 110417161
Chronic myeloid leukaemia recurrent 22.42 16.64 11 154433 386 110434469
Hypertensive hydrocephalus 22.40 16.64 5 154439 10 110434845
White blood cell count abnormal 22.38 16.64 37 154407 6872 110427983
Walking aid user 22.34 16.64 4 154440 25071 110409784
5q minus syndrome 22.34 16.64 10 154434 284 110434571
Corynebacterium bacteraemia 22.28 16.64 9 154435 197 110434658
Eccrine squamous syringometaplasia 22.27 16.64 6 154438 33 110434822
Fear 22.26 16.64 3 154441 23190 110411665
Perirectal abscess 22.16 16.64 21 154423 2213 110432642
Sensorimotor disorder 22.12 16.64 16 154428 1156 110433699
Acute myocardial infarction 22.04 16.64 53 154391 83724 110351131
Blood bilirubin unconjugated increased 22.01 16.64 16 154428 1165 110433690
Acute motor-sensory axonal neuropathy 22.00 16.64 12 154432 526 110434329
Pneumatosis 21.99 16.64 15 154429 986 110433869
Urethral obstruction 21.96 16.64 10 154434 296 110434559
Ichthyosis 21.94 16.64 9 154435 205 110434650
Human polyomavirus infection 21.93 16.64 19 154425 1783 110433072
Tooth disorder 21.81 16.64 7 154437 29502 110405353
Sputum discoloured 21.80 16.64 6 154438 27939 110406916
Cardiac murmur 21.79 16.64 4 154440 24624 110410231
Myelofibrosis 21.75 16.64 24 154420 3027 110431828
Chronic graft versus host disease in eye 21.71 16.64 11 154433 414 110434441
Gout 21.69 16.64 12 154432 36554 110398301
Myeloproliferative neoplasm 21.67 16.64 17 154427 1388 110433467
Mental status changes 21.65 16.64 181 154263 75941 110358914
Acinetobacter sepsis 21.56 16.64 8 154436 138 110434717
Carpal tunnel syndrome 21.52 16.64 3 154441 22607 110412248
Acute leukaemia 21.50 16.64 19 154425 1830 110433025
Full blood count abnormal 21.50 16.64 28 154416 56024 110378831
Chronic myeloid leukaemia transformation 21.44 16.64 10 154434 313 110434542
Rash maculo-papular 21.38 16.64 177 154267 74045 110360810
Acne 21.38 16.64 10 154434 33510 110401345
Monoparesis 21.37 16.64 29 154415 4524 110430331
Genotoxicity 21.29 16.64 6 154438 40 110434815
Juvenile chronic myelomonocytic leukaemia 21.29 16.64 6 154438 40 110434815
Transient acantholytic dermatosis 21.26 16.64 10 154434 319 110434536
Pneumonia moraxella 21.20 16.64 8 154436 145 110434710
Leukaemic lymphoma 21.19 16.64 7 154437 84 110434771
Chronic myelomonocytic leukaemia 21.18 16.64 15 154429 1048 110433807
Myeloblast percentage decreased 21.16 16.64 6 154438 41 110434814
Megacolon 21.09 16.64 28 154416 4277 110430578
Hyperammonaemia 21.09 16.64 54 154390 13678 110421177
B-cell type acute leukaemia 21.05 16.64 17 154427 1447 110433408
Sertoli-cell-only syndrome 21.03 16.64 6 154438 42 110434813
Device related sepsis 20.91 16.64 38 154406 7609 110427246
Pancreatitis 20.83 16.64 211 154233 93322 110341533
Infection in an immunocompromised host 20.83 16.64 19 154425 1908 110432947
Disturbance in attention 20.81 16.64 34 154410 61961 110372894
Overgrowth fungal 20.80 16.64 8 154436 153 110434702
Transplantation complication 20.78 16.64 11 154433 454 110434401
Continuous haemodiafiltration 20.76 16.64 19 154425 1916 110432939
Abdominal wall wound 20.68 16.64 7 154437 91 110434764
Clonal evolution 20.53 16.64 9 154435 243 110434612
Disseminated toxoplasmosis 20.51 16.64 11 154433 466 110434389
Splenic infection fungal 20.42 16.64 8 154436 161 110434694
Human herpesvirus 6 infection reactivation 20.37 16.64 15 154429 1114 110433741
Haematocolpos 20.34 16.64 6 154438 48 110434807
Blindness cortical 20.30 16.64 15 154429 1120 110433735
Abdominal distension 20.29 16.64 152 154292 174951 110259904
Acinetobacter infection 20.28 16.64 25 154419 3548 110431307
Hepatic calcification 20.27 16.64 10 154434 355 110434500
Respiratory syncytial virus infection 20.25 16.64 55 154389 14429 110420426
Blast cell crisis 20.24 16.64 8 154436 165 110434690
Laboratory test abnormal 20.23 16.64 19 154425 44060 110390795
Bronchiectasis 20.21 16.64 13 154431 36480 110398375
Toxic epidermal necrolysis 20.10 16.64 142 154302 56585 110378270
Pneumonia adenoviral 20.06 16.64 12 154432 628 110434227
Encephalitis fungal 20.06 16.64 9 154435 257 110434598
Aspergilloma 20.04 16.64 13 154431 786 110434069
Portal vein embolism 20.01 16.64 7 154437 101 110434754
Oropharyngeal pain 19.99 16.64 109 154335 135167 110299688
Hyperglycaemia 19.94 16.64 194 154250 84896 110349959
Haemoglobin abnormal 19.93 16.64 41 154403 8997 110425858
Infusion site eschar 19.86 16.64 5 154439 20 110434835
Throat tightness 19.85 16.64 11 154433 33478 110401377
Hyperthyroidism 19.82 16.64 8 154436 29253 110405602
CNS ventriculitis 19.80 16.64 12 154432 643 110434212
Metastases to muscle 19.77 16.64 10 154434 375 110434480
Respiratory depression 19.72 16.64 10 154434 31991 110402864
Intervertebral disc protrusion 19.72 16.64 7 154437 27691 110407164
Axonal neuropathy 19.66 16.64 20 154424 2298 110432557
Cardiac failure acute 19.60 16.64 76 154368 24002 110410853
Lipase increased 19.54 16.64 64 154380 18608 110416247
Strongyloidiasis 19.34 16.64 29 154415 4957 110429898
Cauda equina syndrome 19.27 16.64 19 154425 2103 110432752
Cardiomyopathy acute 19.27 16.64 10 154434 396 110434459
Hepatic candidiasis 19.24 16.64 7 154437 114 110434741
Intra-abdominal haemorrhage 19.21 16.64 30 154414 5312 110429543
Leptotrichia infection 19.15 16.64 6 154438 60 110434795
Spinal cord injury 19.15 16.64 17 154427 1648 110433207
Pulmonary veno-occlusive disease 19.07 16.64 19 154425 2129 110432726
Myelitis transverse 19.07 16.64 20 154424 2381 110432474
Medulloblastoma recurrent 19.04 16.64 8 154436 194 110434661
Scrotal oedema 19.01 16.64 17 154427 1664 110433191
Cardiac tamponade 18.98 16.64 46 154398 11261 110423594
Hepatobiliary disease 18.91 16.64 14 154430 1048 110433807
Abdominal compartment syndrome 18.90 16.64 18 154426 1909 110432946
Anaplastic large cell lymphoma T- and null-cell types recurrent 18.89 16.64 6 154438 63 110434792
Herpes virus infection 18.83 16.64 39 154405 8599 110426256
Hip fracture 18.82 16.64 13 154431 35138 110399717
Paraspinal abscess 18.81 16.64 10 154434 416 110434439
Chromosomal mutation 18.80 16.64 6 154438 64 110434791
Haemodialysis 18.79 16.64 61 154383 17658 110417197
Metastases to retroperitoneum 18.77 16.64 10 154434 418 110434437
Emotional distress 18.69 16.64 21 154423 44826 110390029
Tinnitus 18.69 16.64 35 154409 60505 110374350
Vocal cord paralysis 18.64 16.64 22 154422 2984 110431871
Ureteric compression 18.63 16.64 9 154435 305 110434550
Cerebrosclerosis 18.63 16.64 5 154439 27 110434828
Bacterial test positive 18.56 16.64 37 154407 7940 110426915
Paresis 18.54 16.64 28 154416 4816 110430039
Temperature intolerance 18.54 16.64 52 154392 13898 110420957
Precursor B-lymphoblastic lymphoma recurrent 18.48 16.64 5 154439 28 110434827
Subdural haemorrhage 18.46 16.64 33 154411 6525 110428330
Musculoskeletal discomfort 18.46 16.64 5 154439 23533 110411322
Loss of proprioception 18.45 16.64 13 154431 901 110433954
Acute myelomonocytic leukaemia 18.45 16.64 10 154434 433 110434422
Anal inflammation 18.43 16.64 20 154424 2476 110432379
Gastrointestinal wall thickening 18.42 16.64 24 154420 3599 110431256
Central nervous system necrosis 18.36 16.64 10 154434 437 110434418
Vaccination failure 18.36 16.64 20 154424 2486 110432369
Gallbladder empyema 18.34 16.64 7 154437 131 110434724
Superior mesenteric artery syndrome 18.28 16.64 8 154436 215 110434640
CSF lactate decreased 18.26 16.64 4 154440 7 110434848
Interleukin level decreased 18.26 16.64 4 154440 7 110434848
Impaired work ability 18.26 16.64 7 154437 26412 110408443
Hallucination, auditory 18.24 16.64 7 154437 26390 110408465
Generalised oedema 18.15 16.64 88 154356 30616 110404239
Gastroenteritis sapovirus 18.11 16.64 8 154436 220 110434635
Graft versus host disease in eye 18.09 16.64 10 154434 450 110434405
Lymphoma transformation 18.09 16.64 11 154433 593 110434262
Chills 18.08 16.64 370 154074 190210 110244645
Laryngeal inflammation 18.03 16.64 9 154435 328 110434527
Hiatus hernia 17.98 16.64 8 154436 27598 110407257
Neurological examination abnormal 17.97 16.64 12 154432 762 110434093
Mucocutaneous ulceration 17.95 16.64 12 154432 763 110434092
Disease susceptibility 17.93 16.64 9 154435 332 110434523
Gastrointestinal fungal infection 17.90 16.64 12 154432 767 110434088
Hepatic cytolysis 17.90 16.64 135 154309 54918 110379937
Stomatitis necrotising 17.81 16.64 8 154436 229 110434626
Acinetobacter bacteraemia 17.80 16.64 9 154435 337 110434518
Leukostasis syndrome 17.78 16.64 8 154436 230 110434625
Ovarian failure 17.68 16.64 13 154431 963 110433892
Hypernatraemia 17.67 16.64 60 154384 17773 110417082
Therapeutic response delayed 17.61 16.64 15 154429 1375 110433480
Bone disorder 17.59 16.64 4 154440 21188 110413667
Enamel anomaly 17.59 16.64 8 154436 236 110434619
Splenic lesion 17.59 16.64 11 154433 624 110434231
Tooth hypoplasia 17.54 16.64 9 154435 348 110434507
Chronic graft versus host disease oral 17.49 16.64 10 154434 481 110434374
CSF red blood cell count positive 17.39 16.64 6 154438 83 110434772
Magnetic resonance imaging head abnormal 17.33 16.64 23 154421 3512 110431343
Mucoepidermoid carcinoma 17.26 16.64 6 154438 85 110434770
Chronic kidney disease 17.25 16.64 52 154392 76239 110358616
Glaucoma 17.25 16.64 5 154439 22512 110412343
Human metapneumovirus test positive 17.19 16.64 8 154436 249 110434606
Lacrimation increased 17.17 16.64 11 154433 30939 110403916
Penetrating aortic ulcer 17.17 16.64 5 154439 38 110434817
Azoospermia 17.16 16.64 8 154436 250 110434605
Antithrombin III 17.13 16.64 6 154438 87 110434768
Tachycardia 17.10 16.64 426 154018 226219 110208636
Anal abscess 17.08 16.64 45 154399 11593 110423262
Costal cartilage fracture 17.07 16.64 8 154436 253 110434602
Localised infection 17.04 16.64 21 154423 43027 110391828
Ecthyma 16.96 16.64 13 154431 1026 110433829
Abscess limb 16.95 16.64 37 154407 8460 110426395
Mucosal haemorrhage 16.93 16.64 21 154423 2999 110431856
Spinal cord injury thoracic 16.89 16.64 7 154437 164 110434691
Hypoproteinaemia 16.84 16.64 30 154414 5915 110428940
Peripheral sensorimotor neuropathy 16.84 16.64 24 154420 3919 110430936
Periorbital infection 16.77 16.64 7 154437 167 110434688
Pelvic venous thrombosis 16.76 16.64 20 154424 2744 110432111
Activated partial thromboplastin time shortened 16.76 16.64 13 154431 1044 110433811
Blood pressure diastolic increased 16.76 16.64 3 154441 18804 110416051
Incorrect product administration duration 16.76 16.64 4 154440 20494 110414361
Interferon gamma level increased 16.73 16.64 3 154441 0 110434855
Pancreatic infarction 16.73 16.64 3 154441 0 110434855
Catheter site necrosis 16.73 16.64 3 154441 0 110434855
Infective aneurysm 16.69 16.64 15 154429 1477 110433378
Eye swelling 16.69 16.64 13 154431 33035 110401820

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01BC01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ANTIMETABOLITES
Pyrimidine analogues
ATC L01XY01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Combinations of antineoplastic agents
FDA MoA N0000000233 Nucleic Acid Synthesis Inhibitors
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000963 Antimetabolites
MeSH PA D000964 Antimetabolites, Antineoplastic
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
FDA EPC N0000175595 Nucleoside Metabolic Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

L01BC Pyrimidine analogues 9 drugs
azacitidinecapecitabinecarmofurdecitabinefloxuridinefluorouracilgemcitabinetegafurtrifluridine
L01XY Combinations of antineoplastic agents 1 drug
daunorubicin

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Acute lymphoid leukemia indication 91857003 DOID:9952
Acute myeloid leukemia, disease indication 91861009
Acute promyelocytic leukemia, FAB M3 indication 110004001
Lymphomatous meningitis indication 426128009
Meningeal Leukemia indication
Allogeneic bone marrow transplantation off-label use 58390007
Chronic myeloid leukemia off-label use 92818009 DOID:8552
Diffuse non-Hodgkin's lymphoma, large cell off-label use 109969005
Myelodysplastic syndrome off-label use 109995007
Burkitt's lymphoma off-label use 118617000
Progressive Diffuse Large B-Cell Lymphoma off-label use
Adjunct for CNS Disease Prevention in Non-Hodgkin's Lymphoma off-label use
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Mycosis contraindication 3218000 DOID:1564
Pulmonary edema contraindication 19242006 DOID:11396
Viral disease contraindication 34014006 DOID:934
Hyperuricemia contraindication 35885006 DOID:1920
Gastrointestinal ulcer contraindication 40845000
Stomatitis contraindication 61170000 DOID:9637
Diarrhea contraindication 62315008
Adult respiratory distress syndrome contraindication 67782005 DOID:11394
Leukopenia contraindication 84828003 DOID:615
Cardiomyopathy contraindication 85898001 DOID:0050700
Bacterial infectious disease contraindication 87628006
Kidney disease contraindication 90708001 DOID:557
Infectious disease of central nervous system contraindication 128117002
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Bone marrow depression contraindication 307762000
Coma contraindication 371632003
Breastfeeding (mother) contraindication 413712001
Acute cerebellar syndrome contraindication 417017003
Granulocytopenic disorder contraindication 417672002
Vomiting contraindication 422400008
Protozoal Infection contraindication
Intestinal Ischemic Necrosis contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.91 acidic
pKa2 12.58 acidic
pKa3 12.97 acidic
pKa4 4.04 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 7850990 Jan. 23, 2027 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8022279 Sept. 14, 2027 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8092828 April 1, 2029 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10028912 Oct. 15, 2032 METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10028912 Oct. 15, 2032 METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10166184 Oct. 15, 2032 METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10835492 Oct. 15, 2032 METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS March 30, 2028 TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER
100MG;44MG VYXEOS JAZZ PHARMS THERAP N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS Sept. 30, 2028 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
DNA polymerase (alpha/delta/epsilon) Enzyme INHIBITOR CHEMBL CHEMBL
Prostatic acid phosphatase Enzyme GI50 7 WOMBAT-PK
DNA polymerase beta Enzyme WOMBAT-PK
E3 ubiquitin-protein ligase Mdm2 Nuclear other IC50 7.70 CHEMBL
Enoyl-[acyl-carrier-protein] reductase [NADH] Enzyme IC50 4.23 CHEMBL

External reference:

IDSource
4018080 VUID
N0000146419 NUI
D00168 KEGG_DRUG
69-74-9 SECONDARY_CAS_RN
3041 RXNORM
C0010711 UMLSCUI
CHEBI:28680 CHEBI
AR3 PDB_CHEM_ID
CHEMBL803 ChEMBL_ID
DB00987 DRUGBANK_ID
CHEMBL1256472 ChEMBL_ID
D003561 MESH_DESCRIPTOR_UI
6253 PUBCHEM_CID
4827 IUPHAR_LIGAND_ID
1709 INN_ID
04079A1RDZ UNII
17070 MMSL
372 MMSL
4526 MMSL
d00201 MMSL
d04834 MMSL
002649 NDDF
007798 NDDF
017308 NDDF
116089003 SNOMEDCT_US
387511003 SNOMEDCT_US
89265009 SNOMEDCT_US
4018080 VANDF
4021182 VANDF
04079A1RDZ INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 25021-223 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 25021-229 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-155 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 25 sections
CYTARABINE HUMAN PRESCRIPTION DRUG LABEL 1 61703-303 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 22 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-304 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-305 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 61703-319 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 25 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 63323-120 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
Cytarabine Human Prescription Drug Label 1 68083-337 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
Cytarabine Human Prescription Drug Label 1 68083-343 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 22 sections
VYXEOS HUMAN PRESCRIPTION DRUG LABEL 2 68727-745 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 100 mg INTRAVENOUS NDA 27 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-108 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 23 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-109 INJECTION, SOLUTION 2 g INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-168 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections
Cytarabine HUMAN PRESCRIPTION DRUG LABEL 1 71288-169 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 24 sections