etoposide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	1112	33419-42-0

Description:

Molecule	Description
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

Molecule

Description

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:

Property	Value	Reference
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 µM/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

Approvals:

Date	Agency	Company	Orphan
Nov. 10, 1983	FDA
March 26, 2019	PMDA	BRISTOL-MYERS SQUIBB K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	3122.49	17.28	1717	57632	116732	63312941
Neutropenia	1309.99	17.28	1173	58176	173832	63255841
Mucosal inflammation	1103.46	17.28	633	58716	46295	63383378
Pancytopenia	935.79	17.28	753	58596	96180	63333493
Disease progression	843.04	17.28	785	58564	121973	63307700
Bone marrow failure	819.04	17.28	443	58906	28847	63400826
Thrombocytopenia	804.55	17.28	841	58508	150316	63279357
Acute myeloid leukaemia	660.87	17.28	322	59027	16825	63412848
Haematotoxicity	556.98	17.28	238	59111	9138	63420535
Product use in unapproved indication	548.06	17.28	752	58597	178328	63251345
Off label use	545.74	17.28	1618	57731	672844	62756829
Myelodysplastic syndrome	540.77	17.28	279	59070	16475	63413198
Myelosuppression	420.25	17.28	267	59082	23436	63406237
Ovarian failure	404.16	17.28	114	59235	1196	63428477
Sepsis	394.73	17.28	593	58756	152530	63277143
Haemophagocytic lymphohistiocytosis	360.36	17.28	183	59166	10444	63419229
Neutropenic sepsis	349.60	17.28	208	59141	16230	63413443
Second primary malignancy	344.84	17.28	162	59187	7791	63421882
Pain	340.92	17.28	134	59215	740494	62689179
Venoocclusive liver disease	335.05	17.28	137	59212	4698	63424975
Febrile bone marrow aplasia	329.33	17.28	153	59196	7172	63422501
Malignant neoplasm progression	318.24	17.28	388	58961	81733	63347940
Septic shock	311.98	17.28	347	59002	66282	63363391
Multiple organ dysfunction syndrome	301.53	17.28	316	59033	56436	63373237
Neutrophil count decreased	285.35	17.28	306	59043	56100	63373573
Tumour lysis syndrome	285.11	17.28	148	59201	8842	63420831
Arthralgia	280.66	17.28	92	59257	569618	62860055
Joint swelling	277.47	17.28	6	59343	327660	63102013
Anaemia	253.74	17.28	723	58626	292707	63136966
Posterior reversible encephalopathy syndrome	243.55	17.28	169	59180	17176	63412497
Aplasia	239.40	17.28	104	59245	4155	63425518
Diffuse large B-cell lymphoma recurrent	225.39	17.28	84	59265	2236	63427437
Renal salt-wasting syndrome	223.33	17.28	54	59295	288	63429385
Diffuse large B-cell lymphoma refractory	222.93	17.28	71	59278	1159	63428514
Abdominal discomfort	215.99	17.28	24	59325	320861	63108812
Nasopharyngitis	206.45	17.28	7	59342	254250	63175423
Disease recurrence	204.96	17.28	186	59163	27844	63401829
Pyrexia	200.03	17.28	919	58430	469559	62960114
Encephalopathy	199.66	17.28	212	59137	38408	63391265
Platelet count decreased	197.80	17.28	374	58975	115748	63313925
Cytopenia	186.66	17.28	123	59226	11478	63418195
Contraindicated product administered	184.08	17.28	4	59345	217644	63212029
Systemic lupus erythematosus	180.08	17.28	3	59346	208915	63220758
Arthropathy	175.92	17.28	11	59338	234781	63194892
Drug resistance	175.21	17.28	156	59193	22777	63406896
Leukopenia	174.64	17.28	282	59067	77008	63352665
Drug hypersensitivity	173.66	17.28	39	59310	310648	63119025
Product dose omission issue	169.68	17.28	13	59336	234300	63195373
Hepatitis B reactivation	167.86	17.28	74	59275	3063	63426610
Ototoxicity	164.80	17.28	58	59291	1304	63428369
Cardiotoxicity	161.95	17.28	100	59249	8338	63421335
Stem cell transplant	159.01	17.28	61	59288	1761	63427912
Maternal exposure before pregnancy	158.49	17.28	95	59254	7508	63422165
Peripheral swelling	157.70	17.28	29	59320	265913	63163760
Neoplasm progression	155.61	17.28	181	59168	36247	63393426
Pruritus	150.58	17.28	75	59274	361378	63068295
Fall	149.56	17.28	91	59258	392243	63037430
Swelling	147.13	17.28	38	59311	275340	63154333
Bacteraemia	146.60	17.28	125	59224	17223	63412450
Neutropenic colitis	146.46	17.28	67	59282	3028	63426645
Headache	145.63	17.28	230	59119	633011	62796662
Cytomegalovirus infection	145.31	17.28	135	59214	20817	63408856
Venoocclusive disease	144.92	17.28	59	59290	1999	63427674
Rash	143.41	17.28	189	59160	560682	62868991
Musculoskeletal stiffness	143.38	17.28	7	59342	184611	63245062
Glossodynia	141.47	17.28	6	59343	178870	63250803
Aspergillus infection	138.01	17.28	89	59260	8004	63421669
Malignant transformation	136.43	17.28	38	59311	379	63429294
Weight increased	133.66	17.28	39	59310	260753	63168920
Drug intolerance	131.63	17.28	62	59287	308599	63121074
Therapy partial responder	131.51	17.28	96	59253	10562	63419111
Teratoma	129.95	17.28	30	59319	126	63429547
Malaise	127.19	17.28	121	59228	415833	63013840
Candida infection	122.98	17.28	142	59207	28209	63401464
Therapeutic product effect decreased	121.31	17.28	18	59331	193169	63236504
Ovarian germ cell teratoma	121.01	17.28	25	59324	53	63429620
Hypersensitivity	119.94	17.28	62	59287	292623	63137050
Hepatosplenic T-cell lymphoma	118.39	17.28	37	59312	566	63429107
Fatigue	116.65	17.28	433	58916	887595	62542078
Insomnia	114.37	17.28	30	59319	215222	63214451
Pulmonary haemorrhage	112.76	17.28	75	59274	7106	63422567
Human herpesvirus 6 infection	112.27	17.28	55	59294	2902	63426771
Bronchopulmonary aspergillosis	111.61	17.28	80	59269	8555	63421118
Thrombotic microangiopathy	110.08	17.28	86	59263	10475	63419198
Discomfort	108.84	17.28	14	59335	167360	63262313
Colitis	108.12	17.28	176	59173	48352	63381321
Oesophagitis	106.58	17.28	98	59251	14910	63414763
Acute graft versus host disease	104.60	17.28	60	59289	4368	63425305
Graft versus host disease	99.89	17.28	68	59281	6695	63422978
Asthma	98.49	17.28	5	59344	127556	63302117
Urticaria	98.40	17.28	18	59331	165784	63263889
Enterococcal infection	97.53	17.28	71	59278	7777	63421896
Injection site pain	97.41	17.28	6	59343	129794	63299879
Neurotoxicity	96.28	17.28	98	59251	16892	63412781
Clostridium difficile colitis	95.96	17.28	107	59242	20462	63409211
Primary hypogonadism	95.35	17.28	24	59325	155	63429518
Dizziness	94.10	17.28	161	59188	429764	62999909
Pain in extremity	93.79	17.28	103	59246	331383	63098290
Respiratory failure	93.62	17.28	257	59092	101601	63328072
Hypokalaemia	91.55	17.28	258	59091	103546	63326127
Alveolar soft part sarcoma	91.39	17.28	21	59328	86	63429587
Premature menopause	89.44	17.28	33	59316	853	63428820
Anxiety	89.19	17.28	46	59303	217495	63212178
Aplastic anaemia	85.06	17.28	71	59278	9498	63420175
Cystitis haemorrhagic	84.59	17.28	51	59298	4072	63425601
Leukoencephalopathy	83.92	17.28	52	59297	4361	63425312
Klebsiella infection	83.37	17.28	67	59282	8499	63421174
Pericarditis	83.18	17.28	12	59337	131567	63298106
White blood cell count decreased	82.76	17.28	302	59047	138802	63290871
Muscle spasms	82.47	17.28	22	59327	156128	63273545
Osteosarcoma	80.86	17.28	20	59329	119	63429554
Feeling abnormal	78.19	17.28	21	59328	148371	63281302
Lymphopenia	78.14	17.28	91	59258	18236	63411437
Acute respiratory distress syndrome	78.06	17.28	103	59246	23431	63406242
Contusion	77.62	17.28	22	59327	150022	63279651
Enterobacter infection	74.46	17.28	38	59311	2189	63427484
Hepatic enzyme increased	74.12	17.28	49	59300	202279	63227394
Hypomagnesaemia	73.41	17.28	111	59238	28626	63401047
Disseminated intravascular coagulation	72.05	17.28	89	59260	18962	63410711
Fungaemia	71.73	17.28	38	59311	2365	63427308
Sinusitis	71.44	17.28	64	59285	226589	63203084
Teratoma benign	71.39	17.28	16	59333	57	63429616
Bronchitis	71.09	17.28	15	59334	124920	63304753
Impaired healing	70.60	17.28	7	59342	102535	63327138
Cervix disorder	70.21	17.28	25	59324	582	63429091
Skin candida	69.54	17.28	33	59316	1622	63428051
Nephropathy toxic	69.46	17.28	63	59286	9416	63420257
Psoriasis	68.44	17.28	3	59346	86954	63342719
Complications of bone marrow transplant	68.43	17.28	23	59326	448	63429225
Neuropathy peripheral	67.78	17.28	247	59102	113420	63316253
Cytomegalovirus viraemia	67.70	17.28	50	59299	5599	63424074
Human bocavirus infection	67.33	17.28	22	59327	391	63429282
Klebsiella sepsis	67.29	17.28	31	59318	1424	63428249
Blood cholesterol increased	65.85	17.28	6	59343	94026	63335647
Blister	65.38	17.28	20	59329	129794	63299879
Graft versus host disease in skin	64.99	17.28	38	59311	2867	63426806
Myeloid leukaemia	64.28	17.28	21	59328	373	63429300
Ascites	64.14	17.28	127	59222	40601	63389072
Migraine	63.99	17.28	10	59339	103336	63326337
Cytomegalovirus infection reactivation	63.70	17.28	42	59307	3921	63425752
Loss of personal independence in daily activities	63.56	17.28	8	59341	97282	63332391
Capillary leak syndrome	63.45	17.28	34	59315	2166	63427507
Acute promyelocytic leukaemia	63.31	17.28	26	59323	901	63428772
Gene mutation	63.30	17.28	31	59318	1634	63428039
BK virus infection	63.27	17.28	39	59310	3240	63426433
Overdose	63.09	17.28	15	59334	115063	63314610
JC virus infection	62.83	17.28	33	59316	2018	63427655
Acute lymphocytic leukaemia recurrent	62.46	17.28	34	59315	2235	63427438
Arthritis	61.83	17.28	16	59333	115905	63313768
Inappropriate schedule of product administration	60.15	17.28	12	59337	103953	63325720
Lymphoma	59.61	17.28	65	59284	12122	63417551
Post transplant lymphoproliferative disorder	59.10	17.28	44	59305	4987	63424686
Blood pressure increased	58.33	17.28	40	59309	162022	63267651
Epstein-Barr virus infection	58.00	17.28	53	59296	7997	63421676
Injection site erythema	56.42	17.28	6	59343	83168	63346505
Systemic candida	56.10	17.28	36	59313	3209	63426464
Superior vena cava syndrome	56.02	17.28	22	59327	677	63428996
Staphylococcal infection	54.84	17.28	120	59229	41136	63388537
Large intestinal ulcer perforation	54.63	17.28	13	59336	64	63429609
Renal tubular disorder	54.57	17.28	33	59316	2649	63427024
Cytokine release syndrome	54.33	17.28	67	59282	14247	63415426
Secondary immunodeficiency	53.33	17.28	26	59323	1357	63428316
Hospitalisation	53.20	17.28	8	59341	85073	63344600
Pulmonary alveolar haemorrhage	53.00	17.28	40	59309	4628	63425045
Progressive multifocal leukoencephalopathy	52.96	17.28	63	59286	12908	63416765
Herpes simplex	52.96	17.28	51	59298	8220	63421453
Mucormycosis	52.50	17.28	33	59316	2838	63426835
Peripheral sensory neuropathy	51.63	17.28	48	59301	7403	63422270
Folliculitis	50.57	17.28	4	59345	70313	63359360
Injury	50.42	17.28	5	59344	73242	63356431
Neoplasm recurrence	49.95	17.28	31	59318	2607	63427066
Staphylococcal sepsis	49.95	17.28	49	59300	8079	63421594
Pneumatosis intestinalis	49.90	17.28	30	59319	2383	63427290
Cytomegalovirus chorioretinitis	49.73	17.28	27	59322	1766	63427907
Varicella zoster virus infection	49.40	17.28	31	59318	2658	63427015
Acute myeloid leukaemia recurrent	49.40	17.28	26	59323	1597	63428076
Acute graft versus host disease in skin	49.30	17.28	34	59315	3418	63426255
Mobility decreased	49.06	17.28	26	59323	121133	63308540
Deafness	48.20	17.28	71	59278	17886	63411787
Encephalitis viral	47.81	17.28	26	59323	1706	63427967
Pleural effusion	47.71	17.28	193	59156	93017	63336656
Leukaemia	47.65	17.28	36	59313	4172	63425501
Adverse drug reaction	46.53	17.28	9	59340	79705	63349968
Suicidal ideation	46.47	17.28	3	59346	62418	63367255
Refractory anaemia with an excess of blasts	46.42	17.28	17	59332	430	63429243
Gait disturbance	46.35	17.28	62	59287	183116	63246557
Adenovirus infection	45.95	17.28	33	59316	3538	63426135
Memory impairment	45.84	17.28	20	59329	104238	63325435
Hypothyroidism	45.72	17.28	114	59235	42518	63387155
Pneumonia fungal	45.45	17.28	39	59310	5416	63424257
Stress	45.16	17.28	5	59344	67162	63362511
Staphylococcal bacteraemia	44.99	17.28	39	59310	5491	63424182
Infusion related reaction	44.93	17.28	102	59247	245419	63184254
Influenza like illness	44.87	17.28	5	59344	66819	63362854
Pneumothorax	44.67	17.28	65	59284	16196	63413477
Fungal oesophagitis	44.54	17.28	19	59330	725	63428948
Condition aggravated	44.50	17.28	209	59140	402008	63027665
Streptococcal bacteraemia	44.45	17.28	25	59324	1752	63427921
Incorrect dose administered	44.30	17.28	3	59346	59965	63369708
Diffuse large B-cell lymphoma	44.14	17.28	42	59307	6670	63423003
Acute lymphocytic leukaemia	43.71	17.28	28	59321	2488	63427185
Amenorrhoea	43.56	17.28	50	59299	9864	63419809
Respiratory distress	43.14	17.28	97	59252	33854	63395819
Palpitations	43.07	17.28	26	59323	112744	63316929
Dry mouth	42.97	17.28	10	59339	77853	63351820
Epstein-Barr virus associated lymphoproliferative disorder	42.97	17.28	25	59324	1869	63427804
Metastases to central nervous system	42.90	17.28	57	59292	13048	63416625
Cardiomyopathy acute	42.84	17.28	14	59335	249	63429424
Gastrointestinal fungal infection	42.71	17.28	15	59334	335	63429338
Abdominal pain upper	42.64	17.28	80	59269	206364	63223309
Nasal abscess	42.40	17.28	13	59336	186	63429487
Leukaemia recurrent	42.34	17.28	22	59327	1316	63428357
Weight decreased	42.23	17.28	126	59223	276672	63153001
Lower respiratory tract infection	42.09	17.28	37	59312	132270	63297403
Mesenteric abscess	41.99	17.28	11	59338	85	63429588
Blood culture positive	41.81	17.28	35	59314	4700	63424973
Musculoskeletal pain	41.69	17.28	17	59332	92260	63337413
Enterococcal sepsis	41.13	17.28	22	59327	1396	63428277
Splenomegaly	40.39	17.28	51	59298	11106	63418567
Klebsiella bacteraemia	40.34	17.28	23	59326	1655	63428018
Sweat gland tumour	40.21	17.28	11	59338	102	63429571
Clostridium colitis	40.10	17.28	24	59325	1890	63427783
Pseudomonal sepsis	39.94	17.28	26	59323	2375	63427298
Chloroma	39.84	17.28	13	59336	230	63429443
Bacterial infection	39.78	17.28	68	59281	19431	63410242
Medulloblastoma recurrent	39.67	17.28	10	59339	65	63429608
Unmasking of previously unidentified disease	39.60	17.28	19	59330	957	63428716
Oedema peripheral	39.53	17.28	73	59276	189438	63240235
Congestive cardiomyopathy	39.36	17.28	38	59311	6144	63423529
Alopecia	39.34	17.28	172	59177	337364	63092309
Recurrent cancer	39.27	17.28	24	59325	1963	63427710
Encephalitis cytomegalovirus	39.22	17.28	16	59333	545	63429128
Escherichia bacteraemia	39.13	17.28	31	59318	3852	63425821
Cutaneous calcification	39.02	17.28	11	59338	115	63429558
Rhinovirus infection	39.00	17.28	33	59316	4496	63425177
Therapy non-responder	38.71	17.28	157	59192	75744	63353929
Fanconi syndrome	38.71	17.28	21	59328	1371	63428302
Nail pigmentation	38.61	17.28	12	59337	180	63429493
Bacterial sepsis	38.60	17.28	31	59318	3927	63425746
Blood glucose increased	38.54	17.28	15	59334	83741	63345932
Abdominal compartment syndrome	38.36	17.28	16	59333	577	63429096
Clostridium bacteraemia	37.78	17.28	12	59337	194	63429479
Peripheral motor neuropathy	37.64	17.28	22	59327	1659	63428014
Pneumocystis jirovecii pneumonia	37.19	17.28	61	59288	16853	63412820
Nasal congestion	37.10	17.28	8	59341	65652	63364021
Viraemia	37.00	17.28	20	59329	1296	63428377
Sinus polyp	36.93	17.28	14	59335	391	63429282
Venous thrombosis	36.74	17.28	33	59316	4869	63424804
Gastrooesophageal reflux disease	36.60	17.28	22	59327	95617	63334056
Acquired gene mutation	36.47	17.28	18	59331	965	63428708
T-cell lymphoma	36.34	17.28	16	59333	660	63429013
Leukoerythroblastosis	36.03	17.28	12	59337	227	63429446
T-cell lymphoma refractory	35.91	17.28	9	59340	57	63429616
Gastroenteritis norovirus	35.89	17.28	23	59326	2045	63427628
Basal ganglion degeneration	35.55	17.28	14	59335	434	63429239
Injection site reaction	35.47	17.28	6	59343	58518	63371155
Cardiomyopathy	35.44	17.28	61	59288	17523	63412150
Vision blurred	35.38	17.28	21	59328	91903	63337770
Acute kidney injury	35.29	17.28	389	58960	263026	63166647
Mucocutaneous ulceration	35.27	17.28	11	59338	167	63429506
Strongyloidiasis	35.19	17.28	19	59330	1229	63428444
Listeria sepsis	35.06	17.28	16	59333	719	63428954
Pericardial effusion	35.02	17.28	83	59266	29975	63399698
Radiation oesophagitis	35.02	17.28	13	59336	342	63429331
Hepatic failure	34.77	17.28	92	59257	35564	63394109
Hypogammaglobulinaemia	34.71	17.28	38	59311	7117	63422556
Necrotising gastritis	34.65	17.28	9	59340	67	63429606
Gastrointestinal toxicity	33.94	17.28	39	59310	7702	63421971
Blood lactate dehydrogenase increased	33.91	17.28	70	59279	23046	63406627
Cardiac failure	33.89	17.28	169	59180	88973	63340700
Wheezing	33.85	17.28	24	59325	95571	63334102
Sleep disorder	33.76	17.28	17	59332	81549	63348124
Metastases to lung	33.63	17.28	50	59299	12700	63416973
Enteritis	33.42	17.28	40	59309	8246	63421427
Device related infection	33.33	17.28	70	59279	23322	63406351
Neutrophil count abnormal	33.32	17.28	25	59324	2867	63426806
Hepatitis B	33.29	17.28	28	59321	3784	63425889
Hyperhidrosis	33.29	17.28	31	59318	107805	63321868
Metastasis	33.19	17.28	32	59317	5165	63424508
Myeloproliferative neoplasm	33.00	17.28	14	59335	527	63429146
Myocardial infarction	32.91	17.28	27	59322	99866	63329807
Hair follicle tumour benign	32.57	17.28	13	59336	418	63429255
Renal impairment	32.53	17.28	166	59183	88189	63341484
Cerebellar haemangioma	32.47	17.28	9	59340	88	63429585
Epstein Barr virus positive mucocutaneous ulcer	32.11	17.28	13	59336	434	63429239
Renal failure	32.09	17.28	204	59145	117448	63312225
Bone marrow transplant	31.80	17.28	15	59334	727	63428946
Pneumonitis	31.46	17.28	88	59261	35134	63394539
Tumour hyperprogression	31.43	17.28	9	59340	100	63429573
Subdural hygroma	31.31	17.28	11	59338	246	63429427
Plasma cell leukaemia	31.29	17.28	17	59332	1113	63428560
Delayed puberty	31.27	17.28	9	59340	102	63429571
Injection site pruritus	31.26	17.28	3	59346	45113	63384560
Gastroenteritis adenovirus	31.22	17.28	11	59338	248	63429425
Tonsillar haemorrhage	31.14	17.28	11	59338	250	63429423
T-cell type acute leukaemia	31.10	17.28	8	59341	57	63429616
Mouth ulceration	31.04	17.28	84	59265	32900	63396773
Hepatosplenomegaly	31.01	17.28	23	59326	2591	63427082
Ill-defined disorder	31.01	17.28	19	59330	81736	63347937
Tissue infiltration	30.97	17.28	14	59335	615	63429058
Neck pain	30.94	17.28	13	59336	69305	63360368
Oesophageal candidiasis	30.88	17.28	32	59317	5631	63424042
Ejection fraction decreased	30.86	17.28	66	59283	22266	63407407
Back pain	30.52	17.28	135	59214	264010	63165663
Tumour necrosis	30.40	17.28	15	59334	804	63428869
Serum ferritin increased	30.28	17.28	33	59316	6149	63423524
Metastases to diaphragm	30.21	17.28	7	59342	30	63429643
Left ventricular dysfunction	30.18	17.28	46	59303	11942	63417731
Myalgia	30.05	17.28	57	59292	146472	63283201
White blood cell count abnormal	30.02	17.28	33	59316	6209	63423464
Burning sensation	29.99	17.28	7	59342	54400	63375273
Chronic graft versus host disease	29.63	17.28	24	59325	3078	63426595
Depression	29.55	17.28	90	59259	196402	63233271
Pneumococcal sepsis	29.54	17.28	14	59335	686	63428987
Liver injury	29.26	17.28	10	59339	60510	63369163
Stenotrophomonas infection	29.03	17.28	20	59329	2007	63427666
Drug abuse	28.71	17.28	16	59333	72502	63357171
Type 2 diabetes mellitus	28.47	17.28	12	59337	63856	63365817
Confusional state	28.41	17.28	119	59230	236261	63193412
Femur fracture	28.35	17.28	3	59346	41753	63387920
Exposure during pregnancy	28.13	17.28	65	59284	155482	63274191
Cerebral toxoplasmosis	27.88	17.28	15	59334	963	63428710
Urinary tract infection	27.80	17.28	140	59209	264544	63165129
Small cell lung cancer	27.78	17.28	18	59331	1631	63428042
International normalised ratio increased	27.61	17.28	5	59344	46420	63383253
Bacterial tracheitis	27.56	17.28	6	59343	18	63429655
Epiphyses premature fusion	27.08	17.28	7	59342	51	63429622
Enterocolitis	27.00	17.28	35	59314	7823	63421850
Clostridial sepsis	26.94	17.28	12	59337	509	63429164
Synovial sarcoma	26.84	17.28	7	59342	53	63429620
Alpha haemolytic streptococcal infection	26.84	17.28	16	59333	1251	63428422
Parainfluenzae virus infection	26.55	17.28	20	59329	2307	63427366
Cardiopulmonary failure	26.45	17.28	24	59325	3588	63426085
Sinoatrial block	26.39	17.28	14	59335	874	63428799
Acute myelomonocytic leukaemia	26.37	17.28	9	59340	184	63429489
Trichosporon infection	26.28	17.28	10	59339	282	63429391
Suicide attempt	26.28	17.28	12	59337	60906	63368767
Febrile infection	26.24	17.28	17	59332	1540	63428133
B-cell lymphoma recurrent	26.23	17.28	11	59338	402	63429271
Ocular vascular disorder	26.18	17.28	11	59338	404	63429269
Eosinophilic cystitis	26.08	17.28	7	59342	60	63429613
Somnolence	26.05	17.28	83	59266	178602	63251071
Metastases to lymph nodes	25.97	17.28	35	59314	8123	63421550
Thymus enlargement	25.93	17.28	8	59341	117	63429556
Unevaluable event	25.71	17.28	8	59341	51378	63378295
Agranulocytosis	25.68	17.28	66	59283	25068	63404605
Vertigo	25.52	17.28	12	59337	59875	63369798
Rash pruritic	25.45	17.28	12	59337	59787	63369886
Drug clearance increased	25.44	17.28	8	59341	125	63429548
Pseudomonas infection	25.41	17.28	41	59308	11172	63418501
Nervous system disorder	25.40	17.28	55	59294	18711	63410962
Schistocytosis	25.30	17.28	6	59343	29	63429644
Toxic encephalopathy	25.30	17.28	31	59318	6548	63423125
Vomiting	25.25	17.28	693	58656	558924	62870749
Adverse event	25.21	17.28	16	59333	67543	63362130
Acute hepatic failure	25.14	17.28	54	59295	18273	63411400
Dry eye	25.10	17.28	4	59345	40757	63388916
Metastases to bone marrow	25.05	17.28	11	59338	451	63429222
Spinal cord paralysis	24.97	17.28	6	59343	31	63429642
Hypoaesthesia	24.70	17.28	78	59271	168315	63261358
Depressed mood	24.62	17.28	4	59345	40187	63389486
Urinary tract infection bacterial	24.50	17.28	27	59322	5095	63424578
Fungal infection	24.43	17.28	83	59266	36791	63392882
Blood pressure systolic increased	24.40	17.28	7	59342	47390	63382283
Paraneoplastic neurological syndrome	24.40	17.28	5	59344	10	63429663
Wrong technique in product usage process	24.33	17.28	14	59335	62326	63367347
Retinoblastoma	24.27	17.28	7	59342	80	63429593
Uterine enlargement	24.26	17.28	15	59334	1253	63428420
Listeriosis	24.15	17.28	16	59333	1505	63428168
Hypoglycaemia	24.14	17.28	13	59336	60052	63369621
Haematochezia	23.96	17.28	10	59339	53534	63376139
Amnesia	23.90	17.28	11	59338	55574	63374099
Cytogenetic abnormality	23.82	17.28	11	59338	508	63429165
Immune-mediated enterocolitis	23.77	17.28	18	59331	2093	63427580
Retinal pigment epitheliopathy	23.65	17.28	9	59340	254	63429419
Radiation pneumonitis	23.57	17.28	16	59333	1567	63428106
Pulmonary toxicity	23.40	17.28	36	59313	9419	63420254
Loss of consciousness	23.31	17.28	47	59302	118074	63311599
Vena cava thrombosis	23.20	17.28	18	59331	2169	63427504
Metastatic lymphoma	23.15	17.28	8	59341	170	63429503
Atypical haemolytic uraemic syndrome	23.01	17.28	12	59337	723	63428950
Streptococcal sepsis	22.81	17.28	17	59332	1929	63427744
Skin toxicity	22.80	17.28	25	59324	4689	63424984
Haemodynamic instability	22.76	17.28	35	59314	9155	63420518
Toxic neuropathy	22.59	17.28	10	59339	418	63429255
Dysphagia	22.56	17.28	151	59198	88434	63341239
Fluid retention	22.45	17.28	14	59335	59672	63370001
Anaesthesia	22.43	17.28	10	59339	425	63429248
Hepatomegaly	22.35	17.28	40	59309	11849	63417824
Hypertension	22.34	17.28	161	59188	279142	63150531
Drug clearance decreased	22.10	17.28	15	59334	1469	63428204
Cytomegalovirus colitis	21.91	17.28	18	59331	2354	63427319
Genotoxicity	21.85	17.28	5	59344	20	63429653
Prescribed overdose	21.84	17.28	3	59346	34150	63395523
Mucosal erosion	21.81	17.28	15	59334	1501	63428172
Hypoxia	21.77	17.28	112	59237	59680	63369993
Paranasal sinus mucosal hypertrophy	21.66	17.28	5	59344	21	63429652
Follicular thyroid cancer	21.62	17.28	6	59343	59	63429614
Haemoglobinaemia	21.53	17.28	6	59343	60	63429613
Cytokine storm	21.51	17.28	9	59340	327	63429346
Vulvovaginitis	21.49	17.28	9	59340	328	63429345
Respiratory tract infection fungal	21.41	17.28	10	59339	474	63429199
Cerebral salt-wasting syndrome	21.18	17.28	6	59343	64	63429609
Myelopathy	21.13	17.28	19	59330	2807	63426866
Viral haemorrhagic cystitis	21.13	17.28	12	59337	857	63428816
Primary mediastinal large B-cell lymphoma recurrent	21.09	17.28	6	59343	65	63429608
Hyperadrenocorticism	21.08	17.28	9	59340	344	63429329
Surgery	21.07	17.28	4	59345	35908	63393765
Engraftment syndrome	20.95	17.28	10	59339	498	63429175
Plasma cell myeloma refractory	20.94	17.28	9	59340	350	63429323
Ganglioneuroma	20.89	17.28	7	59342	135	63429538
Osteoporosis	20.82	17.28	14	59335	57324	63372349
Neutropenic infection	20.79	17.28	14	59335	1353	63428320
Graft versus host disease in gastrointestinal tract	20.78	17.28	20	59329	3221	63426452
Lymphadenopathy	20.77	17.28	81	59268	38377	63391296
Odynophagia	20.67	17.28	30	59319	7456	63422217
Respiratory syncytial virus infection	20.67	17.28	29	59320	6989	63422684
Neurological decompensation	20.25	17.28	18	59331	2620	63427053
Respiratory symptom	20.23	17.28	20	59329	3327	63426346
Hypovolaemic shock	20.21	17.28	27	59322	6214	63423459
Blood stem cell transplant failure	20.16	17.28	7	59342	151	63429522
Listeria encephalitis	20.08	17.28	8	59341	256	63429417
Rhinorrhoea	20.06	17.28	19	59330	65558	63364115
VIth nerve paresis	20.03	17.28	6	59343	79	63429594
Polyneuropathy	20.03	17.28	43	59306	14546	63415127
Pulmonary vascular disorder	19.94	17.28	9	59340	394	63429279
Appendicitis	19.90	17.28	31	59318	8198	63421475
Iris atrophy	19.89	17.28	6	59343	81	63429592
Peritoneal gliomatosis	19.87	17.28	4	59345	7	63429666
Metastases to spleen	19.82	17.28	7	59342	159	63429514
Oral fungal infection	19.68	17.28	19	59330	3072	63426601
Hypophosphataemia	19.66	17.28	37	59312	11389	63418284
Gastrointestinal mucosal disorder	19.58	17.28	11	59338	769	63428904
Dyspnoea	19.57	17.28	470	58879	660843	62768830
Drug ineffective for unapproved indication	19.42	17.28	73	59276	33990	63395683
Cataract	19.32	17.28	15	59334	57038	63372635
Fungal sepsis	19.30	17.28	13	59336	1257	63428416
Hot flush	19.24	17.28	12	59337	51147	63378526
Rhabdomyosarcoma recurrent	19.16	17.28	5	59344	38	63429635
Granulocytopenia	19.08	17.28	25	59324	5647	63424026
Chest pain	19.00	17.28	121	59228	215838	63213835
Hepatic lesion	18.98	17.28	23	59326	4802	63424871
Gliosis	18.91	17.28	8	59341	299	63429374
Tachycardia	18.89	17.28	181	59168	117975	63311698
Metastases to breast	18.89	17.28	8	59341	300	63429373
Vulvovaginal inflammation	18.84	17.28	11	59338	828	63428845
Retroperitoneal abscess	18.83	17.28	7	59342	185	63429488
Mesenteric haemorrhage	18.82	17.28	5	59344	41	63429632
Pneumonia pneumococcal	18.79	17.28	16	59333	2199	63427474
Skin discolouration	18.73	17.28	6	59343	37822	63391851
Choriocarcinoma	18.72	17.28	5	59344	42	63429631
Plasmacytoma	18.62	17.28	17	59332	2562	63427111
Graft versus host disease in liver	18.52	17.28	10	59339	647	63429026
Adrenocortical carcinoma	18.51	17.28	5	59344	44	63429629
Rectal fissure	18.33	17.28	10	59339	660	63429013
Paraesthesia	18.24	17.28	80	59269	156886	63272787
Dyspepsia	18.23	17.28	43	59306	102153	63327520
Lymphocyte count decreased	18.22	17.28	66	59283	30191	63399482
Limb discomfort	18.11	17.28	3	59346	29713	63399960
Embolism	18.04	17.28	29	59320	7877	63421796
Hypoglossal nerve paresis	18.04	17.28	6	59343	113	63429560
Lung infiltration	18.01	17.28	41	59308	14422	63415251
Ewing's sarcoma	17.93	17.28	3	59346	0	63429673
Transdifferentiation of neoplasm	17.90	17.28	4	59345	14	63429659
Abortion spontaneous	17.85	17.28	11	59338	47184	63382489
Electrolyte imbalance	17.77	17.28	50	59299	20026	63409647
Retinopathy	17.68	17.28	18	59331	3101	63426572
Cystitis bacterial	17.42	17.28	7	59342	229	63429444
Feeling hot	17.35	17.28	13	59336	50341	63379332
Ear infection	17.32	17.28	7	59342	38206	63391467
Acute monocytic leukaemia	17.30	17.28	6	59343	129	63429544
Intra-abdominal haemorrhage	17.29	17.28	16	59333	2453	63427220
Hypocalcaemia	17.29	17.28	67	59282	31646	63398027

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	3196.52	14.45	2598	79084	134251	34740998
Neutropenia	1015.96	14.45	1519	80163	155259	34719990
Mucosal inflammation	793.80	14.45	684	80998	37938	34837311
Disease progression	774.14	14.45	1099	80583	106978	34768271
Pancytopenia	747.81	14.45	1012	80670	94145	34781104
Myelosuppression	730.85	14.45	492	81190	18773	34856476
Bone marrow failure	689.76	14.45	561	81121	28692	34846557
Off label use	678.91	14.45	2330	79352	417194	34458055
Acute myeloid leukaemia	623.09	14.45	437	81245	17833	34857416
Thrombocytopenia	588.92	14.45	1193	80489	155054	34720195
Product use in unapproved indication	580.85	14.45	1008	80674	116491	34758758
Myelodysplastic syndrome	531.61	14.45	405	81277	18803	34856446
Haematotoxicity	440.34	14.45	261	81421	7933	34867316
Venoocclusive liver disease	369.67	14.45	231	81451	7735	34867514
Therapy partial responder	358.33	14.45	243	81439	9373	34865876
Malignant neoplasm progression	357.03	14.45	694	80988	87352	34787897
Tumour lysis syndrome	331.72	14.45	293	81389	16766	34858483
Second primary malignancy	319.65	14.45	210	81472	7676	34867573
Neutrophil count decreased	306.60	14.45	479	81203	50625	34824624
Septic shock	295.70	14.45	570	81112	71264	34803985
Sepsis	292.50	14.45	954	80728	165607	34709642
Diffuse large B-cell lymphoma recurrent	270.77	14.45	138	81544	3090	34872159
Neutropenic sepsis	270.73	14.45	238	81444	13529	34861720
Neoplasm progression	261.68	14.45	297	81385	23003	34852246
Febrile bone marrow aplasia	253.64	14.45	185	81497	8024	34867225
Fall	250.90	14.45	81	81601	202804	34672445
Renal salt-wasting syndrome	243.32	14.45	70	81612	275	34874974
Cytopenia	238.34	14.45	214	81468	12509	34862740
Product dose omission issue	215.54	14.45	17	81665	119694	34755555
Haemophagocytic lymphohistiocytosis	205.95	14.45	199	81483	12774	34862475
Leukopenia	177.13	14.45	428	81254	62428	34812821
Diffuse large B-cell lymphoma refractory	167.23	14.45	74	81608	1192	34874057
Cystitis haemorrhagic	164.23	14.45	123	81559	5556	34869693
Malignant transformation	163.67	14.45	65	81617	786	34874463
Dizziness	161.09	14.45	164	81518	218357	34656892
Arthralgia	159.91	14.45	100	81582	169941	34705308
Aplasia	159.23	14.45	111	81571	4477	34870772
Posterior reversible encephalopathy syndrome	158.58	14.45	153	81529	9801	34865448
Cardiotoxicity	155.96	14.45	119	81563	5529	34869720
Venoocclusive disease	155.77	14.45	92	81590	2775	34872474
Pyrexia	152.24	14.45	1310	80372	331703	34543546
Bacteraemia	150.25	14.45	207	81475	19510	34855739
Neutropenic colitis	147.93	14.45	92	81590	3052	34872197
Fatigue	146.28	14.45	416	81266	370237	34505012
Overdose	143.37	14.45	21	81661	91038	34784211
Fungal infection	136.28	14.45	177	81505	15758	34859491
Stomatitis	135.61	14.45	304	81378	42210	34833039
Insomnia	134.58	14.45	38	81644	103869	34771380
Anaemia	131.69	14.45	964	80718	232371	34642878
Depression	130.49	14.45	33	81649	97065	34778184
Bronchopulmonary aspergillosis	127.20	14.45	164	81518	14495	34860754
Blood pressure increased	126.27	14.45	26	81656	88076	34787173
Malaise	124.21	14.45	151	81531	185674	34689575
Aspergillus infection	123.83	14.45	148	81534	12106	34863143
Disease recurrence	121.26	14.45	196	81486	21294	34853955
Anxiety	120.44	14.45	41	81641	99387	34775862
Pain	119.99	14.45	183	81499	204492	34670757
Blood lactate dehydrogenase increased	119.40	14.45	202	81480	22788	34852461
Respiratory failure	118.36	14.45	535	81147	108037	34767212
Encephalopathy	117.65	14.45	257	81425	35062	34840187
Tremor	117.06	14.45	25	81657	82562	34792687
Drug interaction	116.84	14.45	219	81463	225727	34649522
Rash	115.09	14.45	216	81466	222536	34652713
Stem cell transplant	114.53	14.45	68	81614	2071	34873178
Joint swelling	112.08	14.45	7	81675	59883	34815366
Platelet count decreased	111.01	14.45	563	81119	119154	34756095
Peripheral swelling	110.90	14.45	22	81660	76519	34798730
Neoplasm recurrence	108.83	14.45	67	81615	2182	34873067
Hypogammaglobulinaemia	106.73	14.45	110	81572	7630	34867619
Inappropriate schedule of product administration	103.73	14.45	12	81670	62284	34812965
Progressive multifocal leukoencephalopathy	97.14	14.45	117	81565	9647	34865602
Acute graft versus host disease	96.20	14.45	96	81586	6407	34868842
Hepatitis B reactivation	94.49	14.45	76	81606	3815	34871434
BK virus infection	92.90	14.45	89	81593	5649	34869600
Somnolence	90.48	14.45	76	81606	111040	34764209
Pruritus	88.99	14.45	121	81561	141860	34733389
White blood cell count decreased	87.13	14.45	447	81235	94998	34780251
Clostridium difficile colitis	85.39	14.45	141	81541	15589	34859660
Lymphadenopathy	84.62	14.45	198	81484	28265	34846984
Drug resistance	84.45	14.45	187	81495	25740	34849509
Nasopharyngitis	84.45	14.45	29	81653	69939	34805310
Neuropathy peripheral	83.11	14.45	400	81282	82863	34792386
Cardiac failure congestive	80.94	14.45	47	81635	83223	34792026
Musculoskeletal stiffness	80.24	14.45	8	81674	46672	34828577
Headache	79.75	14.45	224	81458	200411	34674838
Colitis	78.76	14.45	230	81452	37520	34837729
Nephropathy toxic	78.19	14.45	120	81562	12468	34862781
Anaplastic lymphoma kinase gene mutation	77.54	14.45	23	81659	103	34875146
Feeling abnormal	76.67	14.45	26	81656	63209	34812040
Weight increased	76.50	14.45	63	81619	92970	34782279
Cytomegalovirus infection	75.73	14.45	180	81502	25955	34849294
Neurotoxicity	74.06	14.45	143	81539	17867	34857382
Coronary artery disease	74.04	14.45	12	81670	48293	34826956
Lymphopenia	73.77	14.45	135	81547	16200	34859049
Therapy non-responder	73.66	14.45	230	81452	38916	34836333
Epstein-Barr virus infection	73.59	14.45	90	81592	7538	34867711
Pulmonary toxicity	73.50	14.45	81	81601	6066	34869183
Hospitalisation	73.28	14.45	21	81661	56881	34818368
Drug ineffective	73.20	14.45	1483	80199	455268	34419981
Enterococcal bacteraemia	73.18	14.45	49	81633	1848	34873401
Sweat gland tumour	72.30	14.45	30	81652	409	34874840
Muscle spasms	71.94	14.45	43	81639	74958	34800291
B-cell lymphoma recurrent	69.25	14.45	35	81647	769	34874480
Asthma	69.08	14.45	9	81673	42647	34832602
Aggression	68.77	14.45	6	81676	38958	34836291
Blood glucose increased	68.70	14.45	35	81647	66683	34808566
Myocardial infarction	68.25	14.45	111	81571	120974	34754275
Incorrect dose administered	66.95	14.45	8	81674	40507	34834742
Agranulocytosis	66.80	14.45	162	81520	23659	34851590
Hepatitis B	66.68	14.45	76	81606	5907	34869342
Myalgia	66.66	14.45	59	81623	84051	34791198
Osteosarcoma	65.63	14.45	25	81657	268	34874981
Enterococcal infection	65.39	14.45	94	81588	9212	34866037
Candida infection	64.86	14.45	134	81548	17581	34857668
Staphylococcal bacteraemia	64.77	14.45	89	81593	8363	34866886
Cytomegalovirus chorioretinitis	64.51	14.45	59	81623	3530	34871719
Weight decreased	64.15	14.45	205	81477	176096	34699153
Systemic mycosis	64.00	14.45	42	81640	1531	34873718
Engraftment syndrome	62.17	14.45	35	81647	962	34874287
Multiple organ dysfunction syndrome	61.95	14.45	347	81335	76219	34799030
Chest pain	60.98	14.45	128	81554	126634	34748615
Abdominal discomfort	60.70	14.45	32	81650	59803	34815446
Diffuse large B-cell lymphoma	60.12	14.45	80	81602	7290	34867959
Rhabdomyolysis	60.05	14.45	43	81639	68120	34807129
Death	58.83	14.45	621	81061	397428	34477821
Acute promyelocytic leukaemia	58.70	14.45	27	81655	478	34874771
Renal tubular disorder	58.69	14.45	63	81619	4580	34870669
Thrombotic microangiopathy	58.66	14.45	96	81586	10534	34864715
Drug hypersensitivity	57.43	14.45	62	81620	80467	34794782
Adenovirus infection	57.27	14.45	66	81616	5191	34870058
Klebsiella infection	56.78	14.45	84	81598	8447	34866802
Cerebrovascular accident	56.48	14.45	69	81613	84742	34790507
Pneumonitis	56.47	14.45	191	81491	33687	34841562
Sleep disorder	55.60	14.45	5	81677	31683	34843566
Gastrointestinal toxicity	55.43	14.45	48	81634	2671	34872578
Chronic graft versus host disease	54.68	14.45	59	81623	4314	34870935
Bacterial infection	54.36	14.45	122	81560	16941	34858308
Retinal haemorrhage	53.95	14.45	63	81619	5026	34870223
Lymphoma	53.51	14.45	101	81581	12406	34862843
Gait disturbance	52.85	14.45	73	81609	85067	34790182
Influenza like illness	52.39	14.45	3	81679	27631	34847618
Balance disorder	52.35	14.45	15	81667	40639	34834610
Hyperhidrosis	52.09	14.45	60	81622	75632	34799617
Pneumocystis jirovecii pneumonia	52.04	14.45	131	81551	19579	34855670
Pain in extremity	51.88	14.45	139	81543	126374	34748875
Bradycardia	51.66	14.45	60	81622	75358	34799891
Hallucination	51.56	14.45	28	81654	51470	34823779
Chloroma	51.55	14.45	25	81657	501	34874748
Rheumatoid arthritis	51.33	14.45	13	81669	38225	34837024
Graft versus host disease	51.11	14.45	90	81592	10479	34864770
Hyperkalaemia	51.08	14.45	52	81630	69337	34805912
Heart rate decreased	50.68	14.45	7	81675	31738	34843511
Acute myeloid leukaemia recurrent	49.77	14.45	41	81641	2129	34873120
Acute graft versus host disease in skin	49.58	14.45	61	81621	5140	34870109
Diabetes mellitus	49.14	14.45	24	81658	46849	34828400
Epstein-Barr virus associated lymphoproliferative disorder	49.05	14.45	39	81643	1925	34873324
Refractory cancer	48.58	14.45	17	81665	140	34875109
Urticaria	47.93	14.45	45	81637	62332	34812917
Nephrolithiasis	47.70	14.45	7	81675	30326	34844923
Bacterial sepsis	47.53	14.45	60	81622	5190	34870059
Blood stem cell transplant failure	47.30	14.45	22	81660	400	34874849
Ameloblastoma	47.09	14.45	15	81667	89	34875160
Azoospermia	46.38	14.45	22	81660	419	34874830
Dyspnoea	46.30	14.45	612	81070	376170	34499079
Vision blurred	46.00	14.45	25	81657	45938	34829311
Vena cava thrombosis	45.79	14.45	31	81651	1191	34874058
Pneumonia klebsiella	45.67	14.45	47	81635	3253	34871996
Loss of personal independence in daily activities	45.08	14.45	11	81671	33168	34842081
Pulmonary vascular disorder	45.01	14.45	25	81657	669	34874580
Drug dependence	44.79	14.45	3	81679	24214	34851035
Drug reaction with eosinophilia and systemic symptoms	44.74	14.45	11	81671	33001	34842248
Acute respiratory distress syndrome	44.68	14.45	148	81534	25821	34849428
Thymus hypoplasia	44.41	14.45	21	81661	397	34874852
Lymphoid tissue hypoplasia	44.41	14.45	21	81661	397	34874852
Chronic obstructive pulmonary disease	44.22	14.45	30	81652	48888	34826361
Diaphragm muscle weakness	44.09	14.45	16	81666	148	34875101
Neoplasm	44.06	14.45	59	81623	5408	34869841
Unevaluable event	43.89	14.45	11	81671	32579	34842670
Oedema peripheral	43.76	14.45	139	81543	119673	34755576
Prostate cancer	43.58	14.45	19	81663	39630	34835619
Escherichia infection	43.53	14.45	73	81609	8172	34867077
Salivary gland cancer	43.22	14.45	19	81663	301	34874948
Papillary thyroid cancer	43.12	14.45	24	81658	645	34874604
Urinary tract infection	42.90	14.45	82	81600	83999	34791250
Electrocardiogram QT prolonged	42.88	14.45	21	81661	40931	34834318
Loss of consciousness	42.72	14.45	80	81602	82587	34792662
Memory impairment	42.71	14.45	24	81658	43294	34831955
Back pain	42.61	14.45	144	81538	121645	34753604
Psoriasis	42.02	14.45	19	81663	38793	34836456
Central nervous system fungal infection	41.59	14.45	19	81663	331	34874918
Haematochezia	41.45	14.45	29	81653	46505	34828744
Arthritis	41.41	14.45	11	81671	31335	34843914
Pulmonary arteriopathy	40.97	14.45	13	81669	76	34875173
Angioedema	40.93	14.45	18	81664	37356	34837893
Cytomegalovirus viraemia	40.86	14.45	67	81615	7363	34867886
Wheezing	40.73	14.45	23	81659	41379	34833870
Recurrent cancer	40.01	14.45	30	81652	1357	34873892
Blood creatine phosphokinase increased	39.89	14.45	28	81654	44829	34830420
Acute lymphocytic leukaemia	39.88	14.45	42	81640	2987	34872262
Klebsiella sepsis	39.60	14.45	35	81647	2002	34873247
Cardiac disorder	39.58	14.45	26	81656	43100	34832149
Pulmonary veno-occlusive disease	39.50	14.45	21	81661	514	34874735
Hypoglycaemia	39.02	14.45	42	81640	54598	34820651
Epstein-Barr virus infection reactivation	38.98	14.45	27	81655	1077	34874172
Metastases to central nervous system	38.55	14.45	69	81613	8136	34867113
Metastasis	38.53	14.45	48	81634	4096	34871153
Fusarium infection	37.78	14.45	27	81655	1133	34874116
Contusion	37.54	14.45	19	81663	36345	34838904
Mucormycosis	37.40	14.45	57	81625	5885	34869364
Ototoxicity	37.39	14.45	33	81649	1884	34873365
Viral haemorrhagic cystitis	37.36	14.45	27	81655	1153	34874096
Aortic thrombosis	37.19	14.45	23	81659	755	34874494
Swelling	36.95	14.45	27	81655	42339	34832910
Blood pressure systolic increased	36.78	14.45	5	81677	22947	34852302
Metastases to meninges	36.59	14.45	29	81653	1425	34873824
Spinal column injury	36.48	14.45	21	81661	603	34874646
Osteonecrosis	36.25	14.45	96	81586	14794	34860455
Abdominal pain upper	36.22	14.45	70	81612	71420	34803829
Gastrooesophageal reflux disease	35.99	14.45	22	81660	37902	34837347
Leukaemia recurrent	35.97	14.45	30	81652	1585	34873664
Toxicity to various agents	35.73	14.45	298	81384	200064	34675185
Teratoma	35.38	14.45	9	81673	19	34875230
Serotonin syndrome	35.36	14.45	3	81679	19930	34855319
Medulloblastoma recurrent	35.15	14.45	11	81671	61	34875188
Metastases to lung	34.70	14.45	71	81611	9249	34866000
Lactic acidosis	34.67	14.45	19	81663	34753	34840496
Systemic candida	34.39	14.45	43	81639	3683	34871566
Injury	34.38	14.45	4	81678	20683	34854566
Pneumonia adenoviral	34.20	14.45	17	81665	360	34874889
Graft versus host disease in skin	34.18	14.45	44	81638	3881	34871368
Escherichia bacteraemia	33.76	14.45	40	81642	3240	34872009
Juvenile melanoma benign	33.75	14.45	11	81671	71	34875178
Adenoviral hepatitis	33.66	14.45	19	81663	525	34874724
Pseudomonas infection	33.42	14.45	83	81599	12299	34862950
Graft versus host disease in gastrointestinal tract	33.19	14.45	42	81640	3641	34871608
Eosinophilia	33.16	14.45	10	81672	26212	34849037
Graft versus host disease in liver	33.15	14.45	26	81656	1258	34873991
Ganglioneuroblastoma	33.14	14.45	9	81673	27	34875222
Retinopathy proliferative	33.11	14.45	11	81671	76	34875173
Drug ineffective for unapproved indication	32.95	14.45	126	81556	23589	34851660
Sedation	32.68	14.45	5	81677	21001	34854248
Disturbance in attention	32.62	14.45	10	81672	25935	34849314
Wrong technique in product usage process	32.61	14.45	22	81660	35964	34839285
Bronchitis	32.55	14.45	30	81652	41933	34833316
Influenza	32.43	14.45	41	81641	49625	34825624
Fanconi syndrome	32.33	14.45	29	81653	1691	34873558
Dry mouth	32.29	14.45	15	81667	30150	34845099
Mobility decreased	32.23	14.45	15	81667	30113	34845136
Hepatotoxicity	32.22	14.45	117	81565	21368	34853881
Carotid artery thrombosis	32.18	14.45	16	81666	339	34874910
Metastases to liver	32.16	14.45	87	81595	13576	34861673
Disseminated aspergillosis	32.15	14.45	21	81661	759	34874490
Cytomegalovirus infection reactivation	32.07	14.45	49	81633	5069	34870180
Erectile dysfunction	31.90	14.45	5	81677	20632	34854617
Blood cholesterol increased	31.70	14.45	5	81677	20538	34854711
Paraneoplastic neurological syndrome	31.15	14.45	9	81673	36	34875213
Cellulitis gangrenous	31.15	14.45	13	81669	180	34875069
Pulmonary haemorrhage	30.96	14.45	72	81610	10232	34865017
Adverse drug reaction	30.78	14.45	15	81667	29327	34845922
Rhabdomyosarcoma recurrent	30.48	14.45	11	81671	100	34875149
Neuroblastoma	30.45	14.45	13	81669	191	34875058
Neuroblastoma recurrent	30.15	14.45	12	81670	146	34875103
Mantle cell lymphoma recurrent	30.14	14.45	20	81662	743	34874506
Treatment noncompliance	30.04	14.45	14	81668	28086	34847163
Migraine	30.02	14.45	3	81679	17475	34857774
Extravasation	30.00	14.45	29	81653	1861	34873388
Cytogenetic abnormality	29.54	14.45	21	81661	874	34874375
Dyskinesia	29.35	14.45	8	81674	22405	34852844
Delayed puberty	29.12	14.45	13	81669	214	34875035
Enteritis	29.11	14.45	61	81621	8081	34867168
Herpes simplex	29.05	14.45	49	81633	5510	34869739
Minimal residual disease	29.05	14.45	16	81666	421	34874828
Abnormal behaviour	29.00	14.45	11	81671	24958	34850291
Cardio-respiratory arrest	28.98	14.45	53	81629	55220	34820029
Therapy cessation	28.92	14.45	3	81679	16970	34858279
T-cell type acute leukaemia	28.87	14.45	11	81671	118	34875131
Skin toxicity	28.86	14.45	45	81637	4739	34870510
Accidental overdose	28.71	14.45	6	81676	20134	34855115
Hepatic candidiasis	28.60	14.45	9	81673	51	34875198
Dry skin	28.52	14.45	19	81663	31268	34843981
Radiation pneumonitis	28.52	14.45	33	81649	2607	34872642
Heart rate increased	28.48	14.45	40	81642	46303	34828946
Toxic encephalopathy	28.41	14.45	47	81635	5202	34870047
Pseudomonal bacteraemia	28.37	14.45	25	81657	1424	34873825
Body height below normal	28.32	14.45	13	81669	229	34875020
Myelopathy	28.30	14.45	32	81650	2465	34872784
Metastases to muscle	28.17	14.45	13	81669	232	34875017
Dehydration	28.09	14.45	183	81499	129786	34745463
Aspiration bone marrow abnormal	28.00	14.45	11	81671	129	34875120
Metastases to spleen	27.99	14.45	16	81666	453	34874796
Disseminated intravascular coagulation	27.95	14.45	113	81569	21703	34853546
Infection	27.87	14.45	330	81352	90585	34784664
Peripheral T-cell lymphoma unspecified	27.84	14.45	16	81666	458	34874791
Transient ischaemic attack	27.65	14.45	15	81667	27598	34847651
Human herpesvirus 6 infection	27.65	14.45	29	81653	2052	34873197
Metastases to retroperitoneum	27.62	14.45	13	81669	243	34875006
Hepatic infection fungal	27.47	14.45	12	81670	187	34875062
Skin exfoliation	27.33	14.45	15	81667	27417	34847832
Stenotrophomonas infection	27.32	14.45	29	81653	2081	34873168
Embolism	27.23	14.45	58	81624	7771	34867478
Hypoalbuminaemia	27.15	14.45	76	81606	12098	34863151
Refractory anaemia with an excess of blasts	26.99	14.45	15	81667	402	34874847
Liver function test abnormal	26.84	14.45	20	81662	31054	34844195
Encephalitis enteroviral	26.78	14.45	11	81671	146	34875103
Head injury	26.75	14.45	5	81677	18155	34857094
Hyperbilirubinaemia	26.35	14.45	93	81589	16750	34858499
Amnesia	25.78	14.45	15	81667	26548	34848701
Abdominal distension	25.70	14.45	62	81620	58430	34816819
Flagellate dermatitis	25.63	14.45	9	81673	75	34875174
Medication error	25.44	14.45	14	81668	25551	34849698
Flatulence	25.19	14.45	9	81673	21189	34854060
Device related infection	25.12	14.45	93	81589	17144	34858105
Agitation	25.09	14.45	61	81621	57338	34817911
Aplastic anaemia	25.04	14.45	64	81618	9652	34865597
Intestinal atresia	25.02	14.45	9	81673	81	34875168
Candida sepsis	24.91	14.45	22	81660	1257	34873992
Streptococcal bacteraemia	24.87	14.45	27	81655	1988	34873261
Acute lymphocytic leukaemia recurrent	24.76	14.45	33	81649	3011	34872238
Diverticulitis	24.63	14.45	8	81674	19996	34855253
Peripheral sensory neuropathy	24.58	14.45	51	81631	6709	34868540
Therapeutic product effect decreased	24.48	14.45	27	81655	34716	34840533
Diabetic ketoacidosis	24.45	14.45	6	81676	18026	34857223
Paraesthesia	24.44	14.45	73	81609	64099	34811150
Faeces discoloured	24.42	14.45	3	81679	14875	34860374
Cytokine release syndrome	24.32	14.45	112	81570	22765	34852484
International normalised ratio increased	24.26	14.45	46	81636	47281	34827968
Short stature	24.18	14.45	9	81673	90	34875159
Myeloid leukaemia	24.10	14.45	14	81668	409	34874840
Vertigo	23.97	14.45	15	81667	25521	34849728
Blood electrolytes abnormal	23.70	14.45	19	81663	949	34874300
Varicella zoster virus infection	23.70	14.45	25	81657	1781	34873468
Chromaturia	23.66	14.45	3	81679	14517	34860732
Confusional state	23.64	14.45	219	81463	143941	34731308
Benign prostatic hyperplasia	23.60	14.45	3	81679	14492	34860757
Arterial thrombosis	23.58	14.45	23	81659	1492	34873757
Rectal haemorrhage	23.50	14.45	36	81646	40213	34835036
Basal cell naevus syndrome	23.48	14.45	7	81675	32	34875217
Nervous system disorder	23.35	14.45	81	81601	14462	34860787
Road traffic accident	23.28	14.45	6	81676	17444	34857805
Intussusception	23.28	14.45	16	81666	630	34874619
Condition aggravated	23.21	14.45	313	81369	191883	34683366
Traumatic lung injury	23.21	14.45	21	81661	1239	34874010
Leukoencephalopathy	23.16	14.45	38	81644	4177	34871072
Hypertensive hydrocephalus	23.06	14.45	8	81674	64	34875185
Papilloedema	22.98	14.45	30	81652	2683	34872566
Adenovirus reactivation	22.93	14.45	11	81671	215	34875034
Speech disorder	22.88	14.45	16	81666	25670	34849579
Pneumonia fungal	22.87	14.45	51	81631	7049	34868200
Syncope	22.80	14.45	123	81559	91328	34783921
Gastrointestinal mucosal disorder	22.78	14.45	13	81669	367	34874882
Central nervous system lymphoma	22.70	14.45	19	81663	1009	34874240
Psoriatic arthropathy	22.54	14.45	9	81673	19789	34855460
Metastases to lymph nodes	22.52	14.45	40	81642	4688	34870561
Meningitis tuberculous	22.44	14.45	16	81666	669	34874580
Emotional distress	22.43	14.45	4	81678	15022	34860227
Nasal congestion	22.40	14.45	13	81669	23044	34852205
Capillary leak syndrome	22.36	14.45	27	81655	2231	34873018
Post-acute COVID-19 syndrome	22.22	14.45	10	81672	168	34875081
Pneumothorax	22.20	14.45	96	81586	18996	34856253
Pneumonia aspiration	22.13	14.45	40	81642	41863	34833386
Brain sarcoma	22.09	14.45	6	81676	18	34875231
Carbamoyl phosphate synthetase deficiency	22.09	14.45	6	81676	18	34875231
Laboratory test abnormal	22.04	14.45	10	81672	20381	34854868
B-cell lymphoma refractory	21.95	14.45	10	81672	173	34875076
Ill-defined disorder	21.93	14.45	77	81605	13832	34861417
Arrhythmia	21.91	14.45	31	81651	35777	34839472
Therapy interrupted	21.91	14.45	3	81679	13694	34861555
Cardiogenic shock	21.89	14.45	18	81664	26600	34848649
Geotrichum infection	21.84	14.45	14	81668	490	34874759
Myoclonus	21.81	14.45	4	81678	14721	34860528
Eczema	21.62	14.45	8	81674	18428	34856821
Klebsiella bacteraemia	21.47	14.45	21	81661	1367	34873882
Trichosporon infection	21.45	14.45	16	81666	718	34874531
Dyspnoea exertional	21.38	14.45	43	81639	43236	34832013
Hypertransaminasaemia	21.22	14.45	43	81639	5563	34869686
Gait inability	21.19	14.45	11	81671	20747	34854502
Hepatic cirrhosis	21.18	14.45	7	81675	17307	34857942
Streptococcal infection	21.14	14.45	40	81642	4921	34870328
Product administration error	21.09	14.45	6	81676	16338	34858911
Stomatitis necrotising	21.07	14.45	8	81674	85	34875164
Cerebral venous thrombosis	21.06	14.45	16	81666	738	34874511
Clostridium colitis	21.01	14.45	20	81662	1259	34873990
Small cell lung cancer	20.89	14.45	24	81658	1881	34873368
Hepatosplenomegaly	20.80	14.45	36	81646	4133	34871116
Transformation to acute myeloid leukaemia	20.69	14.45	16	81666	758	34874491
Autoimmune neutropenia	20.66	14.45	11	81671	270	34874979
Ventricular tachycardia	20.61	14.45	19	81663	26560	34848689
Osteonecrosis of jaw	20.58	14.45	8	81674	17881	34857368
Palpitations	20.38	14.45	39	81643	39947	34835302
Electrolyte imbalance	20.37	14.45	77	81605	14335	34860914
Escherichia sepsis	20.13	14.45	38	81644	4666	34870583
Disorder of orbit	20.12	14.45	8	81674	97	34875152
Blood pressure decreased	20.05	14.45	58	81624	51457	34823792
Adrenocortical carcinoma	20.03	14.45	6	81676	28	34875221
Lung infiltration	19.97	14.45	71	81611	12834	34862415
Granulocyte count decreased	19.96	14.45	16	81666	799	34874450
Cardiac arrest	19.96	14.45	137	81545	96022	34779227
Gallbladder empyema	19.86	14.45	7	81675	59	34875190
Hepatic steatosis	19.86	14.45	9	81673	18353	34856896
Inflammatory pseudotumour	19.86	14.45	6	81676	29	34875220
Platelet count abnormal	19.77	14.45	29	81653	2893	34872356
Intestinal perforation	19.65	14.45	56	81626	9004	34866245
Bicytopenia	19.63	14.45	26	81656	2358	34872891
Swollen tongue	19.53	14.45	5	81677	14600	34860649
Testicular malignant teratoma	19.52	14.45	5	81677	11	34875238
Neutrophil count abnormal	19.26	14.45	23	81659	1879	34873370
Paternal exposure timing unspecified	19.22	14.45	6	81676	33	34875216
Nightmare	19.10	14.45	5	81677	14386	34860863
Superior vena cava syndrome	18.99	14.45	14	81668	617	34874632
Therapy responder	18.85	14.45	9	81673	174	34875075
Enterocolitis	18.78	14.45	51	81631	7975	34867274
Type 2 diabetes mellitus	18.73	14.45	7	81675	16025	34859224
Chronic myelomonocytic leukaemia	18.54	14.45	14	81668	640	34874609
Burning sensation	18.41	14.45	10	81672	18384	34856865
Small intestinal perforation	18.38	14.45	24	81658	2147	34873102
Heart rate irregular	18.30	14.45	7	81675	15800	34859449
Acute myelomonocytic leukaemia	18.30	14.45	8	81674	125	34875124
Asthenia	18.27	14.45	435	81247	244816	34630433
Arteriosclerosis	18.27	14.45	3	81679	11965	34863284
Flushing	18.20	14.45	134	81548	32286	34842963
Hip fracture	18.18	14.45	3	81679	11922	34863327
Spindle cell sarcoma	18.18	14.45	8	81674	127	34875122
Polyneuropathy	18.17	14.45	76	81606	14820	34860429
Hypokalaemia	18.14	14.45	212	81470	58002	34817247
Neurological decompensation	18.03	14.45	28	81654	2938	34872311
Obesity	18.02	14.45	4	81678	12874	34862375
Dystrophic calcification	18.01	14.45	4	81678	3	34875246
Hypoaesthesia	18.01	14.45	78	81604	61366	34813883
Premature ageing	17.98	14.45	7	81675	80	34875169
Reticulocytosis	17.92	14.45	10	81672	270	34874979
Chronic myeloid leukaemia	17.92	14.45	24	81658	2200	34873049
Plasma cell leukaemia	17.91	14.45	16	81666	928	34874321
Refractory cytopenia with multilineage dysplasia	17.90	14.45	8	81674	132	34875117
Blood fibrinogen decreased	17.90	14.45	18	81664	1212	34874037
Underdose	17.89	14.45	5	81677	13775	34861474
Post transplant lymphoproliferative disorder	17.87	14.45	44	81638	6484	34868765
Accidental exposure to product	17.87	14.45	4	81678	12798	34862451
Pulmonary alveolar haemorrhage	17.85	14.45	48	81634	7464	34867785
Adverse event	17.84	14.45	11	81671	18866	34856383
Fluid retention	17.75	14.45	22	81660	26865	34848384
5q minus syndrome	17.53	14.45	8	81674	139	34875110
Mucoepidermoid carcinoma	17.51	14.45	5	81677	19	34875230
Peripheral sensorimotor neuropathy	17.47	14.45	20	81662	1562	34873687
Pneumonia cytomegaloviral	17.42	14.45	28	81654	3026	34872223
Treatment failure	17.29	14.45	176	81506	46521	34828728
Hypertension	17.26	14.45	220	81462	136223	34739026
Pneumocystis jirovecii infection	17.26	14.45	21	81661	1749	34873500
Pancreatitis	17.26	14.45	41	81641	38850	34836399
Blindness cortical	17.23	14.45	11	81671	382	34874867
Myelitis transverse	17.17	14.45	17	81665	1123	34874126
Gout	17.14	14.45	12	81670	19241	34856008
Abdominal neoplasm	17.03	14.45	11	81671	390	34874859
Lower respiratory tract infection fungal	17.01	14.45	13	81669	605	34874644
Epstein-Barr viraemia	16.93	14.45	18	81664	1294	34873955
Retinal pigment epitheliopathy	16.90	14.45	9	81673	221	34875028
Drug level increased	16.89	14.45	16	81666	22080	34853169
Adenomatous polyposis coli	16.88	14.45	8	81674	152	34875097
Scedosporium infection	16.84	14.45	15	81667	867	34874382
Chemotherapy	16.81	14.45	13	81669	616	34874633
Terminal ileitis	16.79	14.45	9	81673	224	34875025
Thrombosis	16.72	14.45	61	81621	50397	34824852
Hepatic enzyme increased	16.71	14.45	42	81640	39038	34836211
Guillain-Barre syndrome	16.63	14.45	41	81641	6046	34869203
Discomfort	16.60	14.45	12	81670	18926	34856323
Acanthamoeba infection	16.59	14.45	11	81671	408	34874841
Sopor	16.53	14.45	4	81678	12132	34863117
Wound	16.52	14.45	7	81675	14857	34860392
Angina pectoris	16.50	14.45	30	81652	31333	34843916
Atrial fibrillation	16.36	14.45	195	81487	122198	34753051
Metastases to bone marrow	16.33	14.45	12	81670	526	34874723
Embolism arterial	16.31	14.45	13	81669	644	34874605
Septal panniculitis	16.30	14.45	6	81676	58	34875191
Peritoneal lesion	16.27	14.45	7	81675	105	34875144
Renal infarct	16.22	14.45	18	81664	1358	34873891
Atypical teratoid/rhabdoid tumour of CNS	16.22	14.45	4	81678	7	34875242
Burns first degree	16.22	14.45	4	81678	7	34875242
Cardiomyopathy	16.20	14.45	80	81602	16728	34858521
Prostatic specific antigen increased	16.18	14.45	7	81675	14673	34860576
Toxic epidermal necrolysis	16.17	14.45	16	81666	21630	34853619
Psychotic disorder	16.15	14.45	20	81662	24432	34850817
Metastases to bone	16.13	14.45	63	81619	11907	34863342
Splenic infarction	16.12	14.45	22	81660	2053	34873196
Testicular germ cell cancer metastatic	16.12	14.45	6	81676	60	34875189
Chest discomfort	16.12	14.45	69	81613	54461	34820788
Stevens-Johnson syndrome	16.09	14.45	12	81670	18627	34856622
Neuroendocrine tumour of the lung metastatic	16.09	14.45	7	81675	108	34875141
Colony stimulating factor therapy	16.07	14.45	8	81674	170	34875079
Delirium	16.06	14.45	51	81631	43940	34831309
Pneumatosis intestinalis	15.94	14.45	31	81651	3892	34871357
Rhinorrhoea	15.92	14.45	22	81660	25646	34849603
Carnitine deficiency	15.92	14.45	7	81675	111	34875138
Hyperlipidaemia	15.90	14.45	7	81675	14522	34860727
Choriocarcinoma	15.87	14.45	4	81678	8	34875241
Cerebellar tumour	15.86	14.45	6	81676	63	34875186
Mucosal toxicity	15.84	14.45	9	81673	252	34874997
Poikiloderma	15.82	14.45	8	81674	176	34875073
Haemorrhage	15.80	14.45	64	81618	51306	34823943
Delayed engraftment	15.80	14.45	7	81675	113	34875136
Congenital hepatobiliary anomaly	15.79	14.45	5	81677	29	34875220
Deafness	15.77	14.45	60	81622	11205	34864044
Bacillus bacteraemia	15.70	14.45	6	81676	65	34875184
Primitive neuroectodermal tumour	15.70	14.45	6	81676	65	34875184
Recall phenomenon	15.69	14.45	12	81670	559	34874690
Hypomagnesaemia	15.68	14.45	96	81586	21755	34853494
Medulloblastoma	15.61	14.45	6	81676	66	34875183
Localised infection	15.60	14.45	11	81671	17576	34857673
Acute monocytic leukaemia	15.57	14.45	10	81672	351	34874898
Diabetes mellitus inadequate control	15.52	14.45	6	81676	13458	34861791
Clostridium difficile infection	15.49	14.45	86	81596	18812	34856437
Tooth hypoplasia	15.48	14.45	7	81675	119	34875130
Coronary artery thrombosis	15.45	14.45	22	81660	2137	34873112
Hepatic necrosis	15.44	14.45	30	81652	3764	34871485
Skin laceration	15.40	14.45	5	81677	12504	34862745
Hirsutism	15.38	14.45	8	81674	187	34875062
Cholelithiasis	15.38	14.45	16	81666	21132	34854117
Peripheral artery thrombosis	15.36	14.45	23	81659	2337	34872912
Pneumomediastinum	15.31	14.45	23	81659	2344	34872905
Fanconi syndrome acquired	15.30	14.45	21	81661	1970	34873279
Bone sarcoma	15.30	14.45	6	81676	70	34875179
Autoimmune haemolytic anaemia	15.28	14.45	33	81649	4463	34870786
Ewing's sarcoma recurrent	15.26	14.45	4	81678	10	34875239
Subdural haemorrhage	15.20	14.45	27	81655	3164	34872085
Li-Fraumeni syndrome	15.18	14.45	3	81679	0	34875249
Erythema ab igne	15.18	14.45	3	81679	0	34875249
Salivary gland cancer stage IV	15.12	14.45	5	81677	34	34875215
Blood glucose decreased	15.09	14.45	6	81676	13231	34862018
Primary hypogonadism	15.07	14.45	6	81676	73	34875176
Blastic plasmacytoid dendritic cell neoplasia	15.07	14.45	6	81676	73	34875176
JC virus infection	15.07	14.45	22	81660	2186	34873063
CNS ventriculitis	15.01	14.45	9	81673	279	34874970
Blood culture positive	15.01	14.45	34	81648	4749	34870500
Metastatic lymphoma	15.00	14.45	8	81674	197	34875052
Epidural haemorrhage	15	14.45	6	81676	74	34875175
Staphylococcal infection	14.89	14.45	129	81553	32631	34842618
Iron deficiency anaemia	14.88	14.45	3	81679	10326	34864923
Cardiomyopathy acute	14.87	14.45	5	81677	36	34875213
Lethargy	14.79	14.45	48	81634	41074	34834175
Food protein-induced enterocolitis syndrome	14.75	14.45	5	81677	37	34875212
Subcutaneous emphysema	14.74	14.45	16	81666	1178	34874071
Alpha haemolytic streptococcal infection	14.74	14.45	16	81666	1178	34874071
Mediastinum neoplasm	14.73	14.45	4	81678	12	34875237
Platelet transfusion	14.71	14.45	18	81664	1508	34873741
Immune effector cell-associated neurotoxicity syndrome	14.67	14.45	29	81653	3684	34871565
Cerebral artery occlusion	14.66	14.45	13	81669	747	34874502
Nocturia	14.64	14.45	3	81679	10207	34865042
Paranoia	14.55	14.45	5	81677	12063	34863186
Vascular device infection	14.55	14.45	31	81651	4154	34871095
Cerebral toxoplasmosis	14.53	14.45	19	81663	1702	34873547
Pulmonary congestion	14.49	14.45	7	81675	13758	34861491
Dementia	14.46	14.45	7	81675	13741	34861508

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	5815.59	14.56	3961	125001	227038	79388388
Neutropenia	2065.51	14.56	2429	126533	285281	79330145
Pancytopenia	1660.87	14.56	1670	127292	164075	79451351
Mucosal inflammation	1638.05	14.56	1187	127775	74393	79541033
Bone marrow failure	1404.15	14.56	929	128033	50178	79565248
Thrombocytopenia	1281.89	14.56	1844	127118	263415	79352011
Disease progression	1277.92	14.56	1531	127431	182831	79432595
Acute myeloid leukaemia	1128.78	14.56	673	128289	30212	79585214
Off label use	1073.84	14.56	3553	125409	903662	78711764
Product use in unapproved indication	1046.71	14.56	1627	127335	248732	79366694
Myelosuppression	1026.25	14.56	699	128263	39597	79575829
Myelodysplastic syndrome	975.87	14.56	609	128353	29692	79585734
Haematotoxicity	843.07	14.56	439	128523	15080	79600346
Venoocclusive liver disease	777.20	14.56	380	128582	11391	79604035
Malignant neoplasm progression	729.18	14.56	995	127967	134995	79480431
Sepsis	661.76	14.56	1390	127572	268038	79347388
Second primary malignancy	650.65	14.56	360	128602	13990	79601436
Tumour lysis syndrome	601.56	14.56	412	128550	23527	79591899
Septic shock	570.15	14.56	839	128123	121962	79493464
Neutrophil count decreased	556.43	14.56	722	128240	93237	79522189
Febrile bone marrow aplasia	529.00	14.56	304	128658	12716	79602710
Neutropenic sepsis	498.52	14.56	386	128576	26678	79588748
Pain	474.05	14.56	276	128686	703526	78911900
Arthralgia	467.31	14.56	171	128791	571632	79043794
Renal salt-wasting syndrome	447.42	14.56	122	128840	594	79614832
Haemophagocytic lymphohistiocytosis	440.90	14.56	329	128633	21508	79593918
Therapy partial responder	438.46	14.56	300	128662	17097	79598329
Joint swelling	415.38	14.56	11	128951	288635	79326791
Fall	411.71	14.56	138	128824	487491	79127935
Diffuse large B-cell lymphoma recurrent	403.45	14.56	176	128786	4031	79611395
Anaemia	367.76	14.56	1558	127404	443457	79171969
Aplasia	367.74	14.56	201	128761	7619	79607807
Posterior reversible encephalopathy syndrome	366.79	14.56	319	128643	25962	79589464
Stem cell transplant	342.38	14.56	151	128811	3553	79611873
Cytopenia	331.00	14.56	270	128692	20113	79595313
Leukopenia	329.34	14.56	638	128324	115875	79499551
Multiple organ dysfunction syndrome	321.22	14.56	643	128319	119603	79495823
Pyrexia	310.61	14.56	2016	126946	676693	78938733
Platelet count decreased	306.22	14.56	846	128116	193818	79421608
Neoplasm progression	302.43	14.56	395	128567	51287	79564139
Product dose omission issue	301.05	14.56	27	128935	247510	79367916
Encephalopathy	291.86	14.56	446	128516	66951	79548475
Cardiotoxicity	291.82	14.56	204	128758	12035	79603391
Nasopharyngitis	289.95	14.56	35	128927	253846	79361580
Peripheral swelling	287.16	14.56	46	128916	269571	79345855
Malignant transformation	286.90	14.56	98	128864	1120	79614306
Aspergillus infection	282.45	14.56	240	128722	18921	79596505
Bacteraemia	279.86	14.56	304	128658	32520	79582906
Rheumatoid arthritis	279.00	14.56	14	128948	208456	79406970
Neutropenic colitis	274.76	14.56	149	128813	5558	79609868
Abdominal discomfort	266.50	14.56	43	128919	250684	79364742
Headache	265.31	14.56	405	128557	653367	78962059
Bronchopulmonary aspergillosis	260.70	14.56	245	128717	22049	79593377
Malaise	259.68	14.56	246	128716	489623	79125803
Venoocclusive disease	258.76	14.56	133	128829	4440	79610986
Drug hypersensitivity	253.02	14.56	84	128878	298832	79316594
Arthropathy	250.10	14.56	8	128954	177103	79438323
Dizziness	243.84	14.56	296	128666	526145	79089281
Fatigue	241.22	14.56	740	128222	928987	78686439
Pruritus	240.23	14.56	173	128789	394475	79220951
Respiratory failure	238.17	14.56	738	128224	180173	79435253
Cystitis haemorrhagic	235.45	14.56	160	128802	9012	79606414
Musculoskeletal stiffness	233.38	14.56	12	128950	174996	79440430
Cytomegalovirus infection	223.61	14.56	309	128653	42335	79573091
Acute graft versus host disease	220.58	14.56	160	128802	10007	79605419
Rash	219.73	14.56	374	128588	577984	79037442
Disease recurrence	218.48	14.56	311	128651	43798	79571628
Insomnia	218.03	14.56	63	128899	245107	79370319
Weight increased	212.92	14.56	91	128871	277295	79338131
Drug abuse	211.25	14.56	13	128949	162678	79452748
Swelling	203.45	14.56	50	128912	216661	79398765
Overdose	201.62	14.56	29	128933	184177	79431249
Diffuse large B-cell lymphoma refractory	198.50	14.56	78	128884	1357	79614069
Drug resistance	197.93	14.56	290	128672	41923	79573503
Clostridium difficile colitis	195.49	14.56	251	128711	32032	79583394
Secondary immunodeficiency	194.46	14.56	98	128864	3136	79612290
Cytogenetic abnormality	191.00	14.56	71	128891	1054	79614372
Injection site pain	190.30	14.56	4	128958	129834	79485592
Bacterial infection	189.09	14.56	243	128719	31037	79584389
Human herpesvirus 6 infection	188.24	14.56	114	128848	5256	79610170
Anxiety	185.23	14.56	85	128877	248427	79366999
Blood pressure increased	179.47	14.56	59	128903	211301	79404125
Colitis	177.96	14.56	377	128585	72930	79542496
BK virus infection	171.80	14.56	130	128832	8674	79606752
Contraindicated product administered	169.63	14.56	26	128936	157512	79457914
Neuropathy peripheral	166.41	14.56	555	128407	140750	79474676
Asthma	166.17	14.56	14	128948	135081	79480345
Cytomegalovirus chorioretinitis	165.78	14.56	106	128856	5384	79610042
White blood cell count decreased	162.60	14.56	669	128293	187619	79427807
Wound	161.35	14.56	6	128956	116173	79499253
Candida infection	159.93	14.56	249	128713	37965	79577461
Neurotoxicity	159.15	14.56	228	128734	32290	79583136
Ototoxicity	159.06	14.56	86	128876	3188	79612238
Pain in extremity	154.20	14.56	219	128743	364319	79251107
Fungal infection	154.19	14.56	257	128705	41491	79573935
Lymphopenia	153.60	14.56	217	128745	30340	79585086
Therapeutic product effect decreased	149.56	14.56	40	128922	163823	79451603
Nephropathy toxic	146.61	14.56	173	128789	20246	79595180
Inappropriate schedule of product administration	146.29	14.56	21	128941	133607	79481819
Enterococcal infection	145.78	14.56	152	128810	15508	79599918
Contusion	144.21	14.56	32	128930	148744	79466682
Urticaria	143.26	14.56	60	128902	185141	79430285
Feeling abnormal	143.16	14.56	40	128922	159159	79456267
Cytomegalovirus viraemia	142.47	14.56	137	128825	12684	79602742
Graft versus host disease	141.95	14.56	147	128815	14879	79600547
Thrombotic microangiopathy	140.06	14.56	168	128794	20001	79595425
Muscle spasms	137.76	14.56	55	128907	174675	79440751
Hepatitis B reactivation	136.79	14.56	98	128864	6010	79609416
Teratoma	135.32	14.56	35	128927	133	79615293
Discomfort	134.62	14.56	21	128941	125596	79489830
Neoplasm recurrence	133.82	14.56	84	128878	4130	79611296
Pneumocystis jirovecii pneumonia	132.12	14.56	209	128753	32299	79583127
Klebsiella infection	126.03	14.56	141	128821	15579	79599847
Staphylococcal bacteraemia	123.55	14.56	124	128838	12094	79603332
Progressive multifocal leukoencephalopathy	122.88	14.56	159	128803	20441	79594985
Epstein-Barr virus infection	121.96	14.56	133	128829	14283	79601143
Thymus hypoplasia	117.64	14.56	48	128914	925	79614501
Hypersensitivity	116.42	14.56	152	128810	262087	79353339
Renal tubular disorder	116.12	14.56	91	128871	6395	79609031
Arthritis	114.84	14.56	23	128939	114857	79500569
Sweat gland tumour	114.73	14.56	40	128922	488	79614938
Stress	114.53	14.56	3	128959	79609	79535817
Drug intolerance	113.28	14.56	157	128805	263962	79351464
Mycobacterium chelonae infection	112.36	14.56	62	128900	2394	79613032
Glossodynia	111.35	14.56	17	128945	103320	79512106
Bronchitis	109.93	14.56	37	128925	130607	79484819
Somnolence	109.73	14.56	135	128827	238846	79376580
Lymphoid tissue hypoplasia	109.45	14.56	45	128917	885	79614541
Primary hypogonadism	108.22	14.56	30	128932	157	79615269
Depression	107.62	14.56	115	128847	216675	79398751
Ovarian germ cell teratoma	107.36	14.56	25	128937	53	79615373
Parainfluenzae virus infection	106.69	14.56	82	128880	5600	79609826
Blood lactate dehydrogenase increased	106.32	14.56	211	128751	38959	79576467
Loss of personal independence in daily activities	105.80	14.56	19	128943	102561	79512865
Suicidal ideation	105.79	14.56	4	128958	76336	79539090
Acute respiratory distress syndrome	105.04	14.56	225	128737	43842	79571584
Acute promyelocytic leukaemia	104.01	14.56	50	128912	1441	79613985
Blood cholesterol increased	102.06	14.56	9	128953	83711	79531715
Psoriatic arthropathy	101.92	14.56	6	128956	77993	79537433
Pseudomonal sepsis	100.67	14.56	82	128880	6092	79609334
Hepatic enzyme increased	99.73	14.56	89	128873	182521	79432905
Pulmonary haemorrhage	99.59	14.56	121	128841	14596	79600830
Injury	98.19	14.56	7	128955	77489	79537937
Migraine	97.52	14.56	13	128949	87480	79527946
Injection site erythema	96.43	14.56	8	128954	78189	79537237
Klebsiella sepsis	96.24	14.56	62	128900	3190	79612236
Blood pressure fluctuation	94.86	14.56	3	128959	67142	79548284
Osteosarcoma	94.45	14.56	32	128930	356	79615070
Human bocavirus infection	94.36	14.56	38	128924	707	79614719
Chronic graft versus host disease	93.96	14.56	82	128880	6699	79608727
Duodenal ulcer perforation	93.39	14.56	3	128959	66208	79549218
Gait disturbance	93.39	14.56	119	128843	207387	79408039
Chloroma	93.14	14.56	38	128924	732	79614694
Agranulocytosis	92.84	14.56	217	128745	44813	79570613
Aplastic anaemia	92.73	14.56	129	128833	17776	79597650
Myalgia	91.55	14.56	99	128863	185542	79429884
Suicide attempt	90.84	14.56	13	128949	82919	79532507
Tremor	90.38	14.56	85	128877	169998	79445428
Lymphadenopathy	90.16	14.56	238	128724	53009	79562417
Pneumatosis intestinalis	89.94	14.56	78	128884	6319	79609107
Influenza like illness	89.36	14.56	7	128955	71700	79543726
Mobility decreased	89.10	14.56	43	128919	122132	79493294
Hepatitis B	88.76	14.56	87	128875	8245	79607181
Anaplastic lymphoma kinase gene mutation	87.65	14.56	24	128938	119	79615307
Psoriasis	87.34	14.56	19	128943	89568	79525858
Abdominal pain upper	87.28	14.56	142	128820	223677	79391749
Incorrect dose administered	86.34	14.56	11	128951	76619	79538807
Pneumonitis	86.28	14.56	255	128707	60605	79554821
Enterobacter infection	86.01	14.56	66	128896	4496	79610930
Condition aggravated	85.90	14.56	468	128494	500656	79114770
Blister	85.69	14.56	43	128919	119433	79495993
Wheezing	85.17	14.56	41	128921	116623	79498803
Peripheral sensory neuropathy	84.71	14.56	105	128857	12928	79602498
Acute myeloid leukaemia recurrent	84.42	14.56	58	128904	3325	79612101
Adenovirus infection	84.07	14.56	85	128877	8362	79607064
Diffuse large B-cell lymphoma	84.03	14.56	101	128861	12048	79603378
Sinusitis	84.01	14.56	116	128846	195385	79420041
Urinary tract infection	83.90	14.56	201	128761	274311	79341115
Hypogammaglobulinaemia	83.63	14.56	104	128858	12847	79602579
Acute graft versus host disease in skin	83.52	14.56	81	128881	7577	79607849
Engraftment syndrome	82.68	14.56	42	128920	1367	79614059
Pulmonary toxicity	82.27	14.56	103	128859	12811	79602615
Disseminated intravascular coagulation	81.99	14.56	180	128782	35662	79579764
Sleep disorder	81.86	14.56	19	128943	85658	79529768
Metastases to central nervous system	81.86	14.56	116	128846	16259	79599167
Enteritis	81.47	14.56	109	128853	14474	79600952
Drug interaction	81.30	14.56	370	128592	414813	79200613
Weight decreased	81.15	14.56	298	128664	354900	79260526
Oesophagitis	81.10	14.56	143	128819	24146	79591280
Teratoma benign	80.70	14.56	20	128942	61	79615365
Hospitalisation	80.48	14.56	26	128936	94210	79521216
B-cell lymphoma recurrent	80.44	14.56	37	128925	963	79614463
Blood glucose increased	80.06	14.56	43	128919	114932	79500494
Therapy non-responder	79.61	14.56	328	128634	91977	79523449
Leukoencephalopathy	79.31	14.56	80	128882	7849	79607577
Metastasis	79.26	14.56	75	128887	6805	79608621
Impaired healing	78.82	14.56	22	128940	87633	79527793
Cytomegalovirus infection reactivation	78.27	14.56	83	128879	8633	79606793
Myeloid leukaemia	77.96	14.56	33	128929	700	79614726
Epstein-Barr virus associated lymphoproliferative disorder	77.56	14.56	56	128906	3476	79611950
Memory impairment	77.49	14.56	42	128920	111692	79503734
Dry mouth	77.48	14.56	23	128939	87996	79527430
Pneumothorax	77.38	14.56	153	128809	28170	79587256
Alveolar soft part sarcoma	76.52	14.56	20	128942	80	79615346
Oesophageal candidiasis	76.16	14.56	84	128878	9134	79606292
Viraemia	75.90	14.56	51	128911	2818	79612608
Bacterial sepsis	75.28	14.56	79	128883	8119	79607307
Systemic candida	75.15	14.56	72	128890	6634	79608792
Leukaemia recurrent	75.05	14.56	50	128912	2724	79612702
Mucormycosis	74.91	14.56	80	128882	8389	79607037
Stomatitis	74.77	14.56	449	128513	146308	79469118
Blood pressure systolic increased	74.54	14.56	10	128952	66976	79548450
Hyperhidrosis	74.45	14.56	81	128881	151411	79464015
Gene mutation	74.08	14.56	49	128913	2637	79612789
Chest pain	73.97	14.56	223	128739	282081	79333345
Recurrent cancer	73.97	14.56	49	128913	2644	79612782
Ovarian failure	73.79	14.56	31	128931	645	79614781
Palpitations	73.68	14.56	58	128904	126552	79488874
Back pain	73.61	14.56	249	128713	303931	79311495
Graft versus host disease in skin	73.41	14.56	68	128894	6005	79609421
Lymphoma	73.36	14.56	114	128848	17346	79598080
Enterococcal bacteraemia	72.81	14.56	51	128911	3017	79612409
Gastrointestinal toxicity	72.43	14.56	77	128885	8032	79607394
Post transplant lymphoproliferative disorder	72.34	14.56	91	128871	11373	79604053
Vision blurred	71.71	14.56	41	128921	105857	79509569
Nasal congestion	71.13	14.56	18	128944	76534	79538892
Acute lymphocytic leukaemia	70.69	14.56	61	128901	4908	79610518
Cytokine release syndrome	70.44	14.56	170	128792	35828	79579598
Fungaemia	68.66	14.56	58	128904	4533	79610893
Oedema peripheral	68.48	14.56	196	128766	252092	79363334
Dyspnoea	68	14.56	977	127985	856048	78759378
Capillary leak syndrome	67.97	14.56	54	128908	3871	79611555
Herpes simplex	67.94	14.56	91	128871	12096	79603330
Metastases to lung	67.30	14.56	112	128850	18051	79597375
Gastrooesophageal reflux disease	66.90	14.56	43	128919	104203	79511223
Superior vena cava syndrome	66.86	14.56	35	128927	1214	79614212
Hypokalaemia	66.68	14.56	430	128532	143610	79471816
Pulmonary vascular disorder	66.23	14.56	33	128929	1030	79614396
Varicella zoster virus infection	66.20	14.56	56	128906	4385	79611041
Staphylococcal infection	65.94	14.56	226	128736	58069	79557357
Myocardial infarction	65.26	14.56	124	128838	184005	79431421
Acute lymphocytic leukaemia recurrent	65.20	14.56	57	128905	4667	79610759
Complications of bone marrow transplant	65.13	14.56	28	128934	618	79614808
Refractory anaemia with an excess of blasts	65.08	14.56	31	128931	875	79614551
Hypoglycaemia	65.07	14.56	42	128920	101552	79513874
Systemic mycosis	64.86	14.56	45	128917	2621	79612805
Streptococcal bacteraemia	63.28	14.56	50	128912	3556	79611870
Pericarditis	62.89	14.56	46	128916	104190	79511236
Viral haemorrhagic cystitis	62.74	14.56	40	128922	2021	79613405
Depressed mood	62.52	14.56	4	128958	48476	79566950
Hypomagnesaemia	62.20	14.56	192	128770	46719	79568707
Nephrolithiasis	61.63	14.56	7	128955	53284	79562142
Metastases to lymph nodes	61.62	14.56	80	128882	10317	79605109
Coronary artery disease	61.60	14.56	15	128947	65459	79549967
Retinal haemorrhage	61.28	14.56	71	128891	8146	79607280
Heart rate decreased	60.75	14.56	19	128943	70297	79545129
Loss of consciousness	60.48	14.56	112	128850	167831	79447595
Salivary gland cancer	60.12	14.56	24	128938	436	79614990
Klebsiella bacteraemia	59.96	14.56	45	128917	2965	79612461
Hepatosplenic T-cell lymphoma	59.91	14.56	29	128933	849	79614577
Pneumonia fungal	59.90	14.56	82	128880	11128	79604298
Fanconi syndrome	59.80	14.56	44	128918	2812	79612614
Cardiomyopathy	59.68	14.56	139	128823	28635	79586791
Cystitis bacterial	59.41	14.56	27	128935	683	79614743
Drug ineffective	58.31	14.56	2215	126747	1078698	78536728
Pleural effusion	57.34	14.56	417	128545	144845	79470581
Adverse drug reaction	57.25	14.56	18	128944	66374	79549052
Product prescribing error	56.90	14.56	4	128958	44809	79570617
Fusarium infection	56.87	14.56	36	128926	1796	79613630
Angioedema	56.60	14.56	26	128936	76009	79539417
Haematochezia	56.45	14.56	36	128926	87609	79527817
Premature menopause	56.33	14.56	25	128937	597	79614829
Pulmonary arteriopathy	56.02	14.56	16	128946	95	79615331
Injection site pruritus	56.02	14.56	3	128959	42280	79573146
Cardiac failure congestive	55.81	14.56	90	128872	142312	79473114
Clostridium colitis	55.57	14.56	42	128920	2797	79612629
Folliculitis	55.52	14.56	11	128951	55369	79560057
Rhabdomyolysis	55.41	14.56	51	128911	103080	79512346
Balance disorder	55.38	14.56	47	128915	98810	79516616
Lower respiratory tract infection	55.16	14.56	77	128885	129143	79486283
Road traffic accident	55.15	14.56	4	128958	43660	79571766
Norovirus test positive	54.84	14.56	25	128937	637	79614789
Electrocardiogram QT prolonged	54.38	14.56	40	128922	90346	79525080
Aortic thrombosis	54.36	14.56	34	128928	1661	79613765
Myelopathy	54.31	14.56	51	128911	4582	79610844
Skin toxicity	54.06	14.56	67	128895	8247	79607179
Device related infection	53.75	14.56	149	128813	34145	79581281
Hypoaesthesia	53.44	14.56	133	128829	179219	79436207
Blood stem cell transplant failure	53.31	14.56	23	128939	512	79614914
Disseminated aspergillosis	53.29	14.56	29	128933	1089	79614337
Paraneoplastic neurological syndrome	53.17	14.56	14	128948	58	79615368
Paraesthesia	53.13	14.56	130	128832	176193	79439233
Small cell lung cancer	52.84	14.56	41	128921	2839	79612587
Osteonecrosis	52.64	14.56	139	128823	30956	79584470
Ameloblastoma	52.53	14.56	15	128947	89	79615337
Pneumonia klebsiella	52.40	14.56	52	128910	5002	79610424
Vertigo	52.40	14.56	23	128939	69059	79546367
Burning sensation	52.19	14.56	15	128947	58617	79556809
Renal failure	51.93	14.56	525	128437	200443	79414983
Refractory cancer	51.75	14.56	18	128944	218	79615208
T-cell type acute leukaemia	51.45	14.56	17	128945	174	79615252
Escherichia bacteraemia	51.13	14.56	58	128904	6504	79608922
Hyperkalaemia	51.03	14.56	66	128896	114332	79501094
Deafness	50.80	14.56	108	128854	20929	79594497
Sedation	50.59	14.56	11	128951	51884	79563542
Pseudomonas infection	50.12	14.56	107	128855	20796	79594630
Medulloblastoma recurrent	49.92	14.56	15	128947	109	79615317
Pulmonary alveolar haemorrhage	49.81	14.56	76	128886	11381	79604045
Cardiomyopathy acute	49.81	14.56	19	128943	304	79615122
Rash pruritic	49.55	14.56	27	128935	71602	79543824
Wrong technique in product usage process	49.44	14.56	29	128933	73846	79541580
Lactic acidosis	49.43	14.56	26	128936	70333	79545093
Radiation pneumonitis	49.41	14.56	45	128917	3888	79611538
Metastases to spleen	49.23	14.56	23	128939	621	79614805
Stenotrophomonas infection	49.04	14.56	44	128918	3729	79611697
Embolism	48.86	14.56	84	128878	13898	79601528
Exposure during pregnancy	48.66	14.56	55	128907	101077	79514349
Nervous system disorder	48.50	14.56	123	128839	26733	79588693
Type 2 diabetes mellitus	48.35	14.56	16	128946	57106	79558320
Hepatosplenomegaly	47.90	14.56	54	128908	6015	79609411
Radiation oesophagitis	47.68	14.56	23	128939	668	79614758
Trichosporon infection	47.64	14.56	26	128936	982	79614444
Large intestinal ulcer perforation	47.55	14.56	13	128949	64	79615362
Delayed puberty	47.39	14.56	16	128946	176	79615250
Gastrointestinal fungal infection	47.34	14.56	21	128941	501	79614925
Aggression	47.31	14.56	12	128950	50946	79564480
Diaphragm muscle weakness	47.30	14.56	16	128946	177	79615249
Cerebrovascular accident	46.39	14.56	115	128847	155177	79460249
Ejection fraction decreased	46.28	14.56	142	128820	34435	79580991
Amnesia	46.26	14.56	22	128940	63035	79552391
Swollen tongue	45.86	14.56	7	128955	42563	79572863
Heart rate increased	45.72	14.56	78	128884	120646	79494780
Musculoskeletal pain	45.71	14.56	59	128903	102295	79513131
Hallucination	45.35	14.56	43	128919	85702	79529724
Dyspepsia	45.17	14.56	66	128896	108621	79506805
Hyperbilirubinaemia	45.02	14.56	113	128849	24405	79591021
Rhabdomyosarcoma recurrent	44.89	14.56	14	128948	117	79615309
Hypertension	44.38	14.56	333	128629	330659	79284767
Pseudomonal bacteraemia	44.18	14.56	38	128924	3044	79612382
JC virus infection	44.12	14.56	42	128920	3839	79611587
Metastases to bone marrow	43.90	14.56	23	128939	799	79614627
Leukaemia	43.86	14.56	51	128911	5874	79609552
Abscess bacterial	43.59	14.56	23	128939	811	79614615
Confusional state	43.56	14.56	318	128644	317679	79297747
Skin candida	43.36	14.56	32	128930	2055	79613371
Drug ineffective for unapproved indication	43.32	14.56	181	128781	51057	79564369
Maternal exposure during pregnancy	43.26	14.56	98	128864	136440	79478986
Hypoalbuminaemia	43.20	14.56	102	128860	21195	79594231
Medication error	43.11	14.56	29	128933	68613	79546813
Serotonin syndrome	42.98	14.56	10	128952	45017	79570409
Mesenteric abscess	42.75	14.56	14	128948	139	79615287
Influenza	42.73	14.56	91	128871	129515	79485911
Hepatotoxicity	42.32	14.56	180	128782	51172	79564254
Red blood cell sedimentation rate increased	42.30	14.56	11	128951	45931	79569495
Nail pigmentation	42.28	14.56	17	128945	315	79615111
Staphylococcal sepsis	41.98	14.56	81	128881	14645	79600781
Fluid retention	41.85	14.56	31	128931	69778	79545648
Subdural hygroma	41.47	14.56	19	128943	490	79614936
Metastases to liver	41.42	14.56	120	128842	28194	79587232
Surgery	41.38	14.56	3	128959	32763	79582663
Blood culture positive	41.08	14.56	59	128903	8370	79607056
Drug dependence	41.07	14.56	8	128954	40761	79574665
Plasma cell leukaemia	40.78	14.56	29	128933	1757	79613669
Toxic encephalopathy	40.34	14.56	69	128893	11371	79604055
Respiratory distress	40.24	14.56	194	128768	58145	79557281
Gastroenteritis adenovirus	40.01	14.56	17	128945	364	79615062
Fungal oesophagitis	39.94	14.56	23	128939	965	79614461
International normalised ratio increased	39.76	14.56	47	128915	84674	79530752
Eosinophilia	39.63	14.56	12	128950	45333	79570093
Hypertransaminasaemia	39.54	14.56	70	128892	11854	79603572
Encephalitis	39.43	14.56	79	128883	14681	79600745
Chronic obstructive pulmonary disease	39.43	14.56	48	128914	85371	79530055
Graft versus host disease in gastrointestinal tract	39.38	14.56	50	128912	6306	79609120
Acquired gene mutation	39.26	14.56	31	128931	2202	79613224
Encephalitis cytomegalovirus	39.24	14.56	24	128938	1126	79614300
Drug reaction with eosinophilia and systemic symptoms	39.20	14.56	28	128934	64216	79551210
Ear infection	38.64	14.56	5	128957	34427	79580999
Pneumonia	38.59	14.56	1366	127596	658880	78956546
Adverse event	38.41	14.56	25	128937	60189	79555237
Diabetes mellitus	38.40	14.56	42	128920	78348	79537078
Flagellate dermatitis	38.33	14.56	15	128947	258	79615168
Bicytopenia	37.62	14.56	42	128920	4628	79610798
Traumatic lung injury	37.40	14.56	31	128931	2360	79613066
Myelitis	37.40	14.56	31	128931	2360	79613066
Encephalitis viral	37.38	14.56	32	128930	2547	79612879
Accidental overdose	37.37	14.56	9	128953	39572	79575854
Lung infiltration	37.35	14.56	101	128861	22811	79592615
Hepatic cirrhosis	37.01	14.56	6	128956	34900	79580526
Abdominal distension	37.00	14.56	87	128875	119563	79495863
Unevaluable event	36.94	14.56	22	128940	55563	79559863
Gait inability	36.85	14.56	25	128937	58892	79556534
Osteonecrosis of jaw	36.77	14.56	12	128950	43214	79572212
Underdose	36.76	14.56	5	128957	33146	79582280
Chronic myeloid leukaemia	36.70	14.56	37	128925	3627	79611799
Graft versus host disease in liver	36.68	14.56	27	128935	1727	79613699
Therapy cessation	36.54	14.56	8	128954	37554	79577872
Therapy interrupted	36.54	14.56	4	128958	31337	79584089
Rhinovirus infection	36.34	14.56	54	128908	7899	79607527
Neck pain	36.29	14.56	41	128921	75376	79540050
Escherichia infection	36.23	14.56	86	128876	17931	79597495
Femur fracture	36.08	14.56	9	128953	38643	79576783
Neuroblastoma	36.03	14.56	14	128948	236	79615190
Peripheral T-cell lymphoma unspecified	35.98	14.56	19	128943	671	79614755
Injection site reaction	35.97	14.56	22	128940	54763	79560663
Ganglioneuroblastoma	35.94	14.56	9	128953	29	79615397
Faeces discoloured	35.85	14.56	3	128959	29124	79586302
Acute myelomonocytic leukaemia	35.84	14.56	15	128947	309	79615117
Nasal abscess	35.79	14.56	13	128949	180	79615246
Peripheral motor neuropathy	35.57	14.56	35	128927	3332	79612094
Metastases to meninges	35.41	14.56	36	128926	3565	79611861
Mantle cell lymphoma recurrent	35.40	14.56	18	128944	587	79614839
Disturbance in attention	35.35	14.56	19	128943	50782	79564644
Electrolyte imbalance	35.16	14.56	120	128842	30761	79584665
Venous thrombosis	34.96	14.56	50	128912	7066	79608360
Hepatic failure	34.88	14.56	193	128769	61019	79554407
Epstein-Barr virus infection reactivation	34.86	14.56	27	128935	1865	79613561
Focal nodular hyperplasia	34.68	14.56	19	128943	723	79614703
Joint range of motion decreased	34.67	14.56	6	128956	33276	79582150
Extravasation	34.19	14.56	36	128926	3714	79611712
Lower respiratory tract infection fungal	34.11	14.56	20	128942	868	79614558
Blood creatine phosphokinase increased	33.96	14.56	34	128928	66056	79549370
Injection site haemorrhage	33.95	14.56	3	128959	27867	79587559
Frequent bowel movements	33.86	14.56	4	128958	29535	79585891
Adrenocortical carcinoma	33.73	14.56	10	128952	69	79615357
Diffuse alveolar damage	33.57	14.56	35	128927	3569	79611857
Eczema	33.56	14.56	12	128950	40806	79574620
Streptococcal infection	33.45	14.56	55	128907	8775	79606651
Necrotising gastritis	33.13	14.56	10	128952	74	79615352
Acne	32.92	14.56	3	128959	27187	79588239
Hepatic candidiasis	32.89	14.56	10	128952	76	79615350
Dry skin	32.68	14.56	37	128925	67958	79547468
Epstein Barr virus positive mucocutaneous ulcer	32.59	14.56	19	128943	816	79614610
Retinopathy proliferative	32.50	14.56	11	128951	122	79615304
Blood pressure diastolic decreased	32.47	14.56	5	128957	30211	79585215
Sciatica	32.47	14.56	7	128955	33215	79582211
Vena cava thrombosis	32.28	14.56	31	128931	2864	79612562
Drug clearance decreased	32.24	14.56	33	128929	3294	79612132
Enterocolitis	32.19	14.56	72	128890	14440	79600986
Sopor	32.17	14.56	7	128955	33003	79582423
Throat irritation	32.07	14.56	13	128949	40933	79574493
Neurological decompensation	32.04	14.56	41	128921	5212	79610214
Bone marrow transplant	31.89	14.56	23	128939	1425	79614001
Accidental exposure to product	31.86	14.56	6	128956	31316	79584110
T-cell lymphoma	31.71	14.56	22	128940	1281	79614145
Cutaneous calcification	31.64	14.56	11	128951	133	79615293
Infusion related reaction	31.62	14.56	230	128732	230007	79385419
Alpha haemolytic streptococcal infection	31.62	14.56	28	128934	2332	79613094
Flatulence	31.19	14.56	15	128947	42709	79572717
Choriocarcinoma	31.02	14.56	9	128953	57	79615369
T-cell lymphoma refractory	31.02	14.56	9	128953	57	79615369
Encephalitis enteroviral	30.99	14.56	11	128951	142	79615284
Alopecia	30.87	14.56	233	128729	231122	79384304
Cerebellar tumour	30.83	14.56	10	128952	96	79615330
Transient ischaemic attack	30.82	14.56	24	128938	52671	79562755
Head injury	30.70	14.56	11	128951	37358	79578068
Tooth malformation	30.64	14.56	11	128951	147	79615279
Intestinal perforation	30.62	14.56	79	128883	17347	79598079
Toxicity to various agents	30.39	14.56	489	128473	421051	79194375
Central nervous system lymphoma	30.35	14.56	27	128935	2262	79613164
Fanconi syndrome acquired	30.33	14.56	29	128933	2665	79612761
Treatment noncompliance	30.33	14.56	24	128938	52244	79563182
Device issue	30.27	14.56	4	128958	27104	79588322
Azoospermia	30.18	14.56	11	128951	154	79615272
Blood electrolytes abnormal	30.09	14.56	25	128937	1909	79613517
Pregnancy	29.89	14.56	4	128958	26847	79588579
Hypothyroidism	29.73	14.56	165	128797	52227	79563199
Retinopathy	29.65	14.56	34	128928	3857	79611569
Escherichia sepsis	29.58	14.56	51	128911	8457	79606969
Recall phenomenon	29.57	14.56	20	128942	1117	79614309
Plasmacytoma	29.46	14.56	36	128926	4367	79611059
Chest discomfort	29.42	14.56	119	128843	137925	79477501
Diverticulitis	29.39	14.56	19	128943	45917	79569509
Localised infection	29.31	14.56	12	128950	37563	79577863
Prescribed underdose	29.29	14.56	6	128956	29508	79585918
Abortion spontaneous	29.28	14.56	6	128956	29501	79585925
Pneumonia adenoviral	29.28	14.56	15	128947	497	79614929
Upper respiratory tract infection	29.23	14.56	65	128897	91103	79524323
Hip fracture	29.03	14.56	7	128955	30754	79584672
Rhinorrhoea	28.94	14.56	49	128913	76025	79539401
Neutrophil count abnormal	28.90	14.56	32	128930	3494	79611932
Immune effector cell-associated neurotoxicity syndrome	28.60	14.56	41	128921	5807	79609619
Brain sarcoma	28.58	14.56	7	128955	20	79615406
Acute monocytic leukaemia	28.55	14.56	15	128947	524	79614902
Metastases to diaphragm	28.53	14.56	8	128954	44	79615382
Splenomegaly	28.49	14.56	86	128876	20668	79594758
Cerebral salt-wasting syndrome	28.39	14.56	10	128952	126	79615300
Enterococcal sepsis	28.17	14.56	28	128934	2698	79612728
Respiratory arrest	28.00	14.56	31	128931	57519	79557907
Metastases to muscle	27.96	14.56	13	128949	347	79615079
Central nervous system fungal infection	27.83	14.56	14	128948	446	79614980
Cellulitis gangrenous	27.66	14.56	12	128950	271	79615155
Cerebellar haemangioma	27.60	14.56	9	128953	88	79615338
Cataract	27.53	14.56	36	128926	62084	79553342
Peripheral artery thrombosis	27.50	14.56	31	128931	3452	79611974
Retinal pigment epitheliopathy	27.44	14.56	14	128948	460	79614966
Geotrichum infection	27.31	14.56	18	128944	963	79614463
Odynophagia	27.17	14.56	58	128904	11269	79604157
Fungal sepsis	27.12	14.56	23	128939	1807	79613619
Neoplasm	27.04	14.56	51	128911	9065	79606361
Adenovirus reactivation	27.00	14.56	13	128949	376	79615050
Renal impairment	26.97	14.56	381	128581	157402	79458024
Infection	26.78	14.56	544	128418	241168	79374258
Gliosis	26.78	14.56	14	128948	484	79614942
Arterial thrombosis	26.78	14.56	27	128935	2647	79612779
Blood glucose decreased	26.74	14.56	5	128957	26229	79589197
Dyskinesia	26.69	14.56	20	128942	44753	79570673
Iris atrophy	26.68	14.56	10	128952	152	79615274
Leukoerythroblastosis	26.53	14.56	12	128950	300	79615126
Metastases to retroperitoneum	26.53	14.56	13	128949	391	79615035
Osteoporosis	26.49	14.56	29	128933	54083	79561343
Li-Fraumeni syndrome	26.34	14.56	6	128956	11	79615415
Strongyloidiasis	26.29	14.56	32	128930	3866	79611560
Cardiac disorder	26.28	14.56	41	128921	65716	79549710
Abnormal behaviour	26.27	14.56	13	128949	36408	79579018
Cerebral venous thrombosis	26.12	14.56	27	128935	2726	79612700
Viral infection	26.11	14.56	138	128824	42878	79572548
Cardio-respiratory arrest	26.09	14.56	89	128873	108421	79507005
Listeria sepsis	26.06	14.56	16	128946	756	79614670
Cholelithiasis	26.03	14.56	28	128934	52636	79562790
Basal cell naevus syndrome	26.03	14.56	7	128955	32	79615394
Breast cancer	26.01	14.56	11	128951	33770	79581656
Intestinal atresia	25.96	14.56	8	128954	64	79615362
Respiratory syncytial virus infection	25.93	14.56	51	128911	9351	79606075
Myelitis transverse	25.89	14.56	23	128939	1924	79613502
Peripheral sensorimotor neuropathy	25.86	14.56	28	128934	2982	79612444
Pericardial effusion	25.82	14.56	145	128817	46092	79569334
Adenoviral hepatitis	25.78	14.56	17	128945	910	79614516
Sinus polyp	25.77	14.56	14	128948	524	79614902
Bradycardia	25.76	14.56	122	128840	135435	79479991
Papillary thyroid cancer	25.69	14.56	26	128936	2560	79612866
Genotoxicity	25.68	14.56	7	128955	34	79615392
Multiple sclerosis	25.58	14.56	3	128959	22279	79593147
Blood fibrinogen decreased	25.56	14.56	23	128939	1956	79613470
CNS ventriculitis	25.54	14.56	13	128949	425	79615001
Dry eye	25.42	14.56	14	128948	36917	79578509
Granulocyte count decreased	25.32	14.56	22	128940	1786	79613640
Agitation	25.21	14.56	80	128882	99635	79515791
Hot flush	25.15	14.56	31	128931	54846	79560580
Therapy responder	25.12	14.56	13	128949	440	79614986
Hypodontia	25.08	14.56	6	128956	15	79615411
Pulmonary veno-occlusive disease	25.02	14.56	21	128941	1627	79613799
Autoimmune haemolytic anaemia	25.01	14.56	47	128915	8333	79607093
Grip strength decreased	24.97	14.56	3	128959	21866	79593560
Emotional distress	24.94	14.56	17	128945	39952	79575474
Streptococcal sepsis	24.90	14.56	27	128935	2880	79612546
Dysstasia	24.87	14.56	7	128955	27739	79587687
Dyspnoea exertional	24.82	14.56	66	128896	87007	79528419
Disorder of orbit	24.76	14.56	9	128953	125	79615301
Hair follicle tumour benign	24.67	14.56	13	128949	457	79614969
Ewing's sarcoma recurrent	24.54	14.56	6	128956	17	79615409
Procedural pain	24.40	14.56	4	128958	23080	79592346
Tumour hyperprogression	24.35	14.56	10	128952	196	79615230
Carbamoyl phosphate synthetase deficiency	24.28	14.56	6	128956	18	79615408
Tumour necrosis	24.16	14.56	22	128940	1900	79613526
Chromaturia	24.02	14.56	6	128956	25740	79589686
Enterobacter bacteraemia	23.94	14.56	16	128946	876	79614550
Neuroblastoma recurrent	23.94	14.56	10	128952	205	79615221
Respiratory tract infection fungal	23.86	14.56	18	128944	1195	79614231
Clostridial infection	23.57	14.56	37	128925	5677	79609749
Coronavirus infection	23.57	14.56	43	128919	7454	79607972
Post-acute COVID-19 syndrome	23.56	14.56	13	128949	502	79614924
Osteosarcoma metastatic	23.52	14.56	7	128955	49	79615377
Hypoxia	23.50	14.56	263	128699	102980	79512446
Sleep apnoea syndrome	23.46	14.56	15	128947	36463	79578963
Diabetic ketoacidosis	23.40	14.56	13	128949	34109	79581317
Carcinoid crisis	23.37	14.56	13	128949	510	79614916
B-cell lymphoma refractory	23.37	14.56	9	128953	148	79615278
Ascites	23.29	14.56	205	128757	75357	79540069
Liver function test abnormal	23.20	14.56	43	128919	64432	79550994
Serum ferritin increased	23.14	14.56	50	128912	9797	79605629
Human polyomavirus infection	23.07	14.56	17	128945	1089	79614337
Heart rate irregular	23.06	14.56	12	128950	32667	79582759
Platelet disorder	23.01	14.56	26	128936	2903	79612523
Full blood count abnormal	22.96	14.56	19	128943	40455	79574971
Hepatic infection fungal	22.96	14.56	10	128952	228	79615198
Small cell carcinoma	22.88	14.56	11	128951	317	79615109
Amenorrhoea	22.78	14.56	43	128919	7649	79607777
Transdifferentiation of neoplasm	22.77	14.56	8	128954	100	79615326
Depressed level of consciousness	22.75	14.56	80	128882	96572	79518854
Candida sepsis	22.69	14.56	24	128938	2489	79612937
Acute lymphocytic leukaemia refractory	22.67	14.56	9	128953	161	79615265
Product substitution issue	22.59	14.56	3	128959	20253	79595173
Large intestine perforation	22.54	14.56	63	128899	14504	79600922
Sputum discoloured	22.47	14.56	4	128958	21739	79593687
Myeloproliferative neoplasm	22.45	14.56	16	128946	973	79614453
Basal ganglion degeneration	22.41	14.56	12	128950	436	79614990
Pain in jaw	22.30	14.56	25	128937	46126	79569300
Feeling hot	22.24	14.56	39	128923	59695	79555731
Paraparesis	22.13	14.56	29	128933	3774	79611652
Hepatomegaly	22.06	14.56	74	128888	18800	79596626
Iron deficiency anaemia	22.06	14.56	7	128955	25665	79589761
Metastases to bone	22.00	14.56	88	128874	24339	79591087
Withdrawal syndrome	21.90	14.56	8	128954	26846	79588580
Visual impairment	21.85	14.56	76	128886	92055	79523371
Hydrocephalus	21.84	14.56	46	128916	8854	79606572
Hepatic function abnormal	21.84	14.56	197	128765	72910	79542516
Blood urine present	21.83	14.56	4	128958	21293	79594133
Sneezing	21.75	14.56	3	128959	19680	79595746
Arteriosclerotic retinopathy	21.71	14.56	6	128956	31	79615395
Primitive neuroectodermal tumour	21.71	14.56	6	128956	31	79615395
Hypertensive hydrocephalus	21.67	14.56	5	128957	10	79615416
Guillain-Barre syndrome	21.62	14.56	46	128916	8919	79606507
Human herpesvirus 8 infection	21.59	14.56	17	128945	1203	79614223
Inappropriate antidiuretic hormone secretion	21.50	14.56	92	128870	26221	79589205
Skin laceration	21.40	14.56	10	128952	28952	79586474
Testicular malignant teratoma	21.35	14.56	5	128957	11	79615415
Terminal ileitis	21.19	14.56	15	128947	902	79614524
Tooth disorder	21.08	14.56	8	128954	26225	79589201
Meningitis bacterial	21.04	14.56	24	128938	2708	79612718
Hyperlipidaemia	20.90	14.56	8	128954	26085	79589341
Clostridium bacteraemia	20.87	14.56	11	128951	387	79615039
Mucosal infection	20.76	14.56	12	128950	507	79614919
Scedosporium infection	20.73	14.56	18	128944	1460	79613966
Primary mediastinal large B-cell lymphoma recurrent	20.73	14.56	7	128955	77	79615349
Clostridial sepsis	20.72	14.56	15	128947	935	79614491
Hiatus hernia	20.68	14.56	6	128956	23306	79592120
Mucocutaneous ulceration	20.64	14.56	11	128951	396	79615030
Hypophosphataemia	20.62	14.56	75	128887	19838	79595588
Hypoacusis	20.60	14.56	100	128862	30050	79585376
Nightmare	20.60	14.56	8	128954	25853	79589573
Haematopoietic stem cell mobilisation	20.59	14.56	9	128953	207	79615219
Kidney infection	20.56	14.56	5	128957	21846	79593580
Obesity	20.54	14.56	16	128946	35109	79580317
Cerebral toxoplasmosis	20.34	14.56	22	128940	2340	79613086
Toxic neuropathy	20.30	14.56	15	128947	965	79614461
Synovial sarcoma	20.18	14.56	7	128955	84	79615342
Diabetes mellitus inadequate control	20.18	14.56	7	128955	24257	79591169
Polyneuropathy	20.16	14.56	85	128877	24066	79591360
Ileus	20.16	14.56	90	128872	26121	79589305
Flushing	20.16	14.56	225	128737	88043	79527383
Speech disorder developmental	20.14	14.56	13	128949	671	79614755
Colitis ulcerative	20.09	14.56	16	128946	34726	79580700
Premature ageing	20.03	14.56	7	128955	86	79615340
Medulloblastoma	20.03	14.56	7	128955	86	79615340
Musculoskeletal disorder	20.01	14.56	5	128957	21443	79593983
Delirium	19.94	14.56	70	128892	84557	79530869
Adenocarcinoma gastric	19.91	14.56	19	128943	1742	79613684
Pneumomediastinum	19.86	14.56	27	128935	3640	79611786
Gastrointestinal disorder	19.85	14.56	116	128846	122089	79493337
Musculoskeletal discomfort	19.75	14.56	4	128958	19831	79595595
Engraft failure	19.65	14.56	13	128949	700	79614726
Meningitis tuberculous	19.64	14.56	16	128946	1189	79614237
Chronic myelomonocytic leukaemia	19.63	14.56	14	128948	852	79614574
Body temperature decreased	19.62	14.56	14	128948	32131	79583295
Arteriosclerosis	19.62	14.56	3	128959	18224	79597202
Lacrimation increased	19.55	14.56	6	128956	22471	79592955
Limbic encephalitis	19.50	14.56	14	128948	861	79614565
Schistocytosis	19.36	14.56	6	128956	49	79615377
Gallbladder empyema	19.27	14.56	7	128955	97	79615329
Metastatic lymphoma	19.18	14.56	10	128952	344	79615082
Mucosal toxicity	19.15	14.56	12	128950	588	79614838
Autoimmune neutropenia	19.13	14.56	12	128950	589	79614837
Hyperadrenocorticism	19.10	14.56	10	128952	347	79615079
Hypertensive crisis	19.07	14.56	5	128957	20765	79594661
Small intestinal perforation	18.96	14.56	25	128937	3272	79612154
Hypovolaemic shock	18.90	14.56	53	128909	12223	79603203
Pneumonia cytomegaloviral	18.89	14.56	31	128931	4938	79610488
Eosinophilic cystitis	18.89	14.56	7	128955	103	79615323
Platelet transfusion	18.76	14.56	21	128941	2321	79613105
Plasma cell myeloma recurrent	18.74	14.56	31	128931	4970	79610456
Drug clearance increased	18.67	14.56	9	128953	261	79615165
Papilloedema	18.65	14.56	35	128927	6198	79609228
Fracture	18.63	14.56	6	128956	21795	79593631
Atypical teratoid/rhabdoid tumour of CNS	18.57	14.56	5	128957	23	79615403
Renal cell carcinoma	18.53	14.56	36	128926	6542	79608884
Epiphyses premature fusion	18.52	14.56	7	128955	109	79615317
Neuroendocrine tumour of the lung metastatic	18.52	14.56	7	128955	109	79615317
Acanthamoeba infection	18.42	14.56	11	128951	494	79614932
Ewing's sarcoma	18.39	14.56	5	128957	24	79615402
Minimal residual disease	18.38	14.56	11	128951	496	79614930
Testicular germ cell cancer metastatic	18.37	14.56	6	128956	59	79615367
Fusobacterium infection	18.35	14.56	7	128955	112	79615314
Pneumocystis jirovecii infection	18.30	14.56	23	128939	2871	79612555
Clostridium difficile infection	18.26	14.56	125	128837	42560	79572866
Blood stem cell harvest failure	18.24	14.56	7	128955	114	79615312
Immune-mediated enterocolitis	18.18	14.56	30	128932	4800	79610626
Pneumonia aspiration	18.16	14.56	52	128910	66915	79548511
Cold sweat	18.15	14.56	4	128958	18695	79596731
Spinal column injury	18.11	14.56	20	128942	2178	79613248
Epstein-Barr viraemia	18.05	14.56	20	128942	2185	79613241
Ocular vascular disorder	18.05	14.56	11	128951	513	79614913
Inflammatory pseudotumour	18.02	14.56	6	128956	63	79615363
Bacterial tracheitis	18.02	14.56	6	128956	63	79615363
Blindness cortical	18.00	14.56	14	128948	973	79614453
Intracardiac thrombus	17.99	14.56	28	128934	4265	79611161
Opportunistic infection	17.95	14.56	23	128939	2927	79612499
Product intolerance	17.75	14.56	5	128957	28	79615398
Photosensitivity reaction	17.73	14.56	6	128956	21121	79594305
Peritoneal gliomatosis	17.68	14.56	4	128958	7	79615419
Radiation injury	17.68	14.56	13	128949	830	79614596
Lymphocyte count decreased	17.65	14.56	134	128828	47155	79568271
Product administered to patient of inappropriate age	17.65	14.56	32	128930	5521	79609905
Left ventricular dysfunction	17.63	14.56	70	128892	19291	79596135
Psychomotor hyperactivity	17.63	14.56	3	128959	16846	79598580
Vulvovaginal inflammation	17.63	14.56	11	128951	535	79614891
Vulvovaginitis	17.63	14.56	9	128953	296	79615130
Abdominal compartment syndrome	17.62	14.56	17	128945	1580	79613846
Muscle twitching	17.62	14.56	9	128953	24755	79590671
Stomatitis necrotising	17.62	14.56	8	128954	202	79615224
Tissue infiltration	17.60	14.56	12	128950	679	79614747
Ocular hyperaemia	17.60	14.56	12	128950	28194	79587232
Mania	17.54	14.56	4	128958	18256	79597170
Viral hepatitis carrier	17.46	14.56	5	128957	30	79615396
Atypical haemolytic uraemic syndrome	17.45	14.56	14	128948	1018	79614408
Retinal toxicity	17.44	14.56	16	128946	1395	79614031
Glioblastoma multiforme	17.32	14.56	15	128947	1213	79614213
Angina pectoris	17.31	14.56	36	128926	51696	79563730
Subdural haemorrhage	17.30	14.56	33	128929	5915	79609511
Acute kidney injury	17.02	14.56	1014	127948	518390	79097036
Cerebral fungal infection	16.99	14.56	10	128952	437	79614989
Skin discolouration	16.96	14.56	25	128937	41009	79574417
Lymphoma transformation	16.96	14.56	9	128953	321	79615105
Crying	16.96	14.56	8	128954	23035	79592391
Ventricular tachycardia	16.90	14.56	26	128936	41909	79573517
Follicular thyroid cancer	16.86	14.56	6	128956	78	79615348
Uterine enlargement	16.82	14.56	13	128949	895	79614531
Pharyngeal oedema	16.80	14.56	3	128959	16269	79599157
Spindle cell sarcoma	16.79	14.56	8	128954	226	79615200
Bone marrow infiltration	16.77	14.56	12	128950	734	79614692
Rectal haemorrhage	16.74	14.56	65	128897	76235	79539191
Ganglioneuroma	16.73	14.56	7	128955	144	79615282
Hepatorenal failure	16.73	14.56	15	128947	1270	79614156
Administration related reaction	16.56	14.56	8	128954	233	79615193
Food protein-induced enterocolitis syndrome	16.56	14.56	5	128957	37	79615389
Ill-defined disorder	16.54	14.56	53	128909	65822	79549604
Extrapyramidal disorder	16.50	14.56	8	128954	22671	79592755
Hemianopia	16.49	14.56	17	128945	1711	79613715
Renal infarct	16.41	14.56	21	128941	2670	79612756
Blastic plasmacytoid dendritic cell neoplasia	16.40	14.56	6	128956	85	79615341
Renal tubular dysfunction	16.34	14.56	12	128950	765	79614661
Granulocytopenia	16.29	14.56	48	128914	11383	79604043
Adenomatous polyposis coli	16.29	14.56	8	128954	242	79615184
Pyomyositis	16.27	14.56	11	128951	614	79614812
Mental disorder	16.20	14.56	16	128946	31286	79584140
Chromosome analysis abnormal	16.19	14.56	8	128954	245	79615181
Hypocalcaemia	16.19	14.56	137	128825	49787	79565639
Retinal ischaemia	16.18	14.56	12	128950	776	79614650
Prostate cancer	16.10	14.56	18	128944	33250	79582176
Mood swings	16.08	14.56	6	128956	19874	79595552
Liver injury	16.07	14.56	43	128919	56571	79558855
Swelling face	16.06	14.56	60	128902	71152	79544274
Cardiac dysfunction	16.05	14.56	26	128936	4098	79611328
Subcutaneous emphysema	15.96	14.56	17	128945	1777	79613649
Haemodynamic instability	15.96	14.56	63	128899	17319	79598107
Intussusception	15.91	14.56	14	128948	1156	79614270
Gastrointestinal injury	15.91	14.56	13	128949	970	79614456
Blood pressure decreased	15.84	14.56	95	128867	99371	79516055
Impaired work ability	15.82	14.56	6	128956	19675	79595751
Aspiration bone marrow abnormal	15.82	14.56	7	128955	166	79615260
Hydronephrosis	15.81	14.56	63	128899	17391	79598035
Bone sarcoma	15.79	14.56	6	128956	95	79615331
Transformation to acute myeloid leukaemia	15.75	14.56	13	128949	984	79614442
Product quality issue	15.74	14.56	19	128943	33921	79581505
Deep vein thrombosis	15.73	14.56	279	128683	120640	79494786
Autologous bone marrow transplantation therapy	15.72	14.56	4	128958	14	79615412
Cognitive disorder	15.71	14.56	59	128903	69867	79545559
Joint dislocation	15.70	14.56	4	128958	16935	79598491
Appendicitis	15.69	14.56	71	128891	20723	79594703
Oedema	15.67	14.56	121	128841	119459	79495967
Product administration error	15.66	14.56	17	128945	31829	79583597
Peripheral T-cell lymphoma unspecified recurrent	15.61	14.56	5	128957	46	79615380
Plasma cell myeloma refractory	15.55	14.56	11	128951	661	79614765
Colony stimulating factor therapy	15.53	14.56	10	128952	514	79614912
Skin exfoliation	15.53	14.56	42	128920	55058	79560368
Coronary artery thrombosis	15.52	14.56	22	128940	3084	79612342
Urinary bladder haematoma	15.51	14.56	4	128958	15	79615411
Splenic infarction	15.50	14.56	24	128938	3640	79611786
Paranoia	15.49	14.56	6	128956	19426	79596000
Scrotal abscess	15.39	14.56	10	128952	522	79614904
Spinal fracture	15.38	14.56	5	128957	18049	79597377
Mucosal ulceration	15.35	14.56	17	128945	1856	79613570
Noctiphobia	15.30	14.56	4	128958	16	79615410
Injection site rash	15.24	14.56	5	128957	17949	79597477
Paraesthesia oral	15.23	14.56	7	128955	20464	79594962
Metastases to breast	15.19	14.56	8	128954	281	79615145
B-cell lymphoma	15.11	14.56	32	128930	6183	79609243
Stevens-Johnson syndrome	15.10	14.56	25	128937	39141	79576285
Central nervous system necrosis	15.09	14.56	8	128954	285	79615141
Infection reactivation	15.06	14.56	20	128942	2637	79612789
Tonsillar haemorrhage	14.96	14.56	8	128954	290	79615136
Splenic infection fungal	14.93	14.56	6	128956	111	79615315
Amoebic colitis	14.93	14.56	6	128956	111	79615315
Neutropenic infection	14.89	14.56	19	128943	2408	79613018
Small intestinal obstruction	14.88	14.56	85	128877	27187	79588239
B precursor type acute leukaemia	14.78	14.56	9	128953	419	79615007
Liver function test increased	14.78	14.56	26	128936	39747	79575679
Cerebral artery occlusion	14.76	14.56	16	128946	1706	79613720
Growth hormone deficiency	14.72	14.56	9	128953	422	79615004
Dementia	14.71	14.56	11	128951	24648	79590778
Listeria encephalitis	14.69	14.56	8	128954	301	79615125
Toothache	14.60	14.56	7	128955	19963	79595463

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01CB01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS Podophyllotoxin derivatives
FDA MoA	N0000000176	Topoisomerase Inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:59517	DNA synthesis inhibitors
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000972	Antineoplastic Agents, Phytogenic
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D059005	Topoisomerase II Inhibitors
MeSH PA	D059003	Topoisomerase Inhibitors
FDA EPC	N0000175609	Topoisomerase Inhibitor

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

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
DNA topoisomerase 2-alpha	Enzyme	P11388	TOP2A_HUMAN	INHIBITOR	IC50	7.30	IUPHAR	CHEMBL
Canalicular multispecific organic anion transporter 1	Transporter	Q92887	MRP2_HUMAN		Km	3.21	WOMBAT-PK
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN				WOMBAT-PK
Multidrug resistance-associated protein 1	Transporter	P33527	MRP1_HUMAN				WOMBAT-PK
ATP-binding cassette sub-family G member 2	Transporter	Q9UNQ0	ABCG2_HUMAN				WOMBAT-PK
Multidrug resistance-associated protein 6	Transporter	O95255	MRP6_HUMAN				WOMBAT-PK
Canalicular multispecific organic anion transporter 2	Transporter	O15438	MRP3_HUMAN				WOMBAT-PK
DNA topoisomerase 2-beta	Enzyme	Q02880	TOP2B_HUMAN		IC50	7.16	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		Ki	3.28	WOMBAT-PK
Arachidonate 15-lipoxygenase	Enzyme		LOX15_RABIT		IC50	5.50	DRUG MATRIX

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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
Toposar	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5653	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	ANDA	24 sections
Toposar	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5653	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	ANDA	24 sections
Toposar	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5656	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	ANDA	24 sections
Toposar	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5656	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	ANDA	24 sections
Toposar	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5657	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	ANDA	24 sections
Toposar	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5657	INJECTION, SOLUTION, CONCENTRATE	20 mg	INTRAVENOUS	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	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