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)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.22 mg/mL	Benet LZ, Broccatelli F, Oprea TI
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	2707.93	16.63	1516	52437	104029	56134085
Neutropenia	1192.32	16.63	1076	52877	157091	56081023
Mucosal inflammation	928.84	16.63	553	53400	42257	56195857
Pancytopenia	788.87	16.63	664	53289	88051	56150063
Bone marrow failure	759.48	16.63	420	53533	27866	56210248
Thrombocytopenia	704.12	16.63	755	53198	135469	56102645
Acute myeloid leukaemia	671.44	16.63	327	53626	16645	56221469
Product use in unapproved indication	521.89	16.63	658	53295	140164	56097950
Haemophagocytic lymphohistiocytosis	514.17	16.63	228	53725	9344	56228770
Myelodysplastic syndrome	511.15	16.63	269	53684	16137	56221977
Disease progression	460.53	16.63	535	53418	104638	56133476
Haematotoxicity	457.73	16.63	202	53751	8181	56229933
Ovarian failure	410.78	16.63	114	53839	1091	56237023
Off label use	386.70	16.63	1288	52665	554892	55683222
Sepsis	357.91	16.63	547	53406	139293	56098821
Myelosuppression	345.98	16.63	213	53740	17242	56220872
Second primary malignancy	324.18	16.63	153	53800	7249	56230865
Pain	309.78	16.63	125	53828	663059	55575055
Neutropenic sepsis	305.29	16.63	187	53766	14998	56223116
Febrile bone marrow aplasia	297.54	16.63	139	53814	6433	56231681
Venoocclusive liver disease	288.94	16.63	121	53832	4300	56233814
Multiple organ dysfunction syndrome	285.24	16.63	300	53653	52470	56185644
Malignant neoplasm progression	267.58	16.63	341	53612	73246	56164868
Septic shock	260.18	16.63	306	53647	60529	56177585
Tumour lysis syndrome	258.39	16.63	134	53819	7789	56230325
Neutrophil count decreased	258.21	16.63	277	53676	49545	56188569
Joint swelling	249.44	16.63	6	53947	289794	55948320
Arthralgia	248.26	16.63	86	53867	501583	55736531
Posterior reversible encephalopathy syndrome	235.81	16.63	162	53791	15798	56222316
Aplasia	223.64	16.63	98	53855	3898	56234216
Anaemia	213.44	16.63	651	53302	266860	55971254
Diffuse large B-cell lymphoma refractory	210.38	16.63	67	53886	1065	56237049
Renal salt-wasting syndrome	203.05	16.63	50	53903	283	56237831
Pyrexia	198.70	16.63	860	53093	417913	55820201
Encephalopathy	187.57	16.63	199	53754	35126	56202988
Abdominal discomfort	184.59	16.63	24	53929	277250	55960864
Platelet count decreased	181.73	16.63	348	53605	106035	56132079
Nasopharyngitis	181.30	16.63	7	53946	220952	56017162
Diffuse large B-cell lymphoma recurrent	177.84	16.63	66	53887	1691	56236423
Teratoma	172.60	16.63	39	53914	141	56237973
Drug resistance	172.41	16.63	149	53804	20393	56217721
Peripheral swelling	169.76	16.63	15	53938	234711	56003403
Ovarian germ cell teratoma	167.36	16.63	35	53918	78	56238036
Disease recurrence	166.57	16.63	156	53797	23704	56214410
Maternal exposure before pregnancy	165.83	16.63	95	53858	6728	56231386
Stem cell transplant	163.74	16.63	62	53891	1682	56236432
Contraindicated product administered	159.63	16.63	4	53949	186282	56051832
Systemic lupus erythematosus	157.71	16.63	3	53950	180075	56058039
Leukopenia	155.73	16.63	259	53694	70681	56167433
Drug hypersensitivity	154.57	16.63	37	53916	275168	55962946
Cardiotoxicity	153.20	16.63	94	53859	7556	56230558
Ototoxicity	152.68	16.63	53	53900	1113	56237001
Product dose omission issue	151.03	16.63	12	53941	204741	56033373
Arthropathy	149.80	16.63	11	53942	200264	56037850
Venoocclusive disease	145.79	16.63	59	53894	1918	56236196
Bacteraemia	144.77	16.63	120	53833	15511	56222603
Hepatosplenic T-cell lymphoma	141.72	16.63	43	53910	577	56237537
Neutropenic colitis	139.78	16.63	63	53890	2680	56235434
Cytomegalovirus infection	136.30	16.63	127	53826	19169	56218945
Aspergillus infection	135.06	16.63	86	53867	7379	56230735
Fall	132.93	16.63	90	53863	357420	55880694
Pruritus	131.30	16.63	70	53883	316553	55921561
Weight increased	130.70	16.63	30	53923	229673	56008441
Cytopenia	130.06	16.63	93	53860	9662	56228452
Malignant transformation	129.28	16.63	36	53917	349	56237765
Rash	128.59	16.63	171	53782	492876	55745238
Headache	125.45	16.63	215	53738	558829	55679285
Swelling	123.76	16.63	38	53915	239733	55998381
Musculoskeletal stiffness	121.28	16.63	7	53946	156000	56082114
Glossodynia	121.15	16.63	6	53947	152452	56085662
Fatigue	115.13	16.63	381	53572	788171	55449943
Diffuse large B-cell lymphoma	112.65	16.63	75	53878	6941	56231173
Neoplasm progression	112.54	16.63	146	53807	31870	56206244
Pulmonary haemorrhage	112.52	16.63	74	53879	6709	56231405
Hepatitis B reactivation	111.98	16.63	52	53901	2372	56235742
Insomnia	111.26	16.63	24	53929	191836	56046278
Bronchopulmonary aspergillosis	110.67	16.63	79	53874	8185	56229929
Drug intolerance	110.55	16.63	58	53895	264760	55973354
Malaise	108.14	16.63	116	53837	367744	55870370
Therapeutic product effect decreased	107.24	16.63	17	53936	169435	56068679
Oesophagitis	104.09	16.63	95	53858	13962	56224152
Pain in extremity	102.54	16.63	81	53872	297350	55940764
Hypersensitivity	101.48	16.63	60	53893	256348	55981766
Discomfort	99.93	16.63	10	53943	141751	56096363
Osteosarcoma	97.58	16.63	24	53929	135	56237979
Candida infection	96.44	16.63	121	53832	25546	56212568
Graft versus host disease	95.85	16.63	67	53886	6714	56231400
Neurotoxicity	91.02	16.63	93	53860	15702	56222412
Primary hypogonadism	91.02	16.63	23	53930	147	56237967
Asthma	91.00	16.63	4	53949	112766	56125348
Alveolar soft part sarcoma	90.87	16.63	21	53932	86	56238028
Colitis	90.83	16.63	152	53801	41659	56196455
Hypokalaemia	89.70	16.63	245	53708	94192	56143922
Injection site pain	88.78	16.63	6	53947	117112	56121002
Acute graft versus host disease	87.96	16.63	53	53900	4122	56233992
Enterococcal infection	85.60	16.63	64	53889	7120	56230994
Thrombotic microangiopathy	84.55	16.63	71	53882	9340	56228774
Premature menopause	84.16	16.63	31	53922	777	56237337
Urticaria	84.05	16.63	18	53935	144658	56093456
Clostridium difficile colitis	82.93	16.63	96	53857	18642	56219472
Acute lymphocytic leukaemia	82.60	16.63	44	53909	2700	56235414
Dizziness	82.06	16.63	147	53806	375993	55862121
Respiratory failure	80.88	16.63	237	53716	94825	56143289
Nephroblastoma	78.31	16.63	19	53934	100	56238014
Acute lymphocytic leukaemia recurrent	78.20	16.63	40	53913	2257	56235857
Cystitis haemorrhagic	77.87	16.63	48	53905	3889	56234225
Anxiety	76.68	16.63	45	53908	193127	56044987
Muscle spasms	76	16.63	19	53934	137352	56100762
Psoriasis	75.74	16.63	3	53950	92689	56145425
Fungaemia	75.26	16.63	38	53915	2086	56236028
Human herpesvirus 6 infection	75.13	16.63	41	53912	2641	56235473
Nephropathy toxic	73.87	16.63	63	53890	8464	56229650
White blood cell count decreased	73.13	16.63	276	53677	125714	56112400
Cervix disorder	71.97	16.63	25	53928	526	56237588
Leukoencephalopathy	71.30	16.63	46	53907	4036	56234078
Teratoma benign	70.99	16.63	16	53937	57	56238057
Enterobacter infection	70.64	16.63	36	53917	2016	56236098
Disseminated intravascular coagulation	69.89	16.63	86	53867	17799	56220315
Feeling abnormal	69.19	16.63	21	53932	133581	56104533
Pericarditis	68.73	16.63	11	53942	108912	56129202
Cytomegalovirus viraemia	68.68	16.63	49	53904	5071	56233043
Klebsiella infection	68.61	16.63	58	53895	7698	56230416
Complications of bone marrow transplant	68.11	16.63	23	53930	443	56237671
Retinoblastoma	67.91	16.63	17	53936	104	56238010
Acute respiratory distress syndrome	66.39	16.63	93	53860	21833	56216281
Lymphopenia	66.10	16.63	81	53872	16693	56221421
Hypomagnesaemia	65.42	16.63	99	53854	24916	56213198
Sinusitis	65.31	16.63	56	53897	197525	56040589
BK virus infection	64.81	16.63	39	53914	3025	56235089
Therapy partial responder	64.36	16.63	56	53897	7729	56230385
Capillary leak syndrome	63.37	16.63	33	53920	1933	56236181
Post transplant lymphoproliferative disorder	63.33	16.63	45	53908	4627	56233487
Contusion	63.31	16.63	22	53931	128408	56109706
Bronchitis	63.16	16.63	15	53938	112296	56125818
Choriocarcinoma	63.08	16.63	16	53937	104	56238010
Epstein-Barr virus infection	62.33	16.63	54	53899	7409	56230705
Aplastic anaemia	61.57	16.63	58	53895	8870	56229244
Hepatic enzyme increased	61.13	16.63	45	53908	171339	56066775
Human bocavirus infection	60.64	16.63	20	53933	357	56237757
Overdose	59.78	16.63	14	53939	105816	56132298
Hospitalisation	59.40	16.63	3	53950	74997	56163117
Staphylococcal infection	59.21	16.63	119	53834	37499	56200615
Acute promyelocytic leukaemia	59.14	16.63	25	53928	909	56237205
Impaired healing	58.96	16.63	7	53946	86834	56151280
Skin candida	58.49	16.63	28	53925	1368	56236746
Gene mutation	57.50	16.63	28	53925	1421	56236693
Superior vena cava syndrome	56.52	16.63	22	53931	644	56237470
Migraine	56.51	16.63	8	53945	86789	56151325
Graft versus host disease in skin	56.08	16.63	34	53919	2673	56235441
JC virus infection	55.75	16.63	30	53923	1879	56236235
Systemic candida	54.92	16.63	35	53918	3006	56235108
Large intestinal ulcer perforation	54.30	16.63	13	53940	64	56238050
Plasma cell leukaemia	53.47	16.63	25	53928	1158	56236956
Injection site erythema	53.18	16.63	6	53947	77442	56160672
Acute myeloid leukaemia recurrent	53.16	16.63	27	53926	1501	56236613
Blister	53.07	16.63	19	53934	108868	56129246
Mucormycosis	52.78	16.63	33	53920	2741	56235373
Ascites	52.35	16.63	113	53840	37431	56200683
Herpes simplex	52.15	16.63	49	53904	7469	56230645
Neuropathy peripheral	52.10	16.63	216	53737	102677	56135437
Blood pressure increased	51.92	16.63	38	53915	145138	56092976
Loss of personal independence in daily activities	51.82	16.63	8	53945	81361	56156753
Deafness	51.49	16.63	71	53882	16423	56221691
Peripheral sensory neuropathy	51.47	16.63	47	53906	6909	56231205
Arthritis	51.14	16.63	16	53937	99836	56138278
Myeloid leukaemia	51.00	16.63	17	53936	314	56237800
Progressive multifocal leukoencephalopathy	50.58	16.63	60	53893	11953	56226161
Klebsiella sepsis	49.68	16.63	24	53929	1197	56236917
Pleural effusion	49.36	16.63	187	53766	85293	56152821
Secondary immunodeficiency	49.32	16.63	24	53929	1216	56236898
Inappropriate schedule of product administration	49.18	16.63	10	53943	83377	56154737
Blood cholesterol increased	48.90	16.63	6	53947	72573	56165541
Neoplasm recurrence	48.62	16.63	30	53923	2434	56235680
Encephalitis viral	48.60	16.63	26	53927	1609	56236505
T-cell lymphoma	48.43	16.63	20	53933	685	56237429
Staphylococcal bacteraemia	46.17	16.63	39	53914	5170	56232944
Acute graft versus host disease in skin	46.10	16.63	32	53921	3170	56234944
Leukaemia	45.80	16.63	34	53919	3741	56234373
Respiratory distress	44.94	16.63	96	53857	31571	56206543
Streptococcal bacteraemia	44.90	16.63	24	53929	1483	56236631
Varicella zoster virus infection	44.84	16.63	29	53924	2555	56235559
Influenza like illness	43.75	16.63	4	53949	60984	56177130
Blood culture positive	43.67	16.63	35	53918	4311	56233803
Suicidal ideation	43.62	16.63	3	53950	57739	56180375
Pneumatosis intestinalis	43.59	16.63	27	53926	2206	56235908
Epstein-Barr virus associated lymphoproliferative disorder	43.53	16.63	25	53928	1778	56236336
Renal tubular disorder	43.18	16.63	28	53925	2478	56235636
Amenorrhoea	43.09	16.63	48	53905	8938	56229176
Refractory anaemia with an excess of blasts	42.81	16.63	16	53937	418	56237696
Pulmonary alveolar haemorrhage	42.13	16.63	34	53919	4230	56233884
Pneumonia fungal	42.07	16.63	36	53917	4857	56233257
Leukaemia recurrent	41.97	16.63	22	53931	1306	56236808
Mesenteric abscess	41.71	16.63	11	53942	85	56238029
Gait disturbance	41.04	16.63	58	53895	163263	56074851
Unmasking of previously unidentified disease	40.82	16.63	19	53934	871	56237243
Memory impairment	40.67	16.63	16	53937	86541	56151573
Congestive cardiomyopathy	40.51	16.63	38	53915	5781	56232333
Small cell lung cancer	40.47	16.63	23	53930	1603	56236511
Sweat gland tumour	40.43	16.63	11	53942	97	56238017
Alopecia	40.37	16.63	145	53808	293313	55944801
Therapy non-responder	40.30	16.63	140	53813	61215	56176899
Injury	40.19	16.63	5	53948	59846	56178268
Cardiomyopathy acute	40.06	16.63	13	53940	220	56237894
Staphylococcal sepsis	40.05	16.63	42	53911	7307	56230807
Musculoskeletal pain	39.81	16.63	14	53939	81138	56156976
Adenovirus infection	39.80	16.63	30	53923	3378	56234736
Cutaneous calcification	39.47	16.63	11	53942	107	56238007
Abdominal pain upper	39.42	16.63	69	53884	178244	56059870
Weight decreased	39.37	16.63	110	53843	240604	55997510
Stress	39.37	16.63	5	53948	58905	56179209
T-cell type acute leukaemia	39.29	16.63	10	53943	66	56238048
Abdominal compartment syndrome	39.14	16.63	16	53937	534	56237580
Pneumothorax	39.10	16.63	59	53894	14808	56223306
Pseudomonal sepsis	39.08	16.63	25	53928	2161	56235953
Bacterial infection	38.96	16.63	64	53889	17266	56220848
Incorrect dose administered	38.92	16.63	3	53950	52544	56185570
Cytokine release syndrome	38.84	16.63	50	53903	10825	56227289
Peripheral motor neuropathy	38.81	16.63	22	53931	1526	56236588
Encephalitis cytomegalovirus	38.80	16.63	16	53937	546	56237568
Nail pigmentation	38.57	16.63	12	53941	176	56237938
Folliculitis	38.40	16.63	4	53949	54975	56183139
Splenomegaly	38.29	16.63	48	53905	10120	56227994
Gastrointestinal fungal infection	38.27	16.63	13	53940	255	56237859
Clostridium bacteraemia	38.26	16.63	12	53941	181	56237933
Adverse drug reaction	38.02	16.63	8	53945	65124	56172990
Recurrent cancer	37.98	16.63	23	53930	1805	56236309
Fungal oesophagitis	37.84	16.63	16	53937	582	56237532
Acquired gene mutation	37.80	16.63	18	53935	869	56237245
Condition aggravated	37.23	16.63	187	53766	344711	55893403
Oedema peripheral	37.19	16.63	67	53886	171187	56066927
Medulloblastoma recurrent	36.98	16.63	10	53943	86	56238028
Chloroma	36.55	16.63	12	53941	211	56237903
Listeria sepsis	36.51	16.63	16	53937	636	56237478
Nasal abscess	36.50	16.63	11	53942	144	56237970
Cardiomyopathy	36.49	16.63	60	53893	16198	56221916
Enterococcal sepsis	36.34	16.63	20	53933	1310	56236804
Rhinovirus infection	36.08	16.63	30	53923	3892	56234222
Pericardial effusion	35.85	16.63	80	53873	27095	56211019
Mucocutaneous ulceration	35.76	16.63	11	53942	155	56237959
Palpitations	35.74	16.63	26	53927	99646	56138468
Leukoerythroblastosis	35.73	16.63	12	53941	227	56237887
T-cell lymphoma refractory	35.68	16.63	9	53944	57	56238057
Strongyloidiasis	35.28	16.63	19	53934	1192	56236922
Mobility decreased	35.27	16.63	26	53927	98965	56139149
Dry mouth	35.26	16.63	9	53944	64196	56173918
Basal ganglion degeneration	35.21	16.63	14	53939	434	56237680
Bacterial sepsis	35.16	16.63	29	53924	3720	56234394
Hypothyroidism	35.14	16.63	98	53855	38098	56200016
Ill-defined disorder	35.06	16.63	11	53942	68532	56169582
Escherichia bacteraemia	35.06	16.63	28	53925	3432	56234682
Cardiac failure	34.47	16.63	163	53790	81930	56156184
Necrotising gastritis	34.42	16.63	9	53944	67	56238047
Cytomegalovirus chorioretinitis	34.34	16.63	21	53932	1677	56236437
Neuroblastoma	34.29	16.63	10	53943	116	56237998
Venous thrombosis	33.99	16.63	31	53922	4549	56233565
Hypogammaglobulinaemia	33.73	16.63	36	53917	6390	56231724
Hair follicle tumour benign	33.61	16.63	13	53940	374	56237740
Blood glucose increased	33.52	16.63	15	53938	75136	56162978
Angiocentric lymphoma	33.34	16.63	15	53938	635	56237479
Metastases to central nervous system	33.11	16.63	49	53904	12087	56226027
Infusion related reaction	33.04	16.63	97	53856	208834	56029280
Gastroenteritis norovirus	32.82	16.63	21	53932	1816	56236298
Lower respiratory tract infection	32.75	16.63	37	53916	114757	56123357
Bone marrow transplant	32.68	16.63	15	53938	666	56237448
Histiocytic sarcoma	32.53	16.63	9	53944	85	56238029
Acute kidney injury	32.37	16.63	363	53590	240400	55997714
Neutrophil count abnormal	32.29	16.63	24	53929	2646	56235468
Oesophageal candidiasis	32.26	16.63	32	53921	5213	56232901
Klebsiella bacteraemia	32.26	16.63	19	53934	1417	56236697
Cerebellar haemangioma	32.25	16.63	9	53944	88	56238026
Injection site reaction	32.21	16.63	6	53947	53241	56184873
Epstein Barr virus positive mucocutaneous ulcer	32.17	16.63	13	53940	421	56237693
Tumour hyperprogression	32.16	16.63	9	53944	89	56238025
Hepatosplenomegaly	31.98	16.63	23	53930	2410	56235704
Renal failure	31.87	16.63	198	53755	110302	56127812
Hepatitis B	31.85	16.63	27	53926	3597	56234517
Sinus polyp	31.81	16.63	12	53941	322	56237792
Metastases to lung	31.52	16.63	47	53906	11671	56226443
Tumour necrosis	31.43	16.63	15	53938	728	56237386
Delayed puberty	31.29	16.63	9	53944	99	56238015
Subdural hygroma	31.29	16.63	11	53942	240	56237874
Tonsillar haemorrhage	30.87	16.63	11	53942	250	56237864
Gastrooesophageal reflux disease	30.80	16.63	21	53932	83236	56154878
Nasal congestion	30.77	16.63	8	53945	56362	56181752
Tissue infiltration	30.72	16.63	14	53939	611	56237503
Vision blurred	30.57	16.63	21	53932	82922	56155192
Depression	30.42	16.63	81	53872	180036	56058078
Ejection fraction decreased	30.31	16.63	62	53891	19779	56218335
Metastases to diaphragm	30.03	16.63	7	53946	30	56238084
Myocardial infarction	29.84	16.63	27	53926	92843	56145271
Device related infection	29.52	16.63	65	53888	21815	56216299
Injection site pruritus	29.42	16.63	3	53950	41928	56196186
White blood cell count abnormal	29.27	16.63	32	53921	5835	56232279
Metastasis	29.08	16.63	29	53924	4755	56233359
Hepatic failure	28.94	16.63	84	53869	33402	56204712
Cytomegalovirus infection reactivation	28.61	16.63	24	53929	3152	56234962
Plasma cell myeloma	28.54	16.63	104	53849	46542	56191572
Clostridium colitis	28.51	16.63	19	53934	1760	56236354
Drug clearance increased	28.15	16.63	8	53945	84	56238030
Gastrointestinal toxicity	28.01	16.63	32	53921	6124	56231990
Epiphyses premature fusion	27.80	16.63	7	53946	44	56238070
Left ventricular dysfunction	27.64	16.63	43	53910	11080	56227034
Ocular vascular disorder	27.61	16.63	11	53942	343	56237771
Bacterial tracheitis	27.41	16.63	6	53947	18	56238096
Femur fracture	27.08	16.63	3	53950	39292	56198822
Adrenocortical carcinoma	26.91	16.63	7	53946	51	56238063
Sinoatrial block	26.70	16.63	14	53939	832	56237282
International normalised ratio increased	26.56	16.63	5	53948	44036	56194078
Drug abuse	26.44	16.63	16	53937	67594	56170520
Burning sensation	26.41	16.63	7	53946	48689	56189425
Acute myelomonocytic leukaemia	26.38	16.63	9	53944	179	56237935
Neck pain	26.35	16.63	13	53940	61542	56176572
Mouth ulceration	26.24	16.63	75	53878	29565	56208549
Enteritis	26.23	16.63	34	53919	7409	56230705
Hyperhidrosis	26.11	16.63	31	53922	94057	56144057
Chronic graft versus host disease	26.07	16.63	23	53930	3233	56234881
Trichosporon infection	26.04	16.63	10	53943	282	56237832
Parainfluenzae virus infection	25.91	16.63	19	53934	2051	56236063
Retinal pigment epitheliopathy	25.88	16.63	9	53944	190	56237924
Paraneoplastic neurological syndrome	25.82	16.63	5	53948	6	56238108
Vomiting	25.79	16.63	642	53311	497586	55740528
Vertigo	25.78	16.63	10	53943	54562	56183552
Thymus enlargement	25.73	16.63	8	53945	117	56237997
Urinary tract infection	25.58	16.63	131	53822	240382	55997732
Toxic encephalopathy	25.57	16.63	30	53923	5908	56232206
B-cell lymphoma	25.30	16.63	23	53930	3361	56234753
Sleep disorder	25.11	16.63	17	53936	67646	56170468
Suicide attempt	25.09	16.63	12	53941	57824	56180290
Wheezing	25.08	16.63	21	53932	75005	56163109
Urinary tract infection bacterial	25.03	16.63	26	53927	4474	56233640
Listeriosis	24.90	16.63	16	53937	1394	56236720
Uterine enlargement	24.87	16.63	15	53938	1168	56236946
Spinal cord paralysis	24.82	16.63	6	53947	31	56238083
Back pain	24.76	16.63	130	53823	237040	56001074
Metastases to lymph nodes	24.76	16.63	33	53920	7390	56230724
Depressed mood	24.50	16.63	3	53950	36356	56201758
Myeloproliferative neoplasm	24.47	16.63	11	53942	465	56237649
Atypical haemolytic uraemic syndrome	24.41	16.63	12	53941	622	56237492
Enterocolitis	24.34	16.63	32	53921	7072	56231042
Somnolence	24.30	16.63	78	53875	163335	56074779
Respiratory syncytial virus infection	24.20	16.63	28	53925	5433	56232681
Myalgia	24.13	16.63	57	53896	131968	56106146
Radiation pneumonitis	24.10	16.63	16	53937	1473	56236641
Fungal infection	24.07	16.63	78	53875	32915	56205199
Exposure during pregnancy	24.02	16.63	60	53893	136282	56101832
Cytogenetic abnormality	24.01	16.63	11	53942	486	56237628
Blood pressure systolic increased	23.86	16.63	5	53948	40831	56197283
Wrong technique in product usage process	23.84	16.63	13	53940	58155	56179959
Unevaluable event	23.78	16.63	8	53945	47679	56190435
Pseudomonas infection	23.73	16.63	38	53915	10033	56228081
Agranulocytosis	23.73	16.63	61	53892	22598	56215516
Vena cava thrombosis	23.69	16.63	18	53935	2051	56236063
Renal impairment	23.50	16.63	145	53808	80568	56157546
Confusional state	23.50	16.63	111	53842	208044	56030070
Toxic neuropathy	23.44	16.63	10	53943	372	56237742
Cytomegalovirus colitis	23.44	16.63	18	53935	2084	56236030
Congenital retinoblastoma	23.36	16.63	5	53948	13	56238101
Hypoxia	23.34	16.63	108	53845	53789	56184325
Neuroendocrine carcinoma of the skin	23.34	16.63	11	53942	519	56237595
Neutropenic infection	23.09	16.63	14	53939	1101	56237013
Respiratory symptom	22.92	16.63	20	53933	2770	56235344
Drug clearance decreased	22.91	16.63	15	53938	1349	56236765
B-cell lymphoma recurrent	22.83	16.63	10	53943	397	56237717
Anaesthesia	22.78	16.63	10	53943	399	56237715
Nervous system disorder	22.59	16.63	50	53903	16839	56221275
Gestational trophoblastic tumour	22.46	16.63	6	53947	49	56238065
Tachycardia	22.44	16.63	176	53777	105700	56132414
Respiratory tract infection fungal	22.37	16.63	10	53943	417	56237697
Cytokine storm	22.25	16.63	9	53944	292	56237822
Serum ferritin increased	22.13	16.63	27	53926	5538	56232576
Hypoglycaemia	22.12	16.63	13	53940	55802	56182312
Appendicitis	22.04	16.63	31	53922	7301	56230813
Hypophosphataemia	22.04	16.63	36	53917	9666	56228448
Viral haemorrhagic cystitis	21.84	16.63	12	53941	783	56237331
Adverse event	21.80	16.63	13	53940	55363	56182751
Genotoxicity	21.73	16.63	5	53948	20	56238094
Streptococcal sepsis	21.68	16.63	16	53937	1744	56236370
Iris atrophy	21.65	16.63	6	53947	57	56238057
Dry eye	21.65	16.63	4	53949	35712	56202402
Vulvovaginitis	21.64	16.63	9	53944	314	56237800
Metastases to bone marrow	21.64	16.63	9	53944	314	56237800
Paranasal sinus mucosal hypertrophy	21.53	16.63	5	53948	21	56238093
Stenotrophomonas infection	21.52	16.63	16	53937	1765	56236349
Follicular thyroid cancer	21.38	16.63	6	53947	60	56238054
Fanconi syndrome	21.28	16.63	14	53939	1269	56236845
Rash pruritic	21.20	16.63	12	53941	52582	56185532
Acute monocytic leukaemia	21.17	16.63	7	53946	126	56237988
Schistocytosis	20.99	16.63	5	53948	24	56238090
Neurological decompensation	20.99	16.63	18	53935	2436	56235678
Primary mediastinal large B-cell lymphoma recurrent	20.94	16.63	6	53947	65	56238049
Hepatic lesion	20.87	16.63	23	53930	4232	56233882
Ependymoma	20.86	16.63	6	53947	66	56238048
Odynophagia	20.75	16.63	29	53924	6789	56231325
Pulmonary vascular disorder	20.72	16.63	9	53944	350	56237764
Ganglioneuroma	20.72	16.63	7	53946	135	56237979
Pneumocystis jirovecii pneumonia	20.46	16.63	46	53907	15655	56222459
Metastases to spleen	20.25	16.63	7	53946	145	56237969
Rectal fissure	20.18	16.63	10	53943	527	56237587
Ewing's sarcoma	20.15	16.63	4	53949	6	56238108
Loss of consciousness	20.14	16.63	47	53906	109302	56128812
Dysphagia	20.08	16.63	141	53812	81806	56156308
Gliosis	20.03	16.63	8	53945	251	56237863
Gastrointestinal mucosal disorder	20.02	16.63	11	53942	718	56237396
Blood stem cell transplant failure	19.99	16.63	7	53946	151	56237963
Dyspnoea	19.92	16.63	425	53528	592152	55645962
Listeria encephalitis	19.88	16.63	8	53945	256	56237858
VIth nerve paresis	19.88	16.63	6	53947	79	56238035
Enterobacter bacteraemia	19.83	16.63	8	53945	258	56237856
Myelopathy	19.80	16.63	18	53935	2630	56235484
Rhabdomyosarcoma recurrent	19.78	16.63	5	53948	32	56238082
Fungal sepsis	19.77	16.63	13	53940	1178	56236936
Alpha haemolytic streptococcal infection	19.72	16.63	13	53940	1183	56236931
Vulvovaginal inflammation	19.55	16.63	11	53942	752	56237362
Gastrointestinal disorder	19.54	16.63	50	53903	112652	56125462
Fluid retention	19.52	16.63	14	53939	54064	56184050
Amnesia	19.50	16.63	10	53943	46312	56191802
Lymphadenopathy	19.47	16.63	76	53877	35132	56202982
Radiation oesophagitis	19.29	16.63	8	53945	277	56237837
Hypocalcaemia	19.20	16.63	66	53887	28694	56209420
Retroperitoneal abscess	19.17	16.63	7	53946	171	56237943
Haematochezia	19.07	16.63	9	53944	43709	56194405
Medulloblastoma	19.03	16.63	5	53948	38	56238076
Engraftment syndrome	19.03	16.63	9	53944	428	56237686
Surgery	18.94	16.63	4	53949	32482	56205632
Plasmacytoma	18.91	16.63	17	53936	2449	56235665
Metastases to breast	18.90	16.63	8	53945	292	56237822
Lung infiltration	18.74	16.63	41	53912	13697	56224417
Mesenteric haemorrhage	18.70	16.63	5	53948	41	56238073
Cerebral salt-wasting syndrome	18.70	16.63	5	53948	41	56238073
Mucosal erosion	18.63	16.63	13	53940	1298	56236816
Hot flush	18.35	16.63	11	53942	46715	56191399
Osteoporosis	18.11	16.63	14	53939	52038	56186076
Chronic obstructive pulmonary disease	18.07	16.63	17	53936	57398	56180716
Viraemia	18.03	16.63	12	53941	1109	56237005
Human chorionic gonadotropin increased	17.98	16.63	13	53940	1373	56236741
B precursor type acute leukaemia	17.95	16.63	7	53946	206	56237908
Oral fungal infection	17.92	16.63	17	53936	2623	56235491
Hypoglossal nerve paresis	17.89	16.63	6	53947	113	56238001
Transdifferentiation of neoplasm	17.80	16.63	4	53949	14	56238100
Pneumonia respiratory syncytial viral	17.80	16.63	10	53943	682	56237432
Intra-abdominal haemorrhage	17.72	16.63	16	53937	2317	56235797
Liver injury	17.67	16.63	9	53944	41839	56196275
Vascular compression	17.65	16.63	6	53947	118	56237996
Embolism	17.65	16.63	28	53925	7336	56230778
Cardiopulmonary failure	17.65	16.63	19	53934	3406	56234708
Lymphoma	17.63	16.63	34	53919	10394	56227720
Pulmonary toxicity	17.57	16.63	29	53924	7854	56230260
Breast cancer	17.16	16.63	13	53940	48820	56189294
Inguinal hernia	17.10	16.63	14	53939	1777	56236337
Type 2 diabetes mellitus	17.09	16.63	12	53941	46850	56191264
Product administered to patient of inappropriate age	16.83	16.63	17	53936	2831	56235283
Traumatic lung injury	16.79	16.63	13	53940	1523	56236591
Blood stem cell harvest failure	16.77	16.63	5	53948	63	56238051
Skin discolouration	16.72	16.63	6	53947	34350	56203764
Central nervous system lymphoma	16.66	16.63	13	53940	1540	56236574
Aortic thrombosis	16.63	16.63	11	53942	1006	56237108

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	3032.57	14.82	2404	71921	119445	31503574
Neutropenia	975.52	14.82	1408	72917	138956	31484063
Mucosal inflammation	732.81	14.82	623	73702	33804	31589215
Bone marrow failure	669.13	14.82	542	73783	27466	31595553
Pancytopenia	649.56	14.82	906	73419	86410	31536609
Acute myeloid leukaemia	629.43	14.82	444	73881	18228	31604791
Product use in unapproved indication	578.26	14.82	918	73407	98253	31524766
Myelosuppression	569.37	14.82	383	73942	14537	31608482
Thrombocytopenia	533.11	14.82	1088	73237	141659	31481360
Myelodysplastic syndrome	520.85	14.82	401	73924	18850	31604169
Off label use	510.81	14.82	1875	72450	345399	31277620
Disease progression	386.13	14.82	730	73595	89734	31533285
Haematotoxicity	356.04	14.82	217	74108	6920	31616099
Venoocclusive liver disease	348.48	14.82	217	74108	7195	31615824
Second primary malignancy	313.35	14.82	199	74126	6833	31616186
Malignant neoplasm progression	309.48	14.82	615	73710	78383	31544636
Tumour lysis syndrome	291.91	14.82	261	74064	15124	31607895
Sepsis	282.14	14.82	889	73436	151040	31471979
Septic shock	277.25	14.82	530	73795	65628	31557391
Neutrophil count decreased	271.85	14.82	431	73894	45963	31577056
Haemophagocytic lymphohistiocytosis	266.05	14.82	220	74105	11458	31611561
Febrile bone marrow aplasia	255.98	14.82	183	74142	7663	31615356
Diffuse large B-cell lymphoma recurrent	245.69	14.82	126	74199	2849	31620170
Therapy partial responder	230.19	14.82	160	74165	6402	31616617
Neutropenic sepsis	226.93	14.82	206	74119	12173	31610846
Renal salt-wasting syndrome	224.10	14.82	63	74262	222	31622797
Fall	221.49	14.82	80	74245	186009	31437010
Neoplasm progression	207.84	14.82	247	74078	20025	31602994
Cytopenia	203.35	14.82	184	74141	10826	31612193
Product dose omission issue	188.12	14.82	16	74309	105570	31517449
Leukopenia	180.87	14.82	411	73914	57417	31565602
Cardiotoxicity	161.10	14.82	116	74209	4911	31618108
Malignant transformation	161.00	14.82	64	74261	773	31622246
Diffuse large B-cell lymphoma	158.76	14.82	144	74181	8497	31614522
Diffuse large B-cell lymphoma refractory	158.12	14.82	68	74257	1015	31622004
Posterior reversible encephalopathy syndrome	156.43	14.82	148	74177	9219	31613800
Cystitis haemorrhagic	155.82	14.82	116	74209	5173	31617846
Aplasia	150.98	14.82	104	74221	4099	31618920
Dizziness	150.75	14.82	147	74178	199000	31424019
Fatigue	144.56	14.82	362	73963	334844	31288175
Pyrexia	139.18	14.82	1199	73126	302641	31320378
Overdose	135.16	14.82	19	74306	84645	31538374
Stomatitis	133.05	14.82	289	74036	39149	31583870
Arthralgia	132.65	14.82	97	74228	151327	31471692
Venoocclusive disease	130.06	14.82	80	74245	2592	31620427
Depression	120.52	14.82	32	74293	90783	31532236
Insomnia	119.25	14.82	37	74288	94799	31528220
Bronchopulmonary aspergillosis	118.61	14.82	153	74172	13481	31609538
Aspergillus infection	117.37	14.82	140	74185	11388	31611631
Respiratory failure	117.33	14.82	510	73815	100939	31522080
Stem cell transplant	117.06	14.82	68	74257	1980	31621039
Bacteraemia	116.07	14.82	173	74152	17461	31605558
Pain	115.34	14.82	162	74163	186597	31436422
Neutropenic colitis	114.50	14.82	74	74251	2618	31620401
Blood pressure increased	111.63	14.82	25	74300	79608	31543411
Malaise	111.35	14.82	139	74186	168372	31454647
Anaemia	111.20	14.82	868	73457	212654	31410365
Encephalopathy	110.70	14.82	239	74086	32235	31590784
Drug interaction	109.86	14.82	201	74124	208342	31414677
Neoplasm recurrence	107.27	14.82	65	74260	2049	31620970
Rash	107.20	14.82	193	74132	201293	31421726
Tremor	107.11	14.82	24	74301	76396	31546623
Anxiety	106.68	14.82	40	74285	90993	31532026
Fungal infection	104.85	14.82	149	74176	14402	31608617
Peripheral swelling	104.25	14.82	17	74308	67848	31555171
Disease recurrence	100.53	14.82	167	74158	18494	31604525
Acute graft versus host disease	98.52	14.82	95	74230	6058	31616961
Joint swelling	98.19	14.82	7	74318	53424	31569595
Hypogammaglobulinaemia	85.42	14.82	91	74234	6536	31616483
Platelet count decreased	84.40	14.82	494	73831	109941	31513078
BK virus infection	84.10	14.82	80	74245	5015	31618004
Acute lymphocytic leukaemia	83.92	14.82	68	74257	3438	31619581
White blood cell count decreased	83.05	14.82	415	73910	86983	31536036
Inappropriate schedule of product administration	82.04	14.82	11	74314	50812	31572207
Death	81.02	14.82	505	73820	360064	31262955
Drug resistance	80.36	14.82	173	74152	23280	31599739
Weight increased	78.09	14.82	49	74276	82898	31540121
Progressive multifocal leukoencephalopathy	77.97	14.82	102	74223	9111	31613908
Pruritus	77.76	14.82	108	74217	125059	31497960
Hepatitis B reactivation	77.45	14.82	65	74260	3453	31619566
Musculoskeletal stiffness	77.14	14.82	5	74320	41320	31581699
Cardiac failure congestive	75.98	14.82	46	74279	79341	31543678
Enterococcal bacteraemia	75.75	14.82	48	74277	1640	31621379
Nasopharyngitis	75.41	14.82	27	74298	63218	31559801
Anaplastic lymphoma kinase gene mutation	74.55	14.82	22	74303	96	31622923
Somnolence	74.42	14.82	74	74251	99371	31523648
Asthma	74.37	14.82	7	74318	42604	31580415
Cytomegalovirus infection	74.28	14.82	173	74152	24534	31598485
Sweat gland tumour	72.74	14.82	30	74295	401	31622618
Coronary artery disease	72.00	14.82	11	74314	46076	31576943
Rheumatoid arthritis	71.16	14.82	13	74312	47796	31575223
Clostridium difficile colitis	70.68	14.82	122	74203	13934	31609085
Colitis	69.81	14.82	206	74119	33681	31589338
Muscle spasms	69.07	14.82	37	74288	68281	31554738
Multiple organ dysfunction syndrome	68.44	14.82	329	73996	67874	31555145
Aggression	68.18	14.82	5	74320	37286	31585733
Lymphopenia	67.69	14.82	121	74204	14208	31608811
Headache	67.30	14.82	214	74111	183438	31439581
Feeling abnormal	66.83	14.82	25	74300	56977	31566042
Systemic mycosis	66.76	14.82	42	74283	1417	31621602
Cytomegalovirus chorioretinitis	66.66	14.82	59	74266	3369	31619650
Neurotoxicity	66.61	14.82	129	74196	16097	31606922
Candida infection	66.43	14.82	129	74196	16129	31606890
Pulmonary toxicity	66.08	14.82	72	74253	5305	31617714
Lymphadenopathy	65.90	14.82	171	74154	25950	31597069
Neuroblastoma	64.67	14.82	24	74301	237	31622782
Nephropathy toxic	64.38	14.82	104	74221	11249	31611770
Weight decreased	63.91	14.82	179	74146	159773	31463246
Epstein-Barr virus infection	63.58	14.82	80	74245	6873	31616146
Blood glucose increased	63.35	14.82	32	74293	61051	31561968
Adenovirus infection	62.55	14.82	66	74259	4688	31618331
Osteosarcoma	62.21	14.82	24	74301	266	31622753
Myalgia	61.91	14.82	54	74271	77204	31545815
Staphylococcal bacteraemia	61.45	14.82	82	74243	7466	31615553
Renal tubular disorder	61.20	14.82	63	74262	4347	31618672
Psoriasis	60.93	14.82	17	74308	46702	31576317
Thrombotic microangiopathy	60.47	14.82	91	74234	9260	31613759
Hepatitis B	60.15	14.82	71	74254	5710	31617309
Hospitalisation	59.82	14.82	21	74304	49786	31573233
Chest pain	59.47	14.82	115	74210	116842	31506177
Enterococcal infection	59.38	14.82	87	74238	8644	31614375
Rhabdomyolysis	59.23	14.82	38	74287	63543	31559476
Myocardial infarction	59.05	14.82	110	74215	113344	31509675
Oedema peripheral	58.50	14.82	105	74220	109734	31513285
Acute promyelocytic leukaemia	57.91	14.82	27	74298	492	31622527
Small cell lung cancer	57.35	14.82	42	74283	1825	31621194
Incorrect dose administered	57.08	14.82	8	74317	35744	31587275
Neuropathy peripheral	55.55	14.82	335	73990	75314	31547705
Cerebrovascular accident	55.15	14.82	63	74262	79421	31543598
Retinal haemorrhage	54.10	14.82	61	74264	4669	31618350
Epstein-Barr virus associated lymphoproliferative disorder	54.07	14.82	40	74285	1766	31621253
Chloroma	53.94	14.82	26	74299	512	31622507
Pneumonitis	52.67	14.82	175	74150	30477	31592542
Chronic graft versus host disease	52.56	14.82	58	74267	4334	31618685
Pneumocystis jirovecii pneumonia	51.83	14.82	125	74200	18126	31604893
Acute graft versus host disease in skin	51.36	14.82	60	74265	4772	31618247
Chronic obstructive pulmonary disease	50.98	14.82	21	74304	45145	31577874
Ependymoma	50.91	14.82	15	74310	65	31622954
B-cell lymphoma recurrent	50.69	14.82	27	74298	661	31622358
Pneumonia klebsiella	50.62	14.82	47	74278	2857	31620162
Gait disturbance	49.98	14.82	65	74260	77430	31545589
Drug hypersensitivity	49.87	14.82	58	74267	72541	31550478
Bacterial sepsis	49.74	14.82	59	74266	4769	31618250
Vena cava thrombosis	49.37	14.82	31	74294	1042	31621977
Arthritis	49.13	14.82	4	74321	27381	31595638
Pain in extremity	48.67	14.82	127	74198	116076	31506943
Agranulocytosis	48.45	14.82	134	74191	21113	31601906
Azoospermia	48.09	14.82	22	74303	383	31622636
Bradycardia	48.03	14.82	55	74270	69272	31553747
Bacterial infection	47.81	14.82	102	74223	13637	31609382
Influenza like illness	47.70	14.82	3	74322	25434	31597585
Pulmonary vascular disorder	47.50	14.82	25	74300	597	31622422
Blood stem cell transplant failure	47.43	14.82	22	74303	396	31622623
Ameloblastoma	47.03	14.82	15	74310	89	31622930
Graft versus host disease	46.52	14.82	86	74239	10361	31612658
Abdominal discomfort	46.43	14.82	32	74293	51535	31571484
Balance disorder	46.29	14.82	15	74310	37407	31585612
Hyperkalaemia	45.73	14.82	50	74275	64301	31558718
Refractory cancer	45.43	14.82	16	74309	134	31622885
Prostate cancer	44.90	14.82	16	74309	37585	31585434
T-cell type acute leukaemia	44.59	14.82	17	74308	182	31622837
Escherichia infection	44.29	14.82	69	74256	7235	31615784
Hallucination	44.23	14.82	27	74298	46383	31576636
Sleep disorder	44.23	14.82	5	74320	26343	31596676
Papillary thyroid cancer	44.18	14.82	24	74301	612	31622407
Nephrolithiasis	43.92	14.82	6	74319	27333	31595686
Salivary gland cancer	43.85	14.82	19	74306	289	31622730
Engraftment syndrome	43.69	14.82	27	74298	882	31622137
Heart rate decreased	43.57	14.82	7	74318	28259	31594760
Blood creatine phosphokinase increased	43.50	14.82	22	74303	41952	31581067
Medulloblastoma recurrent	43.29	14.82	13	74312	61	31622958
Hyperhidrosis	42.97	14.82	57	74268	67336	31555683
Acute respiratory distress syndrome	42.96	14.82	141	74184	24399	31598620
Klebsiella sepsis	42.34	14.82	35	74290	1820	31621199
Vision blurred	41.92	14.82	23	74302	41892	31581127
Diabetes mellitus	41.63	14.82	24	74301	42532	31580487
Drug dependence	41.35	14.82	3	74322	22576	31600443
Urinary tract infection	41.34	14.82	73	74252	76796	31546223
Recurrent cancer	41.19	14.82	29	74296	1184	31621835
Loss of consciousness	41.12	14.82	74	74251	77281	31545738
Pulmonary arteriopathy	40.92	14.82	13	74312	76	31622943
Drug reaction with eosinophilia and systemic symptoms	40.90	14.82	10	74315	30008	31593011
Diaphragm muscle weakness	40.89	14.82	15	74310	143	31622876
Urticaria	40.53	14.82	45	74280	57472	31565547
Central nervous system fungal infection	40.32	14.82	19	74306	355	31622664
Dyspnoea	40.14	14.82	566	73759	342913	31280106
Unevaluable event	40.10	14.82	11	74314	30564	31592455
Teratoma	39.98	14.82	10	74315	19	31623000
Ototoxicity	39.77	14.82	33	74292	1725	31621294
Metastases to meninges	39.40	14.82	29	74296	1270	31621749
Fusarium infection	39.30	14.82	27	74298	1059	31621960
Metastasis	38.52	14.82	45	74280	3579	31619440
Leukaemia recurrent	38.19	14.82	31	74294	1571	31621448
Viral haemorrhagic cystitis	38.18	14.82	26	74299	1005	31622014
Electrocardiogram QT prolonged	37.76	14.82	21	74304	37966	31585053
Therapy non-responder	37.50	14.82	168	74157	33643	31589376
Angioedema	37.34	14.82	16	74309	33602	31589417
Klebsiella infection	36.99	14.82	66	74259	7737	31615282
Back pain	36.94	14.82	132	74193	109281	31513738
Loss of personal independence in daily activities	35.59	14.82	11	74314	28277	31594742
Memory impairment	35.21	14.82	23	74302	38107	31584912
Escherichia bacteraemia	34.83	14.82	39	74286	2962	31620057
Hypoglycaemia	34.66	14.82	41	74284	50905	31572114
Cardiac disorder	34.42	14.82	25	74300	39189	31583830
Medulloblastoma	34.39	14.82	11	74314	66	31622953
Testicular germ cell cancer metastatic	34.25	14.82	11	74314	67	31622952
Wheezing	34.20	14.82	21	74304	35965	31587054
Osteonecrosis	34.10	14.82	90	74235	13794	31609225
Haematochezia	33.98	14.82	27	74298	40437	31582582
Metastases to liver	33.83	14.82	85	74240	12642	31610377
Pancreatic neuroendocrine tumour metastatic	33.75	14.82	14	74311	190	31622829
Juvenile melanoma benign	33.71	14.82	11	74314	71	31622948
Metastases to lung	33.40	14.82	66	74259	8356	31614663
Pseudomonas infection	33.35	14.82	79	74246	11322	31611697
Abdominal pain upper	33.32	14.82	62	74263	63940	31559079
Epstein-Barr virus infection reactivation	33.11	14.82	22	74303	816	31622203
Ganglioneuroblastoma	33.11	14.82	9	74316	27	31622992
Retinopathy proliferative	33.07	14.82	11	74314	76	31622943
Serotonin syndrome	32.97	14.82	3	74322	18770	31604249
Metastases to central nervous system	32.93	14.82	62	74263	7574	31615445
Gastrointestinal toxicity	32.49	14.82	33	74292	2241	31620778
Cytomegalovirus infection reactivation	32.47	14.82	43	74282	3886	31619133
Injury	32.44	14.82	4	74321	19705	31603314
Enteritis	32.32	14.82	59	74266	7040	31615979
Carotid artery thrombosis	32.30	14.82	16	74309	335	31622684
Blood lactate dehydrogenase increased	32.20	14.82	113	74212	20226	31602793
Pneumonia adenoviral	32.13	14.82	16	74309	339	31622680
Extravasation	31.93	14.82	29	74296	1713	31621306
Contusion	31.77	14.82	19	74306	33009	31590010
Acute lymphocytic leukaemia recurrent	31.44	14.82	38	74287	3132	31619887
Aortic thrombosis	31.39	14.82	20	74305	690	31622329
Systemic candida	31.29	14.82	38	74287	3148	31619871
Fanconi syndrome	31.12	14.82	28	74297	1634	31621385
Cellulitis gangrenous	31.11	14.82	13	74312	180	31622839
Cytogenetic abnormality	31.04	14.82	21	74304	803	31622216
Influenza	30.87	14.82	35	74290	44290	31578729
Delayed puberty	30.72	14.82	13	74312	186	31622833
Acute myeloid leukaemia recurrent	30.70	14.82	30	74295	1944	31621075
Gastrooesophageal reflux disease	30.51	14.82	21	74304	33850	31589169
Pulmonary veno-occlusive disease	30.45	14.82	17	74308	458	31622561
Neoplasm	30.18	14.82	45	74280	4541	31618478
Aspiration bone marrow abnormal	30.06	14.82	11	74314	104	31622915
Swelling	30.04	14.82	26	74299	37332	31585687
Peripheral T-cell lymphoma unspecified	29.94	14.82	18	74307	559	31622460
Lactic acidosis	29.85	14.82	19	74306	31918	31591101
Toxic encephalopathy	29.66	14.82	46	74279	4804	31618215
Blood pressure systolic increased	29.61	14.82	5	74320	19465	31603554
Cytomegalovirus viraemia	29.49	14.82	55	74270	6670	31616349
Primitive neuroectodermal tumour	29.47	14.82	10	74315	74	31622945
Neuroendocrine tumour of the lung metastatic	29.43	14.82	11	74314	111	31622908
Adenoviral hepatitis	29.42	14.82	17	74308	490	31622529
Metastases to muscle	29.24	14.82	13	74312	211	31622808
Erectile dysfunction	29.12	14.82	5	74320	19230	31603789
Metastases to retroperitoneum	29.08	14.82	13	74312	214	31622805
Blood cholesterol increased	28.88	14.82	3	74322	16890	31606129
Mucormycosis	28.86	14.82	49	74276	5521	31617498
Minimal residual disease	28.85	14.82	15	74310	349	31622670
Bronchitis	28.72	14.82	29	74296	38688	31584331
High-grade B-cell lymphoma	28.53	14.82	12	74313	169	31622850
Hepatotoxicity	28.35	14.82	104	74221	19022	31603997
Wrong technique in product usage process	28.31	14.82	22	74303	33321	31589698
Body height below normal	28.28	14.82	13	74312	229	31622790
Disseminated intravascular coagulation	28.22	14.82	109	74216	20428	31602591
Hepatic candidiasis	28.14	14.82	9	74316	54	31622965
Adverse drug reaction	27.98	14.82	12	74313	25189	31597830
Rhabdomyosarcoma recurrent	27.96	14.82	10	74315	88	31622931
Stenotrophomonas infection	27.93	14.82	28	74297	1872	31621147
Streptococcal bacteraemia	27.85	14.82	27	74298	1733	31621286
Pneumonia aspiration	27.61	14.82	30	74295	38696	31584323
Eosinophilia	27.58	14.82	10	74315	23243	31599776
Mobility decreased	27.57	14.82	15	74310	27454	31595565
Pulmonary haemorrhage	27.45	14.82	66	74259	9549	31613470
Central nervous system lymphoma	27.32	14.82	22	74303	1102	31621917
Treatment noncompliance	27.31	14.82	13	74312	25671	31597348
Human herpesvirus 6 infection	27.23	14.82	28	74297	1929	31621090
Cardio-respiratory arrest	27.02	14.82	50	74275	51676	31571343
Abnormal behaviour	27.01	14.82	11	74314	23817	31599202
Encephalitis enteroviral	26.74	14.82	11	74314	146	31622873
Refractory anaemia with an excess of blasts	26.67	14.82	15	74310	410	31622609
Arrhythmia	26.62	14.82	23	74302	33054	31589965
Dyskinesia	26.54	14.82	8	74317	20902	31602117
Diabetic ketoacidosis	26.47	14.82	4	74321	16901	31606118
Toxicity to various agents	26.43	14.82	285	74040	181202	31441817
Device related infection	26.18	14.82	91	74234	16208	31606811
Graft versus host disease in skin	26.15	14.82	37	74288	3560	31619459
Plasma cell leukaemia	26.11	14.82	20	74305	931	31622088
Paraneoplastic neurological syndrome	26.06	14.82	8	74317	41	31622978
Disturbance in attention	26.05	14.82	10	74315	22440	31600579
Liver function test abnormal	25.97	14.82	19	74306	29673	31593346
Myelopathy	25.75	14.82	29	74296	2216	31620803
Intussusception	25.61	14.82	16	74309	533	31622486
Graft versus host disease in gastrointestinal tract	25.61	14.82	36	74289	3443	31619576
Dehydration	25.48	14.82	169	74156	118942	31504077
Therapeutic product effect decreased	25.44	14.82	22	74303	31600	31591419
Radiation pneumonitis	25.40	14.82	30	74295	2414	31620605
Myeloid leukaemia	25.35	14.82	14	74311	369	31622650
Accidental overdose	25.22	14.82	6	74319	18344	31604675
Spinal column injury	25.19	14.82	16	74309	549	31622470
Intestinal atresia	24.99	14.82	9	74316	81	31622938
Capillary leak syndrome	24.81	14.82	27	74298	1986	31621033
Syncope	24.78	14.82	109	74216	85073	31537946
Papilloedema	24.60	14.82	30	74295	2496	31620523
Flatulence	24.50	14.82	7	74318	18941	31604078
Hepatic infection fungal	24.50	14.82	11	74314	183	31622836
Hyperbilirubinaemia	24.49	14.82	87	74238	15663	31607356
Graft versus host disease in liver	24.49	14.82	21	74304	1149	31621870
Embolism	24.26	14.82	53	74272	7200	31615819
Candida sepsis	24.19	14.82	21	74304	1168	31621851
Neuroblastoma recurrent	24.06	14.82	9	74316	91	31622928
Metastases to spleen	24.05	14.82	14	74311	409	31622610
Lymphoma	23.94	14.82	68	74257	10875	31612144
Head injury	23.79	14.82	5	74320	16653	31606366
Mantle cell lymphoma recurrent	23.68	14.82	15	74310	512	31622507
Hypoalbuminaemia	23.62	14.82	68	74257	10960	31612059
Basal cell naevus syndrome	23.46	14.82	7	74318	32	31622987
Streptococcal infection	23.43	14.82	40	74285	4527	31618492
Post transplant lymphoproliferative disorder	23.35	14.82	47	74278	6029	31616990
Herpes simplex	23.13	14.82	43	74282	5202	31617817
Gastrointestinal mucosal disorder	23.13	14.82	13	74312	355	31622664
Heart rate increased	23.05	14.82	38	74287	41072	31581947
Migraine	23.04	14.82	3	74322	14177	31608842
Hypertensive hydrocephalus	23.04	14.82	8	74317	64	31622955
Nervous system disorder	23.02	14.82	76	74249	13187	31609832
Aplastic anaemia	22.95	14.82	60	74265	9143	31613876
Psoriatic arthropathy	22.83	14.82	9	74316	19874	31603145
Flagellate dermatitis	22.82	14.82	8	74317	66	31622953
Cerebral venous thrombosis	22.64	14.82	16	74309	657	31622362
Skin exfoliation	22.59	14.82	14	74311	23860	31599159
Blood electrolytes abnormal	22.45	14.82	18	74307	896	31622123
Bicytopenia	22.30	14.82	26	74299	2063	31620956
Dry mouth	22.25	14.82	15	74310	24443	31598576
Faeces discoloured	22.20	14.82	3	74322	13783	31609236
Anaplastic large-cell lymphoma	22.18	14.82	10	74315	168	31622851
Diverticulitis	22.14	14.82	8	74317	18637	31604382
Trichosporon infection	22.14	14.82	16	74309	681	31622338
Carbamoyl phosphate synthetase deficiency	22.07	14.82	6	74319	18	31623001
Enterocolitis	21.93	14.82	51	74274	7223	31615796
International normalised ratio increased	21.65	14.82	46	74279	45177	31577842
Geotrichum infection	21.59	14.82	14	74311	498	31622521
Transient ischaemic attack	21.55	14.82	15	74310	24041	31598978
Neutrophil count abnormal	21.50	14.82	23	74302	1659	31621360
Abdominal distension	21.50	14.82	55	74270	50629	31572390
Transformation to acute myeloid leukaemia	21.42	14.82	16	74309	717	31622302
Agitation	21.31	14.82	61	74264	54108	31568911
Road traffic accident	21.28	14.82	6	74319	16375	31606644
Short stature	21.21	14.82	8	74317	83	31622936
Chromaturia	21.16	14.82	3	74322	13295	31609724
Emotional distress	21.15	14.82	4	74321	14352	31608667
Stomatitis necrotising	21.04	14.82	8	74317	85	31622934
Pneumothorax	21.03	14.82	87	74238	16823	31606196
Peripheral sensory neuropathy	20.96	14.82	46	74279	6269	31616750
Rectal haemorrhage	20.87	14.82	33	74292	36271	31586748
Laboratory test abnormal	20.82	14.82	9	74316	18805	31604214
Autoimmune neutropenia	20.81	14.82	11	74314	265	31622754
Benign prostatic hyperplasia	20.80	14.82	3	74322	13122	31609897
Confusional state	20.78	14.82	206	74119	133128	31489891
Medication error	20.67	14.82	14	74311	22758	31600261
Burkitt's lymphoma	20.53	14.82	9	74316	141	31622878
Speech disorder	20.50	14.82	16	74309	24185	31598834
Amnesia	20.43	14.82	15	74310	23387	31599632
Myoclonus	20.39	14.82	4	74321	13986	31609033
Disorder of orbit	20.32	14.82	8	74317	94	31622925
Terminal ileitis	20.25	14.82	9	74316	146	31622873
Traumatic lung injury	20.23	14.82	19	74306	1172	31621847
Intestinal perforation	20.21	14.82	54	74271	8335	31614684
Dry skin	20.16	14.82	18	74307	25463	31597556
Visceral oedema	20.16	14.82	5	74320	9	31623010
Gallbladder empyema	20.16	14.82	7	74318	56	31622963
Metastases to lymph nodes	20.10	14.82	36	74289	4232	31618787
Adrenocortical carcinoma	20.01	14.82	6	74319	28	31622991
Type 2 diabetes mellitus	19.99	14.82	5	74320	14779	31608240
B-cell lymphoma refractory	19.92	14.82	9	74316	152	31622867
Vertigo	19.89	14.82	15	74310	23070	31599949
Inflammatory pseudotumour	19.83	14.82	6	74319	29	31622990
Asthenia	19.72	14.82	390	73935	224365	31398654
Hypophosphataemia	19.71	14.82	54	74271	8460	31614559
Hepatosplenomegaly	19.53	14.82	34	74291	3909	31619110
Testicular malignant teratoma	19.50	14.82	5	74320	11	31623008
Prostatic specific antigen increased	19.46	14.82	4	74321	13534	31609485
Escherichia sepsis	19.43	14.82	35	74290	4132	31618887
Flushing	19.35	14.82	129	74196	29999	31593020
Paraesthesia	19.34	14.82	67	74258	56004	31567015
Paternal exposure timing unspecified	19.19	14.82	6	74319	33	31622986
Osteonecrosis of jaw	19.15	14.82	8	74317	17063	31605956
Seminoma	19.11	14.82	10	74315	236	31622783
Product administration error	19.05	14.82	6	74319	15241	31607778
Blood pressure decreased	19.03	14.82	54	74271	48037	31574982
Therapy responder	18.96	14.82	9	74316	171	31622848
Metastases to bone marrow	18.90	14.82	13	74312	511	31622508
Colitis ulcerative	18.77	14.82	10	74315	18519	31604500
Neuroendocrine carcinoma	18.76	14.82	12	74313	417	31622602
Varicella zoster virus infection	18.75	14.82	21	74304	1595	31621424
Blood fibrinogen decreased	18.71	14.82	18	74307	1144	31621875
Hyperlipidaemia	18.69	14.82	4	74321	13156	31609863
Arterial thrombosis	18.68	14.82	20	74305	1444	31621575
Pneumonia fungal	18.67	14.82	44	74281	6285	31616734
Atypical teratoid/rhabdoid tumour of CNS	18.65	14.82	5	74320	14	31623005
Histiocytic sarcoma	18.65	14.82	5	74320	14	31623005
Peripheral sensorimotor neuropathy	18.64	14.82	20	74305	1448	31621571
Hypoaesthesia	18.62	14.82	68	74257	55954	31567065
Lung infiltration	18.60	14.82	67	74258	12146	31610873
Acute myelomonocytic leukaemia	18.50	14.82	8	74317	121	31622898
Leukoencephalopathy	18.49	14.82	33	74292	3869	31619150
Adverse event	18.47	14.82	8	74317	16697	31606322
Gait inability	18.43	14.82	11	74314	19133	31603886
Myelitis transverse	18.35	14.82	17	74308	1030	31621989
Adenovirus reactivation	18.19	14.82	9	74316	188	31622831
Hepatic cirrhosis	18.15	14.82	7	74318	15667	31607352
Reticulocytosis	18.13	14.82	10	74315	263	31622756
Gout	18.13	14.82	10	74315	18164	31604855
Meningitis tuberculous	18.12	14.82	14	74311	660	31622359
Condition aggravated	18.11	14.82	273	74052	163736	31459283
Thymus hypoplasia	18.06	14.82	9	74316	191	31622828
Lymphoid tissue hypoplasia	18.06	14.82	9	74316	191	31622828
Dystrophic calcification	18	14.82	4	74321	3	31623016
Small intestinal perforation	17.98	14.82	23	74302	2009	31621010
Premature ageing	17.95	14.82	7	74318	80	31622939
Spindle cell sarcoma	17.93	14.82	8	74317	131	31622888
Nasal congestion	17.87	14.82	13	74312	20368	31602651
Refractory cytopenia with multilineage dysplasia	17.82	14.82	8	74317	133	31622886
Staphylococcal infection	17.80	14.82	128	74197	30504	31592515
Guillain-Barre syndrome	17.74	14.82	39	74286	5321	31617698
Peripheral T-cell lymphoma unspecified stage III	17.73	14.82	6	74319	44	31622975
Renal infarct	17.58	14.82	18	74307	1234	31621785
Hypertension	17.51	14.82	204	74121	127896	31495123
Mucoepidermoid carcinoma	17.49	14.82	5	74320	19	31623000
Pneumonia cytomegaloviral	17.43	14.82	27	74298	2817	31620202
Splenic infarction	17.41	14.82	22	74303	1898	31621121
Dyspnoea exertional	17.37	14.82	41	74284	38796	31584223
Lower respiratory tract infection fungal	17.31	14.82	13	74312	587	31622432
Brain sarcoma	17.17	14.82	6	74319	49	31622970
Skin laceration	17.16	14.82	3	74322	11388	31611631
Pneumatosis intestinalis	17.09	14.82	31	74294	3680	31619339
Retinal pigment epitheliopathy	17.06	14.82	9	74316	216	31622803
Pneumocystis jirovecii infection	17.00	14.82	20	74305	1602	31621417
Treatment failure	16.98	14.82	158	74167	40634	31582385
Scedosporium infection	16.97	14.82	15	74310	855	31622164
Ewing's sarcoma	16.91	14.82	5	74320	22	31622997
Adenomatous polyposis coli	16.90	14.82	8	74317	151	31622868
Cardiomyopathy	16.85	14.82	76	74249	15257	31607762
Subdural haemorrhage	16.64	14.82	27	74298	2930	31620089
Testicular germ cell tumour	16.58	14.82	4	74321	6	31623013
Rash pruritic	16.56	14.82	19	74306	23919	31599100
Platelet transfusion	16.53	14.82	18	74307	1325	31621694
Epstein-Barr viraemia	16.50	14.82	16	74309	1027	31621992
Oropharyngeal oedema	16.37	14.82	6	74319	57	31622962
Cardiogenic shock	16.37	14.82	17	74308	22391	31600628
Poikiloderma	16.35	14.82	8	74317	163	31622856
Lethargy	16.33	14.82	42	74283	38599	31584420
Hip fracture	16.31	14.82	3	74322	10983	31612036
Electrolyte imbalance	16.30	14.82	64	74261	12084	31610935
Coronary artery thrombosis	16.25	14.82	22	74303	2031	31620988
Peritoneal lesion	16.24	14.82	7	74318	105	31622914
Alpha haemolytic streptococcal infection	16.23	14.82	15	74310	906	31622113
Burns first degree	16.20	14.82	4	74321	7	31623012
Fanconi syndrome acquired	16.19	14.82	21	74304	1859	31621160
Ventricular tachycardia	16.19	14.82	19	74306	23682	31599337
Swollen tongue	16.18	14.82	5	74320	12857	31610162
5q minus syndrome	16.17	14.82	8	74317	167	31622852
CNS ventriculitis	16.14	14.82	9	74316	242	31622777
Granulocyte count decreased	16.13	14.82	13	74312	652	31622367
Hepatic necrosis	16.11	14.82	30	74295	3633	31619386
Hepatic steatosis	16.10	14.82	9	74316	16230	31606789
Eczema	16.09	14.82	8	74317	15409	31607610
Atrial fibrillation	16.01	14.82	180	74145	113603	31509416
Cerebellar tumour	16.01	14.82	6	74319	61	31622958
Mucosal toxicity	16.00	14.82	9	74316	246	31622773
Acanthamoeba infection	15.98	14.82	11	74314	433	31622586
Carnitine deficiency	15.95	14.82	7	74318	110	31622909
Diabetes mellitus inadequate control	15.94	14.82	5	74320	12736	31610283
Superior vena cava syndrome	15.94	14.82	12	74313	544	31622475
Respiratory arrest	15.93	14.82	23	74302	26234	31596785
Cardiac arrest	15.87	14.82	133	74192	88929	31534090
Sudden death	15.86	14.82	7	74318	14450	31608569
Arteriosclerosis	15.86	14.82	3	74322	10764	31612255
Extragonadal primary germ cell tumour mixed	15.86	14.82	4	74321	8	31623011
Blood culture positive	15.84	14.82	34	74291	4564	31618455
Cerebral toxoplasmosis	15.80	14.82	19	74306	1558	31621461
Colony stimulating factor therapy	15.79	14.82	8	74317	176	31622843
Recall phenomenon	15.79	14.82	12	74313	552	31622467
Delayed engraftment	15.78	14.82	7	74318	113	31622906
Retinoblastoma	15.77	14.82	5	74320	29	31622990
Congenital hepatobiliary anomaly	15.77	14.82	5	74320	29	31622990
Lymphoma transformation	15.71	14.82	8	74317	178	31622841
Autoimmune haemolytic anaemia	15.71	14.82	32	74293	4140	31618879
Underdose	15.68	14.82	5	74320	12602	31610417
Bacillus bacteraemia	15.67	14.82	6	74319	65	31622954
Drug ineffective	15.67	14.82	1102	73223	394471	31228548
Chemotherapy	15.66	14.82	12	74313	559	31622460
Blindness cortical	15.64	14.82	10	74315	347	31622672
Clostridium difficile infection	15.64	14.82	81	74244	17198	31605821
Cardiomyopathy acute	15.63	14.82	5	74320	30	31622989
Choriocarcinoma	15.63	14.82	5	74320	30	31622989
Burning sensation	15.60	14.82	10	74315	16737	31606282
Hirsutism	15.55	14.82	8	74317	182	31622837
Heart rate irregular	15.55	14.82	7	74318	14282	31608737
Mediastinum neoplasm	15.54	14.82	4	74321	9	31623010
Epidural haemorrhage	15.51	14.82	6	74319	67	31622952
Therapy interrupted	15.51	14.82	3	74322	10593	31612426
Tooth hypoplasia	15.45	14.82	7	74318	119	31622900
Sopor	15.44	14.82	4	74321	11548	31611471
Vomiting	15.43	14.82	657	73668	223316	31399703
Blood glucose decreased	15.42	14.82	5	74320	12466	31610553
Pneumomediastinum	15.40	14.82	22	74303	2135	31620884
Accidental exposure to product	15.33	14.82	4	74321	11491	31611528
Small cell carcinoma	15.29	14.82	7	74318	122	31622897
Ewing's sarcoma recurrent	15.24	14.82	4	74321	10	31623009
Dementia	15.20	14.82	5	74320	12355	31610664
Cerebral artery occlusion	15.19	14.82	13	74312	709	31622310
Erythema ab igne	15.17	14.82	3	74322	0	31623019
Li-Fraumeni syndrome	15.17	14.82	3	74322	0	31623019
Angina pectoris	15.17	14.82	29	74296	29612	31593407
Drug level increased	15.10	14.82	15	74310	20171	31602848
Non-Hodgkin's lymphoma unspecified histology aggressive	15.10	14.82	5	74320	34	31622985
Salivary gland cancer stage IV	15.10	14.82	5	74320	34	31622985
Primary hypogonadism	15.05	14.82	6	74319	73	31622946
Human herpesvirus 8 infection	15.03	14.82	14	74311	854	31622165
Bone sarcoma	14.98	14.82	6	74319	74	31622945
Hepatitis D	14.97	14.82	5	74320	35	31622984
Fibrinous bronchitis	14.97	14.82	4	74321	11	31623008

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	5230.42	14.44	3567	113446	200751	70610680
Neutropenia	1878.82	14.44	2212	114801	254944	70556487
Pancytopenia	1417.34	14.44	1483	115530	149624	70661807
Mucosal inflammation	1411.78	14.44	1048	115965	66802	70744629
Bone marrow failure	1321.19	14.44	887	116126	48123	70763308
Acute myeloid leukaemia	1130.96	14.44	679	116334	30261	70781170
Thrombocytopenia	1118.16	14.44	1654	115359	237456	70573975
Product use in unapproved indication	1001.08	14.44	1457	115556	206021	70605410
Myelodysplastic syndrome	936.81	14.44	594	116419	29191	70782240
Myelosuppression	817.80	14.44	548	116465	29597	70781834
Off label use	795.23	14.44	2854	114159	740206	70071225
Disease progression	725.71	14.44	1080	115933	155592	70655839
Venoocclusive liver disease	717.28	14.44	351	116662	10327	70801104
Haematotoxicity	693.72	14.44	372	116641	13302	70798129
Second primary malignancy	617.42	14.44	339	116674	12712	70798719
Haemophagocytic lymphohistiocytosis	616.26	14.44	391	116622	19221	70792210
Malignant neoplasm progression	615.55	14.44	875	116138	120864	70690567
Sepsis	604.63	14.44	1280	115733	243265	70568166
Tumour lysis syndrome	528.67	14.44	367	116646	20993	70790438
Febrile bone marrow aplasia	500.73	14.44	287	116726	11704	70799727
Septic shock	495.42	14.44	757	116256	111501	70699930
Neutrophil count decreased	489.26	14.44	645	116368	82911	70728520
Neutropenic sepsis	442.22	14.44	350	116663	24480	70786951
Pain	427.20	14.44	255	116758	628561	70182870
Rheumatoid arthritis	418.81	14.44	14	116999	291791	70519640
Renal salt-wasting syndrome	406.32	14.44	111	116902	532	70810899
Arthralgia	405.61	14.44	162	116851	503228	70308203
Fall	367.46	14.44	137	116876	443959	70367472
Joint swelling	367.43	14.44	11	117002	253200	70558231
Aplasia	358.61	14.44	194	116819	7057	70804374
Posterior reversible encephalopathy syndrome	357.25	14.44	307	116706	24095	70787336
Stem cell transplant	347.48	14.44	152	116861	3433	70807998
Diffuse large B-cell lymphoma recurrent	332.44	14.44	146	116867	3330	70808101
Multiple organ dysfunction syndrome	322.58	14.44	614	116399	107901	70703530
Leukopenia	309.45	14.44	597	116416	105963	70705468
Anaemia	294.83	14.44	1381	115632	402042	70409389
Pyrexia	293.83	14.44	1856	115157	605096	70206335
Peripheral swelling	291.71	14.44	27	116986	236536	70574895
Cardiotoxicity	285.19	14.44	195	116818	10875	70800556
Malignant transformation	276.87	14.44	95	116918	1078	70810353
Therapy partial responder	273.26	14.44	199	116814	12275	70799156
Encephalopathy	270.64	14.44	415	116598	61246	70750185
Aspergillus infection	268.07	14.44	228	116785	17640	70793791
Cytopenia	268.02	14.44	225	116788	17098	70794333
Product dose omission issue	267.65	14.44	25	116988	217443	70593988
Nasopharyngitis	254.60	14.44	33	116980	222173	70589258
Platelet count decreased	251.95	14.44	755	116258	177467	70633964
Bronchopulmonary aspergillosis	242.06	14.44	231	116782	20771	70790660
Neoplasm progression	241.51	14.44	334	116679	44894	70766537
Fatigue	241.30	14.44	638	116375	823681	69987750
Bacteraemia	236.08	14.44	266	116747	29043	70782388
Venoocclusive disease	232.06	14.44	121	116892	4079	70807352
Headache	228.69	14.44	379	116634	580026	70231405
Neutropenic colitis	225.87	14.44	127	116886	4987	70806444
Malaise	225.75	14.44	229	116784	432703	70378728
Diffuse large B-cell lymphoma	225.07	14.44	182	116831	13120	70798311
Dizziness	221.67	14.44	264	116749	463877	70347554
Abdominal discomfort	220.88	14.44	43	116970	214615	70596816
Drug hypersensitivity	218.43	14.44	80	116933	262379	70549052
Respiratory failure	218.18	14.44	693	116320	168042	70643389
Cystitis haemorrhagic	218.12	14.44	150	116863	8443	70802988
Pruritus	213.96	14.44	155	116858	345405	70466026
Cytomegalovirus infection	212.86	14.44	294	116719	39464	70771967
Arthropathy	212.34	14.44	8	117005	150049	70661382
Weight increased	211.80	14.44	68	116945	242263	70569168
Acute graft versus host disease	208.21	14.44	152	116861	9410	70802021
Musculoskeletal stiffness	205.31	14.44	9	117004	147751	70663680
Insomnia	199.62	14.44	56	116957	217750	70593681
Rash	199.53	14.44	335	116678	510227	70301204
Cytogenetic abnormality	193.74	14.44	71	116942	989	70810442
Drug abuse	192.10	14.44	13	117000	147243	70664188
Diffuse large B-cell lymphoma refractory	190.26	14.44	74	116939	1225	70810206
Drug resistance	186.10	14.44	270	116743	37920	70773511
Overdose	185.54	14.44	29	116984	169716	70641715
Secondary immunodeficiency	179.24	14.44	90	116923	2799	70808632
Teratoma	178.36	14.44	45	116968	147	70811284
Injection site pain	174.67	14.44	4	117009	117615	70693816
Bacterial infection	174.56	14.44	217	116796	26275	70785156
Disease recurrence	173.35	14.44	259	116754	37344	70774087
Swelling	171.78	14.44	49	116964	188490	70622941
BK virus infection	160.50	14.44	121	116892	7868	70803563
Anxiety	158.24	14.44	83	116930	220247	70591184
Clostridium difficile colitis	157.58	14.44	216	116797	28780	70782651
Blood pressure increased	157.56	14.44	57	116956	188460	70622971
Pain in extremity	157.12	14.44	186	116827	327896	70483535
Asthma	156.56	14.44	11	117002	120782	70690649
Neurotoxicity	155.82	14.44	218	116795	29608	70781823
Cytomegalovirus chorioretinitis	154.94	14.44	101	116912	5197	70806234
Ototoxicity	154.72	14.44	82	116931	2859	70808572
Colitis	151.38	14.44	329	116684	63485	70747946
White blood cell count decreased	145.43	14.44	611	116402	169530	70641901
Human herpesvirus 6 infection	143.00	14.44	93	116920	4766	70806665
Contraindicated product administered	142.64	14.44	25	116988	134587	70676844
Ovarian germ cell teratoma	139.80	14.44	33	116980	74	70811357
Nephropathy toxic	138.91	14.44	162	116851	18352	70793079
Candida infection	138.69	14.44	223	116790	34250	70777181
Wound	137.18	14.44	6	117007	98726	70712705
Neoplasm recurrence	134.91	14.44	83	116930	3858	70807573
Lymphopenia	132.66	14.44	193	116820	27166	70784265
Acute lymphocytic leukaemia	131.85	14.44	93	116920	5452	70805979
Fungal infection	131.53	14.44	228	116785	37239	70774192
Graft versus host disease	130.72	14.44	142	116871	14881	70796550
Muscle spasms	129.70	14.44	46	116967	154000	70657431
Enterococcal infection	127.18	14.44	138	116875	14444	70796987
Therapeutic product effect decreased	126.91	14.44	39	116974	142979	70668452
Cytomegalovirus viraemia	126.13	14.44	124	116889	11561	70799870
Feeling abnormal	125.94	14.44	39	116974	142280	70669151
Discomfort	119.87	14.44	16	116997	105420	70706011
Urticaria	119.16	14.44	60	116953	162989	70648442
Contusion	118.97	14.44	32	116981	128004	70683427
Thrombotic microangiopathy	118.87	14.44	147	116866	17701	70793730
Hepatitis B reactivation	118.57	14.44	86	116927	5269	70806162
Staphylococcal bacteraemia	118.50	14.44	117	116896	10965	70800466
Inappropriate schedule of product administration	118.36	14.44	18	116995	107537	70703894
Neuropathy peripheral	118.13	14.44	468	116545	126428	70685003
Epstein-Barr virus infection	115.27	14.44	125	116888	13073	70798358
Pneumocystis jirovecii pneumonia	114.78	14.44	190	116823	29892	70781539
Sweat gland tumour	114.70	14.44	40	116973	478	70810953
Mycobacterium chelonae infection	110.66	14.44	61	116952	2303	70809128
Arthritis	108.73	14.44	16	116997	97964	70713467
Renal tubular disorder	108.47	14.44	86	116927	6024	70805407
Small cell lung cancer	107.49	14.44	64	116949	2802	70808629
Psoriasis	107.11	14.44	17	116996	98416	70713015
Primary hypogonadism	104.65	14.44	29	116984	148	70811283
Depression	103.79	14.44	105	116908	198869	70612562
Osteosarcoma	102.17	14.44	35	116978	395	70811036
Progressive multifocal leukoencephalopathy	101.19	14.44	141	116872	19073	70792358
Acute promyelocytic leukaemia	99.72	14.44	49	116964	1453	70809978
Drug intolerance	99.60	14.44	136	116877	225551	70585880
Pseudomonal sepsis	98.44	14.44	78	116935	5459	70805972
Stress	98.31	14.44	3	117010	67963	70743468
Suicidal ideation	97.44	14.44	4	117009	69592	70741839
Somnolence	97.09	14.44	128	116885	215478	70595953
Bronchitis	97.00	14.44	36	116977	117207	70694224
Parainfluenzae virus infection	93.41	14.44	73	116940	5007	70806424
Pulmonary haemorrhage	93.29	14.44	114	116899	13559	70797872
Acute respiratory distress syndrome	92.52	14.44	208	116805	41046	70770385
Chloroma	92.46	14.44	38	116975	731	70810700
Hypersensitivity	91.20	14.44	149	116864	229663	70581768
Chronic graft versus host disease	90.68	14.44	81	116932	6689	70804742
Injection site erythema	90.67	14.44	8	117005	72916	70738515
Glossodynia	89.58	14.44	17	116996	86470	70724961
Suicide attempt	88.18	14.44	13	117000	79497	70731934
Klebsiella infection	87.69	14.44	113	116900	14179	70797252
Tremor	85.95	14.44	78	116935	155546	70655885
Post transplant lymphoproliferative disorder	85.40	14.44	96	116917	10449	70800982
Neuroblastoma	85.32	14.44	29	116984	319	70811112
Klebsiella sepsis	85.32	14.44	55	116958	2776	70808655
Anaplastic lymphoma kinase gene mutation	85.10	14.44	23	116990	105	70811326
Influenza like illness	84.49	14.44	6	117007	65325	70746106
Hepatosplenic T-cell lymphoma	84.42	14.44	38	116975	920	70810511
Blood pressure fluctuation	83.95	14.44	3	117010	59009	70752422
Hepatitis B	83.68	14.44	84	116929	8030	70803401
Psoriatic arthropathy	83.62	14.44	6	117007	64765	70746666
Gait disturbance	83.22	14.44	110	116903	184996	70626435
Loss of personal independence in daily activities	83.18	14.44	19	116994	84891	70726540
Adenovirus infection	83.04	14.44	82	116931	7686	70803745
Acute lymphocytic leukaemia recurrent	82.75	14.44	67	116946	4837	70806594
Myalgia	82.63	14.44	93	116920	167799	70643632
Epstein-Barr virus associated lymphoproliferative disorder	82.49	14.44	57	116956	3232	70808199
Oesophagitis	82.32	14.44	140	116873	22512	70788919
Migraine	82.01	14.44	11	117002	72227	70739204
Hepatic enzyme increased	81.67	14.44	83	116930	156907	70654524
Injury	81.55	14.44	7	117006	65238	70746193
Acute graft versus host disease in skin	81.28	14.44	78	116935	7059	70804372
Peripheral sensory neuropathy	81.06	14.44	100	116913	12010	70799421
Stomatitis	80.69	14.44	422	116591	128089	70683342
Oedema peripheral	80.52	14.44	159	116854	227932	70583499
Teratoma benign	80.30	14.44	20	116993	61	70811370
Disseminated intravascular coagulation	79.40	14.44	173	116840	33425	70778006
Abdominal pain upper	79.19	14.44	123	116890	193479	70617952
Urinary tract infection	79.02	14.44	184	116829	248585	70562846
T-cell type acute leukaemia	78.98	14.44	26	116987	257	70811174
Drug interaction	78.48	14.44	343	116670	381098	70430333
Weight decreased	78.25	14.44	257	116756	310231	70501200
Ovarian failure	77.89	14.44	31	116982	547	70810884
Hospitalisation	76.01	14.44	21	116992	82547	70728884
Alveolar soft part sarcoma	75.54	14.44	20	116993	83	70811348
Blood cholesterol increased	75.38	14.44	9	117004	64595	70746836
Oesophageal candidiasis	75.04	14.44	81	116932	8426	70803005
Enterococcal bacteraemia	74.94	14.44	50	116963	2676	70808755
Bacterial sepsis	74.92	14.44	77	116936	7570	70803861
Leukaemia recurrent	74.13	14.44	50	116963	2725	70808706
Pneumatosis intestinalis	74.07	14.44	68	116945	5819	70805612
Incorrect dose administered	73.78	14.44	11	117002	66708	70744723
Plasma cell leukaemia	73.36	14.44	43	116970	1828	70809603
Condition aggravated	73.34	14.44	410	116603	427225	70384206
Staphylococcal infection	73.21	14.44	224	116789	53180	70758251
Human bocavirus infection	73.05	14.44	30	116983	576	70810855
Gene mutation	72.74	14.44	46	116967	2245	70809186
Aplastic anaemia	72.58	14.44	112	116901	16604	70794827
Recurrent cancer	72.52	14.44	47	116966	2394	70809037
Blood glucose increased	72.11	14.44	40	116973	102942	70708489
Hypogammaglobulinaemia	72.01	14.44	92	116921	11446	70799985
Pulmonary toxicity	72.01	14.44	89	116924	10709	70800722
Blister	71.92	14.44	38	116975	100488	70710943
Metastasis	71.87	14.44	68	116945	6046	70805385
Fungaemia	71.49	14.44	57	116956	4025	70807406
Duodenal ulcer perforation	71.34	14.44	3	117010	51109	70760322
Agranulocytosis	70.88	14.44	185	116828	40113	70771318
Capillary leak syndrome	70.80	14.44	53	116960	3409	70808022
Choriocarcinoma	70.53	14.44	21	116992	144	70811287
Enteritis	70.33	14.44	96	116917	12735	70798696
Nephroblastoma	69.89	14.44	20	116993	117	70811314
Systemic candida	69.75	14.44	66	116947	5868	70805563
Pneumothorax	69.12	14.44	140	116873	25706	70785725
Pulmonary vascular disorder	69.00	14.44	33	116980	921	70810510
Sinusitis	68.70	14.44	108	116905	169087	70642344
Thymus hypoplasia	68.18	14.44	29	116984	610	70810821
Myeloid leukaemia	68.14	14.44	29	116984	611	70810820
Mobility decreased	67.90	14.44	43	116970	102956	70708475
Enterobacter infection	67.51	14.44	55	116958	4005	70807426
Lymphadenopathy	67.20	14.44	205	116808	48586	70762845
Metastases to central nervous system	67.06	14.44	102	116911	14932	70796499
Wheezing	66.78	14.44	36	116977	94134	70717297
Blood pressure systolic increased	66.74	14.44	8	117005	57251	70754180
Systemic mycosis	66.31	14.44	45	116968	2477	70808954
Streptococcal bacteraemia	66.11	14.44	49	116964	3104	70808327
Complications of bone marrow transplant	65.01	14.44	28	116985	608	70810823
Graft versus host disease in skin	65.00	14.44	62	116951	5568	70805863
Pneumonitis	64.83	14.44	218	116795	54379	70757052
Chest pain	63.96	14.44	207	116806	251053	70560378
Viral haemorrhagic cystitis	63.79	14.44	39	116974	1792	70809639
Leukoencephalopathy	63.55	14.44	69	116944	7225	70804206
Memory impairment	63.41	14.44	37	116976	92604	70718827
Mucormycosis	63.27	14.44	72	116941	7942	70803489
Superior vena cava syndrome	63.21	14.44	33	116980	1115	70810316
Engraftment syndrome	63.00	14.44	34	116979	1230	70810201
Impaired healing	62.93	14.44	22	116991	74352	70737079
Dyspnoea	62.88	14.44	894	116119	769166	70042265
Metastases to lung	62.72	14.44	104	116909	16380	70795051
Back pain	62.55	14.44	233	116780	270919	70540512
B-cell lymphoma recurrent	62.18	14.44	30	116983	854	70810577
Vision blurred	62.14	14.44	40	116973	94944	70716487
Sleep disorder	62.06	14.44	19	116994	69853	70741578
Refractory anaemia with an excess of blasts	61.73	14.44	30	116983	868	70810563
Coronary artery disease	61.53	14.44	14	116999	62722	70748709
Acute myeloid leukaemia recurrent	60.78	14.44	46	116967	3008	70808423
Cardiomyopathy	60.28	14.44	134	116879	26239	70785192
Salivary gland cancer	60.17	14.44	24	116989	426	70811005
Lymphoid tissue hypoplasia	60.14	14.44	26	116987	570	70810861
Hypoglycaemia	60.03	14.44	41	116972	94323	70717108
Herpes simplex	60.00	14.44	83	116930	11149	70800282
Depressed mood	59.77	14.44	3	117010	43817	70767614
Pleural effusion	59.34	14.44	399	116614	132465	70678966
Hyperhidrosis	59.33	14.44	78	116935	131508	70679923
Ependymoma	58.76	14.44	17	116996	104	70811327
Cardiac failure congestive	58.35	14.44	83	116930	135374	70676057
Palpitations	58.23	14.44	58	116955	110695	70700736
Fusarium infection	58.07	14.44	36	116977	1696	70809735
Nasal congestion	58.07	14.44	18	116995	65654	70745777
Hypokalaemia	58.01	14.44	393	116620	130795	70680636
Myocardial infarction	57.71	14.44	123	116890	171522	70639909
Dry mouth	57.65	14.44	22	116991	70435	70740996
Balance disorder	57.55	14.44	39	116974	90089	70721342
Loss of consciousness	57.16	14.44	106	116907	155610	70655821
Retinal haemorrhage	57.06	14.44	67	116946	7643	70803788
Varicella zoster virus infection	56.58	14.44	50	116963	4070	70807361
Gastrooesophageal reflux disease	55.77	14.44	41	116972	90798	70720633
Medulloblastoma recurrent	55.72	14.44	17	116996	128	70811303
Pulmonary arteriopathy	55.71	14.44	16	116997	95	70811336
Rhabdomyolysis	55.28	14.44	46	116967	95714	70715717
Therapy non-responder	54.93	14.44	262	116751	76653	70734778
Heart rate decreased	54.83	14.44	17	116996	61998	70749433
Pneumonia klebsiella	54.68	14.44	51	116962	4453	70806978
Rash pruritic	54.39	14.44	18	116995	62973	70748458
Nephrolithiasis	54.21	14.44	7	117006	47316	70764115
Musculoskeletal pain	53.88	14.44	42	116971	90285	70721146
Metastases to lymph nodes	53.50	14.44	71	116942	9167	70802264
Sedation	53.32	14.44	7	117006	46724	70764707
Blood stem cell transplant failure	52.87	14.44	23	116990	512	70810919
Angioedema	52.54	14.44	22	116991	66588	70744843
Injection site pruritus	52.49	14.44	3	117010	39207	70772224
Ameloblastoma	52.24	14.44	15	116998	89	70811342
Premature menopause	52.06	14.44	23	116990	532	70810899
Cytomegalovirus infection reactivation	51.97	14.44	60	116953	6721	70804710
Cerebrovascular accident	51.48	14.44	99	116914	143371	70668060
Deafness	50.95	14.44	104	116909	19199	70792232
Pneumonia fungal	50.86	14.44	72	116941	9881	70801550
Refractory cancer	50.81	14.44	18	116995	226	70811205
Device related infection	49.84	14.44	141	116872	32044	70779387
Delayed puberty	49.65	14.44	16	116997	147	70811284
Electrocardiogram QT prolonged	49.60	14.44	39	116974	83478	70727953
Hypomagnesaemia	49.49	14.44	164	116849	40600	70770831
Myelopathy	49.43	14.44	47	116966	4204	70807227
Osteonecrosis	49.38	14.44	132	116881	29028	70782403
Chronic obstructive pulmonary disease	49.03	14.44	34	116979	77607	70733824
Renal failure	48.96	14.44	502	116511	188568	70622863
Vertigo	48.91	14.44	21	116992	62622	70748809
Aortic thrombosis	48.67	14.44	31	116982	1532	70809899
Cardiomyopathy acute	48.58	14.44	18	116995	259	70811172
Escherichia bacteraemia	48.50	14.44	54	116959	5815	70805616
Viraemia	48.41	14.44	37	116976	2455	70808976
Trichosporon infection	48.32	14.44	26	116987	935	70810496
Hyperkalaemia	48.23	14.44	63	116950	106528	70704903
Paraneoplastic neurological syndrome	47.98	14.44	13	117000	60	70811371
Ejection fraction decreased	47.86	14.44	135	116878	30627	70780804
Pseudomonas infection	47.40	14.44	100	116913	18894	70792537
Large intestinal ulcer perforation	47.30	14.44	13	117000	64	70811367
Aggression	47.13	14.44	11	117002	48435	70762996
Drug dependence	46.65	14.44	4	117009	37317	70774114
Hepatosplenomegaly	46.57	14.44	52	116961	5618	70805813
Adverse drug reaction	46.49	14.44	15	116998	53329	70758102
Gastrointestinal toxicity	46.31	14.44	55	116958	6350	70805081
Wrong technique in product usage process	46.22	14.44	28	116985	68670	70742761
Burning sensation	45.84	14.44	15	116998	52855	70758576
Nervous system disorder	45.73	14.44	114	116899	24032	70787399
Fanconi syndrome	45.63	14.44	37	116976	2676	70808755
Histiocytic sarcoma	45.37	14.44	14	116999	110	70811321
Metastases to spleen	45.13	14.44	21	116992	550	70810881
Plasma cell myeloma	44.97	14.44	239	116774	72962	70738469
Pericarditis	44.93	14.44	44	116969	84661	70726770
Lower respiratory tract infection	44.88	14.44	72	116941	111841	70699590
Central nervous system lymphoma	44.82	14.44	34	116979	2231	70809200
Lactic acidosis	44.45	14.44	26	116987	64998	70746433
Klebsiella bacteraemia	44.23	14.44	36	116977	2618	70808813
Embolism	44.22	14.44	78	116935	12910	70798521
Influenza	43.88	14.44	75	116938	113625	70697806
Metastases to bone marrow	43.85	14.44	22	116991	683	70810748
Diaphragm muscle weakness	43.81	14.44	15	116998	169	70811262
Haematochezia	43.56	14.44	34	116979	73047	70738384
Mesenteric abscess	43.40	14.44	14	116999	129	70811302
T-cell lymphoma	43.31	14.44	27	116986	1285	70810146
Radiation pneumonitis	43.27	14.44	41	116972	3652	70807779
Peripheral T-cell lymphoma unspecified	43.16	14.44	23	116990	811	70810620
Hypoaesthesia	43.15	14.44	121	116892	153618	70657813
Nail pigmentation	43.02	14.44	17	116996	294	70811137
Blood culture positive	42.99	14.44	59	116954	7867	70803564
Lymphoma	42.83	14.44	85	116928	15377	70796054
Stenotrophomonas infection	42.75	14.44	39	116974	3310	70808121
Gastrointestinal fungal infection	42.70	14.44	18	116995	370	70811061
Subdural hygroma	42.63	14.44	19	116994	449	70810982
Road traffic accident	42.59	14.44	4	117009	34678	70776753
Rhabdomyosarcoma recurrent	42.48	14.44	13	117000	99	70811332
Hyperbilirubinaemia	42.16	14.44	106	116907	22462	70788969
Bicytopenia	42.09	14.44	42	116971	3986	70807445
Leukaemia	41.94	14.44	48	116965	5327	70806104
Toxic encephalopathy	41.41	14.44	67	116946	10339	70801092
Abscess bacterial	41.38	14.44	22	116991	772	70810659
Cytokine release syndrome	41.03	14.44	116	116897	26351	70785080
Adrenocortical carcinoma	40.99	14.44	12	117001	77	70811354
High-grade B-cell lymphoma	40.92	14.44	15	116998	209	70811222
Encephalitis cytomegalovirus	40.70	14.44	24	116989	1032	70810399
Blood lactate dehydrogenase increased	40.59	14.44	139	116874	34988	70776443
Exposure during pregnancy	40.56	14.44	51	116962	87666	70723765
Acquired gene mutation	40.43	14.44	31	116982	2067	70809364
Respiratory distress	40.36	14.44	188	116825	54462	70756969
Angiocentric lymphoma	40.28	14.44	23	116990	930	70810501
Serotonin syndrome	40.11	14.44	10	117003	42104	70769327
Hepatotoxicity	39.90	14.44	161	116852	43825	70767606
Metastases to liver	39.71	14.44	113	116900	25765	70785666
Clostridium colitis	39.00	14.44	33	116980	2533	70808898
Swollen tongue	38.96	14.44	7	117006	37039	70774392
JC virus infection	38.91	14.44	38	116975	3513	70807918
Pulmonary alveolar haemorrhage	38.89	14.44	65	116948	10304	70801127
Hallucination	38.87	14.44	41	116972	76219	70735212
Folliculitis	38.85	14.44	11	117002	42559	70768872
Encephalitis viral	38.35	14.44	32	116981	2410	70809021
Testicular germ cell cancer metastatic	38.20	14.44	11	117002	66	70811365
Myelitis	38.19	14.44	31	116982	2246	70809185
Surgery	38.08	14.44	3	117010	29986	70781445
Staphylococcal sepsis	37.42	14.44	74	116939	13353	70798078
Heart rate increased	37.42	14.44	74	116939	106074	70705357
Streptococcal infection	37.39	14.44	55	116958	7816	70803615
International normalised ratio increased	37.26	14.44	47	116966	80679	70730752
Blood creatine phosphokinase increased	37.15	14.44	28	116985	61235	70750196
Peripheral motor neuropathy	37.13	14.44	35	116978	3097	70808334
Amnesia	36.88	14.44	20	116993	52135	70759296
Medulloblastoma	36.69	14.44	12	117001	116	70811315
Therapy cessation	36.21	14.44	6	117007	33670	70777761
Acute myelomonocytic leukaemia	36.19	14.44	15	116998	295	70811136
Primitive neuroectodermal tumour	36.09	14.44	10	117003	51	70811380
Confusional state	36.05	14.44	298	116715	284100	70527331
Maternal exposure during pregnancy	36.03	14.44	86	116927	115259	70696172
Fluid retention	35.90	14.44	31	116982	63354	70748077
Skin candida	35.77	14.44	27	116986	1758	70809673
Ganglioneuroblastoma	35.76	14.44	9	117004	29	70811402
Lung infiltration	35.72	14.44	97	116916	21527	70789904
Focal nodular hyperplasia	35.65	14.44	19	116994	670	70810761
Femur fracture	35.55	14.44	8	117005	36124	70775307
Bone marrow transplant	35.38	14.44	24	116989	1320	70810111
Hypertension	35.37	14.44	315	116698	295718	70515713
Red blood cell sedimentation rate increased	35.24	14.44	10	117003	38632	70772799
Cystitis bacterial	35.20	14.44	17	116996	485	70810946
Flagellate dermatitis	35.12	14.44	14	116999	248	70811183
Diabetes mellitus	35.08	14.44	40	116973	71784	70739647
Epstein-Barr virus infection reactivation	35.06	14.44	25	116988	1491	70809940
Adverse event	34.92	14.44	19	116994	49442	70761989
Osteonecrosis of jaw	34.90	14.44	12	117001	40990	70770441
T-cell lymphoma refractory	34.73	14.44	10	117003	60	70811371
Extravasation	34.72	14.44	35	116978	3362	70808069
Fungal oesophagitis	34.67	14.44	20	116993	825	70810606
Drug reaction with eosinophilia and systemic symptoms	34.56	14.44	27	116986	57986	70753445
Radiation oesophagitis	34.54	14.44	18	116995	606	70810825
Vena cava thrombosis	34.50	14.44	31	116982	2579	70808852
Pneumonia	34.47	14.44	1254	115759	594978	70216453
Paraesthesia	34.22	14.44	124	116889	145413	70666018
Type 2 diabetes mellitus	34.06	14.44	15	116998	44065	70767366
Eosinophilia	33.98	14.44	12	117001	40307	70771124
Lower respiratory tract infection fungal	33.95	14.44	20	116993	858	70810573
Unevaluable event	33.94	14.44	22	116991	52041	70759390
Venous thrombosis	33.83	14.44	48	116965	6601	70804830
Traumatic lung injury	33.72	14.44	29	116984	2276	70809155
Diffuse alveolar damage	33.19	14.44	34	116979	3329	70808102
Faeces discoloured	33.16	14.44	3	117010	26806	70784625
Neuroendocrine tumour of the lung metastatic	33.13	14.44	11	117002	112	70811319
Epstein Barr virus positive mucocutaneous ulcer	33.08	14.44	19	116994	777	70810654
Necrotising gastritis	32.93	14.44	10	117003	74	70811357
Enterocolitis	32.85	14.44	69	116944	12997	70798434
Retinopathy proliferative	32.53	14.44	11	117002	119	70811312
Norovirus test positive	32.36	14.44	16	116997	481	70810950
Respiratory arrest	32.26	14.44	25	116988	53908	70757523
Hepatic candidiasis	32.25	14.44	10	117003	80	70811351
Accidental overdose	32.19	14.44	9	117004	35112	70776319
Encephalitis	32.15	14.44	70	116943	13515	70797916
Underdose	32.12	14.44	5	117008	29378	70782053
Abdominal distension	31.94	14.44	79	116934	104590	70706841
Hepatic cirrhosis	31.90	14.44	6	117007	30725	70780706
Escherichia infection	31.87	14.44	78	116935	16253	70795178
Graft versus host disease in gastrointestinal tract	31.86	14.44	44	116969	5900	70805531
Intestinal perforation	31.70	14.44	77	116936	15967	70795464
Cutaneous calcification	31.65	14.44	11	117002	130	70811301
Emotional distress	31.46	14.44	11	117002	37177	70774254
Graft versus host disease in liver	31.38	14.44	24	116989	1594	70809837
Neuroendocrine carcinoma of the skin	31.35	14.44	21	116992	1131	70810300
Mantle cell lymphoma recurrent	31.33	14.44	16	116997	516	70810915
Plasmacytoma	31.29	14.44	36	116977	4018	70807413
Injection site reaction	31.25	14.44	22	116991	49830	70761601
Injection site haemorrhage	31.19	14.44	3	117010	25524	70785907
Azoospermia	31.06	14.44	11	117002	138	70811293
Medication error	30.84	14.44	29	116984	56883	70754548
Multiple sclerosis	30.82	14.44	3	117010	25282	70786149
Hypoalbuminaemia	30.81	14.44	85	116928	19037	70792394
Encephalitis enteroviral	30.77	14.44	11	117002	142	70811289
Ewing's sarcoma	30.65	14.44	8	117005	31	70811400
Sopor	30.61	14.44	7	117006	31260	70780171
Ear infection	30.58	14.44	5	117008	28331	70783100
Neck pain	30.56	14.44	39	116974	66618	70744813
Colitis ulcerative	30.53	14.44	9	117004	33914	70777517
Recall phenomenon	30.50	14.44	20	116993	1039	70810392
Nasal abscess	30.43	14.44	11	117002	147	70811284
Acne	30.37	14.44	3	117010	24986	70786445
Seminoma	30.29	14.44	12	117001	209	70811222
Chronic myeloid leukaemia	30.25	14.44	36	116977	4165	70807266
B-cell lymphoma	30.06	14.44	44	116969	6225	70805206
Alopecia	29.92	14.44	198	116815	198292	70613139
Sciatica	29.82	14.44	3	117010	24624	70786807
Fanconi syndrome acquired	29.50	14.44	28	116985	2499	70808932
Flatulence	29.49	14.44	13	117000	38168	70773263
Odynophagia	29.48	14.44	57	116956	10118	70801313
Neutrophil count abnormal	29.48	14.44	31	116982	3130	70808301
Localised infection	29.47	14.44	9	117004	33149	70778282
Small cell carcinoma	29.45	14.44	13	117000	300	70811131
Hepatic failure	29.37	14.44	179	116834	57446	70753985
Retinal pigment epitheliopathy	29.36	14.44	14	116999	388	70811043
Iris atrophy	29.10	14.44	10	117003	114	70811317
Rhinovirus infection	29.07	14.44	45	116968	6688	70804743
Head injury	29.05	14.44	10	117003	34131	70777300
Dyspepsia	28.96	14.44	65	116948	89012	70722419
Blood electrolytes abnormal	28.96	14.44	24	116989	1790	70809641
Metastases to muscle	28.83	14.44	13	117000	316	70811115
Metastases to diaphragm	28.37	14.44	8	117005	44	70811387
Breast cancer	28.25	14.44	10	117003	33539	70777892
Bradycardia	28.10	14.44	108	116905	124507	70686924
Myelitis transverse	28.04	14.44	23	116990	1691	70809740
Accidental exposure to product	28.03	14.44	6	117007	28045	70783386
Central nervous system fungal infection	27.98	14.44	14	116999	432	70810999
Leukoerythroblastosis	27.88	14.44	12	117001	260	70811171
Cerebral venous thrombosis	27.72	14.44	27	116986	2488	70808943
Therapy interrupted	27.62	14.44	4	117009	24798	70786633
Splenomegaly	27.60	14.44	81	116932	18789	70792642
Listeria sepsis	27.56	14.44	16	116997	668	70810763
Cerebellar tumour	27.52	14.44	9	117004	87	70811344
Cellulitis gangrenous	27.43	14.44	12	117001	271	70811160
Cerebellar haemangioma	27.43	14.44	9	117004	88	70811343
Electrolyte imbalance	27.36	14.44	102	116911	26759	70784672
Disseminated aspergillosis	27.29	14.44	17	116996	808	70810623
Pneumonia adenoviral	27.23	14.44	14	116999	458	70810973
Drug clearance decreased	27.12	14.44	29	116984	2984	70808447
Metastases to retroperitoneum	27.08	14.44	13	117000	366	70811065
Cardio-respiratory arrest	26.96	14.44	81	116932	100596	70710835
Blood pressure diastolic decreased	26.83	14.44	5	117008	25775	70785656
Skin toxicity	26.83	14.44	45	116968	7153	70804278
Plasmablastic lymphoma	26.81	14.44	15	116998	583	70810848
Disturbance in attention	26.79	14.44	19	116994	42875	70768556
Hypophosphataemia	26.73	14.44	73	116940	16253	70795178
Diverticulitis	26.71	14.44	18	116995	41716	70769715
Blood glucose decreased	26.67	14.44	4	117009	24155	70787276
Escherichia sepsis	26.59	14.44	46	116967	7497	70803934
Alpha haemolytic streptococcal infection	26.55	14.44	24	116989	2013	70809418
Papillary thyroid cancer	26.53	14.44	26	116987	2414	70809017
Device issue	26.47	14.44	4	117009	24021	70787410
Geotrichum infection	26.42	14.44	18	116995	997	70810434
Streptococcal sepsis	26.40	14.44	26	116987	2428	70809003
Hip fracture	26.36	14.44	7	117006	28256	70783175
Toxicity to various agents	26.23	14.44	458	116555	381714	70429717
Li-Fraumeni syndrome	26.22	14.44	6	117007	11	70811420
Metastases to meninges	26.16	14.44	29	116984	3107	70808324
Treatment noncompliance	26.11	14.44	23	116990	46551	70764880
Pregnancy	26.11	14.44	4	117009	23777	70787654
Fungal sepsis	26.09	14.44	22	116991	1681	70809750
Tumour hyperprogression	26.02	14.44	10	117003	160	70811271
Peripheral sensorimotor neuropathy	25.93	14.44	27	116986	2695	70808736
Osteosarcoma metastatic	25.91	14.44	8	117005	63	70811368
Basal cell naevus syndrome	25.89	14.44	7	117006	32	70811399
Intestinal atresia	25.80	14.44	8	117005	64	70811367
Abortion spontaneous	25.78	14.44	6	117007	26473	70784958
Throat irritation	25.76	14.44	13	117000	35291	70776140
Cerebral salt-wasting syndrome	25.70	14.44	9	117004	109	70811322
Genotoxicity	25.54	14.44	7	117006	34	70811397
Gliosis	25.52	14.44	13	117000	417	70811014
Diabetic ketoacidosis	25.51	14.44	10	117003	31502	70779929
Enterococcal sepsis	25.51	14.44	26	116987	2531	70808900
Tumour necrosis	25.38	14.44	22	116991	1745	70809686
Transient ischaemic attack	25.38	14.44	23	116990	45921	70765510
Eczema	25.31	14.44	12	117001	33769	70777662
Platelet disorder	25.22	14.44	26	116987	2565	70808866
Hair follicle tumour benign	25.21	14.44	13	117000	428	70811003
Retinopathy	25.17	14.44	30	116983	3476	70807955
Joint range of motion decreased	25.13	14.44	6	117007	26020	70785411
Therapy responder	25.13	14.44	13	117000	431	70811000
Cataract	25.05	14.44	33	116980	55612	70755819
Abnormal behaviour	24.99	14.44	13	117000	34696	70776735
Chest discomfort	24.82	14.44	113	116900	124268	70687163
Terminal ileitis	24.80	14.44	15	116998	676	70810755
Viral infection	24.71	14.44	127	116886	38264	70773167
Pericardial effusion	24.70	14.44	135	116878	41641	70769790
Anaplastic large-cell lymphoma	24.70	14.44	12	117001	347	70811084
Disorder of orbit	24.58	14.44	9	117004	125	70811306
Atypical teratoid/rhabdoid tumour of CNS	24.45	14.44	7	117006	41	70811390
Gait inability	24.45	14.44	25	116988	47150	70764281
Ewing's sarcoma recurrent	24.42	14.44	6	117007	17	70811414
Respiratory tract infection fungal	24.36	14.44	18	116995	1135	70810296
Carbamoyl phosphate synthetase deficiency	24.17	14.44	6	117007	18	70811413
Pneumonia aspiration	24.11	14.44	41	116972	62248	70749183
Dyspnoea exertional	24.08	14.44	59	116954	78371	70733060
Hyperlipidaemia	24.06	14.44	5	117008	23858	70787573
Upper respiratory tract infection	24.05	14.44	60	116953	79214	70732217
Dysstasia	23.94	14.44	6	117007	25173	70786258
Neuroendocrine carcinoma	23.91	14.44	14	116999	594	70810837
Hypoxia	23.73	14.44	247	116766	93097	70718334
Strongyloidiasis	23.73	14.44	30	116983	3693	70807738
Infusion related reaction	23.66	14.44	210	116803	197324	70614107
Chromaturia	23.57	14.44	5	117008	23523	70787908
Carcinoid crisis	23.41	14.44	13	117000	498	70810933
Dyskinesia	23.37	14.44	20	116993	41054	70770377
Enterobacter bacteraemia	23.30	14.44	14	116999	623	70810808
Hypoacusis	23.30	14.44	98	116915	27171	70784260
Clostridium bacteraemia	23.30	14.44	11	117002	298	70811133
Blood fibrinogen decreased	23.21	14.44	21	116992	1763	70809668
Acute monocytic leukaemia	23.15	14.44	13	117000	509	70810922
Cardiac disorder	23.09	14.44	39	116974	59376	70752055
Agitation	22.99	14.44	78	116935	93297	70718134
Transdifferentiation of neoplasm	22.91	14.44	8	117005	96	70811335
Human herpesvirus 8 infection	22.86	14.44	17	116996	1082	70810349
Amenorrhoea	22.80	14.44	41	116972	6889	70804542
Appendicitis	22.75	14.44	70	116943	16663	70794768
Paraparesis	22.74	14.44	29	116984	3600	70807831
Hot flush	22.74	14.44	29	116984	49555	70761876
Acute lymphocytic leukaemia refractory	22.71	14.44	9	117004	157	70811274
Full blood count abnormal	22.52	14.44	14	116999	33864	70777567
Cholelithiasis	22.43	14.44	27	116986	47313	70764118
Arterial thrombosis	22.43	14.44	24	116989	2472	70808959
Lymphoma transformation	22.41	14.44	10	117003	237	70811194
Dry skin	22.40	14.44	36	116977	55895	70755536
Frequent bowel movements	22.24	14.44	4	117009	21149	70790282
Basal ganglion degeneration	22.19	14.44	12	117001	436	70810995
Gastrointestinal disorder	22.11	14.44	94	116919	105333	70706098
Arteriosclerotic retinopathy	22.09	14.44	6	117007	28	70811403
Liver function test abnormal	22.09	14.44	42	116971	61104	70750327
Adenoviral hepatitis	22.03	14.44	15	116998	830	70810601
Guillain-Barre syndrome	22.03	14.44	44	116969	7996	70803435
Osteoporosis	22.02	14.44	29	116984	48878	70762553
Mucocutaneous ulceration	22.00	14.44	11	117002	339	70811092
Neuroblastoma recurrent	21.92	14.44	8	117005	110	70811321
Adenovirus reactivation	21.91	14.44	11	117002	342	70811089
Coronavirus infection	21.87	14.44	38	116975	6214	70805217
Pseudomonal bacteraemia	21.83	14.44	24	116989	2548	70808883
Mucosal infection	21.82	14.44	12	117001	451	70810980
Candida sepsis	21.79	14.44	23	116990	2332	70809099
Right ventricular failure	21.78	14.44	5	117008	22269	70789162
Hypertensive hydrocephalus	21.57	14.44	5	117008	10	70811421
Sinus polyp	21.55	14.44	12	117001	462	70810969
Depressed level of consciousness	21.55	14.44	73	116940	87358	70724073
Toxic neuropathy	21.51	14.44	15	116998	863	70810568
Gastroenteritis adenovirus	21.45	14.44	10	117003	263	70811168
Autoimmune neutropenia	21.37	14.44	12	117001	470	70810961
Skin laceration	21.30	14.44	8	117005	25870	70785561
CNS ventriculitis	21.25	14.44	11	117002	365	70811066
Testicular malignant teratoma	21.25	14.44	5	117008	11	70811420
Scedosporium infection	21.23	14.44	18	116995	1386	70810045
Rhinorrhoea	21.11	14.44	49	116964	66322	70745109
Administration related reaction	21.11	14.44	8	117005	123	70811308
Sputum discoloured	21.09	14.44	3	117010	18848	70792583
Iron deficiency anaemia	20.98	14.44	6	117007	23066	70788365
Epiphyses premature fusion	20.93	14.44	7	117006	73	70811358
Bacterial tracheitis	20.84	14.44	6	117007	36	70811395
Autoimmune haemolytic anaemia	20.76	14.44	42	116971	7704	70803727
Ileus	20.63	14.44	87	116926	24150	70787281
Dry eye	20.56	14.44	14	116999	32268	70779163
Diabetes mellitus inadequate control	20.39	14.44	6	117007	22639	70788792
Haematopoietic stem cell mobilisation	20.34	14.44	9	117004	209	70811222
Engraft failure	20.26	14.44	13	117000	651	70810780
Heart rate irregular	20.17	14.44	12	117001	29731	70781700
Platelet transfusion	20.16	14.44	21	116992	2097	70809334
Hepatic infection fungal	20.07	14.44	9	117004	216	70811215
Withdrawal syndrome	20	14.44	8	117005	24896	70786535
Epstein-Barr viraemia	20.00	14.44	20	116993	1903	70809528
Premature ageing	19.90	14.44	7	117006	86	70811345
Procedural pain	19.83	14.44	3	117010	18006	70793425
Adenocarcinoma gastric	19.82	14.44	19	116994	1717	70809714
Burkitt's lymphoma	19.80	14.44	8	117005	147	70811284
Kidney infection	19.77	14.44	4	117009	19451	70791980
Sleep apnoea syndrome	19.77	14.44	15	116998	32698	70778733
Hepatic function abnormal	19.75	14.44	185	116828	67811	70743620
Pneumomediastinum	19.67	14.44	26	116987	3344	70808087
Papilloedema	19.62	14.44	35	116978	5843	70805588
Blood urine present	19.62	14.44	4	117009	19349	70792082
Acute kidney injury	19.61	14.44	964	116049	473660	70337771
Pain in jaw	19.52	14.44	25	116988	42644	70768787
Gallbladder empyema	19.47	14.44	7	117006	92	70811339
Ocular vascular disorder	19.44	14.44	11	117002	437	70810994
Neurological decompensation	19.44	14.44	31	116982	4725	70806706
Flushing	19.29	14.44	214	116799	81958	70729473
Ascites	19.23	14.44	183	116830	67364	70744067
Visceral oedema	19.23	14.44	5	117008	19	70811412
Drug clearance increased	19.23	14.44	9	117004	239	70811192
Prostate cancer	19.21	14.44	14	116999	31149	70780282
Human polyomavirus infection	19.16	14.44	15	116998	1031	70810400
Brain sarcoma	19.13	14.44	6	117007	50	70811381
Peripheral artery thrombosis	19.12	14.44	25	116988	3182	70808249
Skin discolouration	19.09	14.44	20	116993	37305	70774126
Product administered to patient of inappropriate age	19.02	14.44	31	116982	4812	70806619
Pneumonia cytomegaloviral	19.02	14.44	30	116983	4531	70806900
Mucosal toxicity	19.01	14.44	12	117001	584	70810847
Peripheral T-cell lymphoma unspecified stage III	18.93	14.44	6	117007	52	70811379
Bone sarcoma	18.88	14.44	7	117006	101	70811330
Small intestinal perforation	18.79	14.44	24	116989	2985	70808446
Cerebral fungal infection	18.78	14.44	10	117003	352	70811079
Respiratory syncytial virus infection	18.75	14.44	40	116973	7615	70803816
Abdominal compartment syndrome	18.74	14.44	17	116996	1432	70809999
Tooth disorder	18.72	14.44	8	117005	23930	70787501
Blood stem cell harvest failure	18.69	14.44	7	117006	104	70811327
Prescribed underdose	18.65	14.44	6	117007	21379	70790052
Musculoskeletal disorder	18.52	14.44	5	117008	19966	70791465
Infection	18.51	14.44	467	116546	210318	70601113
Fracture	18.49	14.44	5	117008	19939	70791492
Vulvovaginal inflammation	18.48	14.44	11	117002	481	70810950
Inflammatory pseudotumour	18.44	14.44	6	117007	57	70811374
Lacrimation increased	18.42	14.44	5	117008	19894	70791537
Glioblastoma multiforme	18.36	14.44	16	116997	1278	70810153
Hiatus hernia	18.31	14.44	6	117007	21128	70790303
Pneumocystis jirovecii infection	18.30	14.44	22	116991	2572	70808859
Sneezing	18.27	14.44	3	117010	16948	70794483
Limbic encephalitis	18.26	14.44	13	117000	773	70810658
Transformation to acute myeloid leukaemia	18.24	14.44	14	116999	935	70810496
Radiation injury	18.21	14.44	13	117000	777	70810654
Neoplasm	18.15	14.44	40	116973	7784	70803647
Clostridial infection	18.14	14.44	32	116981	5297	70806134
Rhabdoid tumour	18.13	14.44	5	117008	25	70811406
Testicular germ cell tumour	17.98	14.44	4	117009	6	70811425
Inappropriate antidiuretic hormone secretion	17.87	14.44	81	116932	23195	70788236
Vulvovaginitis	17.83	14.44	9	117004	283	70811148
Hypocalcaemia	17.83	14.44	131	116882	44728	70766703
Tissue infiltration	17.82	14.44	12	117001	652	70810779
Arteriosclerosis	17.81	14.44	3	117010	16635	70794796
Adenomatous polyposis coli	17.76	14.44	8	117005	194	70811237
Ill-defined disorder	17.75	14.44	40	116973	54701	70756730
Retinal toxicity	17.72	14.44	16	116997	1340	70810091
Bone marrow infiltration	17.62	14.44	11	117002	525	70810906
Stomatitis necrotising	17.57	14.44	8	117005	199	70811232
Acanthamoeba infection	17.56	14.44	11	117002	528	70810903
Non-Hodgkin's lymphoma	17.54	14.44	17	116996	1557	70809874
Hypertensive crisis	17.53	14.44	5	117008	19257	70792174
Neutropenic infection	17.49	14.44	19	116994	1990	70809441
Subdural haemorrhage	17.49	14.44	32	116981	5449	70805982
Musculoskeletal discomfort	17.44	14.44	4	117009	17828	70793603
B-cell lymphoma refractory	17.41	14.44	7	117006	127	70811304
Minimal residual disease	17.39	14.44	10	117003	410	70811021
Viral hepatitis carrier	17.36	14.44	5	117008	30	70811401
Left ventricular dysfunction	17.31	14.44	67	116946	17890	70793541
Hepatorenal failure	17.28	14.44	15	116998	1192	70810239
Hydrocephalus	17.27	14.44	40	116973	8045	70803386
Extragonadal primary germ cell tumour mixed	17.25	14.44	4	117009	8	70811423
Adult T-cell lymphoma/leukaemia	17.25	14.44	11	117002	545	70810886
Primary mediastinal large B-cell lymphoma recurrent	17.18	14.44	6	117007	72	70811359
Feeling hot	17.09	14.44	34	116979	48636	70762795
Renal infarct	17.06	14.44	21	116992	2516	70808915
Granulocyte count decreased	16.92	14.44	16	116997	1421	70810010
Small intestinal obstruction	16.88	14.44	83	116930	24572	70786859
Uterine enlargement	16.86	14.44	13	117000	874	70810557
Pyomyositis	16.84	14.44	11	117002	568	70810863
Angina pectoris	16.81	14.44	34	116979	48349	70763082
Aspiration bone marrow abnormal	16.78	14.44	7	117006	140	70811291
Hemianopia	16.74	14.44	17	116996	1648	70809783
Retinal ischaemia	16.73	14.44	12	117001	722	70810709
Non-Hodgkin's lymphoma unspecified histology aggressive	16.71	14.44	5	117008	35	70811396
Scrotal abscess	16.69	14.44	10	117003	443	70810988
Splenic infarction	16.68	14.44	24	116989	3342	70808089
Spindle cell sarcoma	16.60	14.44	8	117005	227	70811204
Ganglioneuroma	16.60	14.44	7	117006	144	70811287
Renal tubular dysfunction	16.55	14.44	12	117001	735	70810696
Infection reactivation	16.54	14.44	20	116993	2353	70809078
Pneumonia respiratory syncytial viral	16.51	14.44	16	116997	1465	70809966
Serum ferritin increased	16.51	14.44	42	116971	8963	70802468
Mania	16.50	14.44	4	117009	17170	70794261
Food protein-induced enterocolitis syndrome	16.46	14.44	5	117008	37	70811394
Pharyngeal oedema	16.43	14.44	3	117010	15693	70795738
Grip strength decreased	16.41	14.44	3	117010	15682	70795749
Blindness cortical	16.40	14.44	13	117000	910	70810521
Nightmare	16.40	14.44	8	117005	22148	70789283
Clostridium difficile infection	16.38	14.44	115	116898	38701	70772730
Schistocytosis	16.35	14.44	5	117008	38	70811393
Cold sweat	16.28	14.44	4	117009	17012	70794419
Body temperature decreased	16.26	14.44	14	116999	28658	70782773
Skin exfoliation	16.20	14.44	35	116978	48591	70762840
B precursor type acute leukaemia	16.17	14.44	10	117003	469	70810962
Hypothyroidism	16.17	14.44	130	116883	45625	70765806
Restlessness	16.05	14.44	28	116985	42100	70769331
Intussusception	16.05	14.44	13	117000	939	70810492
Psychomotor hyperactivity	16.05	14.44	3	117010	15430	70796001
Coronary artery thrombosis	16.03	14.44	22	116991	2933	70808498
Pulmonary veno-occlusive disease	16.02	14.44	16	116997	1520	70809911
Delirium	15.97	14.44	66	116947	74548	70736883
Follicular thyroid cancer	15.97	14.44	6	117007	90	70811341
Large intestine perforation	15.93	14.44	53	116960	13142	70798289
Photosensitivity reaction	15.88	14.44	6	117007	19334	70792097
Neuroendocrine carcinoma metastatic	15.67	14.44	9	117004	368	70811063
Hypertransaminasaemia	15.66	14.44	41	116972	8902	70802529
Autologous bone marrow transplantation therapy	15.64	14.44	4	117009	14	70811417
Mucosal ulceration	15.62	14.44	17	116996	1784	70809647
Meningitis bacterial	15.59	14.44	20	116993	2498	70808933
Urinary bladder haematoma	15.43	14.44	4	117009	15	70811416
Meningitis tuberculous	15.40	14.44	14	116999	1183	70810248
Amoebic colitis	15.39	14.44	6	117007	100	70811331
Hypovolaemic shock	15.35	14.44	46	116967	10791	70800640
Peripheral T-cell lymphoma unspecified recurrent	15.32	14.44	5	117008	48	70811383
Atypical haemolytic uraemic syndrome	15.32	14.44	12	117001	826	70810605
Human chorionic gonadotropin increased	15.28	14.44	13	117000	1005	70810426
Metastases to breast	15.28	14.44	8	117005	272	70811159
Ocular hyperaemia	15.27	14.44	11	117002	24628	70786803
Obesity	15.27	14.44	13	117000	26758	70784673
Noctiphobia	15.22	14.44	4	117009	16	70811415
Pneumocephalus	15.22	14.44	8	117005	274	70811157
Dementia	15.20	14.44	9	117004	22356	70789075
Anti-platelet antibody positive	15.20	14.44	8	117005	275	70811156
Cerebral artery occlusion	15.19	14.44	16	116997	1618	70809813
Crying	15.18	14.44	8	117005	21191	70790240
Central nervous system necrosis	15.17	14.44	8	117005	276	70811155
Arrhythmia	15.15	14.44	45	116968	56098	70755333
Vocal cord paralysis	15.14	14.44	19	116994	2322	70809109
Retinoblastoma	15.12	14.44	6	117007	105	70811326
Vitreous haemorrhage	15.01	14.44	23	116990	3389	70808042
Mediastinal mass	14.97	14.44	10	117003	536	70810895
Colony stimulating factor therapy	14.92	14.44	10	117003	539	70810892
Product administration error	14.90	14.44	16	116997	29507	70781924
Tonsillar haemorrhage	14.83	14.44	8	117005	289	70811142
Growth hormone deficiency	14.83	14.44	9	117004	408	70811023
Subcutaneous emphysema	14.81	14.44	16	116997	1666	70809765
Visual impairment	14.79	14.44	75	116938	80175	70731256
Angiodysplasia	14.77	14.44	12	117001	870	70810561
Dystonia	14.76	14.44	7	117006	19699	70791732
Chronic myelomonocytic leukaemia	14.67	14.44	12	117001	879	70810552
Idiopathic pneumonia syndrome	14.66	14.44	10	117003	555	70810876
Lethargy	14.63	14.44	69	116944	75181	70736250
Gout	14.62	14.44	10	117003	22996	70788435
Extrapyramidal disorder	14.61	14.44	8	117005	20742	70790689
Listeria encephalitis	14.54	14.44	8	117005	301	70811130
Mood swings	14.48	14.44	6	117007	18280	70793151
Fusobacterium infection	14.48	14.44	6	117007	118	70811313

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
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	0703-5656	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
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