etoposide ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
1112 33419-42-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • etoposide
  • etosid
  • fytosid
  • toposar
  • zuyeyidal
  • VP-16
A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.
  • Molecular weight: 588.56
  • Formula: C29H32O13
  • CLOGP: 0.59
  • LIPINSKI: 2
  • HAC: 13
  • HDO: 3
  • TPSA: 160.83
  • ALOGS: -2.78
  • ROTB: 5

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.11 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 38 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.30 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 52 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.18 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.12 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.70 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.923 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 37.239 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 1.652 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.360 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 48.560 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 52.820 % High 1
herg hERG pIC50 4.241 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.169 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 4.140 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 32.420 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK3,MAP2K6,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,STK33,TEK,TGFBR1,ZAP70 32
kinase-selectivity-class MAP2K6 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 4.966 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 8.091 High 1
mh-clint Mouse hepatocyte intrinsic clearance 20.512 High 1
mppb Mouse plasma protein binding (% unbound) 36.630 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 20.845 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 57.030 % High 1
rat-kpuu-brain Rat brain Kpuu 0.005 % High 1
rh-clint Rat hepatocyte intrinsic clearance 7.925 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 83.780 % High 1
rppb Rat plasma protein binding (% unbound) 26.950 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 776.247 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 26, 2019 PMDA BRISTOL-MYERS SQUIBB K.K.
Nov. 10, 1983 FDA

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 4548.80 18.02 2366 75868 155983 90394230
Neutropenia 1827.96 18.02 1527 76707 223377 90326836
Disease progression 1756.78 18.02 1287 76947 155328 90394885
Mucosal inflammation 1542.79 18.02 824 77410 56801 90493412
Pancytopenia 1355.93 18.02 992 77242 119271 90430942
Off label use 1160.79 18.02 2768 75466 1099484 89450729
Thrombocytopenia 1093.90 18.02 1110 77124 207615 90342598
Bone marrow failure 947.80 18.02 491 77743 31730 90518483
Acute myeloid leukaemia 907.14 18.02 414 77820 20226 90529987
Myelosuppression 879.38 18.02 558 77676 53033 90497180
Myelodysplastic syndrome 766.49 18.02 370 77864 20533 90529680
Haematotoxicity 734.77 18.02 308 77926 12227 90537986
Sepsis 679.61 18.02 806 77428 179008 90371205
Septic shock 509.51 18.02 485 77749 83675 90466538
Febrile bone marrow aplasia 497.14 18.02 217 78017 9521 90540692
Anaemia 469.30 18.02 977 77257 351825 90198388
Malignant neoplasm progression 467.46 18.02 517 77717 106353 90443860
Second primary malignancy 464.82 18.02 211 78023 10167 90540046
Multiple organ dysfunction syndrome 460.31 18.02 418 77816 67918 90482295
Product use in unapproved indication 454.05 18.02 937 77297 335299 90214914
Neutropenic sepsis 453.20 18.02 248 77986 17882 90532331
Haemophagocytic lymphohistiocytosis 452.75 18.02 235 77999 15224 90534989
Pain 440.96 18.02 156 78078 996185 89554028
Venoocclusive liver disease 411.64 18.02 165 78069 5828 90544385
Cytopenia 409.58 18.02 229 78005 17220 90532993
Joint swelling 399.74 18.02 7 78227 503293 90046920
Ovarian failure 396.38 18.02 116 78118 1527 90548686
Tumour lysis syndrome 395.48 18.02 193 78041 10959 90539254
Posterior reversible encephalopathy syndrome 374.66 18.02 236 77998 22103 90528110
Arthralgia 357.80 18.02 114 78120 778408 89771805
Therapy partial responder 350.09 18.02 225 78009 21818 90528395
Neoplasm progression 343.25 18.02 294 77940 44192 90506021
Abdominal discomfort 307.03 18.02 29 78205 477299 90072914
Nasopharyngitis 306.58 18.02 10 78224 407094 90143119
Neutrophil count decreased 302.24 18.02 340 77894 71192 90479021
Disease recurrence 296.93 18.02 252 77982 37401 90512812
Rheumatoid arthritis 292.20 18.02 4 78230 362610 90187603
Diffuse large B-cell lymphoma recurrent 287.73 18.02 110 78124 3416 90546797
Systemic lupus erythematosus 283.29 18.02 6 78228 361890 90188323
Encephalopathy 260.87 18.02 257 77977 46187 90504026
Leukopenia 257.70 18.02 373 77861 100337 90449876
Peripheral swelling 255.53 18.02 29 78205 413077 90137136
Platelet count decreased 253.15 18.02 437 77797 136532 90413681
Drug hypersensitivity 251.20 18.02 48 78186 463561 90086652
Glossodynia 249.24 18.02 6 78228 321773 90228440
Contraindicated product administered 247.85 18.02 6 78228 320133 90230080
Aplasia 247.08 18.02 102 78132 3889 90546324
Diffuse large B-cell lymphoma refractory 244.81 18.02 82 78152 1718 90548495
Arthropathy 241.51 18.02 20 78214 366222 90183991
Neutropenic colitis 236.72 18.02 100 78134 4043 90546170
Swelling 232.14 18.02 41 78193 419017 90131196
Pyrexia 229.88 18.02 1151 77083 659334 89890879
Weight increased 222.74 18.02 45 78189 417882 90132331
Pruritus 220.39 18.02 96 78138 541429 90008784
Musculoskeletal stiffness 217.24 18.02 9 78225 296523 90253690
Renal salt-wasting syndrome 216.74 18.02 55 78179 404 90549809
Hepatitis B reactivation 214.08 18.02 92 78142 3882 90546331
Cytokine release syndrome 211.94 18.02 183 78051 27790 90522423
Cardiotoxicity 210.43 18.02 128 78106 11261 90538952
Rash 210.14 18.02 227 78007 795873 89754340
Cytomegalovirus infection 209.64 18.02 178 78056 26424 90523789
Aspergillus infection 200.89 18.02 122 78112 10701 90539512
Drug resistance 200.50 18.02 184 78050 30265 90519948
Product dose omission issue 194.85 18.02 15 78219 291672 90258541
Thrombotic microangiopathy 190.94 18.02 136 78098 15607 90534606
Malaise 190.76 18.02 137 78097 585849 89964364
Headache 189.30 18.02 283 77951 862463 89687750
Ototoxicity 188.45 18.02 69 78165 1895 90548318
Hypersensitivity 184.29 18.02 81 78153 454596 90095617
Insomnia 183.81 18.02 33 78201 333441 90216772
Bacteraemia 183.52 18.02 153 78081 22147 90528066
Urticaria 181.18 18.02 27 78207 312707 90237506
Discomfort 180.74 18.02 15 78219 274320 90275893
Malignant transformation 178.87 18.02 50 78184 552 90549661
Asthma 178.53 18.02 7 78227 242153 90308060
Aplastic anaemia 178.14 18.02 122 78112 13147 90537066
Impaired healing 171.87 18.02 7 78227 234192 90316021
Fall 168.39 18.02 104 78130 481706 90068507
Therapeutic product effect decreased 167.79 18.02 21 78213 277550 90272663
Drug intolerance 164.36 18.02 91 78143 447500 90102713
Venoocclusive disease 163.09 18.02 66 78168 2389 90547824
Bronchopulmonary aspergillosis 163.04 18.02 109 78125 11289 90538924
Neurotoxicity 161.73 18.02 140 78094 21327 90528886
Folliculitis 157.45 18.02 4 78230 204349 90345864
Stem cell transplant 153.81 18.02 61 78173 2093 90548120
Colitis 153.18 18.02 241 77993 69701 90480512
Blister 152.41 18.02 20 78214 254978 90295235
Blood cholesterol increased 150.04 18.02 7 78227 208005 90342208
Acute respiratory distress syndrome 148.68 18.02 152 78082 28534 90521679
Pericarditis 148.26 18.02 27 78207 270124 90280089
Injury 147.89 18.02 5 78229 197344 90352869
Respiratory failure 147.70 18.02 320 77914 118098 90432115
Clostridium difficile colitis 146.64 18.02 146 78088 26560 90523653
Enterococcal infection 146.42 18.02 97 78137 9894 90540319
Hepatic enzyme increased 143.39 18.02 66 78168 360670 90189543
Drug ineffective for unapproved indication 140.93 18.02 226 78008 66418 90483795
Neuropathy peripheral 139.80 18.02 342 77892 136628 90413585
Contusion 138.09 18.02 25 78209 251191 90299022
Pulmonary haemorrhage 137.71 18.02 86 78148 7927 90542286
Fatigue 137.64 18.02 523 77711 1153500 89396713
Candida infection 135.52 18.02 157 78077 33900 90516313
Hepatosplenic T-cell lymphoma 133.46 18.02 41 78193 643 90549570
Oesophagitis 133.00 18.02 114 78120 17135 90533078
Maternal exposure before pregnancy 131.69 18.02 95 78139 11118 90539095
Sinusitis 129.93 18.02 67 78167 343021 90207192
Acute graft versus host disease 128.94 18.02 72 78162 5396 90544817
Lymphopenia 127.31 18.02 126 78108 22755 90527458
Pain in extremity 127.10 18.02 121 78113 450408 90099805
Graft versus host disease 126.50 18.02 82 78152 8062 90542151
Teratoma 125.97 18.02 30 78204 163 90550050
Klebsiella infection 124.97 18.02 89 78145 10208 90540005
Bone marrow disorder 124.34 18.02 58 78176 2974 90547239
Human herpesvirus 6 infection 123.48 18.02 60 78174 3372 90546841
Injection site pain 121.62 18.02 7 78227 173692 90376521
White blood cell count decreased 120.27 18.02 367 77867 166742 90383471
Sleep disorder 119.60 18.02 15 78219 198015 90352198
Ovarian germ cell teratoma 119.15 18.02 25 78209 66 90550147
Epstein-Barr virus infection 117.76 18.02 86 78148 10258 90539955
Muscle spasms 116.90 18.02 36 78198 251847 90298366
Wheezing 116.08 18.02 31 78203 238049 90312164
Type 2 diabetes mellitus 114.37 18.02 19 78215 203225 90346988
Anxiety 113.60 18.02 63 78171 309709 90240504
Psoriasis 113.40 18.02 3 78231 147751 90402462
Neoplasm recurrence 111.34 18.02 55 78179 3204 90547009
Dry mouth 111.01 18.02 14 78220 184045 90366168
Cystitis haemorrhagic 109.71 18.02 65 78169 5448 90544765
Infusion related reaction 108.39 18.02 120 78114 416660 90133553
Lower respiratory tract infection 107.37 18.02 41 78193 250618 90299595
Dizziness 107.37 18.02 217 78017 589067 89961146
Disseminated intravascular coagulation 105.98 18.02 111 78123 21427 90528786
Mobility decreased 105.77 18.02 42 78192 250692 90299521
Hypokalaemia 102.92 18.02 297 77937 130819 90419394
Klebsiella sepsis 101.79 18.02 43 78191 1738 90548475
Fungaemia 101.15 18.02 52 78182 3298 90546915
Migraine 100.28 18.02 21 78213 190371 90359842
Primary hypogonadism 99.19 18.02 25 78209 178 90550035
Renal tubular disorder 97.47 18.02 50 78184 3157 90547056
Blood lactate dehydrogenase increased 97.28 18.02 116 78118 25816 90524397
Peripheral sensory neuropathy 96.55 18.02 73 78161 9177 90541036
Abdominal pain upper 96.54 18.02 87 78147 332587 90217626
Hypothyroidism 96.08 18.02 168 78066 52959 90497254
JC virus infection 93.23 18.02 46 78188 2673 90547540
Alveolar soft part sarcoma 93.05 18.02 21 78213 86 90550127
Agranulocytosis 92.91 18.02 132 78102 34870 90515343
Metastases to central nervous system 92.80 18.02 94 78140 17448 90532765
Premature menopause 92.68 18.02 37 78197 1292 90548921
Enterobacter infection 92.46 18.02 45 78189 2538 90547675
Hypoaesthesia 91.37 18.02 82 78152 314128 90236085
Gene mutation 91.25 18.02 42 78192 2088 90548125
Adenovirus infection 90.69 18.02 54 78180 4568 90545645
Leukoencephalopathy 90.61 18.02 55 78179 4818 90545395
Acute kidney injury 90.40 18.02 528 77706 319859 90230354
Lymphoma 87.26 18.02 81 78153 13510 90536703
Arthritis 86.99 18.02 19 78215 167296 90382917
BK virus infection 86.82 18.02 52 78182 4446 90545767
Human bocavirus infection 86.64 18.02 27 78207 445 90549768
Post transplant lymphoproliferative disorder 84.19 18.02 60 78174 6889 90543324
Loss of personal independence in daily activities 82.93 18.02 10 78224 136095 90414118
Musculoskeletal pain 82.14 18.02 23 78211 171228 90378985
Hypomagnesaemia 81.20 18.02 125 78109 35463 90514750
Feeling abnormal 81.07 18.02 22 78212 167213 90383000
Drug ineffective 80.68 18.02 1656 76578 1382642 89167571
Osteosarcoma 80.54 18.02 20 78214 133 90550080
Gastrooesophageal reflux disease 80.41 18.02 22 78212 166315 90383898
Nephropathy toxic 80.27 18.02 75 78159 12613 90537600
Bronchitis 80.25 18.02 17 78217 152910 90397303
Polyneuropathy 80.04 18.02 91 78143 19250 90530963
Myeloid leukaemia 80.04 18.02 26 78208 493 90549720
Memory impairment 80.02 18.02 35 78199 197209 90353004
Overdose 79.81 18.02 19 78215 157690 90392523
Gait inability 79.53 18.02 15 78219 146441 90403772
Mucormycosis 78.53 18.02 46 78188 3775 90546438
Deafness 78.41 18.02 97 78137 22417 90527796
Congestive cardiomyopathy 76.68 18.02 58 78176 7296 90542917
Hospitalisation 76.61 18.02 10 78224 128090 90422123
Inappropriate schedule of product administration 76.00 18.02 18 78216 149915 90400298
Cytomegalovirus infection reactivation 75.81 18.02 59 78175 7741 90542472
Pneumonia fungal 74.52 18.02 56 78178 6975 90543238
Ascites 73.71 18.02 141 78093 47599 90502614
Abdominal compartment syndrome 73.24 18.02 27 78207 756 90549457
Ill-defined disorder 73.13 18.02 34 78200 184857 90365356
Renal failure 73.05 18.02 264 77970 130743 90419470
Teratoma benign 72.66 18.02 16 78218 57 90550156
Pneumatosis intestinalis 72.28 18.02 42 78192 3395 90546818
Klebsiella bacteraemia 71.87 18.02 38 78196 2554 90547659
Cytomegalovirus viraemia 70.75 18.02 56 78178 7530 90542683
Complications of bone marrow transplant 70.23 18.02 23 78211 448 90549765
Wound infection 69.53 18.02 6 78228 106396 90443817
Staphylococcal bacteraemia 69.36 18.02 55 78179 7414 90542799
Cervix disorder 69.35 18.02 25 78209 656 90549557
Acute graft versus host disease in skin 69.27 18.02 46 78188 4710 90545503
Pneumothorax 69.05 18.02 84 78150 19083 90531130
Pneumonitis 68.87 18.02 131 78103 44039 90506174
Prescribed overdose 68.12 18.02 4 78230 97621 90452592
Skin candida 67.38 18.02 32 78202 1709 90548504
Acute lymphocytic leukaemia recurrent 67.37 18.02 37 78197 2684 90547529
Capillary leak syndrome 66.78 18.02 37 78197 2730 90547483
Staphylococcal infection 66.27 18.02 136 78098 48303 90501910
Plasma cell myeloma refractory 65.40 18.02 27 78207 1029 90549184
Progressive multifocal leukoencephalopathy 65.36 18.02 74 78160 15581 90534632
Systemic candida 65.16 18.02 45 78189 4914 90545299
Hypercholesterolaemia 65.09 18.02 6 78228 100886 90449327
Cardiac failure 64.77 18.02 225 78009 109271 90440942
Dyspepsia 64.75 18.02 46 78188 198114 90352099
Intentional product misuse 64.64 18.02 3 78231 89601 90460612
Gait disturbance 64.42 18.02 78 78156 260418 90289795
Adverse drug reaction 63.26 18.02 12 78222 116689 90433524
Injection site erythema 63.16 18.02 6 78228 98496 90451717
Graft versus host disease in skin 62.82 18.02 40 78194 3813 90546400
Pleural effusion 62.70 18.02 226 78008 111765 90438448
Depression 62.41 18.02 102 78132 300499 90249714
Herpes simplex 62.15 18.02 59 78175 10122 90540091
Liver injury 62.04 18.02 35 78199 170532 90379681
Engraftment syndrome 60.52 18.02 23 78211 702 90549511
Acute promyelocytic leukaemia 60.36 18.02 26 78208 1103 90549110
Superior vena cava syndrome 60.28 18.02 23 78211 710 90549503
Leukaemia 60.24 18.02 43 78191 4949 90545264
Peripheral venous disease 59.92 18.02 3 78231 83918 90466295
Hypertension 59.80 18.02 199 78035 457333 90092880
Encephalitis viral 59.00 18.02 30 78204 1859 90548354
Secondary immunodeficiency 58.47 18.02 31 78203 2095 90548118
Staphylococcal sepsis 58.47 18.02 55 78179 9328 90540885
Leukoerythroblastosis 58.03 18.02 18 78216 292 90549921
Device related infection 58.02 18.02 90 78144 25696 90524517
Blood pressure increased 57.86 18.02 51 78183 197166 90353047
Respiratory distress 57.65 18.02 113 78121 38833 90511380
Pulmonary alveolar haemorrhage 57.49 18.02 45 78189 5953 90544260
Immune-mediated enterocolitis 57.46 18.02 41 78193 4716 90545497
Neck pain 57.13 18.02 14 78220 113949 90436264
Escherichia bacteraemia 57.09 18.02 44 78190 5691 90544522
Hepatitis B 57.02 18.02 40 78194 4479 90545734
Alopecia 57.00 18.02 227 78007 494844 90055369
Weight decreased 56.98 18.02 155 78079 379755 90170458
Diffuse large B-cell lymphoma 56.42 18.02 52 78182 8593 90541620
B-cell lymphoma recurrent 56.24 18.02 20 78214 504 90549709
Grip strength decreased 55.90 18.02 7 78227 92569 90457644
Injection site reaction 55.51 18.02 7 78227 92073 90458140
Large intestinal ulcer perforation 55.49 18.02 13 78221 65 90550148
Pharyngeal inflammation 55.32 18.02 24 78210 1036 90549177
Pneumocystis jirovecii pneumonia 55.14 18.02 80 78154 21536 90528677
Adverse event 54.05 18.02 17 78217 117401 90432812
Enterocolitis 53.29 18.02 55 78179 10435 90539778
Bacterial infection 52.99 18.02 82 78152 23362 90526851
Varicella zoster virus infection 52.87 18.02 36 78198 3841 90546372
Incorrect dose administered 52.82 18.02 4 78230 78926 90471287
Fanconi syndrome 52.50 18.02 28 78206 1915 90548298
Hypogammaglobulinaemia 52.49 18.02 55 78179 10619 90539594
Stress 52.08 18.02 5 78229 81390 90468823
T-cell type acute leukaemia 51.79 18.02 14 78220 135 90550078
Suicidal ideation 51.61 18.02 3 78231 73852 90476361
Bacterial sepsis 51.48 18.02 39 78195 4916 90545297
Influenza like illness 51.45 18.02 5 78229 80606 90469607
Amnesia 51.23 18.02 15 78219 108490 90441723
Obesity 50.90 18.02 14 78220 105493 90444720
Gastrointestinal toxicity 50.57 18.02 51 78183 9416 90540797
Splenomegaly 50.44 18.02 59 78175 12865 90537348
Oedema peripheral 50.34 18.02 91 78143 257824 90292389
Amenorrhoea 49.95 18.02 56 78178 11666 90538547
Venous thrombosis 49.77 18.02 40 78194 5497 90544716
Prescribed underdose 49.65 18.02 4 78230 75015 90475198
Nervous system disorder 49.47 18.02 76 78158 21517 90528696
Alpha haemolytic streptococcal infection 49.44 18.02 26 78208 1728 90548485
Nail pigmentation 49.14 18.02 15 78219 230 90549983
Ejection fraction decreased 48.74 18.02 84 78150 26169 90524044
Renal impairment 48.56 18.02 200 78034 105221 90444992
Enterococcal sepsis 48.55 18.02 25 78209 1591 90548622
Blood culture positive 48.50 18.02 38 78196 5034 90545179
Small cell lung cancer 48.49 18.02 26 78208 1798 90548415
Therapy non-responder 48.48 18.02 240 77994 136464 90413749
Metastasis 48.20 18.02 41 78193 6096 90544117
Metastases to lung 47.99 18.02 64 78170 15927 90534286
Hepatic failure 47.94 18.02 106 78128 39622 90510591
Gastrointestinal fungal infection 47.93 18.02 17 78217 425 90549788
Refractory anaemia with an excess of blasts 47.89 18.02 17 78217 426 90549787
Leukaemia recurrent 47.88 18.02 24 78210 1443 90548770
Viraemia 47.79 18.02 25 78209 1644 90548569
Pericardial effusion 47.56 18.02 101 78133 36732 90513481
Cardiomyopathy 47.54 18.02 72 78162 20134 90530079
Mouth ulceration 47.50 18.02 106 78128 39868 90510345
Gastroenteritis norovirus 47.24 18.02 28 78206 2348 90547865
Pseudomonal sepsis 47.24 18.02 35 78199 4267 90545946
Acute polyneuropathy 47.23 18.02 17 78217 444 90549769
Cytomegalovirus chorioretinitis 46.78 18.02 28 78206 2391 90547822
Confusional state 46.41 18.02 174 78060 386031 90164182
Recurrent cancer 46.35 18.02 28 78206 2431 90547782
Neutropenic infection 45.89 18.02 25 78209 1784 90548429
Medulloblastoma recurrent 45.85 18.02 12 78222 101 90550112
Clostridium colitis 45.70 18.02 26 78208 2019 90548194
Acute myeloid leukaemia recurrent 45.56 18.02 26 78208 2031 90548182
Paraneoplastic neurological syndrome 45.55 18.02 10 78224 35 90550178
Electrolyte imbalance 45.43 18.02 77 78157 23668 90526545
Pseudomonas infection 45.39 18.02 60 78174 14805 90535408
Blood lactate dehydrogenase decreased 45.31 18.02 14 78220 224 90549989
Rhinovirus infection 45.13 18.02 39 78195 5924 90544289
T-cell lymphoma 44.72 18.02 19 78215 779 90549434
Skin toxicity 44.68 18.02 41 78193 6738 90543475
Left ventricular dysfunction 44.47 18.02 59 78175 14610 90535603
Osteoporosis 44.39 18.02 14 78220 96517 90453696
Nasal congestion 44.32 18.02 9 78225 83405 90466808
Iris atrophy 44.18 18.02 12 78222 118 90550095
Chloroma 44.09 18.02 14 78220 246 90549967
Chronic graft versus host disease 43.94 18.02 33 78201 4106 90546107
Fungal sepsis 43.89 18.02 23 78211 1518 90548695
Peripheral motor neuropathy 43.87 18.02 25 78209 1948 90548265
Anisometropia 43.81 18.02 11 78223 77 90550136
Streptococcal bacteraemia 43.64 18.02 26 78208 2201 90548012
Serum ferritin increased 43.58 18.02 42 78192 7339 90542874
Lung consolidation 43.58 18.02 35 78199 4805 90545408
Enteritis 43.45 18.02 49 78185 10272 90539941
Palpitations 43.02 18.02 33 78201 136695 90413518
Vena cava thrombosis 42.87 18.02 27 78207 2525 90547688
Mesenteric abscess 42.74 18.02 11 78223 86 90550127
Pleuroparenchymal fibroelastosis 42.73 18.02 13 78221 197 90550016
Radiation oesophagitis 42.71 18.02 16 78218 469 90549744
Acute lymphocytic leukaemia 42.58 18.02 28 78206 2820 90547393
Oesophageal candidiasis 42.49 18.02 40 78194 6789 90543424
Cardiomyopathy acute 42.31 18.02 14 78220 282 90549931
Red blood cell sedimentation rate increased 41.68 18.02 10 78224 82585 90467628
Fungal oesophagitis 41.62 18.02 18 78216 771 90549442
Autoimmune disorder 41.36 18.02 8 78226 76736 90473477
T-cell lymphoma refractory 41.29 18.02 10 78224 59 90550154
Sweat gland tumour 40.86 18.02 12 78222 160 90550053
Hepatic cirrhosis 40.16 18.02 4 78230 63249 90486964
Fungal infection 39.79 18.02 103 78131 42558 90507655
Inappropriate antidiuretic hormone secretion 39.65 18.02 65 78169 19440 90530773
Nasal abscess 39.62 18.02 12 78222 179 90550034
Epstein-Barr virus associated lymphoproliferative disorder 39.34 18.02 26 78208 2641 90547572
Metastases to diaphragm 39.29 18.02 9 78225 40 90550173
Product quality issue 39.26 18.02 10 78224 79315 90470898
Death 38.83 18.02 581 77653 455970 90094243
Taste disorder 38.80 18.02 4 78230 61542 90488671
Granulocytopenia 38.69 18.02 37 78197 6404 90543809
Chest pain 38.39 18.02 144 78090 319501 90230712
Fluid retention 38.38 18.02 14 78220 88077 90462136
Ear infection 38.19 18.02 7 78227 69768 90480445
Stenotrophomonas infection 38.14 18.02 25 78209 2504 90547709
Hyperhidrosis 37.90 18.02 37 78197 136268 90413945
Myeloproliferative neoplasm 37.89 18.02 16 78218 646 90549567
Drug abuse 37.76 18.02 12 78222 82335 90467878
Acute myelomonocytic leukaemia 37.73 18.02 12 78222 212 90550001
Rash pruritic 37.66 18.02 12 78222 82202 90468011
Tumour necrosis 37.52 18.02 18 78216 983 90549230
Live birth 37.23 18.02 11 78223 79096 90471117
Epstein-Barr virus infection reactivation 37.09 18.02 21 78213 1616 90548597
Encephalitis cytomegalovirus 36.55 18.02 16 78218 706 90549507
Acute hepatic failure 36.51 18.02 68 78166 22493 90527720
Odynophagia 36.49 18.02 42 78192 9001 90541212
Listeria sepsis 36.26 18.02 16 78218 720 90549493
Clostridium bacteraemia 36.25 18.02 12 78222 242 90549971
Lymphadenopathy 36.18 18.02 104 78130 45671 90504542
Hepatitis B core antibody positive 36.17 18.02 13 78221 338 90549875
Acquired gene mutation 36.17 18.02 19 78215 1260 90548953
Oedema 36.16 18.02 74 78160 200221 90349992
Liver function test increased 36.11 18.02 14 78220 84841 90465372
Neutrophil count abnormal 35.37 18.02 29 78205 4099 90546114
Necrotising gastritis 35.36 18.02 9 78225 67 90550146
Clostridium difficile infection 35.35 18.02 89 78145 36156 90514057
Injection site pruritus 35.26 18.02 3 78231 53831 90496382
Strongyloidiasis 34.82 18.02 20 78214 1582 90548631
Gastrointestinal disorder 34.63 18.02 110 78124 256577 90293636
Pulmonary toxicity 34.37 18.02 46 78188 11485 90538728
Cutaneous calcification 34.29 18.02 11 78223 200 90550013
Hair follicle tumour benign 33.96 18.02 13 78221 405 90549808
Gastroenteritis adenovirus 33.94 18.02 12 78222 297 90549916
Sinus polyp 33.81 18.02 13 78221 410 90549803
Maternal exposure during pregnancy 33.71 18.02 178 78056 359885 90190328
Back pain 33.63 18.02 150 78084 317025 90233188
Unmasking of previously unidentified disease 33.62 18.02 19 78215 1457 90548756
Night sweats 33.49 18.02 37 78197 128729 90421484
Paraesthesia 33.26 18.02 108 78126 250218 90299995
Bacterial tracheitis 33.22 18.02 7 78227 19 90550194
Cerebellar haemangioma 33.18 18.02 9 78225 88 90550125
Myalgia 33.08 18.02 63 78171 175062 90375151
Colitis ulcerative 33.08 18.02 6 78228 60260 90489953
Peripheral sensorimotor neuropathy 32.77 18.02 21 78213 2024 90548189
Optic atrophy 32.63 18.02 19 78215 1542 90548671
Cystitis bacterial 32.45 18.02 12 78222 339 90549874
Mucocutaneous ulceration 32.42 18.02 11 78223 240 90549973
Pregnancy 32.33 18.02 7 78227 62040 90488173
Metastases to bone marrow 32.26 18.02 14 78220 605 90549608
Tonsillar haemorrhage 31.83 18.02 11 78223 254 90549959
Exposure during pregnancy 31.58 18.02 103 78131 238307 90311906
Metastases to meninges 31.50 18.02 26 78208 3709 90546504
Basal ganglion degeneration 31.46 18.02 12 78222 370 90549843
Malnutrition 31.38 18.02 57 78177 18501 90531712
Hypocalcaemia 31.33 18.02 94 78140 42274 90507939
Subdural hygroma 31.32 18.02 11 78223 267 90549946
Blood glucose increased 31.24 18.02 22 78212 95224 90454989
Parainfluenzae virus infection 31.22 18.02 23 78211 2780 90547433
Lymphocyte count decreased 31.03 18.02 83 78151 34967 90515246
Hypoalbuminaemia 31.01 18.02 52 78182 15845 90534368
COVID-19 pneumonia 30.95 18.02 56 78178 18121 90532092
Bone marrow transplant 30.83 18.02 15 78219 845 90549368
Immune effector cell-associated neurotoxicity syndrome 30.67 18.02 31 78203 5737 90544476
Delayed puberty 30.64 18.02 9 78225 120 90550093
Medulloblastoma 30.60 18.02 8 78226 67 90550146
White blood cell count abnormal 30.53 18.02 35 78199 7469 90542744
Gastritis haemorrhagic 30.13 18.02 19 78215 1781 90548432
Depressed mood 29.83 18.02 4 78230 50218 90499995
Hepatosplenomegaly 29.76 18.02 23 78211 2986 90547227
Blood stem cell transplant failure 29.61 18.02 10 78224 215 90549998
Retroperitoneal lymphadenopathy 29.51 18.02 14 78220 746 90549467
Epstein Barr virus positive mucocutaneous ulcer 29.50 18.02 13 78221 583 90549630
Delirium 29.39 18.02 28 78206 104331 90445882
Plasma cell leukaemia 29.37 18.02 16 78218 1142 90549071
Mucoepidermoid carcinoma of salivary gland 29.25 18.02 7 78227 39 90550174
Blood pressure fluctuation 29.24 18.02 5 78229 52408 90497805
Hypoxia 29.22 18.02 132 78102 72267 90477946
Metastatic lymphoma 29.14 18.02 10 78224 226 90549987
Myelopathy 29.10 18.02 24 78210 3420 90546793
Metastases to spleen 29.06 18.02 10 78224 228 90549985
Inflammation 28.95 18.02 70 78164 178522 90371691
Alanine aminotransferase increased 28.87 18.02 188 78046 118150 90432063
Acute graft versus host disease in liver 28.72 18.02 14 78220 792 90549421
Fluid replacement 28.52 18.02 13 78221 632 90549581
Medication error 28.50 18.02 19 78215 84633 90465580
Thymus enlargement 28.30 18.02 9 78225 159 90550054
Primary mediastinal large B-cell lymphoma recurrent 28.16 18.02 8 78226 94 90550119
Tumour hyperprogression 28.14 18.02 9 78225 162 90550051
Metastases to lymph nodes 27.99 18.02 42 78192 11647 90538566
Coagulopathy 27.94 18.02 62 78172 23227 90526986
Trichosporon infection 27.94 18.02 11 78223 370 90549843
Incorrect route of product administration 27.87 18.02 5 78229 50621 90499592
Burning sensation 27.78 18.02 10 78224 63442 90486771
Central nervous system lymphoma 27.75 18.02 19 78215 2046 90548167
Febrile infection 27.71 18.02 19 78215 2050 90548163
Plasma cells increased 27.64 18.02 8 78226 101 90550112
Growth hormone deficiency 27.54 18.02 9 78225 174 90550039
Hydrocephalus 27.49 18.02 30 78204 6064 90544149
Hypertriglyceridaemia 27.49 18.02 34 78200 7855 90542358
Dry eye 27.36 18.02 8 78226 57923 90492290
Genotoxicity 27.33 18.02 6 78228 21 90550192
Vision blurred 27.27 18.02 33 78201 110260 90439953
Radiation pneumonitis 27.13 18.02 18 78216 1840 90548373
RUNX1 gene mutation 27.06 18.02 7 78227 56 90550157
Synovial sarcoma 27.06 18.02 7 78227 56 90550157
Pneumococcal sepsis 27.00 18.02 14 78220 904 90549309
Drug clearance decreased 26.78 18.02 18 78216 1880 90548333
Clostridial sepsis 26.76 18.02 12 78222 561 90549652
Urinary tract infection bacterial 26.73 18.02 30 78204 6255 90543958
Condition aggravated 26.70 18.02 358 77876 595187 89955026
Dyspnoea 26.67 18.02 569 77665 880386 89669827
Suicide attempt 26.65 18.02 16 78218 75383 90474830
Dysphagia 26.56 18.02 177 78057 112101 90438112
Cerebral toxoplasmosis 26.49 18.02 16 78218 1389 90548824
Haemodynamic instability 26.45 18.02 41 78193 11698 90538515
Epiphyses premature fusion 26.43 18.02 7 78227 62 90550151
Infection reactivation 26.42 18.02 18 78216 1922 90548291
Eosinophilic cystitis 26.33 18.02 7 78227 63 90550150
Gastrointestinal necrosis 26.26 18.02 22 78212 3203 90547010
Accidental exposure to product 26.08 18.02 3 78231 42363 90507850
Blood pressure systolic increased 25.88 18.02 9 78225 58336 90491877
Sinoatrial block 25.81 18.02 14 78220 991 90549222
Wrong technique in product usage process 25.56 18.02 15 78219 71556 90478657
Abdominal distension 25.53 18.02 46 78188 130555 90419658
Eczema 25.53 18.02 7 78227 52863 90497350
Spinal cord paralysis 25.45 18.02 6 78228 31 90550182
Therapy interrupted 25.41 18.02 6 78228 50102 90500111
Precursor T-lymphoblastic lymphoma/leukaemia 25.31 18.02 7 78227 74 90550139
Metastases to liver 25.28 18.02 68 78166 28739 90521474
Hyperadrenocorticism 25.27 18.02 11 78223 479 90549734
Somnolence 25.21 18.02 94 78140 208990 90341223
Escherichia sepsis 25.15 18.02 28 78206 5788 90544425
Retinoblastoma 25.15 18.02 7 78227 76 90550137
Peritoneal gliomatosis 25.14 18.02 5 78229 9 90550204
Unevaluable event 25.13 18.02 8 78226 54840 90495373
Cardiopulmonary failure 25.05 18.02 24 78210 4164 90546049
Brain herniation 24.99 18.02 24 78210 4176 90546037
Transfusion 24.98 18.02 50 78184 17438 90532775
Rhabdomyosarcoma recurrent 24.83 18.02 6 78228 35 90550178
Intensive care 24.66 18.02 15 78219 1319 90548894
Dry skin 24.37 18.02 24 78210 88049 90462164
Metastatic choriocarcinoma 24.22 18.02 4 78230 0 90550213
Graft versus host disease in gastrointestinal tract 24.10 18.02 24 78210 4364 90545849
Myocarditis 24.10 18.02 43 78191 13763 90536450
Toxic neuropathy 24.09 18.02 11 78223 537 90549676
Choriocarcinoma 24.02 18.02 6 78228 41 90550172
Vulvovaginitis 23.96 18.02 10 78224 392 90549821
Cytogenetic abnormality 23.89 18.02 11 78223 547 90549666
Mantle cell lymphoma recurrent 23.81 18.02 10 78224 398 90549815
Haemoglobin abnormal 23.78 18.02 30 78204 7070 90543143
Ectopic ACTH syndrome 23.77 18.02 8 78226 170 90550043
Retinal pigment epitheliopathy 23.64 18.02 9 78225 276 90549937
Meningitis bacterial 23.55 18.02 16 78218 1701 90548512
Hepatotoxicity 23.54 18.02 90 78144 45752 90504461
Haematopoietic stem cell mobilisation 23.53 18.02 6 78228 45 90550168
Enterococcal bacteraemia 23.40 18.02 17 78217 2011 90548202
Toxic encephalopathy 23.37 18.02 33 78201 8666 90541547
Eustachian tube dysfunction 23.36 18.02 12 78222 760 90549453
International normalised ratio increased 23.35 18.02 6 78228 47310 90502903
Listeriosis 23.33 18.02 16 78218 1727 90548486
Intentional product use issue 23.33 18.02 102 78132 216790 90333423
Diffuse alopecia 23.28 18.02 14 78220 1206 90549007
Schistocytosis 23.19 18.02 6 78228 48 90550165
Viral haemorrhagic cystitis 23.11 18.02 15 78219 1478 90548735
Osteonecrosis 23.09 18.02 62 78172 26179 90524034
Pneumonia klebsiella 23.06 18.02 20 78214 3052 90547161
Treatment failure 22.81 18.02 161 78073 303767 90246446
Pericardial effusion malignant 22.78 18.02 8 78226 194 90550019
Respiratory syncytial virus infection 22.77 18.02 36 78198 10444 90539769
Neurological decompensation 22.73 18.02 21 78213 3480 90546733
Liver carcinoma ruptured 22.67 18.02 6 78228 53 90550160
Granulocyte count decreased 22.65 18.02 18 78216 2434 90547779
Ocular vascular disorder 22.62 18.02 11 78223 619 90549594
Hepatomegaly 22.62 18.02 41 78193 13285 90536928
Anaesthesia 22.58 18.02 10 78224 454 90549759
Hyperbilirubinaemia 22.55 18.02 42 78192 13894 90536319
Rhabdoid tumour 22.47 18.02 6 78228 55 90550158
KMT2A gene mutation 22.45 18.02 5 78229 19 90550194
Haematochezia 22.45 18.02 17 78217 70896 90479317
Jugular vein thrombosis 22.33 18.02 21 78213 3560 90546653
Hepatic lesion 22.31 18.02 26 78208 5647 90544566
Gastrointestinal mucosal disorder 22.26 18.02 12 78222 839 90549374
Lung infiltration 22.20 18.02 44 78190 15238 90534975
Anal squamous cell carcinoma 22.12 18.02 11 78223 650 90549563
Tissue infiltration 22.01 18.02 12 78222 858 90549355
Hot flush 21.92 18.02 12 78222 59476 90490737
Feeling hot 21.88 18.02 21 78213 77987 90472226
Upper respiratory tract infection 21.83 18.02 49 78185 128269 90421944
Paraparesis 21.80 18.02 19 78215 2919 90547294
Platelet transfusion 21.75 18.02 13 78221 1107 90549106
Follicular thyroid cancer 21.74 18.02 6 78228 63 90550150
Parenteral nutrition 21.63 18.02 8 78226 226 90549987
Postictal state 21.57 18.02 14 78220 1379 90548834
Surgery 21.56 18.02 6 78228 44881 90505332
Dysplasia 21.56 18.02 14 78220 1380 90548833
Drug clearance increased 21.50 18.02 8 78226 230 90549983
Ganglioneuroma 21.49 18.02 7 78227 134 90550079
Cytomegalovirus colitis 21.39 18.02 20 78214 3366 90546847
Respiratory tract infection fungal 21.38 18.02 10 78224 516 90549697
Pneumonia bacterial 21.26 18.02 39 78195 12751 90537462
Pulmonary vascular disorder 21.18 18.02 9 78225 369 90549844
Plasma cell myeloma recurrent 21.17 18.02 22 78212 4206 90546007
Glioblastoma multiforme 21.16 18.02 12 78222 926 90549287
Loss of consciousness 21.15 18.02 57 78177 140181 90410032
Skin discolouration 21.15 18.02 6 78228 44309 90505904
Respiratory symptom 21.07 18.02 22 78212 4230 90545983
Vascular occlusion 21.04 18.02 13 78221 1175 90549038
Acute respiratory failure 21.01 18.02 83 78151 42835 90507378
Myocardial infarction 21.01 18.02 37 78197 105935 90444278
Encephalitis autoimmune 20.95 18.02 16 78218 2042 90548171
Splenic infection fungal 20.87 18.02 5 78229 28 90550185
Follicular lymphoma 20.87 18.02 9 78225 383 90549830
Paranasal sinus mucosal hypertrophy 20.72 18.02 5 78229 29 90550184
Metastases to breast 20.71 18.02 9 78225 390 90549823
Hypovolaemic shock 20.69 18.02 28 78206 7066 90543147
Hypophosphataemia 20.66 18.02 42 78192 14812 90535401
Atypical haemolytic uraemic syndrome 20.55 18.02 12 78222 979 90549234
Hypoglycaemia 20.55 18.02 18 78216 69830 90480383
Swollen tongue 20.54 18.02 7 78227 45949 90504264
VIth nerve paresis 20.50 18.02 6 78228 79 90550134
Listeria encephalitis 20.49 18.02 8 78226 263 90549950
Deep vein thrombosis 20.22 18.02 142 78092 91478 90458735
Blood stem cell harvest failure 20.16 18.02 6 78228 84 90550129
Meningitis aseptic 20.16 18.02 27 78207 6746 90543467
B-cell lymphoma 20.13 18.02 20 78214 3626 90546587
Herpes simplex viraemia 20.07 18.02 9 78225 421 90549792
Vascular compression 20.05 18.02 8 78226 279 90549934
Hepatic function abnormal 19.89 18.02 86 78148 46202 90504011
Ovarian cancer recurrent 19.89 18.02 14 78220 1576 90548637
Embolism 19.82 18.02 32 78202 9449 90540764
Ileus 19.79 18.02 44 78190 16502 90533711
Abortion spontaneous 19.78 18.02 11 78223 54045 90496168
Polyneuropathy in malignant disease 19.72 18.02 6 78228 91 90550122
Herpes simplex pneumonia 19.72 18.02 6 78228 91 90550122
Chylothorax 19.69 18.02 9 78225 440 90549773
Adrenocortical insufficiency acute 19.66 18.02 17 78217 2584 90547629
Uterine enlargement 19.54 18.02 13 78221 1335 90548878
Vulvovaginal inflammation 19.41 18.02 12 78222 1086 90549127
Small cell carcinoma 19.33 18.02 7 78227 186 90550027
Intra-abdominal haemorrhage 19.32 18.02 17 78217 2645 90547568
Hyponatraemia 19.26 18.02 188 78046 133350 90416863
Rhinorrhoea 19.22 18.02 29 78205 88287 90461926
Enterovirus test positive 19.19 18.02 7 78227 190 90550023
Precocious puberty 19.18 18.02 8 78226 313 90549900
Mesenteric haemorrhage 19.11 18.02 5 78229 42 90550171
Visual impairment 19.07 18.02 55 78179 132310 90417903
Disseminated mucormycosis 19.07 18.02 10 78224 661 90549552
Basal cell carcinoma 19.04 18.02 3 78231 33386 90516827
Deafness bilateral 18.95 18.02 14 78220 1699 90548514
Hepatosplenic candidiasis 18.92 18.02 8 78226 324 90549889
Stress cardiomyopathy 18.86 18.02 38 78196 13317 90536896
Sedation 18.82 18.02 9 78225 48162 90502051
Haemoglobinaemia 18.81 18.02 6 78228 107 90550106
Sinusitis aspergillus 18.71 18.02 6 78228 109 90550104
Dehydration 18.71 18.02 253 77981 194194 90356019
Cerebral cavernous malformation 18.69 18.02 4 78230 12 90550201
Metastases to heart 18.66 18.02 7 78227 206 90550007
Plasmacytoma 18.62 18.02 17 78217 2776 90547437
Hypoglossal nerve paresis 18.51 18.02 6 78228 113 90550100
Limb discomfort 18.45 18.02 5 78229 38055 90512158
Deafness neurosensory 18.45 18.02 26 78208 6815 90543398
Angiocentric lymphoma 18.39 18.02 10 78224 711 90549502
Urinary tract infection 18.30 18.02 172 78062 305460 90244753
Klebsiella test positive 18.26 18.02 13 78221 1490 90548723
Vertigo 18.21 18.02 20 78214 69791 90480422
Ewing's sarcoma 18.17 18.02 3 78231 0 90550213
Anti-neuronal antibody 18.17 18.02 3 78231 0 90550213
Epiglottitis 18.10 18.02 9 78225 532 90549681
Tachycardia 18.09 18.02 212 78022 157461 90392752
Mucosal erosion 18.03 18.02 14 78220 1831 90548382
Heart rate decreased 18.02 18.02 12 78222 53493 90496720

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 3900.41 14.98 3403 102463 182300 42333169
Disease progression 1522.31 14.98 1826 104040 141830 42373639
Myelosuppression 1290.17 14.98 951 104915 39510 42475959
Neutropenia 1193.09 14.98 1925 103941 197506 42317963
Off label use 984.16 14.98 3632 102234 634703 41880766
Pancytopenia 942.63 14.98 1304 104562 116439 42399030
Mucosal inflammation 861.09 14.98 819 105047 48555 42466914
Bone marrow failure 813.28 14.98 667 105199 32426 42483043
Thrombocytopenia 812.64 14.98 1586 104280 188693 42326776
Acute myeloid leukaemia 802.47 14.98 564 105302 21692 42493777
Haematotoxicity 601.69 14.98 362 105504 10623 42504846
Myelodysplastic syndrome 597.94 14.98 477 105389 22268 42493201
Therapy partial responder 548.00 14.98 430 105436 19591 42495878
Product use in unapproved indication 490.23 14.98 1274 104592 183182 42332287
Tumour lysis syndrome 457.79 14.98 405 105461 21826 42493643
Malignant neoplasm progression 439.15 14.98 885 104981 107515 42407954
Neoplasm progression 425.30 14.98 438 105428 28562 42486907
Venoocclusive liver disease 418.23 14.98 281 105585 10021 42505448
Second primary malignancy 397.91 14.98 265 105601 9310 42506159
Septic shock 391.13 14.98 765 105101 90907 42424562
Neutrophil count decreased 363.58 14.98 602 105264 62813 42452656
Sepsis 358.92 14.98 1199 104667 198135 42317334
Diffuse large B-cell lymphoma recurrent 356.00 14.98 194 105672 4692 42510777
Neutropenic sepsis 343.31 14.98 298 105568 15648 42499821
Product dose omission issue 304.98 14.98 20 105846 154345 42361124
Fall 303.89 14.98 102 105764 234418 42281051
Febrile bone marrow aplasia 281.39 14.98 220 105646 9961 42505508
Cytopenia 266.88 14.98 270 105596 17227 42498242
Renal salt-wasting syndrome 256.01 14.98 77 105789 339 42515130
Leukopenia 228.17 14.98 545 105321 74201 42441268
Arthralgia 225.78 14.98 114 105752 205124 42310345
Haemophagocytic lymphohistiocytosis 219.30 14.98 248 105618 17974 42497495
Diffuse large B-cell lymphoma refractory 205.37 14.98 100 105766 1897 42513572
Neutropenic colitis 201.01 14.98 130 105736 4340 42511129
Dizziness 198.53 14.98 196 105670 249058 42266411
Cardiotoxicity 188.88 14.98 153 105713 7292 42508177
Inappropriate schedule of product administration 184.77 14.98 14 105852 95888 42419581
Pyrexia 184.76 14.98 1635 104231 392407 42123062
Fungal infection 181.07 14.98 234 105632 19488 42495981
Disease recurrence 179.77 14.98 289 105577 29389 42486080
Fatigue 178.86 14.98 525 105341 435116 42080353
Anaemia 175.14 14.98 1243 104623 279035 42236434
Malignant transformation 174.47 14.98 72 105794 906 42514563
Cystitis haemorrhagic 174.17 14.98 145 105721 7184 42508285
Overdose 173.42 14.98 27 105839 105237 42410232
Drug interaction 171.08 14.98 249 105617 266750 42248719
Bacteraemia 168.58 14.98 256 105610 24784 42490685
Pain 167.23 14.98 218 105648 244630 42270839
Malaise 161.87 14.98 173 105693 211983 42303486
Drug ineffective 161.32 14.98 2321 103545 627876 41887593
Anxiety 159.70 14.98 48 105818 118512 42396957
Aplasia 158.96 14.98 116 105750 4727 42510742
Stomatitis 157.87 14.98 371 105495 49958 42465511
Hypogammaglobulinaemia 157.16 14.98 170 105696 11721 42503748
Venoocclusive disease 152.22 14.98 104 105762 3811 42511658
Depression 151.98 14.98 44 105822 111319 42404150
Blood lactate dehydrogenase increased 151.20 14.98 249 105617 25832 42489637
Rash 150.79 14.98 287 105579 276667 42238802
Bronchopulmonary aspergillosis 150.15 14.98 212 105654 19217 42496252
Posterior reversible encephalopathy syndrome 148.35 14.98 171 105695 12650 42502819
Neoplasm recurrence 147.13 14.98 89 105777 2635 42512834
Drug ineffective for unapproved indication 145.56 14.98 341 105525 45822 42469647
Blood pressure increased 145.24 14.98 37 105829 101891 42413578
Somnolence 143.99 14.98 86 105780 141019 42374450
Pruritus 138.39 14.98 159 105707 188612 42326857
Peripheral swelling 138.15 14.98 28 105838 90242 42425227
Respiratory failure 138.00 14.98 657 105209 127475 42387994
Insomnia 137.10 14.98 61 105805 118192 42397277
Joint swelling 136.68 14.98 8 105858 68014 42447455
Lymphadenopathy 134.31 14.98 272 105594 33093 42482376
Platelet count decreased 133.23 14.98 688 105178 137893 42377576
BK virus infection 132.92 14.98 135 105731 8649 42506820
Tremor 132.80 14.98 38 105828 96891 42418578
Aspergillus infection 130.14 14.98 178 105688 15659 42499810
Intentional product misuse 125.23 14.98 7 105859 61893 42453576
Clostridium difficile colitis 124.67 14.98 204 105662 21048 42494421
Asthma 120.28 14.98 9 105857 62305 42453164
Nasopharyngitis 118.68 14.98 31 105835 83965 42431504
Acute graft versus host disease 118.41 14.98 123 105743 8092 42507377
Headache 116.75 14.98 264 105602 239105 42276364
Therapy non-responder 114.00 14.98 341 105525 53018 42462451
Pulmonary toxicity 111.35 14.98 122 105744 8533 42506936
Cytokine release syndrome 108.14 14.98 298 105568 44229 42471240
Hospitalisation 107.78 14.98 26 105840 74304 42441165
Musculoskeletal stiffness 106.93 14.98 10 105856 57755 42457714
White blood cell count decreased 106.69 14.98 549 105317 109847 42405622
Encephalopathy 104.75 14.98 281 105585 41052 42474417
Stem cell transplant 103.93 14.98 71 105795 2601 42512868
Hepatitis B reactivation 103.47 14.98 88 105778 4490 42510979
Progressive multifocal leukoencephalopathy 102.96 14.98 135 105731 11401 42504068
Lymphoid tissue hypoplasia 102.58 14.98 48 105818 830 42514639
Neuropathy peripheral 102.26 14.98 512 105354 101341 42414128
Weight increased 101.71 14.98 72 105794 107911 42407558
Lymphopenia 101.71 14.98 188 105678 21375 42494094
Incorrect dose administered 101.25 14.98 8 105858 52966 42462503
Thymus hypoplasia 100.33 14.98 47 105819 815 42514654
Sleep disorder 98.66 14.98 5 105861 48090 42467379
Colitis 97.94 14.98 296 105570 46276 42469193
Agranulocytosis 96.33 14.98 226 105640 30386 42485083
Cytomegalovirus infection 94.66 14.98 232 105634 32074 42483395
Gastrointestinal toxicity 93.04 14.98 78 105788 3901 42511568
Candida infection 92.76 14.98 181 105685 21429 42494040
Multiple organ dysfunction syndrome 92.66 14.98 481 105385 96554 42418915
Engraftment syndrome 92.49 14.98 52 105814 1338 42514131
Chronic graft versus host disease 91.89 14.98 93 105773 5932 42509537
Epstein-Barr virus infection 91.85 14.98 117 105749 9601 42505868
Drug hypersensitivity 91.35 14.98 68 105798 99321 42416148
Muscle spasms 91.22 14.98 50 105816 85994 42429475
Cardiac failure congestive 90.37 14.98 50 105816 85552 42429917
Myalgia 89.25 14.98 65 105801 96015 42419454
Metastases to central nervous system 89.05 14.98 119 105747 10236 42505233
Abdominal discomfort 88.49 14.98 38 105828 75217 42440252
Coronary artery disease 87.94 14.98 14 105852 53706 42461763
Feeling abnormal 87.37 14.98 32 105834 69754 42445715
Disseminated aspergillosis 86.99 14.98 54 105812 1676 42513793
Drug resistance 86.94 14.98 233 105633 34015 42481454
Staphylococcal bacteraemia 86.88 14.98 122 105744 10999 42504470
Acute graft versus host disease in skin 84.17 14.98 98 105768 7326 42508143
Aggression 83.48 14.98 7 105859 44156 42471313
Dyspnoea 82.80 14.98 703 105163 441918 42073551
Loss of personal independence in daily activities 81.50 14.98 13 105853 49803 42465666
Pain in extremity 80.99 14.98 157 105709 150447 42365022
Nephropathy toxic 80.91 14.98 148 105718 16690 42498779
Acute myeloid leukaemia recurrent 80.38 14.98 68 105798 3444 42512025
Neurotoxicity 80.37 14.98 180 105686 23471 42491998
Myocardial infarction 79.90 14.98 115 105751 123894 42391575
Diabetes mellitus 79.65 14.98 25 105841 60062 42455407
Bacterial sepsis 79.30 14.98 89 105777 6393 42509076
Pneumonitis 79.27 14.98 256 105610 41462 42474007
Infection 79.25 14.98 513 105353 111555 42403914
Anaplastic lymphoma kinase gene mutation 76.15 14.98 23 105843 103 42515366
Cytomegalovirus chorioretinitis 75.54 14.98 74 105792 4537 42510932
Cytomegalovirus infection reactivation 74.82 14.98 114 105752 11064 42504405
Adenovirus infection 74.07 14.98 88 105778 6721 42508748
Weight decreased 73.63 14.98 267 105599 207681 42307788
B-cell lymphoma recurrent 73.45 14.98 38 105828 824 42514645
Urticaria 71.51 14.98 48 105818 73988 42441481
Gait disturbance 71.24 14.98 83 105783 97917 42417552
Cerebrovascular accident 70.94 14.98 82 105784 97078 42418391
Sweat gland tumour 70.80 14.98 30 105836 405 42515064
Renal tubular disorder 69.85 14.98 73 105793 4836 42510633
Blood glucose increased 69.56 14.98 49 105817 73650 42441819
Chronic obstructive pulmonary disease 69.36 14.98 35 105831 63079 42452390
Graft versus host disease 69.05 14.98 119 105747 12806 42502663
Metastasis 68.80 14.98 71 105795 4634 42510835
Epstein-Barr virus infection reactivation 68.78 14.98 55 105811 2572 42512897
Arthritis 68.76 14.98 11 105855 42054 42473415
Rhabdomyolysis 68.36 14.98 56 105810 77963 42437506
Bradycardia 68.15 14.98 67 105799 85417 42430052
Skin toxicity 66.93 14.98 82 105784 6467 42509002
Enterococcal bacteraemia 65.94 14.98 54 105812 2613 42512856
Osteosarcoma 65.64 14.98 26 105840 292 42515177
Systemic mycosis 64.69 14.98 51 105815 2336 42513133
Balance disorder 64.64 14.98 19 105847 47626 42467843
Hallucination 64.54 14.98 31 105835 57476 42457993
Enterococcal infection 64.52 14.98 111 105755 11928 42503541
Hyperhidrosis 64.35 14.98 78 105788 90434 42425035
Nephrolithiasis 64.02 14.98 8 105858 36822 42478647
Lymphoma 62.74 14.98 121 105745 14200 42501269
Dry skin 62.50 14.98 21 105845 48317 42467152
Haematochezia 61.86 14.98 34 105832 58402 42457067
Diffuse large B-cell lymphoma 61.28 14.98 95 105771 9359 42506110
Heart rate decreased 60.98 14.98 9 105857 36523 42478946
Hepatitis B 60.60 14.98 79 105787 6632 42508837
Escherichia bacteraemia 60.10 14.98 69 105797 5080 42510389
Central nervous system fungal infection 59.93 14.98 27 105839 426 42515043
Drug dependence 59.74 14.98 3 105863 29091 42486378
Hepatotoxicity 59.66 14.98 167 105699 25000 42490469
Rheumatoid arthritis 59.29 14.98 16 105850 42424 42473045
Cytomegalovirus viraemia 58.68 14.98 98 105768 10279 42505190
Vision blurred 58.67 14.98 30 105836 53669 42461800
Electrocardiogram QT prolonged 58.31 14.98 23 105843 47922 42467547
Chest pain 57.07 14.98 168 105698 139362 42376107
Psoriasis 56.40 14.98 25 105841 48579 42466890
Blood stem cell transplant failure 55.70 14.98 26 105840 447 42515022
Bacterial infection 55.62 14.98 174 105692 27705 42487764
Swelling 55.16 14.98 34 105832 54851 42460618
Wheezing 54.97 14.98 34 105832 54747 42460722
Drug reaction with eosinophilia and systemic symptoms 54.88 14.98 18 105848 42057 42473412
Paraneoplastic neurological syndrome 54.76 14.98 17 105849 85 42515384
Brain sarcoma 54.37 14.98 14 105852 29 42515440
Death 54.31 14.98 834 105032 470351 42045118
Angioedema 53.97 14.98 19 105847 42458 42473011
Cardiac disorder 53.96 14.98 27 105839 48905 42466564
Klebsiella infection 53.68 14.98 99 105767 11233 42504236
Graft versus host disease in gastrointestinal tract 53.54 14.98 65 105801 5078 42510391
Hyperkalaemia 53.41 14.98 73 105793 80385 42435084
Viral haemorrhagic cystitis 53.25 14.98 41 105825 1813 42513656
Acute promyelocytic leukaemia 52.99 14.98 29 105837 707 42514762
Contusion 52.97 14.98 19 105847 41966 42473503
Leukaemia recurrent 52.83 14.98 41 105825 1835 42513634
Azoospermia 52.70 14.98 26 105840 508 42514961
Gastrooesophageal reflux disease 52.49 14.98 23 105843 45000 42470469
Retinal haemorrhage 52.22 14.98 68 105798 5702 42509767
Back pain 52.17 14.98 179 105687 141597 42373872
Sedation 52.05 14.98 7 105859 30468 42485001
Escherichia infection 52.03 14.98 98 105768 11298 42504171
Serotonin syndrome 52.02 14.98 3 105863 25842 42489627
Metastases to lung 51.86 14.98 98 105768 11326 42504143
Blood pressure systolic increased 51.33 14.98 5 105861 27963 42487506
Eczema 51.24 14.98 11 105855 34075 42481394
Migraine 51.00 14.98 3 105863 25411 42490058
Skin exfoliation 50.42 14.98 20 105846 41533 42473936
Prostate cancer 50.19 14.98 24 105842 44619 42470850
Accidental overdose 49.62 14.98 6 105860 28324 42487145
Acute respiratory distress syndrome 49.47 14.98 176 105690 29932 42485537
Memory impairment 49.25 14.98 32 105834 50190 42465279
Ameloblastoma 48.97 14.98 16 105850 97 42515372
Dry mouth 48.71 14.98 19 105847 39860 42475609
Metastases to liver 48.62 14.98 118 105748 16208 42499261
Blood cholesterol increased 48.51 14.98 5 105861 26736 42488733
Influenza like illness 48.43 14.98 10 105856 31830 42483639
Neuroblastoma 48.37 14.98 21 105845 302 42515167
Vena cava thrombosis 48.10 14.98 36 105830 1525 42513944
Abdominal pain upper 48.05 14.98 82 105784 82527 42432942
Refractory cancer 48.02 14.98 18 105848 172 42515297
Pseudomonal bacteraemia 47.99 14.98 43 105823 2353 42513116
Chloroma 47.91 14.98 25 105841 552 42514917
Wrong technique in product usage process 47.81 14.98 23 105843 42612 42472857
Hypoglycaemia 47.59 14.98 47 105819 59807 42455662
Epstein-Barr virus associated lymphoproliferative disorder 47.28 14.98 43 105823 2400 42513069
Flagellate dermatitis 47.14 14.98 16 105850 111 42515358
Adverse drug reaction 47.12 14.98 17 105849 37417 42478052
Lactic acidosis 46.94 14.98 27 105839 45234 42470235
Pneumonia klebsiella 46.57 14.98 55 105811 4174 42511295
Graft versus host disease in skin 46.51 14.98 61 105805 5151 42510318
Thrombotic microangiopathy 46.35 14.98 109 105757 14673 42500796
Peripheral sensory neuropathy 45.92 14.98 80 105786 8682 42506787
Toxicity to various agents 45.85 14.98 357 105509 228779 42286690
Blood creatine phosphokinase increased 45.79 14.98 32 105834 48306 42467163
Immune effector cell-associated neurotoxicity syndrome 45.25 14.98 83 105783 9378 42506091
Mucormycosis 45.21 14.98 71 105795 7072 42508397
Disseminated intravascular coagulation 45.15 14.98 150 105716 24644 42490825
Eosinophilia 44.84 14.98 13 105853 32886 42482583
Influenza 44.80 14.98 53 105813 62122 42453347
Pneumocystis jirovecii pneumonia 44.67 14.98 151 105715 25030 42490439
Neoplasm 44.61 14.98 66 105800 6239 42509230
Medulloblastoma recurrent 44.58 14.98 15 105851 101 42515368
Nightmare 44.54 14.98 5 105861 25007 42490462
Treatment noncompliance 44.31 14.98 19 105847 37653 42477816
Unevaluable event 44.14 14.98 15 105851 34273 42481196
Oedema peripheral 44.07 14.98 181 105685 135895 42379574
Loss of consciousness 44.00 14.98 103 105763 92251 42423218
Peripheral T-cell lymphoma unspecified 43.97 14.98 24 105842 582 42514887
Pulmonary vascular disorder 43.79 14.98 25 105841 663 42514806
Abdominal distension 43.78 14.98 69 105797 71666 42443803
Fanconi syndrome 43.67 14.98 36 105830 1758 42513711
Ototoxicity 43.19 14.98 40 105826 2285 42513184
Diaphragm muscle weakness 42.95 14.98 16 105850 150 42515319
Hypertransaminasaemia 42.94 14.98 80 105786 9147 42506322
Metastases to meninges 42.90 14.98 37 105829 1924 42513545
Metastases to lymph nodes 42.75 14.98 63 105803 5935 42509534
Cerebellar tumour 42.35 14.98 15 105851 120 42515349
Salivary gland cancer 41.27 14.98 19 105847 316 42515153
Heart rate increased 41.00 14.98 43 105823 53212 42462257
Vertigo 40.91 14.98 17 105849 34330 42481139
Therapy interrupted 40.78 14.98 4 105862 22246 42493223
Thrombosis 40.77 14.98 67 105799 68444 42447025
Aortic thrombosis 40.59 14.98 28 105838 1042 42514427
Encephalitis enteroviral 40.37 14.98 16 105850 180 42515289
Pulmonary arteriopathy 40.19 14.98 13 105853 76 42515393
Medication error 40.16 14.98 16 105850 33138 42482331
Klebsiella sepsis 39.93 14.98 41 105825 2660 42512809
Systemic candida 39.55 14.98 57 105809 5262 42510207
Recurrent cancer 39.54 14.98 33 105833 1640 42513829
Pseudomonas infection 39.06 14.98 107 105759 15816 42499653
Escherichia sepsis 39.01 14.98 59 105807 5688 42509781
Papillary thyroid cancer 38.83 14.98 24 105842 739 42514730
Depressed mood 38.48 14.98 6 105860 23378 42492091
Graft versus host disease in liver 38.05 14.98 32 105834 1607 42513862
Benign prostatic hyperplasia 38.02 14.98 4 105862 21048 42494421
Hepatic candidiasis 37.56 14.98 12 105854 67 42515402
Neuroblastoma recurrent 37.53 14.98 19 105847 393 42515076
Rhabdomyosarcoma recurrent 37.51 14.98 14 105852 132 42515337
Confusional state 37.42 14.98 253 105613 167344 42348125
Spinal column injury 37.18 14.98 22 105844 625 42514844
Klebsiella bacteraemia 36.98 14.98 37 105829 2327 42513142
Acute lymphocytic leukaemia 36.76 14.98 44 105822 3387 42512082
Therapy cessation 36.64 14.98 4 105862 20446 42495023
Transient ischaemic attack 36.63 14.98 19 105847 33720 42481749
Accidental exposure to product 36.51 14.98 4 105862 20389 42495080
Teratoma 36.47 14.98 10 105856 29 42515440
Hepatosplenomegaly 36.22 14.98 51 105815 4609 42510860
Cardio-respiratory arrest 36.16 14.98 56 105810 58580 42456889
Streptococcal infection 36.14 14.98 59 105807 6073 42509396
Metastases to peritoneum 35.89 14.98 37 105829 2412 42513057
Dehydration 35.79 14.98 206 105660 141561 42373908
Psoriatic arthropathy 35.66 14.98 9 105857 24958 42490511
Agitation 35.45 14.98 66 105800 64248 42451221
Pneumonia adenoviral 35.44 14.98 18 105848 375 42515094
Osteonecrosis 35.39 14.98 103 105763 15762 42499707
Minimal residual disease 35.38 14.98 21 105845 600 42514869
Mobility decreased 35.29 14.98 22 105844 35284 42480185
Pulmonary veno-occlusive disease 35.10 14.98 21 105845 609 42514860
Acute monocytic leukaemia 34.93 14.98 18 105848 387 42515082
Acute graft versus host disease in intestine 34.88 14.98 46 105820 3905 42511564
Palpitations 34.81 14.98 45 105821 50752 42464717
Adenoviral hepatitis 34.74 14.98 20 105846 539 42514930
Urinary tract infection 34.74 14.98 128 105738 99156 42416313
Mantle cell lymphoma recurrent 34.70 14.98 25 105841 998 42514471
Dyskinesia 34.66 14.98 10 105856 25380 42490089
Colitis ulcerative 34.49 14.98 11 105855 26164 42489305
Fusarium infection 34.36 14.98 30 105836 1586 42513883
Full blood count abnormal 33.68 14.98 16 105850 29860 42485609
Fat embolism syndrome 33.35 14.98 11 105855 69 42515400
Juvenile melanoma benign 33.08 14.98 11 105855 71 42515398
Ganglioneuroblastoma 32.60 14.98 9 105857 27 42515442
Flatulence 32.38 14.98 11 105855 25141 42490328
Head injury 32.28 14.98 6 105860 20576 42494893
Hyperlipidaemia 32.22 14.98 7 105859 21509 42493960
Frequent bowel movements 31.99 14.98 7 105859 21400 42494069
Gout 31.66 14.98 15 105851 28040 42487429
Abnormal behaviour 31.65 14.98 13 105853 26438 42489031
Swollen tongue 31.61 14.98 7 105859 21224 42494245
Gastrointestinal mucosal disorder 31.54 14.98 18 105848 477 42514992
Retinopathy proliferative 31.50 14.98 11 105855 84 42515385
Faeces discoloured 31.33 14.98 3 105863 17011 42498458
Arteriosclerosis 31.04 14.98 4 105862 17985 42497484
Ill-defined disorder 30.94 14.98 100 105766 16196 42499273
Therapeutic product effect decreased 30.82 14.98 31 105835 39119 42476350
Cardiogenic shock 30.69 14.98 26 105840 35614 42479855
Body height below normal 30.68 14.98 14 105852 228 42515241
Condition aggravated 30.45 14.98 460 105406 260294 42255175
Pneumonia fungal 30.39 14.98 69 105797 9077 42506392
Carotid artery thrombosis 30.11 14.98 16 105850 367 42515102
Asthenia 29.90 14.98 504 105362 280289 42235180
Cytogenetic abnormality 29.87 14.98 22 105844 909 42514560
Human herpesvirus 6 infection 29.75 14.98 34 105832 2491 42512978
JC virus infection 29.71 14.98 37 105829 2967 42512502
International normalised ratio increased 29.70 14.98 46 105820 48122 42467347
Extravasation 29.55 14.98 33 105833 2357 42513112
Amnesia 29.43 14.98 17 105849 28420 42487049
Discomfort 29.21 14.98 13 105853 25206 42490263
Bronchitis 29.18 14.98 45 105821 47156 42468313
Metastases to retroperitoneum 29.11 14.98 14 105852 258 42515211
Rectal haemorrhage 29.06 14.98 49 105817 49557 42465912
Metastatic lymphoma 28.98 14.98 16 105850 397 42515072
Chromaturia 28.97 14.98 3 105863 15986 42499483
Myoclonus 28.95 14.98 4 105862 17061 42498408
Hypoalbuminaemia 28.92 14.98 95 105771 15515 42499954
Radiation pneumonitis 28.81 14.98 36 105830 2897 42512572
Hypertension 28.72 14.98 271 105595 166933 42348536
Syncope 28.68 14.98 138 105728 99268 42416201
Nervous system disorder 28.66 14.98 101 105765 17094 42498375
Nasal congestion 28.64 14.98 19 105847 29482 42485987
Intestinal perforation 28.62 14.98 75 105791 10799 42504670
Metastases to spleen 28.44 14.98 17 105849 492 42514977
Pulmonary haemorrhage 28.37 14.98 77 105789 11320 42504149
Delayed puberty 28.14 14.98 13 105853 218 42515251
Pneumonia aspiration 27.94 14.98 51 105815 50027 42465442
Aspiration bone marrow abnormal 27.73 14.98 11 105855 124 42515345
Obesity 27.59 14.98 4 105862 16455 42499014
Incorrect route of product administration 27.42 14.98 13 105853 24292 42491177
Product administration error 27.41 14.98 6 105860 18337 42497132
Burning sensation 27.38 14.98 9 105857 21004 42494465
Fluid retention 27.31 14.98 23 105843 31596 42483873
Granulocyte count decreased 27.23 14.98 26 105840 1544 42513925
Dyspnoea exertional 27.16 14.98 52 105814 50096 42465373
Metastases to muscle 27.11 14.98 13 105853 238 42515231
Road traffic accident 27.04 14.98 7 105859 19086 42496383
Hyperbilirubinaemia 26.82 14.98 112 105754 20523 42494946
Emotional distress 26.77 14.98 4 105862 16089 42499380
Choriocarcinoma 26.72 14.98 7 105859 16 42515453
Enterocolitis 26.66 14.98 69 105797 9860 42505609
Transformation to acute myeloid leukaemia 26.54 14.98 22 105844 1083 42514386
Hepatic infection fungal 26.39 14.98 13 105853 253 42515216
Laboratory test abnormal 26.37 14.98 12 105854 22966 42492503
Arrhythmia 26.32 14.98 37 105829 40280 42475189
Paraneoplastic encephalomyelitis 26.14 14.98 7 105859 18 42515451
Central nervous system lymphoma 26.06 14.98 24 105842 1361 42514108
T-cell type acute leukaemia 26.04 14.98 12 105854 200 42515269
Enteritis 25.85 14.98 72 105794 10744 42504725
Cellulitis gangrenous 25.72 14.98 13 105853 268 42515201
Speech disorder 25.37 14.98 21 105845 29100 42486369
Obstructive airways disorder 25.34 14.98 15 105851 24744 42490725
Herpes simplex 25.23 14.98 55 105811 7040 42508429
Bicytopenia 24.97 14.98 35 105831 3149 42512320
Embolism 24.67 14.98 62 105804 8701 42506768
Intestinal atresia 24.48 14.98 9 105857 81 42515388
Hypoaesthesia 24.42 14.98 93 105773 71370 42444099
Cardiac arrest 24.40 14.98 165 105701 109155 42406314
Arteriosclerosis coronary artery 24.34 14.98 8 105858 18669 42496800
Paraesthesia 24.21 14.98 97 105769 73362 42442107
Primitive neuroectodermal tumour 24.19 14.98 9 105857 84 42515385
Papilloedema 24.12 14.98 35 105831 3251 42512218
Neutrophil count abnormal 24.06 14.98 32 105834 2739 42512730
Rickets 24.01 14.98 8 105858 52 42515417
Blood pressure decreased 23.99 14.98 70 105796 58262 42457207
Liver function test abnormal 23.99 14.98 27 105839 32364 42483105
Coronary artery thrombosis 23.97 14.98 29 105837 2257 42513212
Type 2 diabetes mellitus 23.91 14.98 8 105858 18463 42497006
Iris atrophy 23.74 14.98 9 105857 89 42515380
Blood electrolytes abnormal 23.62 14.98 20 105846 1014 42514455
Hypersomnia 23.49 14.98 4 105862 14614 42500855
Troponin increased 23.41 14.98 9 105857 19053 42496416
Hepatic steatosis 23.40 14.98 12 105854 21436 42494033
Staphylococcal infection 23.39 14.98 167 105699 37476 42477993
Stevens-Johnson syndrome 23.32 14.98 13 105853 22165 42493304
Device issue 23.32 14.98 3 105863 13506 42501963
Candida sepsis 23.32 14.98 23 105843 1422 42514047
Superior vena cava syndrome 23.18 14.98 17 105849 698 42514771
Miosis 23.17 14.98 3 105863 13443 42502026
Psychotic disorder 23.14 14.98 23 105843 29185 42486284
Pleuroparenchymal fibroelastosis 23.08 14.98 10 105856 143 42515326
Myelopathy 23.00 14.98 32 105834 2859 42512610
Streptococcal bacteraemia 22.97 14.98 31 105835 2691 42512778
Wound 22.90 14.98 7 105859 17110 42498359
Diarrhoea 22.81 14.98 925 104941 459924 42055545
Central nervous system enteroviral infection 22.81 14.98 8 105858 62 42515407
Limb injury 22.80 14.98 4 105862 14301 42501168
Lymphoma transformation 22.76 14.98 15 105851 517 42514952
Small cell lung cancer 22.66 14.98 27 105839 2068 42513401
Toxic encephalopathy 22.59 14.98 52 105814 6901 42508568
Hypertensive hydrocephalus 22.59 14.98 8 105858 64 42515405
Haemorrhage 22.57 14.98 76 105790 60487 42454982
Basal cell naevus syndrome 22.55 14.98 7 105859 35 42515434
Ventricular tachycardia 22.49 14.98 25 105841 30135 42485334
Parasitic gastroenteritis 22.47 14.98 10 105856 153 42515316
Toxic epidermal necrolysis 22.44 14.98 20 105846 26730 42488739
Delirium 22.35 14.98 62 105804 52457 42463012
B-cell lymphoma refractory 22.34 14.98 11 105855 214 42515255
Intussusception 22.27 14.98 17 105849 742 42514727
Renal failure 22.25 14.98 490 105376 143236 42372233
Injury 22.17 14.98 14 105852 22302 42493167
Reticulocytosis 22.09 14.98 12 105854 288 42515181
Deafness neurosensory 22.02 14.98 36 105830 3710 42511759
Underdose 21.96 14.98 7 105859 16659 42498810
Device related infection 21.78 14.98 104 105762 20175 42495294
Gait inability 21.77 14.98 15 105851 22818 42492651
Carbamoyl phosphate synthetase deficiency 21.73 14.98 6 105860 18 42515451
Aplastic anaemia 21.73 14.98 74 105792 12310 42503159
Neurological decompensation 21.71 14.98 36 105830 3753 42511716
Capillary leak syndrome 21.59 14.98 30 105836 2677 42512792
Clostridium colitis 21.58 14.98 23 105843 1558 42513911
Adenovirus reactivation 21.57 14.98 13 105853 382 42515087
Constipation 21.51 14.98 279 105587 162012 42353457
Drug level increased 21.49 14.98 20 105846 26180 42489289
Mediastinum neoplasm 21.49 14.98 6 105860 19 42515450
Myeloid leukaemia 21.47 14.98 14 105852 474 42514995
Cholelithiasis 21.39 14.98 16 105850 23330 42492139
Bronchiectasis 21.33 14.98 9 105857 18010 42497459
Escherichia test positive 21.27 14.98 21 105845 1300 42514169
Cerebral cavernous malformation 21.21 14.98 7 105859 44 42515425
Pollakiuria 21.18 14.98 15 105851 22490 42492979
Traumatic lung injury 21.12 14.98 21 105845 1311 42514158
Arterial thrombosis 21.07 14.98 24 105842 1752 42513717
Acute lymphocytic leukaemia recurrent 21.06 14.98 35 105831 3656 42511813
Therapy responder 21.01 14.98 10 105856 180 42515289
Hip fracture 20.97 14.98 4 105862 13468 42502001
Tooth hypoplasia 20.83 14.98 11 105855 249 42515220
Prostatic specific antigen increased 20.77 14.98 8 105858 16917 42498552
Pneumonia cytomegaloviral 20.75 14.98 37 105829 4089 42511380
Epstein-Barr viraemia 20.75 14.98 27 105839 2262 42513207
Heart rate irregular 20.69 14.98 7 105859 16043 42499426
Adverse event 20.66 14.98 17 105849 23623 42491846
Leukoencephalopathy 20.66 14.98 41 105825 4913 42510556
Encephalitis autoimmune 20.53 14.98 21 105845 1356 42514113
Central nervous system necrosis 20.48 14.98 11 105855 258 42515211
Erectile dysfunction 20.46 14.98 19 105847 24894 42490575
Atrial fibrillation 20.38 14.98 235 105631 139358 42376111
Sopor 20.38 14.98 4 105862 13198 42502271
Hydrocephalus 20.35 14.98 46 105820 6032 42509437
Post-acute COVID-19 syndrome 20.31 14.98 13 105853 426 42515043
Refractory anaemia with an excess of blasts 20.31 14.98 12 105854 340 42515129
Autoimmune haemolytic anaemia 20.21 14.98 44 105822 5627 42509842
Interstitial lung disease 20.19 14.98 290 105576 78172 42437297
Gastrointestinal fungal infection 20.18 14.98 11 105855 266 42515203
Breath sounds abnormal 20.13 14.98 3 105863 12090 42503379
Hepatic cirrhosis 20.08 14.98 12 105854 19690 42495779
Cataract 20.06 14.98 28 105838 30576 42484893
Pulmonary congestion 20.04 14.98 7 105859 15723 42499746
Chronic myelomonocytic leukaemia 20.03 14.98 16 105850 747 42514722
Premature ageing 20.03 14.98 8 105858 92 42515377
Iron deficiency anaemia 20.03 14.98 4 105862 13035 42502434
Subdural hygroma 19.96 14.98 13 105853 439 42515030
Norovirus infection 19.96 14.98 16 105850 751 42514718
Metastases to bone 19.73 14.98 81 105785 14728 42500741
Angina pectoris 19.72 14.98 32 105834 32864 42482605
Disorder of orbit 19.72 14.98 8 105858 96 42515373
Small intestinal perforation 19.69 14.98 30 105836 2911 42512558
Enterovirus test positive 19.65 14.98 8 105858 97 42515372
Diabetic ketoacidosis 19.65 14.98 16 105850 22351 42493118
Blood fibrinogen decreased 19.59 14.98 22 105844 1581 42513888
Adrenocortical carcinoma 19.49 14.98 6 105860 29 42515440
Flushing 19.49 14.98 158 105708 36870 42478599
Lethargy 19.48 14.98 56 105810 46834 42468635
Diabetes mellitus inadequate control 19.35 14.98 7 105859 15383 42500086
Geotrichum infection 19.34 14.98 14 105852 563 42514906
Toxocariasis 19.33 14.98 6 105860 30 42515439
Testicular malignant teratoma 19.21 14.98 5 105861 11 42515458
Transplant rejection 19.21 14.98 5 105861 13583 42501886
Human rhinovirus test positive 19.19 14.98 11 105855 294 42515175
Acute graft versus host disease in liver 19.18 14.98 24 105842 1934 42513535
Bone sarcoma 19.04 14.98 7 105859 63 42515406
Ageusia 19.04 14.98 3 105863 11602 42503867
Rhinorrhoea 19.00 14.98 31 105835 31763 42483706
Chronic myeloid leukaemia 18.96 14.98 27 105839 2465 42513004
Stomatitis necrotising 18.95 14.98 8 105858 107 42515362
Trichosporon infection 18.90 14.98 17 105849 935 42514534
Pulmonary arterial hypertension 18.87 14.98 62 105804 10125 42505344
Gastric ulcer 18.78 14.98 11 105855 18251 42497218
Bile duct necrosis 18.66 14.98 7 105859 67 42515402
Localised infection 18.62 14.98 14 105852 20359 42495110
Graft complication 18.58 14.98 15 105851 711 42514758
Gallbladder empyema 18.57 14.98 7 105859 68 42515401
Inflammatory pseudotumour 18.56 14.98 6 105860 35 42515434
Parasitic pneumonia 18.56 14.98 6 105860 35 42515434
Critical illness 18.53 14.98 10 105856 237 42515232
Interleukin-2 receptor increased 18.52 14.98 9 105857 170 42515299
Treatment failure 18.38 14.98 237 105629 62387 42453082
Plasma cell myeloma refractory 18.35 14.98 20 105846 1390 42514079
Product substitution issue 18.34 14.98 3 105863 11287 42504182
Dementia 18.31 14.98 9 105857 16471 42498998
Adenomatous polyposis coli 18.28 14.98 9 105857 175 42515294
Hepatitis E 18.26 14.98 30 105836 3104 42512365
Post transplant lymphoproliferative disorder 18.26 14.98 57 105809 9063 42506406
Acanthamoeba infection 18.24 14.98 13 105853 510 42514959
Alpha haemolytic streptococcal infection 18.13 14.98 23 105843 1879 42513590
Encephalitis 18.11 14.98 57 105809 9101 42506368
Varicella zoster virus infection 18.08 14.98 27 105839 2574 42512895
Rash pruritic 18.06 14.98 35 105831 33568 42481901
Plasmacytoma 18.05 14.98 36 105830 4328 42511141
Hypokalaemia 18.02 14.98 264 105602 71457 42444012
Delusion 18.02 14.98 7 105859 14727 42500742
Nocturia 18.02 14.98 4 105862 12108 42503361
Respiratory symptom 17.93 14.98 3 105863 11103 42504366
Radiation hepatitis 17.88 14.98 6 105860 40 42515429
Intervertebral disc protrusion 17.86 14.98 3 105863 11069 42504400
Metastases to testicle 17.80 14.98 7 105859 77 42515392
Parathyroid tumour malignant 17.80 14.98 7 105859 77 42515392
Hepatic failure 17.64 14.98 158 105708 37942 42477527
Biliary abscess 17.63 14.98 6 105860 42 42515427
Acute myeloid leukaemia refractory 17.60 14.98 8 105858 129 42515340
Autoimmune neutropenia 17.56 14.98 11 105855 347 42515122
Visual impairment 17.54 14.98 52 105814 43061 42472408
Pseudomonal sepsis 17.52 14.98 35 105831 4214 42511255
Colony stimulating factor therapy 17.48 14.98 9 105857 193 42515276
5q minus syndrome 17.43 14.98 8 105858 132 42515337
Refractory cytopenia with multilineage dysplasia 17.43 14.98 8 105858 132 42515337
Urinary bladder haematoma 17.42 14.98 5 105861 18 42515451
Ejection fraction decreased 17.39 14.98 104 105762 21983 42493486
Hepatic enzyme increased 17.37 14.98 57 105809 45727 42469742
Abdominal neoplasm 17.36 14.98 12 105854 448 42515021
Acute myelomonocytic leukaemia 17.36 14.98 9 105857 196 42515273
Photosensitivity reaction 17.34 14.98 5 105861 12697 42502772
Hallucination, visual 17.29 14.98 16 105850 21004 42494465
Paternal exposure timing unspecified 17.27 14.98 6 105860 45 42515424
Metastases to chest wall 17.25 14.98 10 105856 273 42515196
Chromosome analysis abnormal 17.24 14.98 9 105857 199 42515270
Hirsutism 17.22 14.98 10 105856 274 42515195
Device related sepsis 17.22 14.98 33 105833 3854 42511615
Irritability 17.21 14.98 27 105839 28101 42487368
Foetal exposure during pregnancy 17.20 14.98 60 105806 47251 42468218
Mucoepidermoid carcinoma 17.01 14.98 5 105861 20 42515449
Blood glucose decreased 16.99 14.98 7 105859 14212 42501257
Subileus 16.98 14.98 31 105835 3490 42511979
Pseudomonas aeruginosa meningitis 16.83 14.98 6 105860 49 42515420
Polyneuropathy 16.75 14.98 91 105775 18570 42496899
Radiation oesophagitis 16.72 14.98 12 105854 476 42514993
Testicular cancer metastatic 16.69 14.98 7 105859 92 42515377
Skin laceration 16.67 14.98 7 105859 14051 42501418
Cerebrospinal fluid leakage 16.63 14.98 14 105852 704 42514765
Paranoia 16.61 14.98 7 105859 14019 42501450
Haematocrit decreased 16.56 14.98 39 105827 34869 42480600
Mental impairment 16.54 14.98 5 105861 12312 42503157
Lower respiratory tract infection fungal 16.52 14.98 13 105853 594 42514875
Peritoneal lesion 16.51 14.98 8 105858 150 42515319
Spindle cell sarcoma 16.42 14.98 8 105858 152 42515317
Neck pain 16.36 14.98 31 105835 29983 42485486
Recall phenomenon 16.35 14.98 13 105853 603 42514866
Distal intestinal obstruction syndrome 16.31 14.98 12 105854 495 42514974
Chest discomfort 16.27 14.98 92 105774 63524 42451945
Platelet count abnormal 16.19 14.98 31 105835 3618 42511851
Clostridium difficile infection 16.15 14.98 104 105762 22555 42492914
Anaplastic large cell lymphoma T- and null-cell types recurrent 16.13 14.98 6 105860 56 42515413
Restlessness 16.13 14.98 30 105836 29219 42486250
Haematoma 16.12 14.98 28 105838 27995 42487474
Endothelial dysfunction 16.10 14.98 7 105859 101 42515368
Clostridial infection 16.08 14.98 32 105834 3842 42511627
Impaired work ability 16.07 14.98 5 105861 12086 42503383
Guillain-Barre syndrome 16.05 14.98 47 105819 7216 42508253
Dyspepsia 16.02 14.98 51 105815 41301 42474168
Burns first degree 15.97 14.98 4 105862 7 42515462
Atypical teratoid/rhabdoid tumour of CNS 15.97 14.98 4 105862 7 42515462
Lung infiltration 15.95 14.98 73 105793 13916 42501553
Septal panniculitis 15.94 14.98 6 105860 58 42515411
Product storage error 15.94 14.98 4 105862 11136 42504333
Dysphonia 15.85 14.98 29 105837 28421 42487048
Body temperature decreased 15.82 14.98 8 105858 14405 42501064
Unresponsive to stimuli 15.78 14.98 34 105832 31369 42484100
Diverticulitis 15.78 14.98 20 105846 22753 42492716
Plasma cells decreased 15.76 14.98 6 105860 60 42515409
Electrolyte imbalance 15.76 14.98 84 105782 17017 42498452
Sudden death 15.76 14.98 11 105855 16618 42498851
Cerebral venous thrombosis 15.75 14.98 16 105850 1025 42514444
Renal disorder 15.73 14.98 30 105836 28950 42486519
Myelitis transverse 15.64 14.98 18 105848 1329 42514140
Pneumonia mycoplasmal 15.63 14.98 14 105852 766 42514703
Retinal pigment epitheliopathy 15.62 14.98 9 105857 243 42515226
Fungaemia 15.62 14.98 28 105838 3108 42512361
Gastritis 15.61 14.98 22 105844 23925 42491544
Delayed engraftment 15.51 14.98 7 105859 111 42515358
Congenital hepatobiliary anomaly 15.49 14.98 5 105861 29 42515440
Dysarthria 15.49 14.98 49 105817 39758 42475711
Drug level decreased 15.45 14.98 3 105863 9974 42505495
Optic ischaemic neuropathy 15.41 14.98 26 105840 2749 42512720
Metastases to bone marrow 15.40 14.98 12 105854 540 42514929
Lacrimation increased 15.38 14.98 5 105861 11753 42503716
Blood urine present 15.33 14.98 5 105861 11728 42503741
Abnormal DNA methylation 15.31 14.98 4 105862 9 42515460
Nodule 15.26 14.98 6 105860 12528 42502941
Meningitis tuberculous 15.24 14.98 13 105853 666 42514803
Sinusitis 15.23 14.98 63 105803 47229 42468240
Paraneoplastic syndrome 15.23 14.98 14 105852 792 42514677
Chemotherapy 15.22 14.98 14 105852 793 42514676
Carnitine deficiency 15.17 14.98 7 105859 117 42515352
Encephalitis cytomegalovirus 15.13 14.98 17 105849 1222 42514247
Fanconi syndrome acquired 15.12 14.98 22 105844 2048 42513421
Plasma cell leukaemia 15.12 14.98 17 105849 1223 42514246
Tumour compression 15.12 14.98 8 105858 182 42515287
Cystitis viral 15.10 14.98 17 105849 1225 42514244
Testicular germ cell cancer metastatic 15.10 14.98 6 105860 68 42515401
Eye disorder 15.08 14.98 5 105861 11607 42503862
Ewing's sarcoma recurrent 15.02 14.98 4 105862 10 42515459
Erythema ab igne 15.00 14.98 3 105863 0 42515469
Li-Fraumeni syndrome 15.00 14.98 3 105863 0 42515469
Haematopoietic stem cell mobilisation 14.99 14.98 10 105856 352 42515117

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 7952.04 14.93 5322 165020 311445 110107512
Neutropenia 2834.19 14.93 3174 167168 371446 110047511
Disease progression 2733.54 14.93 2556 167786 241478 110177479
Pancytopenia 2326.09 14.93 2185 168157 207428 110211529
Myelosuppression 2274.91 14.93 1552 168790 92788 110326169
Mucosal inflammation 2098.77 14.93 1488 168854 94653 110324304
Off label use 1920.78 14.93 5838 164504 1494347 108924610
Thrombocytopenia 1892.08 14.93 2500 167842 346385 110072572
Bone marrow failure 1674.07 14.93 1067 169275 56781 110362176
Acute myeloid leukaemia 1541.59 14.93 872 169470 37238 110381719
Myelodysplastic syndrome 1211.77 14.93 742 169600 36742 110382215
Haematotoxicity 1183.34 14.93 600 169742 20482 110398475
Malignant neoplasm progression 1039.63 14.93 1312 169030 173255 110245702
Sepsis 1019.01 14.93 1815 168527 325531 110093426
Septic shock 912.63 14.93 1168 169174 156360 110262597
Venoocclusive liver disease 889.17 14.93 445 169897 14762 110404195
Product use in unapproved indication 882.80 14.93 2053 168289 445324 109973633
Tumour lysis syndrome 875.47 14.93 562 169780 30239 110388718
Therapy partial responder 820.29 14.93 579 169763 36482 110382475
Second primary malignancy 811.31 14.93 443 169899 17625 110401332
Febrile bone marrow aplasia 709.73 14.93 401 169941 17064 110401893
Neutropenic sepsis 665.74 14.93 474 169868 30272 110388685
Neutrophil count decreased 658.51 14.93 870 169472 120071 110298886
Pain 653.07 14.93 329 170013 954626 109464331
Arthralgia 641.75 14.93 202 170140 779430 109639527
Anaemia 632.95 14.93 2065 168277 545021 109873936
Neoplasm progression 631.20 14.93 629 169713 63966 110354991
Joint swelling 618.95 14.93 13 170329 442832 109976125
Cytopenia 547.74 14.93 418 169924 29698 110389259
Haemophagocytic lymphohistiocytosis 526.09 14.93 416 169926 31143 110387814
Diffuse large B-cell lymphoma recurrent 520.66 14.93 234 170108 6065 110412892
Multiple organ dysfunction syndrome 515.13 14.93 875 169467 150835 110268122
Fall 474.14 14.93 169 170173 603313 109815644
Posterior reversible encephalopathy syndrome 473.53 14.93 403 169939 33458 110385499
Renal salt-wasting syndrome 463.48 14.93 130 170212 758 110418199
Nasopharyngitis 462.31 14.93 39 170303 394322 110024635
Leukopenia 456.81 14.93 821 169521 147970 110270987
Peripheral swelling 442.22 14.93 52 170290 403982 110014975
Neutropenic colitis 424.85 14.93 220 170122 7845 110411112
Abdominal discomfort 422.94 14.93 54 170288 393804 110025153
Aplasia 409.68 14.93 213 170129 7660 110411297
Platelet count decreased 407.65 14.93 1015 169327 229428 110189529
Drug hypersensitivity 404.04 14.93 101 170241 453989 109964968
Pyrexia 390.55 14.93 2540 167802 895725 109523232
Cardiotoxicity 388.04 14.93 270 170072 16611 110402346
Malaise 387.86 14.93 282 170060 671537 109747420
Rheumatoid arthritis 382.46 14.93 19 170323 299594 110119363
Product dose omission issue 382.14 14.93 30 170312 321752 110097205
Bronchopulmonary aspergillosis 376.40 14.93 335 170007 29528 110389429
Aspergillus infection 374.90 14.93 313 170029 25303 110393654
Disease recurrence 374.30 14.93 465 169877 60319 110358638
Arthropathy 370.99 14.93 17 170325 287505 110131452
Headache 370.45 14.93 491 169851 881886 109537071
Systemic lupus erythematosus 369.86 14.93 4 170338 254334 110164623
Musculoskeletal stiffness 362.82 14.93 16 170326 279806 110139151
Pruritus 354.38 14.93 230 170112 581330 109837627
Weight increased 353.24 14.93 104 170238 419540 109999417
Respiratory failure 351.29 14.93 920 169422 214412 110204545
Swelling 347.29 14.93 61 170281 350980 110067977
Bacteraemia 344.34 14.93 374 169968 42016 110376941
Malignant transformation 342.65 14.93 117 170225 1408 110417549
Cytokine release syndrome 341.90 14.93 479 169863 69827 110349130
Encephalopathy 341.50 14.93 516 169826 80539 110338418
Stem cell transplant 332.94 14.93 154 170188 4273 110414684
Wound 330.89 14.93 6 170336 234431 110184526
Clostridium difficile colitis 324.18 14.93 368 169974 43410 110375547
Rash 323.34 14.93 478 169864 820486 109598471
Asthma 322.23 14.93 15 170327 250276 110168681
Drug ineffective 309.89 14.93 3635 166707 1516905 108902052
Insomnia 307.78 14.93 87 170255 360503 110058454
Cytomegalovirus infection 305.95 14.93 398 169944 54046 110364911
Dizziness 304.69 14.93 377 169965 697816 109721141
Fatigue 303.77 14.93 917 169425 1215041 109203916
Neuropathy peripheral 283.22 14.93 757 169585 178520 110240437
Urticaria 281.41 14.93 72 170270 318785 110100172
Cystitis haemorrhagic 279.97 14.93 195 170147 12014 110406943
Glossodynia 274.24 14.93 17 170325 221987 110196970
Psoriatic arthropathy 273.80 14.93 6 170336 196755 110222202
Drug ineffective for unapproved indication 270.12 14.93 531 169811 102307 110316650
Venoocclusive disease 269.37 14.93 150 170192 6200 110412757
Contraindicated product administered 268.92 14.93 33 170309 248234 110170723
Acute graft versus host disease 266.00 14.93 193 170149 12688 110406269
Duodenal ulcer perforation 257.39 14.93 3 170339 177697 110241260
Lymphopenia 256.46 14.93 313 170029 39857 110379100
Bacterial infection 254.72 14.93 334 170008 45702 110373255
Anxiety 251.94 14.93 108 170234 344970 110073987
BK virus infection 251.77 14.93 188 170154 12918 110406039
Injection site pain 249.25 14.93 5 170337 177917 110241040
Secondary immunodeficiency 247.58 14.93 128 170214 4548 110414409
Discomfort 246.68 14.93 23 170319 214684 110204273
Thymus hypoplasia 245.93 14.93 94 170248 1593 110417364
Neurotoxicity 245.69 14.93 314 170028 41893 110377064
Contusion 243.24 14.93 35 170307 233326 110185631
Human herpesvirus 6 infection 243.02 14.93 142 170200 6439 110412518
Blood cholesterol increased 241.36 14.93 10 170332 184775 110234182
Lymphoid tissue hypoplasia 239.95 14.93 92 170250 1573 110417384
Neoplasm recurrence 239.60 14.93 130 170212 5102 110413855
Fungal infection 239.37 14.93 341 170001 50465 110368492
White blood cell count decreased 237.14 14.93 835 169507 228555 110190402
Drug resistance 234.75 14.93 357 169985 56017 110362940
Colitis 232.89 14.93 498 169844 101825 110317132
Overdose 232.52 14.93 40 170302 233754 110185203
Therapeutic product effect decreased 231.87 14.93 47 170295 244269 110174688
Sleep disorder 231.66 14.93 20 170322 198624 110220333
Drug abuse 223.96 14.93 12 170330 177399 110241558
Wheezing 222.56 14.93 59 170283 255171 110163786
Diffuse large B-cell lymphoma refractory 222.29 14.93 98 170244 2423 110416534
Pain in extremity 221.92 14.93 254 170088 486864 109932093
Muscle spasms 221.38 14.93 76 170266 278081 110140876
Impaired healing 220.94 14.93 23 170319 196694 110222263
Inappropriate schedule of product administration 218.25 14.93 28 170314 203609 110215348
Hypersensitivity 213.43 14.93 185 170157 403813 110015144
Candida infection 212.72 14.93 313 170029 47696 110371261
Blister 209.10 14.93 47 170295 227329 110191628
Injury 209.04 14.93 17 170325 177248 110241709
Dry mouth 206.03 14.93 31 170311 199917 110219040
Cytomegalovirus viraemia 203.70 14.93 189 170153 17575 110401382
Folliculitis 203.61 14.93 14 170328 167639 110251318
Epstein-Barr virus infection 202.67 14.93 193 170149 18545 110400412
Mobility decreased 199.35 14.93 59 170283 237363 110181594
Cytogenetic abnormality 197.10 14.93 73 170269 1129 110417828
Hepatic enzyme increased 195.09 14.93 127 170215 320765 110098192
Agranulocytosis 194.78 14.93 345 169997 61415 110357542
Enterococcal infection 194.57 14.93 196 170146 20170 110398787
Graft versus host disease 194.53 14.93 189 170153 18617 110400340
Metastases to central nervous system 193.52 14.93 206 170136 22611 110396346
Type 2 diabetes mellitus 193.28 14.93 23 170319 177209 110241748
Ototoxicity 190.17 14.93 103 170239 4028 110414929
Blood pressure increased 188.32 14.93 81 170261 258292 110160665
Abdominal pain upper 185.43 14.93 159 170183 348952 110070005
Cytomegalovirus chorioretinitis 185.21 14.93 123 170219 7005 110411952
Depression 184.36 14.93 132 170210 317203 110101754
Thrombotic microangiopathy 184.24 14.93 226 170116 28923 110390034
Migraine 182.98 14.93 24 170318 171628 110247329
Staphylococcal bacteraemia 180.71 14.93 172 170170 16516 110402441
C-reactive protein abnormal 176.44 14.93 5 170337 129690 110289267
Arthritis 172.61 14.93 26 170316 167560 110251397
Pericarditis 172.38 14.93 61 170281 219053 110199904
Blood lactate dehydrogenase increased 169.57 14.93 270 170072 44064 110374893
Nephropathy toxic 168.77 14.93 210 170132 27268 110391689
Intentional product misuse 167.71 14.93 9 170333 132895 110286062
Sinusitis 167.69 14.93 127 170215 296561 110122396
Klebsiella infection 166.79 14.93 179 170163 19830 110399127
Hepatitis B reactivation 165.70 14.93 117 170225 7367 110411590
Human bocavirus infection 164.96 14.93 63 170279 1065 110417892
Renal tubular disorder 164.16 14.93 116 170226 7313 110411644
Acute respiratory distress syndrome 163.68 14.93 294 170048 52904 110366053
Lower respiratory tract infection 162.19 14.93 86 170256 243020 110175937
Cytomegalovirus infection reactivation 161.67 14.93 169 170173 18164 110400793
Joint range of motion decreased 161.10 14.93 6 170336 121826 110297131
Chronic graft versus host disease 160.45 14.93 126 170216 9331 110409626
Hypoaesthesia 156.28 14.93 152 170190 314071 110104886
Aplastic anaemia 156.12 14.93 190 170152 24118 110394839
Lymphadenopathy 156.08 14.93 320 170022 63515 110355442
Loss of personal independence in daily activities 155.14 14.93 23 170319 149997 110268960
Pneumonitis 154.41 14.93 355 169987 76176 110342781
Adenovirus infection 151.94 14.93 130 170212 10864 110408093
Hypogammaglobulinaemia 150.71 14.93 170 170172 19906 110399051
Gastrooesophageal reflux disease 150.56 14.93 45 170297 179931 110239026
Drug intolerance 148.89 14.93 248 170094 406264 110012693
Enterobacter infection 147.91 14.93 99 170243 5712 110413245
Feeling abnormal 147.91 14.93 47 170295 180664 110238293
Stress 147.37 14.93 3 170339 105345 110313612
Pneumocystis jirovecii pneumonia 145.55 14.93 247 170095 42488 110376469
Progressive multifocal leukoencephalopathy 144.19 14.93 185 170157 24771 110394186
Disseminated intravascular coagulation 142.44 14.93 240 170102 41046 110377911
Acute graft versus host disease in skin 140.34 14.93 123 170219 10617 110408340
Pulmonary toxicity 139.62 14.93 154 170188 17592 110401365
Road traffic accident 139.60 14.93 6 170336 107392 110311565
Psoriasis 139.05 14.93 24 170318 139969 110278988
Teratoma 138.49 14.93 36 170306 149 110418808
Memory impairment 138.39 14.93 65 170277 196879 110222078
Viraemia 137.09 14.93 83 170259 4019 110414938
Pneumatosis intestinalis 136.92 14.93 110 170232 8419 110410538
Peripheral sensory neuropathy 136.89 14.93 148 170194 16532 110402425
Somnolence 133.29 14.93 157 170185 297292 110121665
Mycobacterium chelonae infection 131.75 14.93 73 170269 2987 110415970
Bacterial sepsis 131.44 14.93 117 170225 10309 110408648
Gait disturbance 131.04 14.93 141 170201 278067 110140890
Hospitalisation 129.89 14.93 30 170312 142463 110276494
Pseudomonal sepsis 129.18 14.93 109 170233 8937 110410020
Metastasis 127.17 14.93 104 170238 8163 110410794
Gastrointestinal toxicity 126.64 14.93 118 170224 11030 110407927
Suicidal ideation 126.40 14.93 4 170338 93933 110325024
Skin toxicity 124.84 14.93 120 170222 11663 110407294
Acute myeloid leukaemia recurrent 124.71 14.93 85 170257 5054 110413903
Gait inability 123.74 14.93 29 170313 136347 110282610
Renal failure 123.57 14.93 681 169661 225893 110193064
Pulmonary haemorrhage 122.94 14.93 139 170203 16317 110402640
Cystitis bacterial 121.21 14.93 52 170290 1201 110417756
Klebsiella sepsis 120.99 14.93 77 170265 4076 110414881
Engraftment syndrome 120.22 14.93 59 170283 1873 110417084
Enteritis 120.21 14.93 148 170194 19008 110399949
Musculoskeletal pain 118.78 14.93 67 170275 182956 110236001
Sweat gland tumour 117.19 14.93 41 170301 533 110418424
Incorrect dose administered 116.65 14.93 12 170330 103629 110315328
Obesity 115.77 14.93 18 170324 113333 110305624
Peripheral venous disease 115.32 14.93 3 170339 84114 110334843
Disseminated aspergillosis 114.62 14.93 62 170280 2418 110416539
Injection site erythema 113.93 14.93 8 170334 94168 110324789
Norovirus test positive 113.15 14.93 46 170296 924 110418033
Dyspepsia 112.75 14.93 78 170264 190887 110228070
B-cell lymphoma recurrent 111.83 14.93 48 170294 1110 110417847
Maternal exposure during pregnancy 110.51 14.93 138 170204 254745 110164212
Mucormycosis 110.27 14.93 107 170235 10521 110408436
Klebsiella bacteraemia 109.84 14.93 77 170265 4792 110414165
Sciatica 108.53 14.93 9 170333 92390 110326567
Myalgia 107.75 14.93 110 170232 222271 110196686
Oesophagitis 107.23 14.93 173 170169 28542 110390415
Bronchitis 107.01 14.93 54 170288 156978 110261979
Hypertension 106.85 14.93 414 169928 509670 109909287
Leukaemia recurrent 106.31 14.93 64 170278 3067 110415890
Infusion related reaction 106.12 14.93 272 170070 380890 110038067
Primary hypogonadism 105.92 14.93 31 170311 215 110418742
Parainfluenzae virus infection 105.74 14.93 87 170255 6887 110412070
Ovarian germ cell teratoma 105.57 14.93 25 170317 63 110418894
Suicide attempt 104.28 14.93 17 170325 103377 110315580
Therapy non-responder 103.26 14.93 498 169844 156809 110262148
Metastases to lung 103.07 14.93 151 170191 22912 110396045
Lower limb fracture 102.13 14.93 3 170339 75345 110343612
Fungaemia 100.91 14.93 80 170262 6006 110412951
Acute promyelocytic leukaemia 100.66 14.93 52 170290 1844 110417113
Dyspnoea 99.87 14.93 1158 169184 1105714 109313243
Grip strength decreased 99.39 14.93 6 170336 80168 110338789
Hepatotoxicity 99.29 14.93 267 170075 63133 110355824
Escherichia bacteraemia 99.26 14.93 99 170243 10065 110408892
Pneumonia fungal 97.48 14.93 117 170225 14637 110404320
Wound infection 96.98 14.93 16 170326 96449 110322508
Paraneoplastic neurological syndrome 96.90 14.93 27 170315 153 110418804
Osteosarcoma 96.72 14.93 33 170309 396 110418561
Adverse drug reaction 96.65 14.93 22 170320 105537 110313420
Weight decreased 96.03 14.93 383 169959 467674 109951283
Lymphoma 95.90 14.93 136 170206 20035 110398922
Paraesthesia 95.45 14.93 175 170167 276346 110142611
Post transplant lymphoproliferative disorder 95.36 14.93 119 170223 15494 110403463
Chloroma 94.77 14.93 39 170303 809 110418148
Blood pressure fluctuation 94.60 14.93 5 170337 74819 110344138
Immune effector cell-associated neurotoxicity syndrome 94.04 14.93 115 170227 14667 110404290
Diffuse large B-cell lymphoma 93.65 14.93 119 170223 15779 110403178
Staphylococcal infection 93.35 14.93 278 170064 69666 110349291
Chest pain 93.33 14.93 284 170058 376091 110042866
Frequent bowel movements 92.74 14.93 4 170338 71386 110347571
Hepatitis B 90.89 14.93 92 170250 9520 110409437
Influenza like illness 90.38 14.93 14 170328 88398 110330559
Pneumothorax 89.95 14.93 180 170162 35105 110383852
Graft versus host disease in skin 89.23 14.93 85 170257 8169 110410788
Palpitations 88.83 14.93 69 170273 159143 110259814
Tremor 88.17 14.93 109 170233 202123 110216834
Systemic candida 88.04 14.93 92 170250 9882 110409075
Drug interaction 87.69 14.93 434 169908 499749 109919208
Blood pressure systolic increased 87.48 14.93 12 170330 82979 110335978
Anaplastic lymphoma kinase gene mutation 87.35 14.93 24 170318 128 110418829
Amnesia 86.98 14.93 27 170315 105381 110313576
Bone marrow disorder 86.56 14.93 63 170279 4160 110414797
Neck pain 85.93 14.93 41 170301 123089 110295868
Oesophageal candidiasis 85.44 14.93 97 170245 11437 110407520
Fanconi syndrome 84.91 14.93 58 170284 3461 110415496
JC virus infection 84.44 14.93 68 170274 5222 110413735
Viral haemorrhagic cystitis 84.34 14.93 57 170285 3342 110415615
Gene mutation 83.88 14.93 57 170285 3372 110415585
Leukoencephalopathy 83.30 14.93 86 170256 9109 110409848
Confusional state 83.11 14.93 405 169937 468275 109950682
Recurrent cancer 81.60 14.93 56 170286 3367 110415590
Nasal congestion 81.41 14.93 25 170317 98257 110320700
Enterococcal bacteraemia 81.27 14.93 62 170280 4399 110414558
Hypokalaemia 81.19 14.93 520 169822 181928 110237029
Adverse event 81.03 14.93 33 170309 108776 110310181
Teratoma benign 80.94 14.93 20 170322 64 110418893
Systemic mycosis 80.49 14.93 58 170284 3771 110415186
Metastases to lymph nodes 79.96 14.93 107 170235 14925 110404032
Myeloid leukaemia 79.21 14.93 35 170307 870 110418087
Back pain 79.00 14.93 299 170043 370697 110048260
Herpes simplex 78.98 14.93 109 170233 15655 110403302
Oedema peripheral 78.64 14.93 252 170090 328408 110090549
Medication error 78.39 14.93 32 170310 105334 110313623
Hypothyroidism 78.37 14.93 269 170073 72630 110346327
Condition aggravated 78.27 14.93 739 169603 734097 109684860
Mantle cell lymphoma recurrent 78.12 14.93 36 170306 990 110417967
Superior vena cava syndrome 77.66 14.93 39 170303 1302 110417655
Alveolar soft part sarcoma 77.48 14.93 20 170322 80 110418877
Ejection fraction decreased 77.39 14.93 185 170157 40695 110378262
Ear infection 76.84 14.93 5 170337 62727 110356230
Metastases to liver 76.78 14.93 169 170173 35217 110383740
Red blood cell sedimentation rate increased 76.49 14.93 14 170328 78288 110340669
Exposure during pregnancy 76.44 14.93 87 170255 167337 110251620
Oedema 75.97 14.93 129 170213 209847 110209110
Hyperhidrosis 75.47 14.93 107 170235 187191 110231766
Hypercholesterolaemia 75.43 14.93 23 170319 90814 110328143
Epstein-Barr virus associated lymphoproliferative disorder 75.11 14.93 61 170281 4741 110414216
Small cell lung cancer 74.41 14.93 52 170290 3220 110415737
Osteonecrosis 74.19 14.93 162 170180 33579 110385378
Deafness 73.85 14.93 141 170201 26568 110392389
Nephrolithiasis 73.65 14.93 8 170334 66204 110352753
Pseudomonal bacteraemia 73.64 14.93 58 170284 4313 110414644
Blood stem cell transplant failure 73.44 14.93 31 170311 687 110418270
Pseudomonas infection 73.30 14.93 144 170198 27709 110391248
Enterocolitis 73.27 14.93 116 170226 18833 110400124
Hepatosplenic T-cell lymphoma 72.53 14.93 34 170308 973 110417984
Hypomagnesaemia 72.24 14.93 231 170111 60139 110358818
Capillary leak syndrome 71.86 14.93 60 170282 4848 110414109
Device related infection 71.77 14.93 176 170166 39343 110379614
Abdominal distension 71.58 14.93 99 170243 175004 110243953
Injection site reaction 71.39 14.93 24 170318 89046 110329911
Colitis ulcerative 71.07 14.93 16 170326 77347 110341610
Live birth 71.03 14.93 11 170331 69473 110349484
Rhinovirus infection 70.64 14.93 89 170253 11700 110407257
Epstein-Barr virus infection reactivation 70.55 14.93 55 170287 4029 110414928
Retinal haemorrhage 70.54 14.93 80 170262 9421 110409536
Ovarian failure 70.44 14.93 33 170309 943 110418014
Cardiomyopathy 70.37 14.93 158 170184 33367 110385590
Underdose 69.88 14.93 8 170334 63546 110355411
Haematochezia 69.76 14.93 46 170296 115478 110303479
Alopecia 69.49 14.93 307 170035 364446 110054511
Rash pruritic 69.44 14.93 32 170310 98037 110320920
Vision blurred 69.36 14.93 58 170284 128964 110289993
Acute lymphocytic leukaemia 69.33 14.93 63 170279 5702 110413255
Hepatosplenomegaly 68.69 14.93 68 170274 6851 110412106
Heart rate decreased 68.63 14.93 21 170321 82735 110336222
Hepatic cirrhosis 68.46 14.93 11 170331 67615 110351342
Angioedema 68.42 14.93 33 170309 98467 110320490
Nervous system disorder 68.27 14.93 151 170191 31570 110387387
Medulloblastoma recurrent 67.77 14.93 21 170321 181 110418776
Pulmonary vascular disorder 67.52 14.93 33 170309 1038 110417919
Acute lymphocytic leukaemia recurrent 67.17 14.93 62 170280 5725 110413232
Blood glucose increased 67.09 14.93 63 170279 132433 110286524
Hypoalbuminaemia 67.01 14.93 142 170200 28832 110390125
Sedation 66.92 14.93 13 170329 69670 110349287
Ill-defined disorder 66.84 14.93 86 170256 156767 110262190
Injection site pruritus 66.16 14.93 3 170339 51255 110367702
Depressed mood 66.00 14.93 8 170334 60801 110358156
Hepatic failure 65.64 14.93 244 170098 68495 110350462
Pneumonia klebsiella 65.51 14.93 65 170277 6567 110412390
Brain sarcoma 65.40 14.93 15 170327 31 110418926
Prescribed underdose 65.09 14.93 11 170331 65163 110353794
Fluid retention 64.89 14.93 32 170310 94275 110324682
Eczema 64.34 14.93 16 170326 72277 110346680
Streptococcal bacteraemia 64.09 14.93 55 170287 4614 110414343
Varicella zoster virus infection 63.99 14.93 63 170279 6305 110412652
Hypoglycaemia 63.90 14.93 51 170291 116053 110302904
T-cell type acute leukaemia 63.87 14.93 23 170319 327 110418630
Autoimmune disorder 63.34 14.93 12 170330 65471 110353486
Product prescribing error 63.15 14.93 4 170338 51327 110367630
Pleuroparenchymal fibroelastosis 63.05 14.93 23 170319 340 110418617
Neuroblastoma 62.86 14.93 23 170319 343 110418614
Pregnancy 62.76 14.93 4 170338 51063 110367894
Flagellate dermatitis 62.74 14.93 22 170320 288 110418669
Complications of bone marrow transplant 62.64 14.93 27 170315 631 110418326
Graft versus host disease in gastrointestinal tract 62.36 14.93 73 170269 8895 110410062
Escherichia sepsis 62.27 14.93 78 170264 10194 110408763
Dry skin 62.17 14.93 45 170297 107608 110311349
Night sweats 61.84 14.93 69 170273 133914 110285043
Gastrointestinal fungal infection 61.40 14.93 28 170314 751 110418206
Radiation pneumonitis 61.39 14.93 53 170289 4483 110414474
Inflammation 60.87 14.93 129 170213 193109 110225848
Urinary tract infection 60.71 14.93 277 170065 326005 110092952
Swollen tongue 60.70 14.93 10 170332 60352 110358605
Pleural effusion 60.66 14.93 475 169867 177234 110241723
Hyperbilirubinaemia 60.45 14.93 141 170201 30530 110388427
Cerebellar tumour 60.29 14.93 19 170323 174 110418783
Burning sensation 60.29 14.93 16 170326 69196 110349761
Clostridium colitis 60.23 14.93 46 170296 3269 110415688
Aortic thrombosis 59.95 14.93 39 170303 2144 110416813
Product quality issue 59.94 14.93 22 170320 77277 110341680
Coronary artery disease 59.80 14.93 18 170324 71672 110347285
Osteoporosis 59.32 14.93 30 170312 87122 110331835
Rhabdomyosarcoma recurrent 59.26 14.93 18 170324 144 110418813
Refractory anaemia with an excess of blasts 59.16 14.93 28 170314 819 110418138
Taste disorder 59.11 14.93 14 170328 65373 110353584
Salivary gland cancer 58.76 14.93 24 170318 488 110418469
Venous thrombosis 58.75 14.93 69 170273 8436 110410521
Fusarium infection 58.30 14.93 42 170300 2729 110416228
Iris atrophy 58.27 14.93 19 170323 196 110418761
Wrong technique in product usage process 58.07 14.93 31 170311 87317 110331640
Plasma cell myeloma refractory 58.04 14.93 37 170305 1964 110416993
Pneumonia 57.94 14.93 1763 168579 874951 109544006
Radiation oesophagitis 57.72 14.93 28 170314 866 110418091
Metastases to meninges 57.71 14.93 54 170288 5074 110413883
Liver injury 57.59 14.93 89 170253 150324 110268633
Myelopathy 57.59 14.93 56 170286 5520 110413437
Vertigo 57.50 14.93 31 170311 86839 110332118
Lactic acidosis 57.35 14.93 36 170306 92775 110326182
Balance disorder 57.18 14.93 57 170285 116503 110302454
Serotonin syndrome 56.88 14.93 11 170331 59142 110359815
Gastrointestinal disorder 56.83 14.93 187 170155 241765 110177192
Pulmonary arteriopathy 56.79 14.93 16 170326 95 110418862
Escherichia infection 56.57 14.93 118 170224 23698 110395259
Premature menopause 56.54 14.93 29 170313 1013 110417944
Encephalitis 56.52 14.93 103 170239 18736 110400221
Ameloblastoma 56.51 14.93 16 170326 97 110418860
Polyneuropathy 56.48 14.93 141 170201 31871 110387086
Hypertransaminasaemia 56.24 14.93 119 170223 24136 110394821
Metastases to spleen 56.21 14.93 27 170315 817 110418140
Electrolyte imbalance 56.03 14.93 154 170188 36874 110382083
Vena cava thrombosis 55.95 14.93 45 170297 3449 110415508
Accidental exposure to product 55.73 14.93 6 170336 50002 110368955
Respiratory distress 55.67 14.93 232 170110 68642 110350315
Streptococcal infection 55.61 14.93 76 170266 10814 110408143
Therapy interrupted 55.46 14.93 6 170336 49816 110369141
Liver function test increased 55.19 14.93 34 170308 88514 110330443
Subdural hygroma 54.86 14.93 24 170318 582 110418375
Peripheral T-cell lymphoma unspecified 54.81 14.93 27 170315 864 110418093
Diabetes mellitus 54.26 14.93 44 170298 99337 110319620
Influenza 54.01 14.93 112 170230 168989 110249968
Myocardial infarction 53.46 14.93 137 170205 191946 110227011
Granulocyte count decreased 52.90 14.93 46 170296 3928 110415029
Alpha haemolytic streptococcal infection 52.76 14.93 44 170298 3549 110415408
Loss of consciousness 52.37 14.93 143 170199 196163 110222794
Infection 52.37 14.93 816 169526 361384 110057573
Heart rate increased 52.35 14.93 88 170254 143746 110275211
Leukaemia 51.94 14.93 61 170281 7457 110411500
Embolism 51.35 14.93 91 170251 16198 110402759
T-cell lymphoma refractory 51.25 14.93 15 170327 104 110418853
Accidental overdose 51.21 14.93 9 170333 51825 110367132
Drug dependence 50.94 14.93 8 170334 50012 110368945
Limb discomfort 50.81 14.93 3 170339 40851 110378106
Nail pigmentation 50.71 14.93 20 170322 370 110418587
Pharyngeal inflammation 50.48 14.93 32 170310 1682 110417275
Rhabdomyolysis 50.28 14.93 67 170275 120334 110298623
Encephalitis cytomegalovirus 49.72 14.93 33 170309 1877 110417080
Immune-mediated enterocolitis 48.90 14.93 69 170273 10116 110408841
Delirium 48.78 14.93 83 170259 134942 110284015
Haematopoietic stem cell mobilisation 48.68 14.93 20 170322 413 110418544
Metastases to bone marrow 48.68 14.93 26 170316 988 110417969
Inappropriate antidiuretic hormone secretion 48.48 14.93 138 170204 33713 110385244
Choriocarcinoma 48.18 14.93 13 170329 64 110418893
Acute monocytic leukaemia 48.18 14.93 22 170320 592 110418365
Central nervous system fungal infection 47.94 14.93 22 170320 599 110418358
Trichosporon infection 47.86 14.93 28 170314 1272 110417685
Abscess bacterial 47.74 14.93 25 170317 912 110418045
Large intestinal ulcer perforation 47.53 14.93 13 170329 68 110418889
Cardiac failure congestive 47.39 14.93 101 170241 150899 110268058
Acquired gene mutation 47.38 14.93 37 170305 2717 110416240
Renal impairment 47.36 14.93 471 169871 187974 110230983
Diaphragm muscle weakness 47.20 14.93 16 170326 188 110418769
Bicytopenia 47.19 14.93 55 170287 6669 110412288
Plasma cell myeloma recurrent 46.78 14.93 56 170286 6986 110411971
Encephalitis viral 46.61 14.93 38 170304 2969 110415988
Delayed puberty 46.60 14.93 16 170326 196 110418761
Drug reaction with eosinophilia and systemic symptoms 46.52 14.93 35 170307 82060 110336897
Cardiomyopathy acute 46.49 14.93 19 170323 387 110418570
Acute polyneuropathy 46.44 14.93 23 170319 745 110418212
Limb injury 46.10 14.93 3 170339 37633 110381324
Refractory cancer 46.07 14.93 17 170325 260 110418697
Hallucination 45.97 14.93 53 170289 101379 110317578
Surgery 45.88 14.93 5 170337 41278 110377679
Eosinophilia 45.76 14.93 16 170326 57920 110361037
Plasmacytoma 45.49 14.93 48 170294 5214 110413743
Intestinal perforation 45.41 14.93 100 170242 20844 110398113
T-cell lymphoma 45.36 14.93 29 170313 1547 110417410
Viral infection 45.32 14.93 182 170160 52957 110366000
Peripheral sensorimotor neuropathy 45.29 14.93 42 170300 3901 110415056
Electrocardiogram QT prolonged 45.13 14.93 61 170281 108899 110310058
Hepatic function abnormal 45.07 14.93 263 170079 89032 110329925
Gastroenteritis adenovirus 45.06 14.93 19 170323 420 110418537
Fungal sepsis 45.01 14.93 33 170309 2204 110416753
Acute myelomonocytic leukaemia 44.89 14.93 19 170323 424 110418533
Blood culture positive 44.87 14.93 62 170280 8914 110410043
Stenotrophomonas infection 44.64 14.93 50 170292 5808 110413149
Splenomegaly 44.37 14.93 109 170233 24389 110394568
Chronic obstructive pulmonary disease 44.32 14.93 62 170280 109096 110309861
Clostridium difficile infection 44.03 14.93 178 170164 51951 110367006
Peripheral motor neuropathy 44.02 14.93 42 170300 4044 110414913
Odynophagia 43.45 14.93 78 170264 14023 110404934
Staphylococcal sepsis 43.24 14.93 88 170254 17366 110401591
Mesenteric abscess 43.24 14.93 14 170328 141 110418816
Feeling hot 43.05 14.93 46 170296 91060 110327897
Rectal haemorrhage 42.98 14.93 74 170268 119759 110299198
Laryngitis 42.70 14.93 7 170335 42404 110376553
Chronic myeloid leukaemia 42.43 14.93 42 170300 4231 110414726
Hepatic candidiasis 42.37 14.93 13 170329 108 110418849
Abdominal compartment syndrome 42.37 14.93 30 170312 1897 110417060
Encephalitis enteroviral 42.36 14.93 16 170326 262 110418695
Hydrocephalus 42.18 14.93 65 170277 10310 110408647
Therapy cessation 41.76 14.93 9 170333 44848 110374109
Adenovirus reactivation 41.33 14.93 21 170321 719 110418238
Neurological decompensation 41.30 14.93 52 170290 6831 110412126
Cerebrovascular accident 41.27 14.93 142 170200 181142 110237815
Neutrophil count abnormal 41.17 14.93 45 170297 5087 110413870
Metastatic lymphoma 41.13 14.93 20 170322 622 110418335
Acute graft versus host disease in intestine 41.05 14.93 47 170295 5592 110413365
Hepatitis E 40.92 14.93 42 170300 4417 110414540
Hyperkalaemia 40.83 14.93 93 170249 135703 110283254
Diffuse alveolar damage 40.59 14.93 40 170302 4007 110414950
Myelitis 40.39 14.93 36 170306 3177 110415780
Procedural pain 40.32 14.93 4 170338 35561 110383396
Acne 40.10 14.93 3 170339 33517 110385440
Central nervous system lymphoma 40.05 14.93 35 170307 3009 110415948
Graft versus host disease in liver 40.01 14.93 32 170310 2433 110416524
Azoospermia 39.86 14.93 15 170327 243 110418714
Lung infiltration 39.85 14.93 105 170237 24523 110394434
Onychomycosis 39.61 14.93 6 170336 38525 110380432
Skin candida 39.46 14.93 31 170311 2297 110416660
Upper respiratory tract infection 39.44 14.93 90 170252 131238 110287719
Encephalitis autoimmune 39.41 14.93 37 170305 3491 110415466
Injection site haemorrhage 39.39 14.93 3 170339 33025 110385932
Aggression 39.38 14.93 21 170321 59189 110359768
Acute kidney injury 39.30 14.93 1268 169074 634162 109784795
Pneumonia cytomegaloviral 39.30 14.93 51 170291 6903 110412054
Treatment noncompliance 38.99 14.93 33 170309 72957 110346000
Left ventricular dysfunction 38.87 14.93 101 170241 23392 110395565
Visual impairment 38.87 14.93 94 170248 134334 110284623
Granulocytopenia 38.75 14.93 70 170272 12645 110406312
Joint dislocation 38.36 14.93 4 170338 34186 110384771
Neuroblastoma recurrent 38.18 14.93 18 170324 522 110418435
Extravasation 38.03 14.93 42 170300 4803 110414154
Faeces discoloured 38.02 14.93 4 170338 33944 110385013
Plasma cell leukaemia 37.99 14.93 29 170313 2059 110416898
Fungal oesophagitis 37.91 14.93 23 170319 1118 110417839
Interstitial lung disease 37.83 14.93 354 169988 138980 110279977
Necrotising gastritis 37.75 14.93 11 170331 75 110418882
Primary mediastinal large B-cell lymphoma recurrent 37.05 14.93 12 170330 121 110418836
Flatulence 36.94 14.93 17 170325 52132 110366825
Pulmonary alveolar haemorrhage 36.86 14.93 90 170252 20060 110398897
Toxic encephalopathy 36.86 14.93 76 170266 15138 110403819
Dry eye 36.79 14.93 20 170322 55773 110363184
Traumatic lung injury 36.69 14.93 31 170311 2546 110416411
International normalised ratio increased 36.52 14.93 48 170294 86724 110332233
Device issue 36.38 14.93 5 170337 34530 110384427
Ganglioneuroblastoma 36.38 14.93 9 170333 29 110418928
Neoplasm 36.32 14.93 63 170279 11024 110407933
Metastases to peritoneum 36.26 14.93 44 170298 5566 110413391
Blood pressure diastolic decreased 35.96 14.93 6 170336 35879 110383078
Nightmare 35.77 14.93 8 170334 38855 110380102
Lower respiratory tract infection fungal 35.68 14.93 20 170322 837 110418120
Incorrect route of product administration 35.42 14.93 28 170314 64033 110354924
Transient ischaemic attack 35.33 14.93 28 170314 63954 110355003
Sneezing 35.23 14.93 4 170338 31980 110386977
Guillain-Barre syndrome 35.13 14.93 61 170281 10683 110408274
Metastases to diaphragm 35.13 14.93 10 170332 62 110418895
Device dislocation 34.83 14.93 4 170338 31700 110387257
Cholelithiasis 34.72 14.93 28 170314 63394 110355563
Sopor 34.71 14.93 7 170335 36539 110382418
Deafness neurosensory 34.62 14.93 57 170285 9562 110409395
Drug clearance decreased 34.57 14.93 37 170305 4085 110414872
Throat irritation 34.16 14.93 20 170322 53532 110365425
Retinopathy 34.09 14.93 38 170304 4391 110414566
Unevaluable event 33.88 14.93 25 170317 59202 110359755
Lymphocyte count decreased 33.85 14.93 176 170166 57067 110361890
Head injury 33.76 14.93 12 170330 43005 110375952
Abortion spontaneous 33.76 14.93 6 170336 34276 110384681
Poisoning 33.72 14.93 3 170339 29102 110389855
Ileus 33.55 14.93 114 170228 30615 110388342
Panic attack 33.49 14.93 3 170339 28937 110390020
Plasma cells increased 33.27 14.93 11 170331 119 110418838
Autoimmune haemolytic anaemia 33.26 14.93 59 170283 10508 110408449
Retroperitoneal lymphadenopathy 33.07 14.93 23 170319 1413 110417544
Metastases to bone 33.04 14.93 115 170227 31257 110387700
Medulloblastoma 33.02 14.93 11 170331 122 110418835
Pulmonary veno-occlusive disease 32.99 14.93 27 170315 2121 110416836
Hip fracture 32.83 14.93 7 170335 35144 110383813
Rhinorrhoea 32.77 14.93 68 170274 102598 110316359
Disability 32.74 14.93 4 170338 30219 110388738
Skin exfoliation 32.47 14.93 53 170289 87598 110331359
Pneumonia adenoviral 32.39 14.93 17 170325 623 110418334
Respiratory syncytial virus infection 32.36 14.93 70 170272 14414 110404543
Leukoerythroblastosis 32.33 14.93 14 170328 331 110418626
Enterovirus test positive 32.21 14.93 14 170328 334 110418623
Nasal abscess 32.20 14.93 12 170330 189 110418768
Anisometropia 32.19 14.93 10 170332 87 110418870
Platelet transfusion 32.09 14.93 30 170312 2816 110416141
Adrenocortical carcinoma 32.09 14.93 10 170332 88 110418869
Sputum discoloured 32.06 14.93 3 170339 27942 110391015
Focal nodular hyperplasia 31.87 14.93 19 170323 894 110418063
Speech disorder developmental 31.76 14.93 19 170323 900 110418057
Fat embolism syndrome 31.65 14.93 11 170331 140 110418817
Full blood count abnormal 31.62 14.93 24 170318 56028 110362929
Blood electrolytes abnormal 31.34 14.93 26 170316 2082 110416875
Tooth malformation 31.17 14.93 11 170331 147 110418810
Minimal residual disease 31.12 14.93 19 170323 934 110418023
Retinopathy proliferative 31.10 14.93 11 170331 148 110418809
Serum ferritin increased 30.87 14.93 61 170281 11786 110407171
Transdifferentiation of neoplasm 30.86 14.93 10 170332 101 110418856
Paraesthesia oral 30.85 14.93 7 170335 33664 110385293
Acute graft versus host disease in liver 30.79 14.93 27 170315 2332 110416625
KMT2A gene mutation 30.61 14.93 8 170334 34 110418923
Pericardial effusion 30.50 14.93 171 170171 57046 110361911
Fanconi syndrome acquired 30.46 14.93 30 170312 3004 110415953
Splenic infection fungal 30.44 14.93 11 170331 158 110418799
Asthenia 30.21 14.93 819 169523 688180 109730777
Bone marrow transplant 30.08 14.93 23 170319 1637 110417320
Pneumonia bacterial 30.07 14.93 99 170243 26162 110392795
Enterococcal sepsis 30.04 14.93 31 170311 3281 110415676
Tumour necrosis 30.04 14.93 27 170315 2409 110416548
Subileus 30.01 14.93 43 170299 6394 110412563
Genotoxicity 29.88 14.93 8 170334 38 110418919
Blood fibrinogen decreased 29.78 14.93 28 170314 2647 110416310
Hypersomnia 29.71 14.93 4 170338 28057 110390900
Gastroenteritis viral 29.61 14.93 6 170336 31220 110387737
Meningitis bacterial 29.60 14.93 30 170312 3109 110415848
Metastases to retroperitoneum 29.44 14.93 14 170328 414 110418543
Hypertriglyceridaemia 29.39 14.93 72 170270 16082 110402875
Hot flush 29.39 14.93 35 170307 66001 110352956
Hepatic infection fungal 29.31 14.93 13 170329 326 110418631
Geotrichum infection 29.30 14.93 20 170322 1192 110417765
Lacrimation increased 29.24 14.93 6 170336 30944 110388013
Clostridial infection 29.23 14.93 42 170300 6260 110412697
Retinitis 29.07 14.93 7 170335 32320 110386637
Recall phenomenon 29.01 14.93 21 170321 1375 110417582
Bradycardia 28.92 14.93 132 170210 155385 110263572
Myeloproliferative neoplasm 28.89 14.93 21 170321 1384 110417573
Central nervous system necrosis 28.86 14.93 14 170328 433 110418524
Neutropenic infection 28.76 14.93 30 170312 3215 110415742
Primitive neuroectodermal tumour 28.76 14.93 8 170334 45 110418912
Therapy responder 28.71 14.93 14 170328 438 110418519
Small cell carcinoma 28.67 14.93 13 170329 344 110418613
Peripheral artery thrombosis 28.38 14.93 33 170309 3991 110414966
Deep vein thrombosis 28.35 14.93 335 170007 139552 110279405
Paraparesis 28.20 14.93 35 170307 4531 110414426
Hyperlipidaemia 28.14 14.93 10 170332 35838 110383119
Disseminated cryptococcosis 28.03 14.93 27 170315 2630 110416327
Cerebellar haemangioma 28.03 14.93 9 170333 88 110418869
Escherichia test positive 28.01 14.93 31 170311 3553 110415404
Acute myeloid leukaemia refractory 27.86 14.93 12 170330 280 110418677
Dyskinesia 27.80 14.93 23 170319 51423 110367534
Metastases to muscle 27.73 14.93 13 170329 372 110418585
Epstein Barr virus positive mucocutaneous ulcer 27.60 14.93 19 170323 1148 110417809
Adenoviral hepatitis 27.60 14.93 18 170324 994 110417963
Cutaneous calcification 27.48 14.93 11 170331 212 110418745
Paraneoplastic syndrome 27.46 14.93 20 170322 1322 110417635
Disseminated mucormycosis 27.32 14.93 24 170318 2078 110416879
Blood creatine phosphokinase increased 27.25 14.93 44 170298 73033 110345924
Meningitis aseptic 27.15 14.93 52 170290 9818 110409139
Coronary artery thrombosis 27.00 14.93 29 170313 3215 110415742
Stomatitis 26.77 14.93 574 169768 269668 110149289
Sinus congestion 26.60 14.93 7 170335 30452 110388505
Retinal pigment epitheliopathy 26.60 14.93 14 170328 516 110418441
Muscle spasticity 26.56 14.93 11 170331 35904 110383053
Cardiac disorder 26.54 14.93 48 170294 76232 110342725
Osteonecrosis of jaw 26.53 14.93 21 170321 47996 110370961
Liver carcinoma ruptured 26.45 14.93 12 170330 318 110418639
Flushing 26.40 14.93 262 170080 104474 110314483
B-cell lymphoma refractory 26.35 14.93 10 170332 166 110418791
Intestinal atresia 26.34 14.93 8 170334 64 110418893
Iron deficiency anaemia 26.18 14.93 8 170334 31551 110387406
Arterial thrombosis 26.16 14.93 28 170314 3091 110415866
Gastrointestinal mucosal disorder 26.02 14.93 19 170323 1261 110417696
Sleep apnoea syndrome 25.95 14.93 15 170327 40432 110378525
Blood bilirubin increased 25.87 14.93 203 170139 75769 110343188
Basal cell naevus syndrome 25.85 14.93 7 170335 35 110418922
Arteriosclerotic retinopathy 25.85 14.93 7 170335 35 110418922
Listeria sepsis 25.78 14.93 16 170326 810 110418147
Cerebral cavernous malformation 25.69 14.93 7 170335 36 110418921
Hair follicle tumour benign 25.64 14.93 13 170329 443 110418514
Agitation 25.42 14.93 89 170253 112962 110305995
COVID-19 pneumonia 25.37 14.93 119 170223 37024 110381933
Blood glucose decreased 25.34 14.93 7 170335 29481 110389476
Fear 25.30 14.93 3 170339 23190 110395767
B-cell lymphoma 25.22 14.93 42 170300 7112 110411845
Transformation to acute myeloid leukaemia 25.21 14.93 20 170322 1503 110417454
Arteriosclerosis 25.13 14.93 4 170338 24763 110394194
Product substitution issue 25.11 14.93 3 170339 23058 110395899
Ear pain 25.01 14.93 27 170315 53199 110365758
Lung consolidation 24.99 14.93 52 170290 10424 110408533
Gliosis 24.95 14.93 15 170327 717 110418240
Chromosome analysis abnormal 24.87 14.93 11 170331 274 110418683
Localised infection 24.84 14.93 18 170324 43030 110375927
Ewing's sarcoma recurrent 24.83 14.93 6 170336 17 110418940
Li-Fraumeni syndrome 24.83 14.93 6 170336 17 110418940
Hiatus hernia 24.78 14.93 6 170336 27600 110391357
Acute lymphocytic leukaemia refractory 24.73 14.93 10 170332 198 110418759
Hypocalcaemia 24.70 14.93 179 170163 65187 110353770
Epstein-Barr viraemia 24.66 14.93 29 170313 3550 110415407
Amenorrhoea 24.62 14.93 48 170294 9183 110409774
Myelitis transverse 24.58 14.93 24 170318 2377 110416580
Cardiac failure 24.58 14.93 416 169926 187210 110231747
Carbamoyl phosphate synthetase deficiency 24.57 14.93 6 170336 18 110418939
Dysstasia 24.56 14.93 10 170332 32976 110385981
Disorder of orbit 24.55 14.93 9 170333 135 110418822
Obstructive airways disorder 24.49 14.93 21 170321 46128 110372829
Blood urine present 24.41 14.93 4 170338 24241 110394716
Ectopic ACTH syndrome 24.41 14.93 10 170332 205 110418752
Abnormal behaviour 24.31 14.93 15 170327 39024 110379933
Mucoepidermoid carcinoma of salivary gland 24.31 14.93 9 170333 139 110418818
Papillary thyroid cancer 24.31 14.93 26 170316 2868 110416089
Strongyloidiasis 24.27 14.93 34 170308 4952 110414005
Cataract 24.24 14.93 54 170288 79431 110339526
Withdrawal syndrome 24.21 14.93 9 170333 31371 110387586
Hyperferritinaemia 24.13 14.93 17 170325 1066 110417891
Kidney infection 24.11 14.93 5 170337 25594 110393363
Platelet disorder 24.04 14.93 29 170313 3646 110415311
Cardiac dysfunction 23.93 14.93 38 170304 6185 110412772
Parkinsonism 23.88 14.93 3 170339 22184 110396773
Osteosarcoma metastatic 23.86 14.93 7 170335 49 110418908
CNS ventriculitis 23.83 14.93 14 170328 641 110418316
Rash erythematous 23.83 14.93 57 170285 81775 110337182
Streptococcal sepsis 23.82 14.93 34 170308 5038 110413919
Breast cancer 23.74 14.93 15 170327 38527 110380430
Intracardiac thrombus 23.65 14.93 31 170311 4237 110414720
Hepatosplenic candidiasis 23.62 14.93 14 170328 652 110418305
Optic atrophy 23.60 14.93 24 170318 2497 110416460
Human herpesvirus 8 infection 23.59 14.93 21 170321 1850 110417107
Cellulitis gangrenous 23.53 14.93 12 170330 414 110418543
Stomatitis necrotising 23.47 14.93 10 170332 227 110418730
Musculoskeletal discomfort 23.44 14.93 4 170338 23534 110395423
Gastrointestinal necrosis 23.43 14.93 39 170303 6601 110412356
Cerebral venous thrombosis 23.43 14.93 27 170315 3235 110415722
Chromaturia 23.37 14.93 8 170334 29352 110389605
Basal ganglion degeneration 23.27 14.93 12 170330 424 110418533
Respiratory tract infection fungal 23.24 14.93 18 170324 1306 110417651
Carcinoid crisis 23.24 14.93 13 170329 542 110418415
Ocular hyperaemia 23.23 14.93 16 170326 39270 110379687
Impaired work ability 23.21 14.93 6 170336 26413 110392544
Premature ageing 23.15 14.93 8 170334 100 110418857
Transfusion 23.14 14.93 89 170253 25383 110393574
Central nervous system enteroviral infection 23.08 14.93 8 170334 101 110418856
Parasitic gastroenteritis 23.07 14.93 10 170332 237 110418720
RUNX1 gene mutation 23.05 14.93 7 170335 56 110418901
Large intestine perforation 23.04 14.93 67 170275 16562 110402395
Heart rate irregular 23.02 14.93 12 170330 34262 110384695
Hepatomegaly 22.99 14.93 79 170263 21335 110397622
Quadriplegia 22.91 14.93 30 170312 4097 110414860
Papilloedema 22.85 14.93 41 170301 7368 110411589
Gout 22.84 14.93 14 170328 36552 110382405
Ascites 22.83 14.93 231 170111 92577 110326380
Extrapyramidal disorder 22.75 14.93 8 170334 28859 110390098
Lung disorder 22.72 14.93 173 170169 179874 110239083
Dyspnoea exertional 22.68 14.93 83 170259 103977 110314980
Endothelial dysfunction 22.62 14.93 11 170331 342 110418615
Hypodontia 22.62 14.93 5 170337 8 110418949
Swelling face 22.61 14.93 70 170272 92251 110326706
Chromosomal deletion 22.55 14.93 9 170333 172 110418785
Tooth hypoplasia 22.51 14.93 11 170331 346 110418611
Meningitis cryptococcal 22.48 14.93 32 170310 4730 110414227
Anaplastic large cell lymphoma T- and null-cell types recurrent 22.42 14.93 7 170335 62 110418895
Skin laceration 22.40 14.93 12 170330 33741 110385216
Congestive cardiomyopathy 22.37 14.93 60 170282 14159 110404798
Hypoxia 22.33 14.93 301 170041 129214 110289743
Brain herniation 22.33 14.93 45 170297 8818 110410139
Coronavirus infection 22.33 14.93 47 170295 9498 110409459
Idiopathic pneumonia syndrome 22.31 14.93 15 170327 872 110418085
Eosinophil count increased 22.30 14.93 3 170339 21055 110397902
Multiple sclerosis 22.27 14.93 6 170336 25692 110393265
Peritoneal gliomatosis 22.25 14.93 5 170337 9 110418948
Tumour hyperprogression 22.25 14.93 11 170331 355 110418602
Lymphoma transformation 22.21 14.93 13 170329 591 110418366
Diabetes mellitus inadequate control 22.21 14.93 9 170333 29766 110389191
Malnutrition 22.13 14.93 92 170250 27187 110391770
Chronic myelomonocytic leukaemia 22.11 14.93 16 170326 1047 110417910
Eastern Cooperative Oncology Group performance status worsened 22.04 14.93 25 170317 2944 110416013
Device related sepsis 21.92 14.93 41 170301 7606 110411351
Hypertensive hydrocephalus 21.91 14.93 5 170337 10 110418947
Acanthamoeba infection 21.84 14.93 13 170329 610 110418347
Respiratory arrest 21.83 14.93 35 170307 58264 110360693
Opportunistic infection 21.63 14.93 27 170315 3516 110415441
Infection reactivation 21.63 14.93 29 170313 4052 110414905
Testicular malignant teratoma 21.59 14.93 5 170337 11 110418946
Colony stimulating factor therapy 21.48 14.93 13 170329 629 110418328
Metastatic neoplasm 21.40 14.93 35 170307 5838 110413119
Bronchiectasis 21.40 14.93 15 170327 36478 110382479
Mental disorder 21.39 14.93 17 170325 38774 110380183
Glioblastoma multiforme 21.37 14.93 18 170324 1472 110417485
Hypoacusis 21.36 14.93 109 170233 35082 110383875
Toxic neuropathy 21.32 14.93 16 170326 1107 110417850
Cerebral salt-wasting syndrome 21.24 14.93 10 170332 289 110418668
Graft complication 21.21 14.93 16 170326 1116 110417841
Injection site rash 21.20 14.93 5 170337 23414 110395543
Limbic encephalitis 21.13 14.93 14 170328 794 110418163
Cardio-respiratory arrest 21.13 14.93 99 170243 115737 110303220
Blood stem cell harvest failure 21.12 14.93 8 170334 132 110418825
Mucosal infection 21.11 14.93 12 170330 516 110418441
Pneumomediastinum 21.11 14.93 32 170310 5004 110413953
Fracture 21.08 14.93 6 170336 24782 110394175
Drug tolerance decreased 21.08 14.93 8 170334 27532 110391425
Pneumonia pseudomonal 21.06 14.93 40 170302 7506 110411451
Angina pectoris 20.96 14.93 40 170302 62255 110356702
Parvovirus B19 infection 20.95 14.93 24 170318 2857 110416100
Sinus polyp 20.95 14.93 13 170329 658 110418299
Precursor T-lymphoblastic lymphoma/leukaemia 20.91 14.93 8 170334 136 110418821
General physical health deterioration 20.90 14.93 497 169845 424798 109994159
Pain in jaw 20.84 14.93 29 170313 51148 110367809
Intentional product use issue 20.83 14.93 263 170079 247643 110171314
Haemodynamic instability 20.82 14.93 80 170262 22808 110396149
Diffuse alopecia 20.80 14.93 17 170325 1333 110417624
Eye pain 20.79 14.93 28 170314 50071 110368886
Skin discolouration 20.77 14.93 27 170315 49019 110369938
Bile duct necrosis 20.75 14.93 7 170335 81 110418876
Gastritis haemorrhagic 20.69 14.93 25 170317 3148 110415809
Hepatorenal failure 20.69 14.93 17 170325 1343 110417614
Epiphyses premature fusion 20.54 14.93 8 170334 143 110418814
Synovial sarcoma 20.44 14.93 7 170335 85 110418872
Candida sepsis 20.42 14.93 24 170318 2937 110416020
Gastrointestinal inflammation 20.29 14.93 45 170297 9424 110409533
Osteosarcoma recurrent 20.28 14.93 8 170334 148 110418809
Metastases to adrenals 20.23 14.93 18 170324 1585 110417372
Bone marrow infiltration 20.22 14.93 14 170328 854 110418103
Pneumonia respiratory syncytial viral 20.16 14.93 23 170319 2726 110416231
Bone sarcoma 20.15 14.93 7 170335 89 110418868
Peripheral blood stem cell apheresis 20.14 14.93 8 170334 151 110418806
Testicular cancer metastatic 20.08 14.93 7 170335 90 110418867
Small intestinal perforation 20.06 14.93 29 170313 4347 110414610
Dysplasia 19.92 14.93 19 170323 1829 110417128
Clostridial sepsis 19.89 14.93 15 170327 1046 110417911
Micturition urgency 19.88 14.93 3 170339 19317 110399640
Biliary abscess 19.87 14.93 6 170336 47 110418910
Adenocarcinoma gastric 19.84 14.93 20 170322 2059 110416898
Diabetes insipidus 19.81 14.93 36 170306 6534 110412423
Urinary bladder haematoma 19.78 14.93 5 170337 18 110418939
Human rhinovirus test positive 19.73 14.93 16 170326 1241 110417716
Mania 19.71 14.93 4 170338 20792 110398165
Retinal toxicity 19.70 14.93 18 170324 1641 110417316
Spinal column injury 19.68 14.93 21 170321 2310 110416647
Metastatic choriocarcinoma 19.68 14.93 4 170338 3 110418954
Product administration error 19.67 14.93 17 170325 37200 110381757
Gastroenteritis norovirus 19.66 14.93 26 170316 3585 110415372
Hyperadrenocorticism 19.63 14.93 12 170330 591 110418366
Drug effective for unapproved indication 19.55 14.93 57 170285 14110 110404847
Follicular lymphoma 19.55 14.93 13 170329 742 110418215
Immunosuppression 19.49 14.93 66 170276 17693 110401264
Polyarthritis 19.38 14.93 3 170339 18960 110399997
Body temperature decreased 19.36 14.93 17 170325 36918 110382039
Muscle twitching 19.35 14.93 11 170331 29924 110389033
Brain oedema 19.35 14.93 97 170245 31001 110387956
Incorrect product administration duration 19.31 14.93 4 170338 20494 110398463
Cerebral toxoplasmosis 19.27 14.93 24 170318 3118 110415839
Diverticulitis 19.23 14.93 33 170309 53489 110365468
Cytomegalovirus colitis 19.18 14.93 37 170305 7024 110411933
Atypical teratoid/rhabdoid tumour of CNS 19.18 14.93 5 170337 21 110418936
Blood pressure diastolic increased 19.17 14.93 3 170339 18804 110400153
Gastrin-releasing peptide precursor increased 19.14 14.93 4 170338 4 110418953
Vulvovaginitis 19.14 14.93 10 170332 363 110418594
Cardiac murmur 19.11 14.93 7 170335 24621 110394336
Bacterial tracheitis 19.10 14.93 7 170335 105 110418852
Clostridium bacteraemia 19.06 14.93 11 170331 487 110418470
Transplant rejection 19.03 14.93 7 170335 24560 110394397
Ulcer 19.03 14.93 23 170319 43093 110375864
Diabetic ketoacidosis 19.03 14.93 22 170320 42036 110376921
Psychomotor hyperactivity 19.01 14.93 4 170338 20273 110398684
Neuroendocrine tumour of the lung metastatic 19.01 14.93 8 170334 176 110418781
Polyneuropathy in malignant disease 19 14.93 11 170331 490 110418467
B precursor type acute leukaemia 19 14.93 11 170331 490 110418467
Neuroectodermal neoplasm 18.99 14.93 5 170337 22 110418935
Herpes simplex test positive 18.98 14.93 12 170330 628 110418329
Atypical haemolytic uraemic syndrome 18.85 14.93 17 170325 1523 110417434
Chest discomfort 18.79 14.93 174 170168 173674 110245283
Fluid replacement 18.78 14.93 14 170328 959 110417998
Iron deficiency 18.71 14.93 3 170339 18473 110400484
Crying 18.71 14.93 8 170334 25620 110393337
Pain of skin 18.68 14.93 4 170338 20025 110398932
Epilepsy 18.66 14.93 85 170257 100124 110318833
Ewing's sarcoma 18.63 14.93 5 170337 24 110418933
Engraft failure 18.49 14.93 13 170329 813 110418144
Dermatomyositis 18.47 14.93 28 170314 4378 110414579
Drug clearance increased 18.44 14.93 10 170332 392 110418565
Angioimmunoblastic T-cell lymphoma recurrent 18.30 14.93 5 170337 26 110418931
Foetal growth restriction 18.23 14.93 23 170319 3027 110415930
Ulcer haemorrhage 18.23 14.93 6 170336 22565 110396392
Ageusia 18.17 14.93 4 170338 19641 110399316
Toxocariasis 18.15 14.93 5 170337 27 110418930
Product administered to patient of inappropriate age 18.14 14.93 39 170303 7997 110410960
Radiation injury 18.10 14.93 14 170328 1014 110417943
Critical illness 17.99 14.93 11 170331 542 110418415
Testicular germ cell cancer metastatic 17.98 14.93 6 170336 67 110418890
Tissue infiltration 17.92 14.93 14 170328 1029 110417928
Arachnoiditis 17.91 14.93 14 170328 1030 110417927
Mucosal toxicity 17.90 14.93 12 170330 694 110418263
Radiation hepatitis 17.87 14.93 4 170338 7 110418950
Autoimmune neutropenia 17.82 14.93 12 170330 699 110418258
Ureteric compression 17.80 14.93 9 170333 305 110418652
Hydronephrosis 17.80 14.93 71 170271 20594 110398363
Toothache 17.79 14.93 7 170335 23568 110395389
Hepatic lesion 17.79 14.93 40 170302 8453 110410504
Bone marrow necrosis 17.79 14.93 10 170332 421 110418536
Gallbladder empyema 17.67 14.93 7 170335 131 110418826
Intensive care 17.61 14.93 20 170322 2359 110416598
Myoclonus 17.53 14.93 15 170327 32983 110385974
Diffuse large B-cell lymphoma stage IV 17.51 14.93 13 170329 885 110418072
Viral hepatitis carrier 17.43 14.93 5 170337 32 110418925
Adenomatous polyposis coli 17.37 14.93 9 170333 321 110418636
Enterobacter bacteraemia 17.37 14.93 16 170326 1474 110417483
Dementia 17.31 14.93 14 170328 31659 110387298
Head discomfort 17.31 14.93 4 170338 18996 110399961
Vulvovaginal inflammation 17.26 14.93 12 170330 737 110418220
Abnormal DNA methylation 17.21 14.93 4 170338 9 110418948
Proctitis bacterial 17.20 14.93 7 170335 141 110418816
Tracheal fistula 17.19 14.93 8 170334 225 110418732
Product intolerance 17.17 14.93 5 170337 34 110418923
Klebsiella test positive 17.15 14.93 20 170322 2426 110416531
Nodule 17.13 14.93 15 170327 32616 110386341
Photosensitivity reaction 17.13 14.93 9 170333 25580 110393377
Dysarthria 17.10 14.93 69 170273 84052 110334905
Schistocytosis 17.08 14.93 6 170336 79 110418878
Ganglioneuroma 17.02 14.93 7 170335 145 110418812
Blastic plasmacytoid dendritic cell neoplasia 17.01 14.93 6 170336 80 110418877
Bone infarction 16.94 14.93 11 170331 603 110418354
Toxicity to various agents 16.92 14.93 588 169754 479967 109938990
Breath sounds abnormal 16.91 14.93 9 170333 25395 110393562
Anti-platelet antibody positive 16.88 14.93 9 170333 341 110418616
Blindness cortical 16.88 14.93 14 170328 1121 110417836
Hyperuricaemia 16.83 14.93 55 170287 14476 110404481
Food protein-induced enterocolitis syndrome 16.80 14.93 5 170337 37 110418920
Muscle rigidity 16.76 14.93 8 170334 24023 110394934
Impaired quality of life 16.74 14.93 13 170329 30004 110388953
Peripheral nerve injury 16.74 14.93 14 170328 1134 110417823
Emotional distress 16.72 14.93 27 170315 44820 110374137
Hypovolaemic shock 16.72 14.93 55 170287 14528 110404429
Mucoepidermoid carcinoma 16.68 14.93 6 170336 85 110418872
Paraneoplastic retinopathy 16.64 14.93 4 170338 11 110418946
Post-acute COVID-19 syndrome 16.61 14.93 16 170326 1559 110417398
Human polyomavirus infection 16.59 14.93 17 170325 1785 110417172
Parasitic pneumonia 16.57 14.93 5 170337 39 110418918
Sedation complication 16.53 14.93 5 170337 19850 110399107
Muscular weakness 16.53 14.93 276 170066 248192 110170765
Reticulocytosis 16.52 14.93 11 170331 629 110418328
Generalised oedema 16.52 14.93 92 170250 30612 110388345
Metastases to salivary gland 16.49 14.93 6 170336 88 110418869
Skin ulcer 16.49 14.93 47 170295 63598 110355359
Uterine enlargement 16.44 14.93 13 170329 972 110417985
Primary mediastinal large B-cell lymphoma refractory 16.43 14.93 3 170339 0 110418957
Blood test abnormal 16.40 14.93 12 170330 28542 110390415
Renal cell carcinoma 16.38 14.93 36 170306 7494 110411463
Eosinophilic cystitis 16.34 14.93 7 170335 161 110418796
Infectious pleural effusion 16.29 14.93 28 170314 4863 110414094
Metastases to breast 16.29 14.93 9 170333 366 110418591
Benign prostatic hyperplasia 16.29 14.93 4 170338 18230 110400727
Pneumonia aspiration 16.29 14.93 67 170275 81166 110337791
Parathyroid tumour malignant 16.26 14.93 7 170335 163 110418794
Lymphoproliferative disorder 16.26 14.93 35 170307 7183 110411774
Rickets 16.25 14.93 6 170336 92 110418865
Spindle cell sarcoma 16.24 14.93 8 170334 256 110418701
Retinal ischaemia 16.19 14.93 13 170329 994 110417963
Follicular thyroid cancer 16.19 14.93 6 170336 93 110418864
Subdural haemorrhage 16.17 14.93 33 170309 6525 110412432
Hemianopia 16.16 14.93 21 170321 2847 110416110
Tumour haemorrhage 16.14 14.93 29 170313 5216 110413741
Rales 16.12 14.93 9 170333 24730 110394227
Thymus enlargement 16.11 14.93 7 170335 167 110418790
Cardiac tamponade 16.10 14.93 46 170296 11261 110407696
Sarcoma 16.08 14.93 13 170329 1004 110417953
Norovirus infection 16.06 14.93 19 170323 2340 110416617
Ventricular tachycardia 16.06 14.93 33 170309 49976 110368981
Chronic graft versus host disease in skin 16.05 14.93 20 170322 2599 110416358
Coagulopathy 16.02 14.93 113 170229 40798 110378159
Inflammatory pseudotumour 15.96 14.93 6 170336 97 110418860
Aortic wall hypertrophy 15.94 14.93 5 170337 45 110418912
Paraneoplastic encephalomyelitis 15.92 14.93 7 170335 172 110418785
Pharyngeal oedema 15.91 14.93 3 170339 16425 110402532
B-cell aplasia 15.88 14.93 9 170333 385 110418572
Cancer fatigue 15.83 14.93 9 170333 387 110418570
Miosis 15.83 14.93 7 170335 21976 110396981
Heavy menstrual bleeding 15.82 14.93 3 170339 16362 110402595
Pneumocystis jirovecii infection 15.74 14.93 26 170316 4374 110414583
Aspiration bone marrow abnormal 15.73 14.93 7 170335 177 110418780
Pericardial effusion malignant 15.63 14.93 8 170334 278 110418679
Cystitis viral 15.60 14.93 15 170327 1458 110417499
Hallucination, visual 15.57 14.93 23 170319 39582 110379375
Deafness bilateral 15.55 14.93 20 170322 2684 110416273
Eustachian tube dysfunction 15.54 14.93 11 170331 695 110418262
Pseudomonas aeruginosa meningitis 15.52 14.93 6 170336 105 110418852
Product storage error 15.52 14.93 7 170335 21721 110397236
Noctiphobia 15.50 14.93 4 170338 16 110418941
Abdominal neoplasm 15.47 14.93 11 170331 700 110418257
Movement disorder 15.46 14.93 20 170322 36384 110382573
Femur fracture 15.45 14.93 28 170314 44441 110374516
Scedosporium infection 15.44 14.93 19 170323 2439 110416518
Meningitis tuberculous 15.43 14.93 14 170328 1264 110417693
Renal tubular dysfunction 15.41 14.93 12 170330 878 110418079
Diarrhoea 15.40 14.93 1529 168813 1137976 109280981
Vocal cord paralysis 15.38 14.93 21 170321 2985 110415972
Combined immunodeficiency 15.34 14.93 7 170335 188 110418769
Tonsillar haemorrhage 15.32 14.93 8 170334 290 110418667
Hepatic angiosarcoma 15.26 14.93 6 170336 110 110418847
Infusion site pain 15.22 14.93 4 170338 17415 110401542
Pulmonary arterial hypertension 15.20 14.93 94 170248 32474 110386483
Musculoskeletal disorder 15.13 14.93 8 170334 22656 110396301
Autologous haematopoietic stem cell transplant 15.11 14.93 6 170336 113 110418844
Metastases to heart 15.11 14.93 9 170333 423 110418534
Laboratory test abnormal 15.10 14.93 28 170314 44051 110374906
Spinal fracture 15.09 14.93 8 170334 22625 110396332
Small intestinal obstruction 15.05 14.93 93 170249 32120 110386837
Torsade de pointes 15.05 14.93 8 170334 22592 110396365
Peripheral T-cell lymphoma unspecified recurrent 15.05 14.93 5 170337 55 110418902
Affect lability 14.97 14.93 5 170337 18632 110400325
Hypoglossal nerve paresis 14.97 14.93 6 170336 116 110418841
Delusion 14.97 14.93 9 170333 23746 110395211

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01CB01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
Podophyllotoxin derivatives
FDA MoA N0000000176 Topoisomerase Inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000972 Antineoplastic Agents, Phytogenic
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D059005 Topoisomerase II Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:59517 DNA synthesis inhibitor
FDA EPC N0000175609 Topoisomerase Inhibitor

Related Drugs by ATC class:

L01CB Podophyllotoxin derivatives 1 drug

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

DiseaseRelationSNOMED_IDDOID
Small cell carcinoma of lung indication 254632001 DOID:5409
Malignant tumor of testis indication 363449006 DOID:2998
Treatment prior to tumor-specific T-cell infusion therapy indication
Allogeneic bone marrow transplantation off-label use 58390007
Ewing's sarcoma off-label use 76909002 DOID:3369
Acute myeloid leukemia, disease off-label use 91861009
Kaposi's sarcoma off-label use 109385007
Diffuse non-Hodgkin's lymphoma, large cell off-label use 109969005
Multiple myeloma off-label use 109989006 DOID:9538
Hodgkin's disease off-label use 118599009
Burkitt's lymphoma off-label use 118617000
Non-small cell lung cancer off-label use 254637007 DOID:3908
Osteosarcoma of bone off-label use 307576001 DOID:3376
Malignant tumor of ovary off-label use 363443007 DOID:2394
Neuroblastoma off-label use 432328008 DOID:769
Ovarian Germ Cell Tumor Carcinoma off-label use
Neuroendocrine Prostate Carcinoma off-label use
Progressive Diffuse Large B-Cell Lymphoma off-label use
Testicular Germ Cell Tumor off-label use
Acute hemorrhage contraindication 8573003
Fibrosis of lung contraindication 51615001 DOID:3770
Metabolic acidosis contraindication 59455009
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Leukopenia contraindication 84828003 DOID:615
Hypoalbuminemia contraindication 119247004
Impaired renal function disorder contraindication 197663003
Drug-induced hepatitis contraindication 235876009
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.96 acidic
pKa2 13.08 acidic
pKa3 13.86 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
DNA topoisomerase 2-alpha Enzyme INHIBITOR IC50 7.30 IUPHAR CHEMBL
Canalicular multispecific organic anion transporter 1 Transporter Km 3.21 WOMBAT-PK
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
Multidrug resistance-associated protein 1 Transporter WOMBAT-PK
ATP-binding cassette sub-family G member 2 Transporter WOMBAT-PK
Multidrug resistance-associated protein 6 Transporter WOMBAT-PK
Canalicular multispecific organic anion transporter 2 Transporter WOMBAT-PK
DNA topoisomerase 2-beta Enzyme IC50 7.16 CHEMBL
Multidrug resistance protein 1 Transporter Ki 3.28 WOMBAT-PK
Arachidonate 15-lipoxygenase Enzyme IC50 5.50 DRUG MATRIX

External reference:

IDSource
4018141 VUID
N0000146478 NUI
D00125 KEGG_DRUG
4018141 VANDF
C0015133 UMLSCUI
CHEBI:4911 CHEBI
EVP PDB_CHEM_ID
CHEMBL44657 ChEMBL_ID
D005047 MESH_DESCRIPTOR_UI
DB00773 DRUGBANK_ID
6815 IUPHAR_LIGAND_ID
3835 INN_ID
6PLQ3CP4P3 UNII
36462 PUBCHEM_CID
220347 RXNORM
4209 MMSL
4709 MMSL
6665 MMSL
d00230 MMSL
002674 NDDF
387316009 SNOMEDCT_US
56928005 SNOMEDCT_US
CHEMBL1200645 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 0143-9376 INJECTION 20 mg INTRAVENOUS ANDA 22 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 0143-9510 INJECTION 20 mg INTRAVENOUS ANDA 22 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 0143-9511 INJECTION 20 mg INTRAVENOUS ANDA 22 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 0143-9512 INJECTION 20 mg INTRAVENOUS ANDA 22 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 0378-3266 CAPSULE 50 mg ORAL ANDA 24 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 16729-114 INJECTION 20 mg INTRAVENOUS ANDA 22 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 63323-104 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 14 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 68001-265 INJECTION 20 mg INTRAVENOUS ANDA 22 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 68001-681 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 24 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 68001-682 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 24 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 68001-683 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 24 sections
VePesid HUMAN PRESCRIPTION DRUG LABEL 1 69238-2811 CAPSULE 50 mg ORAL NDA 23 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 71288-175 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 24 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 71288-176 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 24 sections
Etoposide HUMAN PRESCRIPTION DRUG LABEL 1 71288-177 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS ANDA 24 sections
ETOPOSIDE HUMAN PRESCRIPTION DRUG LABEL 1 83270-451 CAPSULE 50 mg ORAL NDA 14 sections
Avopef HUMAN PRESCRIPTION DRUG LABEL 1 83831-144 INJECTION 100 mg INTRAVENOUS NDA 21 sections
Avopef HUMAN PRESCRIPTION DRUG LABEL 1 83831-145 INJECTION 500 mg INTRAVENOUS NDA 21 sections