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Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
antineoplastic agents, platinum derivatives	4392	15663-27-1

Description:

Molecule	Description
Synonyms: cisplatin platinum diamminodichloride cis-Platinum	An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle. Molecular weight: 300.05 Formula: Cl2H6N2Pt CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

cisplatin
platinum diamminodichloride
cis-Platinum

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

Molecular weight: 300.05
Formula: Cl2H6N2Pt
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	2.53 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2.30 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.75 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
Dec. 19, 1978	FDA	HQ SPCLT PHARMA

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
Disease progression	2222.65	17.57	1460	73234	155155	90398598
Febrile neutropenia	1609.53	17.57	1204	73490	157145	90396608
Neutropenia	1575.28	17.57	1375	73319	223529	90330224
Malignant neoplasm progression	1141.69	17.57	838	73856	106032	90447721
Thrombocytopenia	972.38	17.57	1020	73674	207705	90346048
Myelosuppression	939.00	17.57	572	74122	53019	90500734
Anaemia	823.27	17.57	1218	73476	351584	90202169
Haematotoxicity	765.60	17.57	313	74381	12222	90541531
Mucosal inflammation	721.16	17.57	498	74196	57127	90496626
Bone marrow failure	559.23	17.57	342	74352	31879	90521874
Pancytopenia	556.04	17.57	586	74108	119677	90434076
Ototoxicity	463.93	17.57	135	74559	1829	90551924
Off label use	461.57	17.57	1958	72736	1100294	89453459
Vomiting	434.56	17.57	1529	73165	786764	89766989
Therapy partial responder	405.71	17.57	243	74451	21800	90531953
Neutrophil count decreased	387.74	17.57	380	74314	71152	90482601
Acute myeloid leukaemia	383.68	17.57	229	74465	20411	90533342
Leukopenia	367.74	17.57	434	74260	100276	90453477
Arthralgia	357.73	17.57	100	74594	778422	89775331
Neoplasm progression	346.84	17.57	290	74404	44196	90509557
Myelodysplastic syndrome	337.62	17.57	212	74482	20691	90533062
Joint swelling	332.20	17.57	21	74673	503279	90050474
Nausea	331.29	17.57	1790	72904	1108526	89445227
Dehydration	307.02	17.57	564	74130	193883	90359870
Hypomagnesaemia	298.33	17.57	242	74452	35346	90518407
Hypokalaemia	292.24	17.57	444	74250	130672	90423081
Posterior reversible encephalopathy syndrome	286.19	17.57	196	74498	22143	90531610
Sepsis	270.61	17.57	511	74183	179303	90374450
Renal salt-wasting syndrome	269.93	17.57	65	74629	394	90553359
Second primary malignancy	265.62	17.57	142	74552	10236	90543517
Acute kidney injury	263.65	17.57	716	73978	319671	90234082
Arthropathy	261.81	17.57	9	74685	366233	90187520
Abdominal discomfort	260.53	17.57	41	74653	477287	90076466
Diffuse large B-cell lymphoma recurrent	256.81	17.57	100	74594	3426	90550327
Rheumatoid arthritis	255.45	17.57	10	74684	362604	90191149
Gastrointestinal toxicity	254.92	17.57	134	74560	9333	90544420
Pain	254.01	17.57	269	74425	996072	89557681
Platelet count decreased	245.35	17.57	420	74274	136549	90417204
Nephropathy toxic	238.99	17.57	142	74552	12546	90541207
Peripheral swelling	235.83	17.57	31	74663	413075	90140678
Metastases to central nervous system	227.28	17.57	155	74539	17387	90536366
Cytopenia	223.28	17.57	153	74541	17296	90536457
Contraindicated product administered	215.19	17.57	12	74682	320127	90233626
Neuropathy peripheral	214.41	17.57	396	74298	136574	90417179
Musculoskeletal stiffness	212.90	17.57	7	74687	296525	90257228
Deafness	203.39	17.57	160	74534	22354	90531399
Swelling	203.25	17.57	48	74646	419010	90134743
Wound	201.66	17.57	12	74682	302968	90250785
Hyponatraemia	201.43	17.57	380	74314	133158	90420595
Nasopharyngitis	194.75	17.57	48	74646	407056	90146697
Metastases to lung	194.70	17.57	136	74558	15855	90537898
Therapeutic product effect decreased	194.27	17.57	8	74686	277563	90276190
Weight increased	192.82	17.57	53	74641	417874	90135879
Pulmonary embolism	192.04	17.57	368	74326	130452	90423301
Drug resistance	182.38	17.57	171	74523	30278	90523475
Pericarditis	181.93	17.57	10	74684	270141	90283612
Neutropenic sepsis	181.60	17.57	137	74557	17993	90535760
Product dose omission issue	178.70	17.57	17	74677	291670	90262083
Septic shock	177.59	17.57	278	74416	83882	90469871
Metastases to liver	172.97	17.57	162	74532	28645	90525108
Cardiotoxicity	172.65	17.57	111	74583	11278	90542475
Neurotoxicity	167.38	17.57	140	74554	21327	90532426
White blood cell count decreased	165.74	17.57	401	74293	166708	90387045
Oesophagitis	165.41	17.57	127	74567	17122	90536631
Drug hypersensitivity	161.10	17.57	91	74603	463518	90090235
Disease recurrence	155.43	17.57	173	74521	37480	90516273
Fibromyalgia	155.08	17.57	3	74691	206266	90347487
Polyneuropathy	154.67	17.57	128	74566	19213	90534540
Fall	154.34	17.57	104	74590	481706	90072047
Asthma	154.08	17.57	12	74682	242148	90311605
Headache	153.31	17.57	300	74394	862446	89691307
Pyrexia	153.30	17.57	999	73695	659486	89894267
Renal failure	151.49	17.57	334	74360	130673	90423080
Blister	148.18	17.57	18	74676	254980	90298773
Aortic thrombosis	146.63	17.57	51	74643	1261	90552492
Renal impairment	145.49	17.57	289	74405	105132	90448621
Sinusitis	144.77	17.57	51	74643	343037	90210716
Contusion	142.90	17.57	19	74675	251197	90302556
Hypocalcaemia	142.11	17.57	175	74519	42193	90511560
Mobility decreased	140.18	17.57	20	74674	250714	90303039
Folliculitis	139.33	17.57	7	74687	204346	90349407
Insomnia	138.28	17.57	51	74643	333423	90220330
Injury	137.02	17.57	6	74688	197343	90356410
Bone marrow disorder	136.42	17.57	61	74633	2971	90550782
Cardiomyopathy	135.69	17.57	121	74573	20085	90533668
Infusion related reaction	133.39	17.57	90	74604	416690	90137063
Osteoarthritis	132.51	17.57	7	74687	195723	90358030
Wheezing	130.76	17.57	20	74674	238060	90315693
Hepatic enzyme increased	129.35	17.57	68	74626	360668	90193085
Discomfort	126.05	17.57	35	74659	274300	90279453
Tumour lysis syndrome	124.58	17.57	90	74604	11062	90542691
Pain in extremity	123.14	17.57	114	74580	450415	90103338
Urogenital fistula	122.15	17.57	35	74659	447	90553306
Teratoma	122.13	17.57	29	74665	164	90553589
Electrolyte imbalance	120.90	17.57	122	74572	23623	90530130
Ovarian germ cell teratoma	120.31	17.57	25	74669	66	90553687
Muscle spasms	117.86	17.57	31	74663	251852	90301901
Blood cholesterol increased	117.66	17.57	16	74678	207996	90345757
Cholangitis	116.34	17.57	73	74621	7109	90546644
Impaired healing	115.09	17.57	26	74668	234173	90319580
Condition aggravated	114.57	17.57	197	74497	595348	89958405
Pruritus	111.77	17.57	171	74523	541354	90012399
Type 2 diabetes mellitus	111.77	17.57	17	74677	203227	90350526
Hydronephrosis	111.71	17.57	88	74606	12314	90541439
Diffuse large B-cell lymphoma refractory	110.05	17.57	45	74649	1755	90551998
Lower respiratory tract infection	109.65	17.57	35	74659	250624	90303129
Ascites	109.56	17.57	164	74530	47576	90506177
Rash	107.84	17.57	319	74375	795781	89757972
Urticaria	107.67	17.57	62	74632	312672	90241081
Metastases to lymph nodes	107.58	17.57	84	74610	11605	90542148
Migraine	106.84	17.57	15	74679	190377	90363376
Product use in unapproved indication	98.50	17.57	541	74153	335695	90218058
Sleep disorder	97.26	17.57	22	74672	198008	90355745
Injection site pain	96.72	17.57	14	74680	173685	90380068
Arthritis	96.70	17.57	12	74682	167303	90386450
Bursitis	94.82	17.57	3	74691	131651	90422102
Joint range of motion decreased	94.55	17.57	4	74690	135639	90418114
Drug intolerance	93.61	17.57	140	74554	447451	90106302
Renal tubular necrosis	93.47	17.57	85	74609	14470	90539283
Inappropriate antidiuretic hormone secretion	93.47	17.57	97	74597	19408	90534345
Metastases to skin	92.92	17.57	42	74652	2098	90551655
Cytokine release syndrome	92.92	17.57	115	74579	27858	90525895
Renal tubular disorder	90.93	17.57	47	74647	3160	90550593
Oesophageal fistula	90.86	17.57	23	74671	176	90553577
Hypophagia	90.50	17.57	129	74565	35808	90517945
Metastases to bone	88.19	17.57	107	74587	25398	90528355
Palmar-plantar erythrodysaesthesia syndrome	84.84	17.57	110	74584	27913	90525840
Hypoaesthesia	84.04	17.57	81	74613	314129	90239624
Memory impairment	83.69	17.57	29	74665	197215	90356538
Tinnitus	83.51	17.57	137	74557	42965	90510788
Loss of personal independence in daily activities	83.12	17.57	8	74686	136097	90417656
Neutropenic colitis	82.30	17.57	48	74646	4095	90549658
Depression	82.14	17.57	76	74618	300525	90253228
Alopecia	81.07	17.57	180	74514	494891	90058862
Pleural effusion	79.88	17.57	238	74456	111753	90442000
Metastases to peritoneum	79.54	17.57	47	74647	4108	90549645
Metastasis	78.95	17.57	54	74640	6083	90547670
Deep vein thrombosis	78.39	17.57	208	74486	91412	90462341
Blood creatinine increased	77.63	17.57	221	74473	101165	90452588
Blood lactate dehydrogenase increased	77.27	17.57	101	74593	25831	90527922
Gait inability	76.62	17.57	14	74680	146442	90407311
Gait disturbance	75.84	17.57	62	74632	260434	90293319
Deafness bilateral	75.59	17.57	34	74660	1679	90552074
Lymphoma	75.06	17.57	73	74621	13518	90540235
Teratoma benign	73.39	17.57	16	74678	57	90553696
Maternal exposure during pregnancy	72.96	17.57	115	74579	359948	90193805
Obesity	70.69	17.57	4	74690	105503	90448250
Encephalopathy	69.74	17.57	132	74562	46312	90507441
Road traffic accident	69.37	17.57	5	74689	107621	90446132
Febrile bone marrow aplasia	68.75	17.57	60	74634	9678	90544075
Diarrhoea	68.64	17.57	1120	73574	938070	89615683
Haemoglobin decreased	67.89	17.57	289	74405	161667	90392086
Leukoencephalopathy	67.76	17.57	45	74649	4828	90548925
Liver injury	67.48	17.57	28	74666	170539	90383214
Thrombotic microangiopathy	66.10	17.57	73	74621	15670	90538083
Malignant transformation	65.74	17.57	23	74671	579	90553174
Pneumonitis	65.66	17.57	125	74569	44045	90509708
Radiation skin injury	65.55	17.57	27	74667	1073	90552680
Ovarian cancer recurrent	65.24	17.57	30	74664	1560	90552193
Dizziness	64.82	17.57	258	74436	589026	89964727
Ill-defined disorder	64.53	17.57	36	74658	184855	90368898
Multiple organ dysfunction syndrome	64.50	17.57	161	74533	68175	90485578
Adverse drug reaction	63.60	17.57	10	74684	116691	90437062
Gastrooesophageal reflux disease	63.12	17.57	29	74665	166308	90387445
Exposure during pregnancy	63.10	17.57	62	74632	238348	90315405
Neoplasm recurrence	62.74	17.57	37	74657	3222	90550531
Gastrointestinal perforation	62.66	17.57	41	74653	4291	90549462
Metastases to breast	62.49	17.57	20	74674	379	90553374
Hypersensitivity	62.27	17.57	181	74513	454496	90099257
Adverse event	61.90	17.57	11	74683	117407	90436346
Hypercholesterolaemia	61.42	17.57	6	74688	100886	90452867
Hospitalisation	61.36	17.57	15	74679	128085	90425668
Charles Bonnet syndrome	60.85	17.57	13	74681	41	90553712
Deafness neurosensory	60.45	17.57	48	74646	6793	90546960
Abdominal compartment syndrome	59.84	17.57	23	74671	760	90552993
Overdose	59.07	17.57	28	74666	157681	90396072
Large intestine perforation	59.02	17.57	55	74639	9657	90544096
Respiratory failure	58.97	17.57	223	74471	118195	90435558
Peripheral artery thrombosis	58.69	17.57	31	74663	2179	90551574
Anxiety	58.06	17.57	104	74590	309668	90244085
Liver abscess	57.80	17.57	36	74658	3460	90550293
Hepatic function abnormal	56.86	17.57	121	74573	46167	90507586
Malnutrition	54.85	17.57	72	74622	18486	90535267
Bronchitis	54.49	17.57	29	74665	152898	90400855
Treatment failure	53.47	17.57	106	74588	303822	90249931
Death	53.33	17.57	593	74101	455958	90097795
Ileus	53.31	17.57	67	74627	16479	90537274
Intentional product misuse	52.82	17.57	6	74688	89598	90464155
Malaise	52.26	17.57	277	74417	585709	89968044
Immune-mediated enterocolitis	52.24	17.57	38	74656	4719	90549034
Vena cava thrombosis	51.84	17.57	30	74664	2522	90551231
Prescribed overdose	51.78	17.57	9	74685	97616	90456137
Night sweats	51.15	17.57	21	74673	128745	90425008
Recall phenomenon	51.14	17.57	21	74673	828	90552925
Dry mouth	50.88	17.57	46	74648	184013	90369740
Disseminated intravascular coagulation	50.85	17.57	75	74619	21463	90532290
Venoocclusive liver disease	50.72	17.57	41	74653	5952	90547801
Peripheral ischaemia	50.58	17.57	40	74654	5627	90548126
Injection site erythema	50.28	17.57	10	74684	98492	90455261
Product quality issue	50.23	17.57	4	74690	79321	90474432
Injection site reaction	49.92	17.57	8	74686	92072	90461681
Prescribed underdose	49.78	17.57	3	74691	75016	90478737
Feeling abnormal	49.66	17.57	39	74655	167196	90386557
Cystitis haemorrhagic	49.40	17.57	39	74655	5474	90548279
Lower limb fracture	49.35	17.57	6	74688	85007	90468746
Intestinal perforation	49.24	17.57	59	74635	13822	90539931
Intentional product use issue	49.11	17.57	64	74630	216828	90336925
Suicidal ideation	48.86	17.57	3	74691	73852	90479901
Osteoporosis	48.85	17.57	10	74684	96521	90457232
Musculoskeletal pain	48.30	17.57	42	74652	171209	90382544
Metastases to adrenals	48.27	17.57	21	74673	957	90552796
Hypoalbuminaemia	47.49	17.57	62	74632	15835	90537918
Fatigue	47.27	17.57	669	74025	1153354	89400399
Decreased appetite	47.15	17.57	496	74198	376044	90177709
Peripheral sensory neuropathy	46.12	17.57	47	74647	9203	90544550
Stem cell transplant	45.57	17.57	26	74668	2128	90551625
Fluid intake reduced	45.22	17.57	33	74661	4119	90549634
Cataract	44.64	17.57	4	74690	72088	90481665
Neck pain	44.60	17.57	19	74675	113944	90439809
Abdominal pain	43.93	17.57	509	74185	395212	90158541
Bacterial abdominal infection	43.81	17.57	9	74685	22	90553731
Hypothyroidism	43.80	17.57	119	74575	53008	90500745
Muscular weakness	43.76	17.57	64	74630	206602	90347151
Myasthenia gravis crisis	43.42	17.57	20	74674	1044	90552709
Mesenteric abscess	43.25	17.57	11	74683	86	90553667
Lung disorder	43.20	17.57	36	74658	149847	90403906
Drug clearance decreased	43.10	17.57	24	74670	1874	90551879
Peritonitis	42.80	17.57	66	74628	19639	90534114
Hypovolaemic shock	42.77	17.57	40	74654	7054	90546699
Urinary tract toxicity	42.71	17.57	7	74687	0	90553753
Haemophagocytic lymphohistiocytosis	42.66	17.57	58	74636	15401	90538352
Anastomotic leak	42.39	17.57	17	74677	630	90553123
Systemic candida	42.12	17.57	34	74660	4925	90548828
Bacteraemia	42.01	17.57	70	74624	22230	90531523
Joint stiffness	41.82	17.57	7	74687	78035	90475718
Gastric perforation	41.81	17.57	24	74670	1987	90551766
Chemical peritonitis	41.78	17.57	11	74683	100	90553653
Abdominal pain upper	41.57	17.57	138	74556	332536	90221217
Delirium	41.48	17.57	17	74677	104342	90449411
Nasal congestion	41.47	17.57	9	74685	83405	90470348
Radiation injury	41.31	17.57	17	74677	674	90553079
Amnesia	41.03	17.57	19	74675	108486	90445267
Tumour haemorrhage	40.91	17.57	24	74670	2070	90551683
Hepatic cirrhosis	40.58	17.57	3	74691	63250	90490503
Large intestinal ulcer perforation	40.54	17.57	10	74684	68	90553685
Nasal abscess	40.16	17.57	12	74682	179	90553574
Cervix carcinoma recurrent	40.04	17.57	12	74682	181	90553572
Chronic kidney disease	39.96	17.57	111	74583	50080	90503673
Acquired gene mutation	39.92	17.57	20	74674	1259	90552494
Performance status decreased	39.91	17.57	31	74663	4249	90549504
Pseudomonal sepsis	39.77	17.57	31	74663	4271	90549482
Dermatitis	39.54	17.57	68	74626	22152	90531601
Anisometropia	39.34	17.57	10	74684	78	90553675
Somnolence	39.33	17.57	70	74624	209014	90344739
Metastases to meninges	39.13	17.57	29	74665	3706	90550047
Wernicke's encephalopathy	38.81	17.57	8	74686	20	90553733
Cervix neoplasm	38.71	17.57	12	74682	204	90553549
Live birth	38.40	17.57	9	74685	79098	90474655
Wound infection	38.16	17.57	20	74674	106382	90447371
Embolism	38.15	17.57	43	74651	9438	90544315
Herpes simplex encephalitis	38.05	17.57	14	74680	409	90553344
Hyperbilirubinaemia	38.02	17.57	52	74642	13884	90539869
Ear infection	37.96	17.57	6	74688	69769	90483984
Ureteric rupture	37.87	17.57	7	74687	7	90553746
Nail disorder	37.34	17.57	3	74691	59064	90494689
Dysphagia	37.15	17.57	187	74507	112091	90441662
Pregnancy	36.96	17.57	4	74690	62043	90491710
Systemic infection	36.92	17.57	31	74663	4744	90549009
Enteritis	36.82	17.57	44	74650	10277	90543476
Bicytopenia	36.66	17.57	28	74666	3743	90550010
Bladder perforation	36.58	17.57	11	74683	168	90553585
Product use issue	36.49	17.57	144	74550	329775	90223978
Cardiac tamponade	36.37	17.57	33	74661	5599	90548154
Radiation oesophagitis	36.19	17.57	14	74680	471	90553282
Nephritis bacterial	35.97	17.57	8	74686	32	90553721
Frequent bowel movements	35.69	17.57	3	74691	56932	90496821
Fluid retention	35.58	17.57	14	74680	88077	90465676
Thrombophlebitis migrans	35.56	17.57	12	74682	270	90553483
Hypophosphataemia	35.46	17.57	52	74642	14802	90538951
Axillary vein thrombosis	35.42	17.57	13	74681	377	90553376
White blood cell count abnormal	35.38	17.57	37	74657	7467	90546286
Oedema	35.08	17.57	70	74624	200225	90353528
Cerebral ischaemia	34.86	17.57	36	74658	7160	90546593
Mantle cell lymphoma recurrent	34.85	17.57	13	74681	395	90553358
Fanconi syndrome	34.65	17.57	21	74673	1922	90551831
Stress	34.45	17.57	12	74682	81383	90472370
Embryonal rhabdomyosarcoma	34.40	17.57	7	74687	16	90553737
Hepatic lesion	34.23	17.57	32	74662	5641	90548112
Gastrointestinal fungal infection	33.84	17.57	13	74681	429	90553324
Melanoderma	33.72	17.57	11	74683	222	90553531
Immune-mediated hepatic disorder	33.60	17.57	20	74674	1772	90551981
Cerebellar haemangioma	33.59	17.57	9	74685	88	90553665
Cerebral venous thrombosis	33.59	17.57	22	74672	2306	90551447
Incorrect dose administered	32.79	17.57	12	74682	78918	90474835
Immune-mediated lung disease	32.71	17.57	20	74674	1860	90551893
Hyperphosphataemia	32.71	17.57	26	74668	3685	90550068
Hyperadrenocorticism	32.54	17.57	13	74681	477	90553276
Chloroma	32.54	17.57	11	74683	249	90553504
Neutrophil count abnormal	32.33	17.57	27	74667	4101	90549652
Balance disorder	32.31	17.57	20	74674	97060	90456693
Inappropriate schedule of product administration	32.16	17.57	46	74648	149887	90403866
Haemolytic uraemic syndrome	32.11	17.57	23	74671	2788	90550965
Metastases to abdominal wall	32.09	17.57	10	74684	173	90553580
Cerebral infarction	32.06	17.57	69	74625	26527	90527226
Extremity necrosis	31.97	17.57	20	74674	1937	90551816
Pericardial effusion	31.87	17.57	84	74610	36749	90517004
Liver function test increased	31.86	17.57	15	74679	84840	90468913
Unmasking of previously unidentified disease	31.72	17.57	18	74676	1458	90552295
Varicella zoster virus infection	31.71	17.57	26	74668	3851	90549902
Immune-mediated encephalitis	31.39	17.57	13	74681	524	90553229
Abortion spontaneous	30.92	17.57	4	74690	54052	90499701
Cytomegalovirus infection	30.91	17.57	68	74626	26534	90527219
Sinus polyp	30.81	17.57	12	74682	411	90553342
Immune-mediated hypothyroidism	30.81	17.57	18	74676	1540	90552213
Radiation pneumonitis	30.38	17.57	19	74675	1839	90551914
Inflammation	29.94	17.57	64	74630	178528	90375225
Urinary tract infection bacterial	29.65	17.57	31	74663	6254	90547499
Tumour associated fever	29.61	17.57	12	74682	457	90553296
Arteriospasm coronary	29.54	17.57	28	74666	5022	90548731
Colitis	29.43	17.57	125	74569	69817	90483936
Dyspepsia	29.23	17.57	76	74618	198084	90355669
Unevaluable event	29.21	17.57	5	74689	54843	90498910
Thymus enlargement	28.71	17.57	9	74685	159	90553594
Acoustic stimulation tests abnormal	28.69	17.57	8	74686	92	90553661
Underdose	28.60	17.57	5	74689	54012	90499741
Asthenia	28.53	17.57	607	74087	533144	90020609
Pulmonary haemorrhage	28.32	17.57	34	74660	7979	90545774
Lymphopenia	28.31	17.57	60	74634	22821	90530932
Procalcitonin abnormal	28.31	17.57	6	74688	18	90553735
Alveolar soft part sarcoma	28.15	17.57	8	74686	99	90553654
Plasma cells increased	28.00	17.57	8	74686	101	90553652
Wrong technique in product usage process	27.89	17.57	12	74682	71559	90482194
Enterococcal sepsis	27.63	17.57	17	74677	1599	90552154
RUNX1 gene mutation	27.38	17.57	7	74687	56	90553697
Confusional state	27.37	17.57	196	74498	386009	90167744
Cannabinoid hyperemesis syndrome	27.06	17.57	7	74687	59	90553694
Pneumonia salmonella	27.05	17.57	5	74689	5	90553748
Stress cardiomyopathy	26.61	17.57	43	74651	13312	90540441
Metastases to abdominal cavity	26.57	17.57	12	74682	598	90553155
Fungaemia	26.42	17.57	22	74672	3328	90550425
Enterocolitis infectious	26.30	17.57	18	74676	2029	90551724
Bacterial sepsis	26.22	17.57	26	74668	4929	90548824
Klebsiella sepsis	26.11	17.57	17	74677	1764	90551989
Respiratory distress	26.09	17.57	81	74613	38865	90514888
Medication error	26.07	17.57	19	74675	84633	90469120
Therapy interrupted	25.75	17.57	5	74689	50103	90503650
Amputation stump pain	25.72	17.57	6	74688	31	90553722
Granulocytopenia	25.55	17.57	29	74665	6412	90547341
Urogenital disorder	25.38	17.57	7	74687	77	90553676
Peritoneal gliomatosis	25.37	17.57	5	74689	9	90553744
Osteosarcoma	25.33	17.57	8	74686	145	90553608
Tubulointerstitial nephritis	25.27	17.57	61	74633	25282	90528471
Vesical fistula	25.23	17.57	8	74686	147	90553606
Osteoradionecrosis	25.18	17.57	8	74686	148	90553605
Odynophagia	25.06	17.57	34	74660	9009	90544744
Clostridium bacteraemia	25.06	17.57	9	74685	245	90553508
Upper respiratory tract infection	25.00	17.57	42	74652	128276	90425477
Influenza like illness	24.95	17.57	18	74676	80593	90473160
Candida infection	24.86	17.57	73	74621	33984	90519769
Staphylococcal infection	24.75	17.57	92	74602	48347	90505406
Myasthenic syndrome	24.65	17.57	10	74684	382	90553371
Rhinorrhoea	24.48	17.57	22	74672	88294	90465459
Suicide attempt	24.45	17.57	16	74678	75383	90478370
Interstitial lung disease	24.39	17.57	126	74568	76279	90477474
Acute respiratory distress syndrome	24.39	17.57	65	74629	28621	90525132
Aortic embolus	24.17	17.57	6	74688	42	90553711
Blood sodium decreased	23.92	17.57	63	74631	27550	90526203
Eustachian tube dysfunction	23.88	17.57	12	74682	760	90552993
Radiation proctitis	23.85	17.57	5	74689	14	90553739
Oesophageal stenosis	23.84	17.57	22	74672	3814	90549939
Malignant peritoneal neoplasm	23.79	17.57	12	74682	766	90552987
Staphylococcal bacteraemia	23.67	17.57	30	74664	7439	90546314
Klebsiella test positive	23.65	17.57	15	74679	1488	90552265
Carbohydrate antigen 19-9 increased	23.60	17.57	9	74685	291	90553462
Neutropenic infection	23.46	17.57	16	74678	1793	90551960
Chylothorax	23.34	17.57	10	74684	439	90553314
Device related sepsis	23.26	17.57	24	74670	4769	90548984
Mucosal erosion	23.18	17.57	16	74678	1829	90551924
Anti-Muellerian hormone level decreased	23.15	17.57	7	74687	109	90553644
Fistula of small intestine	23.11	17.57	10	74684	450	90553303
Pelvic fluid collection	22.99	17.57	13	74681	1046	90552707
Immune effector cell-associated neurotoxicity syndrome	22.94	17.57	26	74668	5742	90548011
Median nerve injury	22.68	17.57	5	74689	19	90553734
Therapy responder	22.66	17.57	9	74685	325	90553428
Hypoacusis	22.57	17.57	62	74632	27788	90525965
Hepatotoxicity	22.53	17.57	86	74608	45756	90507997
Jaw operation	22.52	17.57	12	74682	859	90552894
Failure to thrive	22.37	17.57	31	74663	8380	90545373
Blood stem cell transplant failure	22.30	17.57	8	74686	217	90553536
Osteosarcoma metastatic	22.28	17.57	5	74689	21	90553732
Fibrosis	22.27	17.57	26	74668	5926	90547827
Plasma cell myeloma recurrent	22.03	17.57	22	74672	4206	90549547
Respiratory symptom	21.92	17.57	22	74672	4230	90549523
Pneumonia fungal	21.91	17.57	28	74666	7003	90546750
Lip swelling	21.74	17.57	3	74691	38607	90515146
Radiotherapy	21.72	17.57	12	74682	923	90552830
Blood pressure fluctuation	21.72	17.57	8	74686	52405	90501348
Haemoglobin abnormal	21.69	17.57	28	74666	7072	90546681
Myocarditis	21.67	17.57	40	74654	13766	90539987
Maternal death affecting foetus	21.64	17.57	4	74690	4	90553749
Blood magnesium decreased	21.60	17.57	43	74651	15650	90538103
Pulmonary vascular disorder	21.58	17.57	9	74685	369	90553384
Blood pressure immeasurable	21.28	17.57	14	74680	1478	90552275
Enterocolitis	21.21	17.57	34	74660	10456	90543297
Skin toxicity	21.13	17.57	27	74667	6752	90547001
Gastrointestinal necrosis	21.03	17.57	19	74675	3206	90550547
Small cell lung cancer	21.01	17.57	15	74679	1809	90551944
Gastroenteritis radiation	20.94	17.57	10	74684	567	90553186
Brain oedema	20.83	17.57	45	74649	17340	90536413
VIth nerve paresis	20.77	17.57	6	74688	79	90553674
Cytomegalovirus oesophagitis	20.75	17.57	9	74685	407	90553346
Vision blurred	20.66	17.57	37	74657	110256	90443497
Blindness cortical	20.64	17.57	10	74684	585	90553168
Blood glucose increased	20.64	17.57	29	74665	95217	90458536
Cervix cancer metastatic	20.63	17.57	6	74688	81	90553672
Enterocutaneous fistula	20.60	17.57	14	74680	1560	90552193
Blood pressure increased	20.58	17.57	88	74606	197129	90356624
Sedation	20.56	17.57	7	74687	48164	90505589
Superior sagittal sinus thrombosis	20.54	17.57	11	74683	795	90552958
Device related infection	20.50	17.57	57	74637	25729	90528024
Lymphangioleiomyomatosis	20.49	17.57	8	74686	276	90553477
Streptococcal bacteraemia	20.48	17.57	16	74678	2211	90551542
Lymphocele	20.48	17.57	11	74683	800	90552953
Autoimmune hypothyroidism	20.43	17.57	8	74686	278	90553475
Leukaemic lymphoma	20.43	17.57	6	74688	84	90553669
Blood culture positive	20.40	17.57	23	74671	5049	90548704
Oesophageal-pulmonary fistula	20.37	17.57	4	74690	7	90553746
Bile duct cancer recurrent	20.37	17.57	4	74690	7	90553746
Plasma cell myeloma refractory	20.36	17.57	12	74682	1044	90552709
Aspergilloma	20.35	17.57	8	74686	281	90553472
Immune-mediated myocarditis	20.29	17.57	13	74681	1312	90552441
Clostridium difficile colitis	20.22	17.57	58	74636	26648	90527105
Accidental exposure to product	20.21	17.57	5	74689	42361	90511392
Blood lactate dehydrogenase abnormal	20.15	17.57	9	74685	437	90553316
Hypoxia	20.14	17.57	115	74579	72284	90481469
Bronchial fistula	20.14	17.57	5	74689	35	90553718
Pulmonary toxicity	20.14	17.57	35	74659	11496	90542257
Ovarian vein thrombosis	20.11	17.57	6	74688	89	90553664
Necrosis	20.09	17.57	26	74668	6584	90547169
Influenza	20.09	17.57	54	74640	139210	90414543
Pneumothorax	20.05	17.57	47	74647	19120	90534633
Taste disorder	20.04	17.57	13	74681	61533	90492220
Pneumatosis intestinalis	20.00	17.57	19	74675	3418	90550335
Metastases to soft tissue	19.99	17.57	8	74686	295	90553458
Burning sensation	19.86	17.57	14	74680	63438	90490315
Alpha 1 foetoprotein increased	19.83	17.57	7	74687	181	90553572
Central nervous system vasculitis	19.81	17.57	12	74682	1097	90552656
Pulmonary fistula	19.70	17.57	4	74690	9	90553744
Ischaemic stroke	19.63	17.57	51	74643	22115	90531638
Irritability	19.55	17.57	3	74691	35659	90518094
Osteolysis	19.47	17.57	19	74675	3531	90550222
Marchiafava-Bignami disease	19.41	17.57	4	74690	10	90553743
Lymphadenopathy	19.40	17.57	82	74612	45693	90508060
Aplasia	19.39	17.57	20	74674	3971	90549782
Salivary gland cancer	19.37	17.57	7	74687	194	90553559
Tumour thrombosis	19.34	17.57	5	74689	42	90553711
Radiation mucositis	19.34	17.57	5	74689	42	90553711
Plasma cell leukaemia	19.33	17.57	12	74682	1146	90552607
Agranulocytosis	19.17	17.57	68	74626	34934	90518819
Femur fracture	19.15	17.57	7	74687	46075	90507678
Medulloblastoma recurrent	19.09	17.57	6	74688	107	90553646
Pleuroparenchymal fibroelastosis	19.07	17.57	7	74687	203	90553550
Immune-mediated dermatitis	19.06	17.57	11	74683	920	90552833
Proteinuria	19.02	17.57	52	74642	23239	90530514
Small intestinal obstruction	18.96	17.57	49	74645	21185	90532568
Sudden death	18.90	17.57	33	74661	10876	90542877
C-reactive protein increased	18.89	17.57	81	74613	181308	90372445
Roseolovirus test positive	18.88	17.57	6	74688	111	90553642
Parvovirus B19 test positive	18.88	17.57	6	74688	111	90553642
Oesophagobronchial fistula	18.84	17.57	5	74689	47	90553706
Tumour pseudoprogression	18.83	17.57	10	74684	711	90553042
Hypoglossal nerve paresis	18.78	17.57	6	74688	113	90553640
Pain in jaw	18.77	17.57	8	74686	47977	90505776
Uterine atrophy	18.75	17.57	5	74689	48	90553705
Acute myelomonocytic leukaemia	18.63	17.57	7	74687	217	90553536
Chronic obstructive pulmonary disease	18.61	17.57	20	74674	73809	90479944
Cardiopulmonary failure	18.59	17.57	20	74674	4168	90549585
Neurosensory hypoacusis	18.54	17.57	7	74687	220	90553533
Surgery	18.35	17.57	7	74687	44880	90508873
Blood creatine phosphokinase increased	18.34	17.57	3	74691	34020	90519733
Immune-mediated hyperthyroidism	18.32	17.57	8	74686	368	90553385
Papillitis	18.30	17.57	5	74689	53	90553700
Oroticaciduria	18.19	17.57	4	74690	15	90553738
Adrenocortical carcinoma	18.13	17.57	5	74689	55	90553698
Hiccups	18.12	17.57	17	74677	3009	90550744
Localised infection	18.00	17.57	3	74691	33559	90520194
Fungal oesophagitis	17.98	17.57	10	74684	779	90552974
Metastatic neoplasm	17.96	17.57	21	74673	4794	90548959
Metastases to pelvis	17.96	17.57	9	74685	567	90553186
Serum ferritin abnormal	17.91	17.57	7	74687	242	90553511
Sinus tachycardia	17.91	17.57	58	74636	28455	90525298
Procedural pain	17.85	17.57	3	74691	33357	90520396
Metastases to kidney	17.80	17.57	7	74687	246	90553507
Transdifferentiation of neoplasm	17.79	17.57	4	74690	17	90553736
Myalgia	17.75	17.57	79	74615	175046	90378707
Water intoxication	17.74	17.57	9	74685	582	90553171
Throat irritation	17.69	17.57	9	74685	48686	90505067
Hypotension	17.66	17.57	371	74323	325026	90228727
Aortitis	17.65	17.57	12	74682	1338	90552415
Hallucination	17.61	17.57	17	74677	65942	90487811
Squamous cell carcinoma of the cervix	17.60	17.57	8	74686	405	90553348

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
Disease progression	1722.64	13.22	1956	105119	141700	42372560
Febrile neutropenia	1470.39	13.22	2055	105020	183648	42330612
Neutropenia	1234.26	13.22	1967	105108	197464	42316796
Malignant neoplasm progression	1118.06	13.22	1368	105707	107032	42407228
Myelosuppression	1104.44	13.22	871	106204	39590	42474670
Thrombocytopenia	790.24	13.22	1578	105497	188701	42325559
Mucosal inflammation	741.78	13.22	759	106316	48615	42465645
Therapy partial responder	518.06	13.22	418	106657	19603	42494657
Pancytopenia	505.22	13.22	991	106084	116752	42397508
Neoplasm progression	437.41	13.22	447	106628	28553	42485707
Haematotoxicity	429.50	13.22	294	106781	10691	42503569
Leukopenia	380.09	13.22	677	106398	74069	42440191
Anaemia	371.80	13.22	1539	105536	278739	42235521
Bone marrow failure	357.03	13.22	428	106647	32665	42481595
Neutrophil count decreased	337.40	13.22	586	106489	62829	42451431
Neutropenic sepsis	320.45	13.22	288	106787	15658	42498602
Dehydration	320.34	13.22	930	106145	140837	42373423
Acute myeloid leukaemia	313.89	13.22	331	106744	21925	42492335
Stomatitis	313.14	13.22	499	106576	49830	42464430
Product dose omission issue	309.14	13.22	20	107055	154345	42359915
Renal salt-wasting syndrome	289.95	13.22	85	106990	331	42513929
Nephropathy toxic	282.34	13.22	275	106800	16563	42497697
Off label use	279.22	13.22	2629	104446	635706	41878554
Vomiting	264.54	13.22	1428	105647	288295	42225965
Second primary malignancy	252.05	13.22	202	106873	9373	42504887
Drug abuse	242.78	13.22	4	107071	104767	42409493
Nausea	241.26	13.22	1762	105313	395037	42119223
Dysphagia	237.29	13.22	548	106527	72171	42442089
Aortic thrombosis	235.76	13.22	92	106983	978	42513282
Arthralgia	231.84	13.22	113	106962	205125	42309135
Completed suicide	226.44	13.22	3	107072	96462	42417798
Fall	212.47	13.22	167	106908	234353	42279907
Myelodysplastic syndrome	203.53	13.22	268	106807	22477	42491783
Diffuse large B-cell lymphoma recurrent	203.44	13.22	136	106939	4750	42509510
Renal impairment	190.83	13.22	660	106415	109568	42404692
Ototoxicity	189.91	13.22	100	106975	2225	42512035
Drug interaction	180.88	13.22	244	106831	266755	42247505
Tumour lysis syndrome	165.92	13.22	240	106835	21991	42492269
Decreased appetite	158.59	13.22	926	106149	192211	42322049
Metastases to central nervous system	158.56	13.22	161	106914	10194	42504066
Headache	152.88	13.22	228	106847	239141	42275119
Cardiotoxicity	142.75	13.22	131	106944	7314	42506946
Overdose	141.76	13.22	44	107031	105220	42409040
White blood cell count decreased	139.29	13.22	598	106477	109798	42404462
Diffuse large B-cell lymphoma refractory	138.33	13.22	77	106998	1920	42512340
Intentional product misuse	136.97	13.22	4	107071	61896	42452364
Platelet count decreased	132.77	13.22	693	106382	137888	42376372
Pulmonary embolism	130.03	13.22	620	106455	118992	42395268
Weight increased	128.73	13.22	55	107020	107928	42406332
Acute kidney injury	127.99	13.22	1447	105628	365890	42148370
Anxiety	126.73	13.22	70	107005	118490	42395770
Depression	124.57	13.22	62	107013	111301	42402959
Hospitalisation	124.45	13.22	19	107056	74311	42439949
Pyrexia	122.22	13.22	1518	105557	392524	42121736
Metastases to lung	121.90	13.22	147	106928	11277	42502983
Septic shock	121.38	13.22	504	106571	91168	42423092
Hyponatraemia	114.69	13.22	532	106543	100930	42413330
Muscle spasms	114.00	13.22	37	107038	86007	42428253
Nasopharyngitis	113.28	13.22	35	107040	83961	42430299
Insomnia	112.34	13.22	80	106995	118173	42396087
Rhabdomyolysis	109.82	13.22	30	107045	77989	42436271
Cholangitis	109.53	13.22	135	106940	10592	42503668
Peripheral swelling	109.16	13.22	45	107030	90225	42424035
Oesophagitis	108.55	13.22	161	106914	15086	42499174
Radiation pneumonitis	106.41	13.22	75	107000	2858	42511402
Arterial thrombosis	105.64	13.22	62	107013	1714	42512546
Pulmonary toxicity	105.07	13.22	119	106956	8536	42505724
Radiation skin injury	104.02	13.22	47	107028	738	42513522
Injection site pain	103.37	13.22	12	107063	57786	42456474
Asthma	101.90	13.22	17	107058	62297	42451963
Pain in extremity	101.44	13.22	138	106937	150466	42363794
Metastases to liver	100.25	13.22	161	106914	16165	42498095
Joint swelling	99.88	13.22	24	107051	67998	42446262
Condition aggravated	97.93	13.22	332	106743	260422	42253838
Blood lactate dehydrogenase increased	97.89	13.22	208	106867	25873	42488387
Febrile bone marrow aplasia	97.37	13.22	124	106951	10057	42504203
Deafness neurosensory	96.39	13.22	78	106997	3668	42510592
Musculoskeletal stiffness	96.16	13.22	15	107060	57750	42456510
Anastomotic leak	95.20	13.22	44	107031	730	42513530
Suicide attempt	95.16	13.22	5	107070	46095	42468165
Suicidal ideation	94.10	13.22	7	107068	48154	42466106
Sepsis	93.73	13.22	836	106239	198498	42315762
Blood pressure increased	92.87	13.22	72	107003	101856	42412404
Deafness	92.46	13.22	138	106937	13002	42501258
Cardiac failure congestive	90.79	13.22	51	107024	85551	42428709
Interstitial lung disease	90.56	13.22	414	106661	78048	42436212
Wheezing	89.45	13.22	15	107060	54766	42459494
Aorto-oesophageal fistula	89.29	13.22	22	107053	34	42514226
Neuropathy peripheral	89.10	13.22	497	106578	101356	42412904
Myalgia	88.65	13.22	67	107008	96013	42418247
Gastrointestinal toxicity	88.19	13.22	76	106999	3903	42510357
Metastases to lymph nodes	87.74	13.22	91	106984	5907	42508353
Hypophagia	85.48	13.22	201	106874	26755	42487505
Somnolence	83.71	13.22	141	106934	140964	42373296
Hypomagnesaemia	83.44	13.22	206	106869	28282	42485978
Inappropriate schedule of product administration	83.32	13.22	71	107004	95831	42418429
Drug reaction with eosinophilia and systemic symptoms	82.54	13.22	6	107069	42069	42472191
Portal venous gas	82.12	13.22	35	107040	474	42513786
Hypertension	81.98	13.22	187	106888	167017	42347243
Pneumonitis	80.24	13.22	259	106816	41459	42472801
Osteoradionecrosis	79.93	13.22	22	107053	64	42514196
Peripheral artery thrombosis	79.84	13.22	61	107014	2636	42511624
Pruritus	79.54	13.22	228	106847	188543	42325717
Malignant transformation	76.86	13.22	41	107034	937	42513323
Neutropenic colitis	76.78	13.22	74	107001	4396	42509864
Cardiac disorder	76.43	13.22	15	107060	48917	42465343
Psoriasis	75.71	13.22	15	107060	48589	42465671
Oesophageal fistula	75.44	13.22	29	107046	295	42513965
Immune-mediated hepatic disorder	74.73	13.22	57	107018	2457	42511803
Reactive capillary endothelial proliferation	73.78	13.22	18	107057	26	42514234
Neoplasm recurrence	72.81	13.22	58	107017	2666	42511594
Gastric perforation	72.48	13.22	61	107014	3032	42511228
Tremor	72.38	13.22	82	106993	96847	42417413
Dizziness	72.36	13.22	351	106724	248903	42265357
Hypokalaemia	72.30	13.22	364	106711	71357	42442903
Heart rate decreased	72.26	13.22	5	107070	36527	42477733
Arthritis	72.14	13.22	10	107065	42055	42472205
Odynophagia	72.04	13.22	87	106988	6683	42507577
Drug hypersensitivity	71.09	13.22	87	106988	99302	42414958
Hallucination	70.59	13.22	28	107047	57479	42456781
Influenza	70.43	13.22	34	107041	62141	42452119
Radiation oesophagitis	70.37	13.22	31	107044	457	42513803
Peripheral ischaemia	70.09	13.22	84	106991	6401	42507859
Hepatitis B	69.39	13.22	85	106990	6626	42507634
Vena cava thrombosis	68.74	13.22	45	107030	1516	42512744
Aggression	68.01	13.22	14	107061	44149	42470111
Deep vein thrombosis	67.59	13.22	376	106699	76581	42437679
Pain	67.52	13.22	351	106724	244497	42269763
Disease recurrence	67.10	13.22	195	106880	29483	42484777
Tumour necrosis	66.61	13.22	45	107030	1599	42512661
Metastasis	66.35	13.22	70	107005	4635	42509625
Electrolyte imbalance	66.04	13.22	138	106937	16963	42497297
Gait disturbance	65.74	13.22	90	106985	97910	42416350
Sleep disorder	64.90	13.22	20	107055	48075	42466185
Incorrect dose administered	64.68	13.22	26	107049	52948	42461312
Mobility decreased	63.95	13.22	7	107068	35299	42478961
Inappropriate antidiuretic hormone secretion	63.32	13.22	133	106942	16408	42497852
Loss of personal independence in daily activities	63.24	13.22	23	107052	49793	42464467
Vision blurred	62.93	13.22	28	107047	53671	42460589
Wrong technique in product usage process	62.66	13.22	15	107060	42620	42471640
Colitis	62.33	13.22	257	106818	46315	42467945
Oesophageal stenosis	62.16	13.22	47	107028	1999	42512261
B-cell lymphoma recurrent	61.80	13.22	34	107041	828	42513432
Oesophagobronchial fistula	61.76	13.22	22	107053	177	42514083
Abdominal discomfort	61.43	13.22	59	107016	75196	42439064
Renal failure	61.03	13.22	590	106485	143136	42371124
Chronic obstructive pulmonary disease	60.83	13.22	42	107033	63072	42451188
Urticaria	60.49	13.22	58	107017	73978	42440282
Rheumatoid arthritis	60.31	13.22	16	107059	42424	42471836
Product use in unapproved indication	59.66	13.22	717	106358	183739	42330521
Tinnitus	59.62	13.22	184	106891	28754	42485506
Intestinal ischaemia	59.58	13.22	94	106981	9294	42504966
Cytopenia	59.36	13.22	134	106941	17363	42496897
Splenic infarction	59.15	13.22	49	107026	2382	42511878
Feeling abnormal	58.98	13.22	53	107022	69733	42444527
Respiratory failure	58.91	13.22	535	106540	127597	42386663
Hiccups	58.89	13.22	108	106967	12063	42502197
Immune-mediated renal disorder	58.52	13.22	27	107048	446	42513814
General physical health deterioration	58.50	13.22	609	106466	150637	42363623
Sedation	57.94	13.22	5	107070	30470	42483790
Confusional state	57.14	13.22	222	106853	167375	42346885
Aplasia	56.10	13.22	65	107010	4778	42509482
Acute respiratory distress syndrome	55.26	13.22	184	106891	29924	42484336
Dermatitis	54.49	13.22	103	106972	11772	42502488
Coronary artery disease	54.13	13.22	34	107041	53686	42460574
Electrocardiogram QT prolonged	53.12	13.22	27	107048	47918	42466342
Nasal congestion	53.05	13.22	6	107069	29495	42484765
Pharyngeal inflammation	52.33	13.22	28	107047	644	42513616
Blood pressure fluctuation	52.31	13.22	4	107071	26904	42487356
Acquired gene mutation	51.82	13.22	38	107037	1542	42512718
Adverse drug reaction	51.54	13.22	15	107060	37419	42476841
Product prescribing error	50.43	13.22	4	107071	26108	42488152
Memory impairment	50.31	13.22	32	107043	50190	42464070
Renal infarct	50.13	13.22	40	107035	1843	42512417
Immune-mediated dermatitis	49.86	13.22	34	107041	1227	42513033
Enteritis	49.86	13.22	94	106981	10722	42503538
Prostate cancer	49.66	13.22	25	107050	44618	42469642
Immune-mediated enterocolitis	49.39	13.22	66	107009	5611	42508649
Lymphadenopathy	49.36	13.22	190	106885	33175	42481085
Renal tubular disorder	48.86	13.22	61	107014	4848	42509412
Ameloblastoma	48.79	13.22	16	107059	97	42514163
Osteosarcoma	48.45	13.22	21	107054	297	42513963
Angioedema	48.45	13.22	23	107052	42454	42471806
Swelling	48.43	13.22	40	107035	54845	42459415
Leukoencephalopathy	48.42	13.22	61	107014	4893	42509367
Oesophageal perforation	48.18	13.22	33	107042	1200	42513060
Bacterial translocation	47.48	13.22	26	107049	627	42513633
Gout	47.33	13.22	7	107068	28048	42486212
Tumour perforation	47.21	13.22	24	107051	495	42513765
Serotonin syndrome	47.13	13.22	5	107070	25840	42488420
Balance disorder	46.85	13.22	31	107044	47614	42466646
Blood stem cell transplant failure	46.34	13.22	23	107052	450	42513810
Pulmonary vascular disorder	46.21	13.22	26	107049	662	42513598
Hyperammonaemic encephalopathy	46.13	13.22	45	107030	2713	42511547
Bacteraemia	45.93	13.22	153	106922	24887	42489373
Teratoma	45.79	13.22	12	107063	27	42514233
Pneumatosis intestinalis	45.63	13.22	58	107017	4694	42509566
Neurotoxicity	45.61	13.22	147	106928	23504	42490756
Progressive multifocal leukoencephalopathy	45.61	13.22	94	106981	11442	42502818
Atypical haemolytic uraemic syndrome	45.53	13.22	24	107051	535	42513725
Dry skin	45.48	13.22	33	107042	48305	42465955
Large intestine perforation	45.36	13.22	84	106991	9452	42504808
Haematochezia	45.19	13.22	48	107027	58388	42455872
Chest discomfort	45.14	13.22	56	107019	63560	42450700
Metastases to peritoneum	44.83	13.22	42	107033	2407	42511853
Cataract	44.52	13.22	11	107064	30593	42483667
Blood cholesterol increased	44.37	13.22	7	107068	26734	42487526
Hypoglycaemia	44.27	13.22	51	107024	59803	42454457
Tumour haemorrhage	44.12	13.22	50	107025	3588	42510672
Rash	44.04	13.22	464	106611	276490	42237770
Osteoarthritis	43.79	13.22	5	107070	24400	42489860
Lactic acidosis	43.77	13.22	30	107045	45231	42469029
Foetal exposure during pregnancy	43.60	13.22	33	107042	47278	42466982
Sinusitis	43.57	13.22	33	107042	47259	42467001
Bone formation decreased	42.85	13.22	11	107064	22	42514238
Tracheo-oesophageal fistula	42.83	13.22	23	107052	533	42513727
Immune-mediated hypothyroidism	42.59	13.22	31	107044	1243	42513017
Back pain	42.04	13.22	198	106877	141578	42372682
Therapeutic product effect decreased	41.96	13.22	23	107052	39127	42475133
Alopecia	41.91	13.22	165	106910	29111	42485149
Contusion	41.71	13.22	27	107048	41958	42472302
Carotid artery thrombosis	41.65	13.22	20	107055	363	42513897
Accidental overdose	41.56	13.22	10	107065	28320	42485940
Mantle cell lymphoma recurrent	41.45	13.22	28	107047	995	42513265
Lymphoma	41.34	13.22	103	106972	14218	42500042
Eastern Cooperative Oncology Group performance status worsened	41.28	13.22	31	107044	1305	42512955
Salivary gland cancer	41.06	13.22	19	107056	316	42513944
Nephrolithiasis	40.41	13.22	21	107054	36809	42477451
Pulmonary arteriopathy	40.04	13.22	13	107062	76	42514184
Influenza like illness	39.90	13.22	15	107060	31825	42482435
Accidental exposure to product	39.73	13.22	3	107072	20390	42493870
Bradycardia	39.16	13.22	99	106976	85385	42428875
Depressed mood	39.07	13.22	6	107069	23378	42490882
Bicytopenia	39.02	13.22	44	107031	3140	42511120
Cytomegalovirus oesophagitis	39.00	13.22	22	107053	563	42513697
Blood pressure systolic increased	38.88	13.22	11	107064	27957	42486303
Radiation mucositis	38.63	13.22	17	107058	250	42514010
Cerebral infarction	38.59	13.22	168	106907	31001	42483259
Blood creatine phosphokinase increased	38.17	13.22	39	107036	48299	42465961
Azoospermia	38.11	13.22	21	107054	513	42513747
Immune-mediated myocarditis	37.92	13.22	36	107039	2098	42512162
International normalised ratio increased	37.88	13.22	39	107036	48129	42466131
Death	37.21	13.22	901	106174	470284	42043976
Localised infection	37.00	13.22	4	107071	20369	42493891
Frequent bowel movements	36.91	13.22	5	107070	21402	42492858
Skin toxicity	36.71	13.22	62	107013	6487	42507773
Embolism	36.54	13.22	73	107002	8690	42505570
Embolism arterial	36.33	13.22	24	107051	821	42513439
Thrombophlebitis migrans	36.27	13.22	18	107057	352	42513908
Arterial occlusive disease	36.06	13.22	50	107025	4403	42509857
Osteosarcoma recurrent	35.72	13.22	13	107062	112	42514148
Blood creatinine increased	35.69	13.22	428	106647	109575	42404685
Anastomotic complication	35.59	13.22	19	107056	435	42513825
Dyspnoea	35.59	13.22	844	106231	441777	42072483
Unevaluable event	35.52	13.22	21	107054	34267	42479993
Primitive neuroectodermal tumour	35.50	13.22	12	107063	81	42514179
Cystitis haemorrhagic	35.41	13.22	65	107010	7264	42506996
Migraine	35.32	13.22	10	107065	25404	42488856
Recall phenomenon	35.31	13.22	21	107054	595	42513665
Dyskinesia	35.27	13.22	10	107065	25380	42488880
Thrombotic microangiopathy	35.23	13.22	99	106976	14683	42499577
Hepatitis B reactivation	34.99	13.22	50	107025	4528	42509732
Visual impairment	34.94	13.22	34	107041	43079	42471181
Chemotherapy	34.89	13.22	23	107052	784	42513476
Gastrooesophageal reflux disease	34.79	13.22	37	107038	44986	42469274
Hyperhidrosis	34.74	13.22	114	106961	90398	42423862
Malaise	34.69	13.22	353	106722	211803	42302457
Hypercreatininaemia	34.60	13.22	20	107055	537	42513723
Psychotic disorder	34.58	13.22	15	107060	29193	42485067
Transient ischaemic attack	34.48	13.22	21	107054	33718	42480542
Hypochloraemia	34.18	13.22	24	107051	909	42513351
Adrenal insufficiency	34.15	13.22	115	106960	18809	42495451
Chloroma	33.94	13.22	20	107055	557	42513703
Bronchial fistula	33.93	13.22	15	107060	223	42514037
Agitation	33.90	13.22	69	107006	64245	42450015
Performance status decreased	33.82	13.22	50	107025	4670	42509590
Eczema	33.75	13.22	22	107053	34064	42480196
Gait inability	33.61	13.22	8	107067	22825	42491435
Blood glucose increased	33.25	13.22	86	106989	73613	42440647
Oedema peripheral	33.15	13.22	203	106872	135873	42378387
Lymphopenia	32.88	13.22	124	106951	21439	42492821
Treatment noncompliance	32.56	13.22	28	107047	37644	42476616
Illness	32.51	13.22	11	107064	24919	42489341
Paraneoplastic syndrome	32.51	13.22	22	107053	784	42513476
Blood sodium decreased	32.44	13.22	110	106965	18052	42496208
Hypoacusis	32.30	13.22	112	106963	18590	42495670
Diabetes mellitus	32.07	13.22	64	107011	60023	42454237
Myocardial infarction	31.79	13.22	182	106893	123827	42390433
Hypocalcaemia	31.70	13.22	155	106920	30018	42484242
Choriocarcinoma	31.50	13.22	8	107067	15	42514245
Cytokine release syndrome	31.08	13.22	205	106870	44322	42469938
Acquired tracheo-oesophageal fistula	31.05	13.22	12	107063	124	42514136
Arteriospasm coronary	30.84	13.22	48	107027	4690	42509570
Granulocyte count decreased	30.83	13.22	28	107047	1542	42512718
Peripheral sensory neuropathy	30.72	13.22	68	107007	8694	42505566
Hypogammaglobulinaemia	30.69	13.22	82	106993	11809	42502451
Enterocolitis	30.34	13.22	73	107002	9856	42504404
Upper respiratory tract infection	30.05	13.22	37	107038	42136	42472124
Product administration error	29.99	13.22	5	107070	18338	42495922
Radiation injury	29.83	13.22	18	107057	524	42513736
Drug resistance	29.82	13.22	167	106908	34081	42480179
Pancreatitis	29.75	13.22	39	107036	43229	42471031
Empyema	29.55	13.22	44	107031	4136	42510124
Wound	29.51	13.22	4	107071	17113	42497147
Road traffic accident	29.50	13.22	6	107069	19087	42495173
Spinal column injury	29.34	13.22	19	107056	628	42513632
Injection site swelling	29.18	13.22	4	107071	16969	42497291
Abnormal behaviour	29.14	13.22	15	107060	26436	42487824
Sleep apnoea syndrome	29.12	13.22	9	107066	21599	42492661
Peritonitis	29.12	13.22	108	106967	18525	42495735
Drug intolerance	29.02	13.22	104	106971	80320	42433940
Eosinophilia	28.99	13.22	24	107051	32875	42481385
Hyperlipidaemia	28.93	13.22	9	107066	21507	42492753
Coronary artery thrombosis	28.71	13.22	32	107043	2254	42512006
Disseminated intravascular coagulation	28.70	13.22	131	106944	24663	42489597
Therapy interrupted	28.70	13.22	10	107065	22240	42492020
Disturbance in attention	28.60	13.22	20	107055	29846	42484414
Blood HIV RNA increased	28.58	13.22	27	107048	1564	42512696
Cough	28.42	13.22	298	106777	177805	42336455
Neurosensory hypoacusis	28.34	13.22	7	107068	11	42514249
Irritability	28.06	13.22	18	107057	28110	42486150
Obesity	28.01	13.22	4	107071	16455	42497805
Injection site erythema	27.97	13.22	8	107067	20187	42494073
Agranulocytosis	27.81	13.22	151	106924	30461	42483799
Toxicity to various agents	27.68	13.22	407	106668	228729	42285531
Ill-defined disorder	27.63	13.22	97	106978	16199	42498061
Infected neoplasm	27.54	13.22	12	107063	172	42514088
Urinary tract infection	27.49	13.22	142	106933	99142	42415118
Tumour pseudoprogression	27.30	13.22	22	107053	1028	42513232
Oral candidiasis	27.29	13.22	89	106986	14316	42499944
Hot flush	27.23	13.22	11	107064	22340	42491920
Emotional distress	27.18	13.22	4	107071	16089	42498171
Osteoporosis	26.88	13.22	3	107072	14903	42499357
Hallucination, auditory	26.78	13.22	3	107072	14861	42499399
Metastases to bone	26.72	13.22	90	106985	14719	42499541
Therapy cessation	26.71	13.22	9	107066	20441	42493819
Immune-mediated lung disease	26.64	13.22	38	107037	3435	42510825
Papillary thyroid cancer	26.50	13.22	19	107056	744	42513516
Incorrect route of product administration	26.45	13.22	14	107061	24291	42489969
Benign prostatic hyperplasia	26.24	13.22	10	107065	21042	42493218
Burning sensation	26.16	13.22	10	107065	21003	42493257
Cholelithiasis	26.07	13.22	13	107062	23333	42490927
Labelled drug-drug interaction medication error	26.03	13.22	4	107071	15578	42498682
Blood creatine decreased	25.58	13.22	13	107062	268	42513992
Hepatic candidiasis	25.53	13.22	9	107066	70	42514190
Diaphragm muscle weakness	25.42	13.22	11	107064	155	42514105
Cerebral venous thrombosis	25.36	13.22	21	107054	1020	42513240
Immune-mediated cholangitis	25.14	13.22	16	107059	513	42513747
Eye pain	25.00	13.22	6	107069	17024	42497236
Lung lobectomy	24.88	13.22	9	107066	76	42514184
Flagellate dermatitis	24.77	13.22	10	107065	117	42514143
Speech disorder	24.74	13.22	22	107053	29099	42485161
Rectal haemorrhage	24.66	13.22	55	107020	49551	42464709
Abdominal neoplasm	24.61	13.22	15	107060	445	42513815
Liver function test abnormal	24.60	13.22	27	107048	32364	42481896
Infectious pleural effusion	24.57	13.22	35	107040	3160	42511100
Oesophageal-pulmonary fistula	24.57	13.22	7	107068	24	42514236
Immune-mediated adrenal insuficiency	24.53	13.22	18	107057	731	42513529
Obstructive airways disorder	24.49	13.22	16	107059	24743	42489517
Swelling face	24.40	13.22	20	107055	27534	42486726
Diarrhoea	24.40	13.22	1402	105673	459447	42054813
Blood chloride decreased	24.29	13.22	40	107035	4099	42510161
Extravasation	24.27	13.22	30	107045	2360	42511900
Withdrawal syndrome	24.21	13.22	4	107071	14771	42499489
Delusion	24.12	13.22	4	107071	14730	42499530
Testicular malignant teratoma	24.08	13.22	6	107069	10	42514250
Fanconi syndrome	24.07	13.22	26	107049	1768	42512492
Poisoning	24.04	13.22	4	107071	14695	42499565
Hepatic steatosis	23.87	13.22	12	107063	21436	42492824
Transplant rejection	23.85	13.22	3	107072	13585	42500675
Bronchitis	23.74	13.22	52	107023	47149	42467111
Blindness cortical	23.62	13.22	15	107060	479	42513781
Oesophageal haemorrhage	23.52	13.22	23	107052	1391	42512869
Metastatic lymphoma	23.47	13.22	14	107061	399	42513861
Basal cell carcinoma	23.44	13.22	14	107061	22719	42491541
Loss of consciousness	23.41	13.22	136	106939	92218	42422042
Lymphangiosis carcinomatosa	23.37	13.22	20	107055	1017	42513243
Procalcitonin decreased	23.37	13.22	12	107063	253	42514007
Thrombophlebitis	23.12	13.22	38	107037	3888	42510372
Blood glucose decreased	22.97	13.22	4	107071	14215	42500045
Superior mesenteric artery syndrome	22.95	13.22	9	107066	97	42514163
Dermatitis acneiform	22.69	13.22	56	107019	7683	42506577
Liver abscess	22.66	13.22	43	107032	4927	42509333
Metastases to chest wall	22.62	13.22	12	107063	271	42513989
Mesenteric artery thrombosis	22.61	13.22	17	107058	717	42513543
Full blood count abnormal	22.58	13.22	25	107050	29851	42484409
Paranoia	22.54	13.22	4	107071	14022	42500238
Palmar-plantar erythrodysaesthesia syndrome	22.54	13.22	107	106968	20475	42493785
Gene mutation	22.49	13.22	25	107050	1756	42512504
Underdose	22.35	13.22	7	107068	16659	42497601
Hypoalbuminaemia	22.35	13.22	88	106987	15522	42498738
Angina pectoris	22.26	13.22	30	107045	32866	42481394
Head injury	22.19	13.22	12	107063	20570	42493690
Hypercholesterolaemia	22.16	13.22	3	107072	12846	42501414
Granulocyte-colony stimulating factor level increased	22.02	13.22	5	107070	4	42514256
Colitis ulcerative	21.96	13.22	20	107055	26155	42488105
Gastrointestinal perforation	21.94	13.22	40	107035	4446	42509814
Adenoviral hepatitis	21.93	13.22	15	107060	544	42513716
Deafness bilateral	21.89	13.22	22	107053	1375	42512885
EGFR gene mutation	21.81	13.22	11	107064	223	42514037
Hypersomnia	21.76	13.22	5	107070	14613	42499647
Bronchiectasis	21.74	13.22	9	107066	18010	42496250
Muscular weakness	21.68	13.22	122	106953	83376	42430884
Medication error	21.67	13.22	31	107044	33123	42481137
Respiratory alkalosis	21.55	13.22	28	107047	2316	42511944
Discomfort	21.48	13.22	19	107056	25200	42489060
Device issue	21.39	13.22	4	107071	13505	42500755
Hip fracture	21.31	13.22	4	107071	13468	42500792
Metastases to testicle	21.29	13.22	8	107067	76	42514184
Miosis	21.25	13.22	4	107071	13442	42500818
Cerebral ischaemia	21.09	13.22	51	107024	6908	42507352
Limb injury	21.08	13.22	5	107070	14300	42499960
Hypoaesthesia	21.04	13.22	100	106975	71363	42442897
Fatigue	21.02	13.22	888	106187	434753	42079507
Pleural effusion	21.00	13.22	352	106723	96814	42417446
Joint stiffness	20.96	13.22	3	107072	12319	42501941
Chromaturia	20.94	13.22	7	107068	15982	42498278
Refractory cancer	20.90	13.22	10	107065	180	42514080
Brachiocephalic vein thrombosis	20.78	13.22	9	107066	127	42514133
Seizure	20.77	13.22	198	106877	120363	42393897
Blood triglycerides increased	20.75	13.22	7	107068	15889	42498371
Skin exfoliation	20.71	13.22	46	107029	41507	42472753
Cellulitis	20.68	13.22	82	106993	61503	42452757
Swollen tongue	20.62	13.22	14	107061	21217	42493043
Human chorionic gonadotropin increased	20.54	13.22	6	107069	23	42514237
Nocturia	20.48	13.22	3	107072	12109	42502151
Heart rate increased	20.48	13.22	67	107008	53188	42461072
Rib fracture	20.44	13.22	8	107067	16563	42497697
Necrosis	20.43	13.22	49	107026	6602	42507658
Retinal toxicity	20.34	13.22	14	107061	513	42513747
Soft tissue disorder	20.33	13.22	17	107058	837	42513423
Premature baby	20.26	13.22	17	107058	23136	42491124
Subdural haematoma	20.24	13.22	17	107058	23121	42491139
Fluid retention	20.23	13.22	30	107045	31589	42482671
Thrombocytosis	20.17	13.22	40	107035	4735	42509525
Eosinophil percentage decreased	20.06	13.22	11	107064	266	42513994
Blood test abnormal	20.06	13.22	4	107071	12902	42501358
Subclavian vein thrombosis	20.02	13.22	18	107057	978	42513282
Testicular cancer metastatic	20.02	13.22	8	107067	91	42514169
Product quality issue	19.91	13.22	10	107065	17872	42496388
Myoclonus	19.83	13.22	9	107066	17056	42497204
Haemorrhagic tumour necrosis	19.82	13.22	5	107070	9	42514251
Pulmonary oedema	19.81	13.22	68	107007	53204	42461056
Aortitis	19.78	13.22	15	107060	641	42513619
Blister	19.70	13.22	24	107051	27466	42486794
Abdominal distension	19.62	13.22	103	106972	71632	42442628
Peritoneal lesion	19.49	13.22	9	107066	149	42514111
Coma	19.49	13.22	69	107006	53485	42460775
Adrenocortical carcinoma	19.43	13.22	6	107069	29	42514231
Metastases to skin	19.40	13.22	14	107061	554	42513706
Neutrophil count abnormal	19.34	13.22	29	107046	2742	42511518
Dyspnoea exertional	19.34	13.22	63	107012	50085	42464175
Lung infiltration	19.34	13.22	78	106997	13911	42500349
B-cell lymphoma refractory	19.30	13.22	10	107065	215	42514045
Toxocariasis	19.26	13.22	6	107069	30	42514230
Amnesia	19.17	13.22	26	107049	28411	42485849
Radiotherapy to bone	19.16	13.22	5	107070	11	42514249
Mucosal pain	19.16	13.22	5	107070	11	42514249
Laryngeal pain	19.11	13.22	28	107047	2594	42511666
Cardiogenic shock	18.98	13.22	38	107037	35602	42478658
Iliac artery occlusion	18.96	13.22	9	107066	159	42514101
Pneumonia adenoviral	18.96	13.22	12	107063	381	42513879
Vascular injury	18.94	13.22	11	107064	298	42513962
Metastases to meninges	18.93	13.22	24	107051	1937	42512323
Procedural vomiting	18.93	13.22	10	107065	224	42514036
Radiotherapy to lung	18.86	13.22	5	107070	12	42514248
Vertigo	18.83	13.22	36	107039	34311	42479949
End stage renal disease	18.83	13.22	9	107066	16549	42497711
Lymphadenopathy mediastinal	18.80	13.22	31	107044	3180	42511080
Medulloblastoma recurrent	18.79	13.22	8	107067	108	42514152
Injury	18.79	13.22	17	107058	22299	42491961
Laboratory test abnormal	18.76	13.22	18	107057	22960	42491300
Procedural nausea	18.73	13.22	8	107067	109	42514151
Eye irritation	18.69	13.22	3	107072	11315	42502945
Dementia	18.67	13.22	9	107066	16471	42497789
Blood magnesium decreased	18.66	13.22	52	107023	7674	42506586
Recurrent cancer	18.62	13.22	22	107053	1651	42512609
Haematoma	18.51	13.22	26	107049	27997	42486263
Parasitic pneumonia	18.49	13.22	6	107069	35	42514225
Necrotising oesophagitis	18.45	13.22	17	107058	954	42513306
Transformation to acute myeloid leukaemia	18.43	13.22	18	107057	1087	42513173
Metastatic neoplasm	18.39	13.22	32	107043	3429	42510831
Haemorrhoids	18.38	13.22	10	107065	17087	42497173
Renal tubular necrosis	18.37	13.22	93	106982	18261	42495999
Bladder cancer	18.29	13.22	10	107065	17037	42497223
Arteritis	18.27	13.22	13	107062	503	42513757
Muscle rigidity	18.20	13.22	4	107071	12055	42502205
Dysphonia	18.20	13.22	27	107048	28423	42485837
Carotid artery dissection	18.00	13.22	9	107066	179	42514081
Cerebral venous sinus thrombosis	17.99	13.22	15	107060	736	42513524
Morphoea	17.97	13.22	10	107065	249	42514011
Surgery	17.95	13.22	11	107064	17605	42496655
Gastrointestinal necrosis	17.95	13.22	35	107040	4093	42510167
Lip swelling	17.93	13.22	13	107062	19040	42495220
Staphylococcal bacteraemia	17.83	13.22	65	107010	11056	42503204
Neoplasm	17.83	13.22	45	107030	6260	42508000
Transitional cell carcinoma recurrent	17.81	13.22	5	107070	16	42514244
Cardiac murmur	17.80	13.22	5	107070	12770	42501490
Neuralgia	17.75	13.22	23	107052	25624	42488636
Parathyroid tumour malignant	17.72	13.22	7	107068	77	42514183
Rhinorrhoea	17.71	13.22	33	107042	31761	42482499
Paraneoplastic dermatomyositis	17.64	13.22	7	107068	78	42514182
Sarcoma	17.62	13.22	12	107063	432	42513828
Respiratory depression	17.59	13.22	13	107062	18855	42495405
Candida pneumonia	17.39	13.22	15	107060	771	42513489
Traumatic lung injury	17.34	13.22	19	107056	1313	42512947
Abdominal pain upper	17.23	13.22	129	106946	82480	42431780
Mitral valve incompetence	17.22	13.22	10	107065	16479	42497781
Pneumonia escherichia	17.20	13.22	14	107061	664	42513596
Oesophageal squamous cell carcinoma metastatic	17.19	13.22	4	107071	4	42514256
Trigeminal nerve paresis	17.19	13.22	4	107071	4	42514256
Vibrio vulnificus infection	17.19	13.22	4	107071	4	42514256
Liver function test increased	17.11	13.22	15	107060	19983	42494277
Dysstasia	17.05	13.22	7	107068	14079	42500181
Refeeding syndrome	17.03	13.22	7	107068	86	42514174
Polyneuropathy	16.92	13.22	92	106983	18569	42495691
Staphylococcus test positive	16.91	13.22	32	107043	3660	42510600
Adrenocorticotropic hormone deficiency	16.90	13.22	19	107056	1351	42512909
Palpitations	16.83	13.22	68	107007	50729	42463531
Plasma cell leukaemia	16.69	13.22	18	107057	1222	42513038
Skin ulcer	16.67	13.22	24	107051	25577	42488683
Candida test positive	16.62	13.22	12	107063	475	42513785
Metastases to adrenals	16.62	13.22	17	107058	1085	42513175
Hepatic cirrhosis	16.59	13.22	15	107060	19687	42494573
Intestinal infarction	16.44	13.22	13	107062	591	42513669
Osteomyelitis	16.42	13.22	13	107062	18210	42496050
Adenocarcinoma gastric	16.37	13.22	19	107056	1399	42512861
Intestinal gangrene	16.31	13.22	4	107071	6	42514254
Mucosal toxicity	16.31	13.22	10	107065	300	42513960
White blood cell disorder	16.20	13.22	22	107053	1899	42512361
Acne	16.16	13.22	7	107068	13637	42500623
Gastrointestinal ischaemia	16.16	13.22	10	107065	305	42513955
Therapy non-responder	16.16	13.22	205	106870	53154	42461106
Infection	16.15	13.22	382	106693	111686	42402574
Body temperature decreased	16.13	13.22	8	107067	14405	42499855
Ear infection	16.10	13.22	6	107069	12798	42501462
Venous thrombosis	16.09	13.22	33	107042	4002	42510258
Therapeutic embolisation	16.07	13.22	10	107065	308	42513952
Neuroblastoma recurrent	16.03	13.22	11	107064	401	42513859
Limb discomfort	16.02	13.22	6	107069	12761	42501499
Systemic toxicity	15.97	13.22	6	107069	57	42514203
Metastases to pleura	15.94	13.22	13	107062	618	42513642
Hepatorenal failure	15.91	13.22	13	107062	620	42513640
Gastrointestinal obstruction	15.90	13.22	17	107058	1143	42513117
Extremity necrosis	15.81	13.22	24	107051	2295	42511965
Oesophageal pain	15.79	13.22	16	107059	1010	42513250
Visceral venous thrombosis	15.73	13.22	5	107070	27	42514233
Inferior vena caval occlusion	15.70	13.22	6	107069	60	42514200
Wound evisceration	15.60	13.22	7	107068	108	42514152
Erectile dysfunction	15.59	13.22	24	107051	24889	42489371
Ganglioneuroma	15.58	13.22	4	107071	8	42514252
Red blood cell sedimentation rate increased	15.58	13.22	3	107072	9921	42504339
Mediastinitis	15.54	13.22	16	107059	1029	42513231
Blood phosphorus increased	15.53	13.22	6	107069	12519	42501741
Tendonitis	15.52	13.22	3	107072	9891	42504369
Hepatic enzyme increased	15.35	13.22	61	107014	45723	42468537
Intestinal perforation	15.33	13.22	61	107014	10813	42503447
Cancer with a high tumour mutational burden	15.29	13.22	5	107070	30	42514230
Osteosarcoma metastatic	15.26	13.22	4	107071	9	42514251
Abnormal DNA methylation	15.26	13.22	4	107071	9	42514251
Movement disorder	15.22	13.22	9	107066	14689	42499571
Blood loss anaemia	15.17	13.22	3	107072	9733	42504527
Gastroenteritis sapovirus	15.15	13.22	8	107067	179	42514081
Stress cardiomyopathy	15.13	13.22	26	107049	2759	42511501
Dermatitis diaper	15.11	13.22	10	107065	343	42513917
Meningitis tuberculous	15.11	13.22	13	107062	666	42513594
Thrombotic thrombocytopenic purpura	15.04	13.22	31	107044	3773	42510487
Heart rate irregular	15.04	13.22	11	107064	16039	42498221
Testicular germ cell cancer metastatic	15.03	13.22	6	107069	68	42514192
Anaplastic lymphoma kinase gene mutation	14.99	13.22	7	107068	119	42514141
DNA mismatch repair protein gene mutation	14.97	13.22	4	107071	10	42514250
Radiation fibrosis	14.97	13.22	3	107072	0	42514260
Pharyngeal stenosis	14.97	13.22	3	107072	0	42514260
Salivary gland cancer recurrent	14.97	13.22	3	107072	0	42514260
Eye pruritus	14.94	13.22	5	107070	11407	42502853
Restless legs syndrome	14.90	13.22	3	107072	9611	42504649
Herpes zoster	14.88	13.22	49	107026	38828	42475432
Blood urea decreased	14.85	13.22	18	107057	1388	42512872
Candida infection	14.78	13.22	99	106976	21511	42492749
Small cell lung cancer	14.73	13.22	22	107053	2073	42512187
Pneumocystis jirovecii pneumonia	14.68	13.22	111	106964	25070	42489190
Carbohydrate antigen 19-9 increased	14.68	13.22	9	107066	270	42513990
Urine sodium increased	14.58	13.22	6	107069	74	42514186
Rash pruritic	14.55	13.22	40	107035	33563	42480697
Cerebrovascular accident	14.51	13.22	165	106910	96995	42417265
Dyslipidaemia	14.47	13.22	3	107072	9415	42504845
Metapneumovirus bronchiolitis	14.44	13.22	4	107071	12	42514248
Blastic plasmacytoid dendritic cell neoplasia	14.44	13.22	6	107069	76	42514184
Rhinitis	14.42	13.22	6	107069	11971	42502289
Chondrosarcoma	14.40	13.22	5	107070	37	42514223
Hallucination, visual	14.39	13.22	19	107056	21001	42493259
Adult failure to thrive	14.37	13.22	6	107069	77	42514183
Hyperglycaemic hyperosmolar nonketotic syndrome	14.37	13.22	19	107056	1599	42512661
Myeloid leukaemia	14.36	13.22	11	107064	477	42513783
Cerebral haemorrhage	14.31	13.22	50	107025	38916	42475344
Blood creatinine	14.30	13.22	6	107069	78	42514182
Exposure to radiation	14.30	13.22	6	107069	78	42514182
Failure to thrive	14.21	13.22	54	107021	9368	42504892
Necrosis ischaemic	14.19	13.22	10	107065	381	42513879
Alpha 1 foetoprotein increased	14.11	13.22	13	107062	729	42513531
Flatulence	14.11	13.22	26	107049	25126	42489134
Drug clearance decreased	14.09	13.22	22	107053	2156	42512104
Malnutrition	14.07	13.22	73	107002	14469	42499791
Dry eye	14.05	13.22	11	107064	15495	42498765
Chemotherapeutic drug level increased	14.05	13.22	9	107066	292	42513968
Campylobacter test positive	13.96	13.22	6	107069	83	42514177
Acute coronary syndrome	13.96	13.22	74	107001	14791	42499469
Radiation hepatitis	13.95	13.22	5	107070	41	42514219
Hypothermia	13.93	13.22	7	107068	12508	42501752
Monocyte count decreased	13.91	13.22	18	107057	1483	42512777
Cell-mediated immune deficiency	13.83	13.22	6	107069	85	42514175
Myelitis transverse	13.83	13.22	17	107058	1330	42512930
Lung cancer metastatic	13.82	13.22	26	107049	2960	42511300
Carcinoembryonic antigen increased	13.81	13.22	14	107061	884	42513376
Ureteric compression	13.78	13.22	9	107066	302	42513958
Ureteric dilatation	13.73	13.22	8	107067	218	42514042
Tumour thrombosis	13.70	13.22	8	107067	219	42514041
Hepatic lesion	13.69	13.22	33	107042	4461	42509799
Peripheral blood stem cell apheresis	13.57	13.22	7	107068	149	42514111
Metastatic gastric cancer	13.57	13.22	7	107068	149	42514111
Device malfunction	13.56	13.22	7	107068	12320	42501940
Penile vein thrombosis	13.56	13.22	4	107071	16	42514244
Torulopsis infection	13.56	13.22	4	107071	16	42514244
Ischaemic stroke	13.53	13.22	99	106976	22134	42492126
Pharyngeal ulceration	13.50	13.22	10	107065	412	42513848
Haemorrhage	13.39	13.22	93	106982	60470	42453790
Type 2 diabetes mellitus	13.37	13.22	16	107059	18455	42495805
Increased appetite	13.35	13.22	3	107072	8903	42505357
Malocclusion	13.35	13.22	6	107069	93	42514167
Cerebral toxoplasmosis	13.30	13.22	21	107054	2077	42512183
Pneumothorax	13.29	13.22	103	106972	23440	42490820
Prescribed overdose	13.27	13.22	8	107067	12919	42501341
Plasmacytoma	13.24	13.22	32	107043	4332	42509928

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
Disease progression	3076.92	14.02	2666	158488	241368	110186777
Febrile neutropenia	2889.35	14.02	2889	158265	313878	110114267
Myelosuppression	2720.48	14.02	1700	159454	92640	110335505
Neutropenia	2662.76	14.02	2992	158162	371628	110056517
Malignant neoplasm progression	2356.96	14.02	1985	159169	172582	110255563
Thrombocytopenia	1783.59	14.02	2361	158793	346524	110081621
Mucosal inflammation	1322.17	14.02	1106	160048	95035	110333110
Pancytopenia	1163.60	14.02	1479	159675	208134	110220011
Anaemia	1152.04	14.02	2490	158664	544596	109883549
Haematotoxicity	1039.50	14.02	540	160614	20542	110407603
Bone marrow failure	860.83	14.02	697	160457	57151	110370994
Therapy partial responder	806.89	14.02	561	160593	36500	110391645
Acute myeloid leukaemia	719.58	14.02	529	160625	37581	110390564
Leukopenia	707.88	14.02	974	160180	147817	110280328
Neutrophil count decreased	685.65	14.02	863	160291	120078	110308067
Neoplasm progression	666.49	14.02	632	160522	63963	110364182
Off label use	649.31	14.02	4058	157096	1496127	108932018
Arthralgia	631.03	14.02	178	160976	779454	109648691
Renal salt-wasting syndrome	550.06	14.02	147	161007	741	110427404
Dehydration	522.24	14.02	1215	159939	278296	110149849
Second primary malignancy	505.84	14.02	320	160834	17748	110410397
Joint swelling	486.99	14.02	43	161111	442802	109985343
Myelodysplastic syndrome	461.40	14.02	405	160749	37079	110391066
Neutropenic sepsis	454.17	14.02	369	160785	30377	110397768
Acute kidney injury	444.35	14.02	1967	159187	633463	109794682
Vomiting	437.36	14.02	2535	158619	908140	109520005
Ototoxicity	430.95	14.02	178	160976	3953	110424192
Nephropathy toxic	419.05	14.02	336	160818	27142	110401003
Renal impairment	405.49	14.02	867	160287	187578	110240567
Aortic thrombosis	400.64	14.02	142	161012	2041	110426104
Nausea	395.56	14.02	3110	158044	1232580	109195565
Platelet count decreased	385.40	14.02	960	160194	229483	110198662
Pain	373.09	14.02	509	160645	954446	109473699
Arthropathy	372.15	14.02	10	161144	287512	110140633
Peripheral swelling	366.30	14.02	72	161082	403962	110024183
Diffuse large B-cell lymphoma recurrent	364.96	14.02	180	160974	6119	110422026
Sepsis	364.58	14.02	1177	159977	326169	110101976
Fall	350.41	14.02	224	160930	603258	109824887
Systemic lupus erythematosus	348.93	14.02	4	161150	254334	110173811
Product dose omission issue	348.92	14.02	33	161121	321749	110106396
Nasopharyngitis	347.73	14.02	75	161079	394286	110033859
Rheumatoid arthritis	346.44	14.02	23	161131	299590	110128555
Metastases to central nervous system	341.55	14.02	276	160878	22541	110405604
Weight increased	336.74	14.02	97	161057	419547	110008598
Completed suicide	336.28	14.02	3	161151	242378	110185767
Musculoskeletal stiffness	330.98	14.02	19	161135	279803	110148342
Headache	330.93	14.02	484	160670	881893	109546252
Abdominal discomfort	323.54	14.02	87	161067	393771	110034374
Tumour lysis syndrome	322.63	14.02	304	160850	30497	110397648
Neuropathy peripheral	322.20	14.02	768	160386	178509	110249636
Pulmonary embolism	316.89	14.02	853	160301	213621	110214524
Hypomagnesaemia	309.34	14.02	410	160744	59960	110368185
Septic shock	304.02	14.02	694	160460	156834	110271311
Glossodynia	302.26	14.02	4	161150	222000	110206145
White blood cell count decreased	301.20	14.02	874	160280	228516	110199629
Drug hypersensitivity	300.48	14.02	143	161011	453947	109974198
Swelling	295.07	14.02	74	161080	350967	110077178
Pemphigus	291.54	14.02	4	161150	214566	110213579
Pyrexia	287.70	14.02	2263	158891	896002	109532143
Wound	286.47	14.02	13	161141	234424	110193721
Metastases to lung	285.43	14.02	250	160904	22813	110405332
Asthma	273.08	14.02	25	161129	250266	110177879
Cardiotoxicity	269.33	14.02	212	160942	16669	110411476
Therapeutic product effect decreased	267.64	14.02	24	161130	244292	110183853
Hyponatraemia	267.38	14.02	810	160344	216843	110211302
Hypokalaemia	261.81	14.02	718	160436	181730	110246415
Wheezing	261.79	14.02	32	161122	255198	110172947
Mobility decreased	255.61	14.02	25	161129	237397	110190748
Cholangitis	253.86	14.02	202	160952	16133	110412012
Insomnia	251.93	14.02	105	161049	360485	110067660
Gastrointestinal toxicity	245.48	14.02	170	160984	10978	110417167
Metastases to liver	240.41	14.02	277	160877	35109	110393036
Muscle spasms	238.87	14.02	56	161098	278101	110150044
Drug abuse	234	14.02	5	161149	177406	110250739
Contraindicated product administered	231.83	14.02	41	161113	248226	110179919
Pain in extremity	230.54	14.02	222	160932	486896	109941249
Osteoarthritis	230.29	14.02	8	161146	182615	110245530
Fibromyalgia	228.72	14.02	4	161150	170905	110257240
Deafness	228.38	14.02	236	160918	26473	110401672
Dysphagia	225.86	14.02	610	160544	152990	110275155
Renal failure	222.22	14.02	781	160373	225793	110202352
Sinusitis	221.16	14.02	78	161076	296610	110131535
Oesophagitis	217.68	14.02	238	160916	28477	110399668
Cytopenia	216.90	14.02	243	160911	29873	110398272
Contusion	216.89	14.02	39	161115	233322	110194823
Disease recurrence	210.15	14.02	343	160811	60441	110367704
Blister	209.16	14.02	39	161115	227337	110200808
Decreased appetite	199.73	14.02	1281	159873	474565	109953580
Blood cholesterol increased	197.47	14.02	20	161134	184765	110243380
Duodenal ulcer perforation	195.83	14.02	17	161137	177683	110250462
Urticaria	193.68	14.02	112	161042	318745	110109400
Injection site pain	193.44	14.02	18	161136	177904	110250241
Condition aggravated	191.82	14.02	499	160655	734337	109693808
Injury	189.91	14.02	19	161135	177246	110250899
Depression	189.17	14.02	114	161040	317221	110110924
Discomfort	188.79	14.02	41	161113	214666	110213479
Pericarditis	186.36	14.02	45	161109	219069	110209076
Posterior reversible encephalopathy syndrome	185.94	14.02	238	160916	33623	110394522
Drug resistance	184	14.02	310	160844	56064	110372081
Sleep disorder	182.86	14.02	34	161120	198610	110229535
Migraine	182.33	14.02	19	161135	171633	110256512
Deep vein thrombosis	179.64	14.02	529	160625	139358	110288787
Metastases to lymph nodes	178.13	14.02	159	160995	14873	110413272
Infusion related reaction	177.62	14.02	176	160978	380986	110047159
Pruritus	175.73	14.02	365	160789	581195	109846950
Anxiety	173.01	14.02	149	161005	344929	110083216
Neurotoxicity	172.12	14.02	257	160897	41950	110386195
Arthritis	171.84	14.02	21	161133	167565	110260580
Overdose	171.60	14.02	63	161091	233731	110194414
Anastomotic leak	171.26	14.02	67	161087	1285	110426860
Hepatic enzyme increased	169.01	14.02	132	161022	320760	110107385
Type 2 diabetes mellitus	168.22	14.02	28	161126	177204	110250941
C-reactive protein abnormal	165.94	14.02	5	161149	129690	110298455
Intentional product misuse	163.54	14.02	7	161147	132897	110295248
Pneumonitis	162.00	14.02	350	160804	76181	110351964
Diffuse large B-cell lymphoma refractory	160.97	14.02	77	161077	2444	110425701
Drug intolerance	160.94	14.02	214	160940	406298	110021847
Electrolyte imbalance	160.44	14.02	232	160922	36796	110391349
Inappropriate antidiuretic hormone secretion	159.84	14.02	221	160933	33630	110394515
Oesophageal fistula	157.66	14.02	49	161105	454	110427691
Interstitial lung disease	156.63	14.02	503	160651	138831	110289314
Folliculitis	155.80	14.02	28	161126	167625	110260520
Radiation skin injury	155.73	14.02	66	161088	1566	110426579
Impaired healing	154.86	14.02	47	161107	196670	110231475
Radiation pneumonitis	151.64	14.02	90	161064	4446	110423699
Lower respiratory tract infection	151.04	14.02	83	161071	243023	110185122
Maternal exposure during pregnancy	148.50	14.02	94	161060	254789	110173356
Dizziness	148.50	14.02	521	160633	697672	109730473
Tinnitus	148.25	14.02	294	160860	60246	110367899
Psoriasis	147.38	14.02	16	161138	139977	110288168
Peripheral artery thrombosis	145.49	14.02	84	161070	3940	110424205
Teratoma	145.38	14.02	37	161117	148	110427997
Product use in unapproved indication	142.53	14.02	1127	160027	446250	109981895
Gait disturbance	138.36	14.02	121	161033	278087	110150058
Memory impairment	138.02	14.02	57	161097	196887	110231258
Cytokine release syndrome	136.92	14.02	311	160843	69995	110358150
Malignant transformation	136.69	14.02	59	161095	1466	110426679
Metastasis	136.59	14.02	106	161048	8161	110419984
Loss of personal independence in daily activities	135.26	14.02	27	161127	149993	110278152
Gait inability	135.23	14.02	19	161135	136357	110291788
Febrile bone marrow aplasia	134.54	14.02	146	161008	17319	110410826
Hypophagia	134.24	14.02	260	160894	52366	110375779
Joint range of motion decreased	133.29	14.02	12	161142	121820	110306325
Obesity	133.03	14.02	8	161146	113343	110314802
Deafness neurosensory	132.73	14.02	111	161043	9508	110418637
Hypocalcaemia	131.60	14.02	293	160861	65073	110363072
Blood creatinine increased	130.12	14.02	570	160584	182319	110245826
Hypoaesthesia	129.94	14.02	160	160994	314063	110114082
Renal tubular disorder	128.75	14.02	98	161056	7331	110420814
Hospitalisation	127.73	14.02	26	161128	142467	110285678
Immune-mediated hepatic disorder	127.51	14.02	80	161074	4370	110423775
Respiratory failure	127.43	14.02	636	160518	214696	110213449
Neutropenic colitis	125.89	14.02	100	161054	7965	110420180
Road traffic accident	124.78	14.02	8	161146	107390	110320755
Pulmonary toxicity	124.05	14.02	141	161013	17605	110410540
Venoocclusive liver disease	123.97	14.02	131	161023	15076	110413069
Blood lactate dehydrogenase increased	122.95	14.02	227	160927	44107	110384038
Neoplasm recurrence	122.81	14.02	83	161071	5149	110422996
Exposure during pregnancy	116.44	14.02	49	161105	167375	110260770
Leukoencephalopathy	116.44	14.02	101	161053	9094	110419051
Rash	115.58	14.02	712	160442	820252	109607893
Peripheral ischaemia	115.51	14.02	109	161045	10949	110417196
Gastrooesophageal reflux disease	113.89	14.02	60	161094	179916	110248229
Gastric perforation	112.85	14.02	77	161077	4852	110423293
Palmar-plantar erythrodysaesthesia syndrome	112.44	14.02	209	160945	40816	110387329
Immune-mediated enterocolitis	111.41	14.02	103	161051	10082	110418063
Bone marrow disorder	111.26	14.02	72	161082	4151	110423994
Hiccups	110.53	14.02	114	161040	12755	110415390
Arterial thrombosis	109.83	14.02	64	161090	3055	110425090
Aorto-oesophageal fistula	109.20	14.02	26	161128	73	110428072
Bacteraemia	108.81	14.02	210	160944	42180	110385965
Stress	108.48	14.02	13	161141	105335	110322810
Sciatica	107	14.02	7	161147	92392	110335753
Ovarian germ cell teratoma	106.95	14.02	25	161129	63	110428082
Nasal congestion	106.66	14.02	10	161144	98272	110329873
Suicidal ideation	106.22	14.02	8	161146	93929	110334216
Colitis	103.93	14.02	357	160797	101966	110326179
Hypercholesterolaemia	101.97	14.02	8	161146	90829	110337316
Polyneuropathy	101.75	14.02	174	160980	31838	110396307
Radiation oesophagitis	101.72	14.02	41	161113	853	110427292
Hypersensitivity	100.19	14.02	281	160873	403717	110024428
Blood pressure increased	100.18	14.02	138	161016	258235	110169910
Thrombotic microangiopathy	98.72	14.02	163	160991	28986	110399159
Renal tubular necrosis	98.66	14.02	167	160987	30308	110397837
Malaise	98.51	14.02	575	160579	671244	109756901
Red blood cell sedimentation rate increased	96.74	14.02	4	161150	78298	110349847
Musculoskeletal pain	96.67	14.02	75	161079	182948	110245197
Acute respiratory distress syndrome	96.64	14.02	229	160925	52969	110375176
Acquired gene mutation	95.62	14.02	56	161098	2698	110425447
Portal venous gas	95.33	14.02	34	161120	498	110427647
Adverse drug reaction	95.14	14.02	19	161135	105540	110322605
Recall phenomenon	93.30	14.02	44	161110	1352	110426793
Metastases to peritoneum	92.83	14.02	72	161082	5538	110422607
Suicide attempt	92.38	14.02	19	161135	103375	110324770
Dermatitis	92.05	14.02	154	161000	27683	110400462
Odynophagia	91.78	14.02	108	161046	13993	110414152
Hypoacusis	91.13	14.02	175	160979	35016	110393129
Cerebral infarction	90.78	14.02	220	160934	51618	110376527
Enteritis	90.34	14.02	125	161029	19031	110409114
Somnolence	90.28	14.02	186	160968	297263	110130882
Osteoradionecrosis	89.79	14.02	24	161130	121	110428024
Hepatitis B	89.59	14.02	89	161065	9523	110418622
Metastases to bone	88.71	14.02	162	160992	31210	110396935
Deafness bilateral	88.70	14.02	53	161101	2651	110425494
Bronchitis	88.60	14.02	60	161094	156972	110271173
Feeling abnormal	88.13	14.02	80	161074	180631	110247514
Illness	87.49	14.02	9	161145	82162	110345983
Cystitis haemorrhagic	87.02	14.02	98	161056	12111	110416034
Injection site erythema	86.90	14.02	16	161138	94160	110333985
Large intestine perforation	86.79	14.02	114	161040	16515	110411630
Osteoporosis	86.73	14.02	12	161142	87140	110341005
Dry mouth	86.70	14.02	98	161056	199850	110228295
Inappropriate schedule of product administration	84.87	14.02	103	161051	203534	110224611
Pleural effusion	84.19	14.02	494	160660	177215	110250930
Disseminated intravascular coagulation	84.15	14.02	186	160968	41100	110387045
Cardiomyopathy	83.51	14.02	164	160990	33361	110394784
Metastases to skin	83.14	14.02	48	161106	2251	110425894
Oesophagobronchial fistula	82.98	14.02	26	161128	248	110427897
Reactive capillary endothelial proliferation	82.36	14.02	18	161136	29	110428116
Teratoma benign	82.05	14.02	20	161134	64	110428081
Abdominal pain upper	82.04	14.02	249	160905	348862	110079283
Urogenital fistula	81.86	14.02	29	161125	416	110427729
Confusional state	81.65	14.02	378	160776	468302	109959843
Bicytopenia	81.41	14.02	72	161082	6652	110421493
Immune-mediated renal disorder	80.68	14.02	33	161121	714	110427431
Immune-mediated dermatitis	80.66	14.02	47	161107	2243	110425902
Night sweats	79.97	14.02	48	161106	133935	110294210
Myalgia	79.16	14.02	126	161028	222255	110205890
Osteosarcoma	79.08	14.02	28	161126	401	110427744
Lymphadenopathy	78.67	14.02	238	160916	63597	110364548
Vena cava thrombosis	78.62	14.02	54	161100	3440	110424705
Oesophageal stenosis	78.39	14.02	63	161091	5102	110423043
Frequent bowel movements	78.17	14.02	7	161147	71383	110356762
Immune-mediated hypothyroidism	78.17	14.02	50	161104	2825	110425320
Influenza	77.64	14.02	79	161075	169022	110259123
Mantle cell lymphoma recurrent	76.86	14.02	35	161119	991	110427154
Drug interaction	76.55	14.02	422	160732	499761	109928384
Prescribed overdose	76.39	14.02	17	161137	87564	110340581
B-cell lymphoma recurrent	75.86	14.02	36	161118	1122	110427023
Peritonitis	75.82	14.02	155	160999	32452	110395693
Tumour haemorrhage	75.44	14.02	62	161092	5183	110422962
Tumour necrosis	75.40	14.02	46	161108	2390	110425755
Diarrhoea	74.75	14.02	2180	158974	1137325	109290820
Liver abscess	74.63	14.02	73	161081	7666	110420479
Injection site reaction	74.33	14.02	19	161135	89051	110339094
Hepatic function abnormal	74.22	14.02	292	160862	89003	110339142
Wrong technique in product usage process	74.11	14.02	18	161136	87330	110340815
Aplasia	73.57	14.02	73	161081	7800	110420345
Balance disorder	73.52	14.02	39	161115	116521	110311624
Drug reaction with eosinophilia and systemic symptoms	73.52	14.02	15	161139	82080	110346065
Live birth	72.98	14.02	8	161146	69476	110358669
Blood pressure fluctuation	72.83	14.02	11	161143	74813	110353332
Sedation	70.76	14.02	9	161145	69674	110358471
Injection site swelling	70.61	14.02	5	161149	61785	110366360
Radiation injury	70.55	14.02	33	161121	995	110427150
Heart rate decreased	70.32	14.02	17	161137	82739	110345406
Cataract	70.20	14.02	15	161139	79470	110348675
Chloroma	70.13	14.02	31	161123	817	110427328
Prescribed underdose	69.74	14.02	7	161147	65167	110362978
Stomatitis	69.74	14.02	650	160504	269592	110158553
Product quality issue	69.48	14.02	14	161140	77285	110350860
Immune-mediated myocarditis	69.27	14.02	50	161104	3448	110424697
Pulmonary vascular disorder	69.26	14.02	33	161121	1038	110427107
Performance status decreased	69.06	14.02	68	161086	7198	110420947
Intestinal ischaemia	68.09	14.02	100	161054	16079	110412066
Rhabdomyolysis	67.92	14.02	46	161108	120355	110307790
Incorrect dose administered	67.88	14.02	33	161121	103608	110324537
Embolism	67.57	14.02	100	161054	16189	110411956
Joint stiffness	67.52	14.02	9	161145	67234	110360911
Serotonin syndrome	66.98	14.02	5	161149	59148	110368997
Ear infection	66.45	14.02	7	161147	62725	110365420
Oesophageal perforation	66.36	14.02	37	161117	1622	110426523
Intentional product use issue	66.29	14.02	166	160988	247740	110180405
Renal infarct	66.03	14.02	48	161106	3347	110424798
Cytomegalovirus oesophagitis	65.66	14.02	31	161123	955	110427190
Blood stem cell transplant failure	65.08	14.02	28	161126	690	110427455
Immune-mediated lung disease	64.64	14.02	57	161097	5246	110422899
Hypertension	64.27	14.02	457	160697	509627	109918518
Amnesia	63.98	14.02	37	161117	105371	110322774
Skin toxicity	63.39	14.02	82	161072	11701	110416444
Bronchial fistula	63.00	14.02	21	161133	248	110427897
Muscular weakness	62.91	14.02	171	160983	248297	110179848
Influenza like illness	62.88	14.02	25	161129	88387	110339758
Fatigue	62.44	14.02	1325	159829	1214633	109213512
Pregnancy	61.80	14.02	3	161151	51064	110377081
Pneumatosis intestinalis	61.71	14.02	69	161085	8460	110419685
Arteriospasm coronary	61.40	14.02	71	161083	9029	110419116
Haemophagocytic lymphohistiocytosis	60.76	14.02	139	161015	31420	110396725
Thrombophlebitis migrans	59.87	14.02	27	161127	747	110427398
Metastases to breast	59.85	14.02	22	161132	353	110427792
Liver function test increased	59.83	14.02	27	161127	88521	110339624
Hypoalbuminaemia	59.57	14.02	131	161023	28843	110399302
Gastrointestinal perforation	58.60	14.02	63	161091	7393	110420752
Lymphopenia	58.45	14.02	159	160995	40011	110388134
Medication error	58.45	14.02	41	161113	105325	110322820
Vision blurred	58.40	14.02	61	161093	128961	110299184
Osteosarcoma metastatic	58.11	14.02	14	161140	42	110428103
Tumour perforation	57.96	14.02	25	161129	620	110427525
Atypical haemolytic uraemic syndrome	57.96	14.02	33	161121	1507	110426638
Fanconi syndrome	57.87	14.02	45	161109	3474	110424671
Pulmonary arteriopathy	57.67	14.02	16	161138	95	110428050
Ameloblastoma	57.39	14.02	16	161138	97	110428048
Hepatic cirrhosis	57.25	14.02	14	161140	67612	110360533
Extremity necrosis	56.91	14.02	46	161108	3756	110424389
Ill-defined disorder	56.64	14.02	88	161066	156765	110271380
Salivary gland cancer	56.60	14.02	23	161131	489	110427656
Peripheral sensory neuropathy	56.11	14.02	93	161061	16587	110411558
Chronic obstructive pulmonary disease	56.04	14.02	46	161108	109112	110319033
Agranulocytosis	55.46	14.02	207	160947	61553	110366592
Splenic infarction	55.29	14.02	48	161106	4326	110423819
Bone erosion	55.24	14.02	3	161151	46368	110381777
Hydronephrosis	55.03	14.02	104	161050	20561	110407584
Liver injury	54.68	14.02	84	161070	150329	110277816
Empyema	54.57	14.02	53	161101	5517	110422628
Accidental exposure to product	54.49	14.02	5	161149	50003	110378142
Hallucination	54.27	14.02	41	161113	101391	110326754
Wound infection	54.22	14.02	37	161117	96428	110331717
Metastases to adrenals	54.09	14.02	32	161122	1571	110426574
Drug clearance decreased	53.66	14.02	46	161108	4076	110424069
Nail disorder	53.11	14.02	10	161144	57925	110370220
Progressive multifocal leukoencephalopathy	52.64	14.02	114	161040	24842	110403303
Enterocolitis	52.50	14.02	97	161057	18852	110409293
Osteosarcoma recurrent	52.29	14.02	16	161138	140	110428005
Electrocardiogram QT prolonged	52.21	14.02	49	161105	108911	110319234
Underdose	52.18	14.02	14	161140	63540	110364605
Cerebral venous thrombosis	52.10	14.02	41	161113	3221	110424924
Inflammation	51.96	14.02	129	161025	193109	110235036
Dyspepsia	51.73	14.02	127	161027	190838	110237307
Intestinal perforation	51.61	14.02	102	161052	20842	110407303
Neck pain	51.59	14.02	62	161092	123068	110305077
Charles Bonnet syndrome	51.08	14.02	13	161141	52	110428093
Granulocyte count decreased	51.02	14.02	44	161110	3930	110424215
Plasma cell myeloma recurrent	51.00	14.02	57	161097	6985	110421160
Alopecia	50.83	14.02	317	160837	364436	110063709
Oedema	50.57	14.02	148	161006	209828	110218317
Coronary artery thrombosis	50.15	14.02	40	161114	3204	110424941
Upper respiratory tract infection	50.02	14.02	71	161083	131257	110296888
Hepatitis B reactivation	49.84	14.02	58	161096	7426	110420719
Cerebral ischaemia	49.76	14.02	74	161080	12030	110416115
Hypothyroidism	49.39	14.02	224	160930	72675	110355470
Fluid retention	49.34	14.02	39	161115	94268	110333877
Blood sodium decreased	49.23	14.02	145	161009	38174	110389971
Blood pressure systolic increased	49.14	14.02	30	161124	82961	110345184
Lactic acidosis	49.04	14.02	38	161116	92773	110335372
Back pain	48.36	14.02	329	160825	370667	110057478
Rhinorrhoea	48.22	14.02	47	161107	102619	110325526
Malnutrition	48.00	14.02	116	161038	27163	110400982
Haemoglobin decreased	47.52	14.02	563	160591	248164	110179981
Cardiac disorder	47.41	14.02	26	161128	76254	110351891
Oedema peripheral	47.16	14.02	283	160871	328377	110099768
Burning sensation	46.93	14.02	21	161133	69191	110358954
Product prescribing error	46.76	14.02	9	161145	51322	110376823
Anastomotic complication	46.27	14.02	21	161133	590	110427555
Heart rate increased	46.15	14.02	87	161067	143747	110284398
Necrosis	45.85	14.02	69	161085	11337	110416808
Tremor	45.53	14.02	147	161007	202085	110226060
Oesophageal-pulmonary fistula	45.17	14.02	11	161143	35	110428110
Hypogammaglobulinaemia	44.99	14.02	94	161060	19982	110408163
Hypoglycaemia	44.99	14.02	62	161092	116042	110312103
Pharyngeal inflammation	44.61	14.02	29	161125	1685	110426460
Eastern Cooperative Oncology Group performance status worsened	44.61	14.02	36	161118	2933	110425212
Ascites	44.58	14.02	259	160895	92549	110335596
Blindness cortical	44.55	14.02	25	161129	1110	110427035
Staphylococcal bacteraemia	44.46	14.02	84	161070	16604	110411541
Radiation mucositis	44.45	14.02	17	161137	306	110427839
Laryngitis	44.24	14.02	5	161149	42406	110385739
X-ray abnormal	43.80	14.02	3	161151	38114	110390031
Drug withdrawal syndrome	43.71	14.02	3	161151	38051	110390094
Dyspnoea	43.69	14.02	1254	159900	1105618	109322527
Tumour pseudoprogression	43.68	14.02	28	161126	1588	110426557
Cardiac failure congestive	43.64	14.02	97	161057	150903	110277242
Bacterial translocation	43.19	14.02	27	161127	1465	110426680
Swollen tongue	43.03	14.02	17	161137	60345	110367800
Angioedema	42.99	14.02	48	161106	98452	110329693
Incorrect route of product administration	42.56	14.02	20	161134	64041	110364104
Embolism arterial	42.46	14.02	29	161125	1830	110426315
Dry skin	42.20	14.02	57	161097	107596	110320549
Nightmare	42.04	14.02	4	161150	38859	110389286
Pneumothorax	42.02	14.02	130	161024	35155	110392990
Small cell lung cancer	41.55	14.02	36	161118	3236	110424909
Lymphangiosis carcinomatosa	41.38	14.02	32	161122	2450	110425695
Product use issue	41.32	14.02	275	160879	311420	110116725
Eye pain	41.20	14.02	11	161143	50088	110378057
Hepatic lesion	40.92	14.02	56	161098	8437	110419708
Lung disorder	40.44	14.02	131	161023	179916	110248229
Localised infection	40.39	14.02	7	161147	43041	110385104
Dermatitis acneiform	40.34	14.02	69	161085	12626	110415519
Tracheo-oesophageal fistula	40.30	14.02	20	161134	689	110427456
Adverse event	40.28	14.02	60	161094	108749	110319396
Lymphoma	40.12	14.02	90	161064	20081	110408064
Lip swelling	40.04	14.02	12	161142	50655	110377490
Candida infection	39.89	14.02	157	160997	47852	110380293
Metastases to meninges	39.72	14.02	43	161111	5085	110423060
Stem cell transplant	39.44	14.02	40	161114	4387	110423758
Nervousness	39.32	14.02	4	161150	36847	110391298
Colitis ulcerative	39.21	14.02	33	161121	77330	110350815
Immune-mediated cholangitis	38.91	14.02	21	161133	863	110427282
Hypercreatininaemia	38.68	14.02	24	161130	1285	110426860
Abortion spontaneous	38.53	14.02	3	161151	34279	110393866
Lung lobectomy	38.35	14.02	14	161140	220	110427925
Metastatic neoplasm	38.25	14.02	45	161109	5828	110422317
Chemical peritonitis	38.23	14.02	15	161139	290	110427855
Extravasation	38.19	14.02	41	161113	4804	110423341
Swelling face	38.13	14.02	47	161107	92274	110335871
Muscle spasticity	38.06	14.02	4	161150	35911	110392234
Adrenal insufficiency	37.99	14.02	142	161012	42248	110385897
Limb injury	37.88	14.02	5	161149	37631	110390514
Hyperammonaemic encephalopathy	37.68	14.02	43	161111	5391	110422754
Neoplasm	37.54	14.02	62	161092	11025	110417120
Hypophosphataemia	37.44	14.02	120	161034	33062	110395083
Multiple organ dysfunction syndrome	37.16	14.02	361	160793	151349	110276796
Basal cell carcinoma	37.11	14.02	10	161144	45260	110382885
Plasmacytoma	37.10	14.02	42	161112	5220	110422925
Herpes simplex encephalitis	36.99	14.02	20	161134	825	110427320
Adrenocortical carcinoma	36.93	14.02	11	161143	87	110428058
Injection site haemorrhage	36.81	14.02	3	161151	33025	110395120
Infectious pleural effusion	36.13	14.02	40	161114	4851	110423294
Refractory cancer	36.05	14.02	14	161140	263	110427882
Thrombophlebitis	36.05	14.02	50	161104	7629	110420516
Therapy interrupted	35.57	14.02	14	161140	49808	110378337
Gastrointestinal necrosis	35.39	14.02	46	161108	6594	110421551
Immune effector cell-associated neurotoxicity syndrome	35.23	14.02	71	161083	14711	110413434
Pancreatitis	35.19	14.02	51	161103	93482	110334663
Throat irritation	35.14	14.02	17	161137	53535	110374610
Product administration error	35.03	14.02	6	161148	37211	110390934
Choriocarcinoma	35.01	14.02	10	161144	67	110428078
Oesophageal haemorrhage	34.97	14.02	26	161128	1877	110426268
Palpitations	34.95	14.02	117	161037	159095	110269050
Eye irritation	34.75	14.02	4	161150	33448	110394697
Bone formation decreased	34.73	14.02	11	161143	109	110428036
Abdominal compartment syndrome	34.68	14.02	26	161128	1901	110426244
Neutrophil count abnormal	34.56	14.02	40	161114	5092	110423053
Large intestinal ulcer perforation	34.51	14.02	10	161144	71	110428074
Visual impairment	34.39	14.02	92	161062	134336	110293809
Ischaemic stroke	34.33	14.02	135	161019	41128	110387017
Device related infection	34.27	14.02	131	161023	39388	110388757
Gout	34.19	14.02	6	161148	36560	110391585
Haemoptysis	34.18	14.02	199	160955	71155	110356990
Eczema	34.06	14.02	33	161121	72260	110355885
Acquired tracheo-oesophageal fistula	34.01	14.02	12	161142	170	110427975
Ureteric rupture	33.89	14.02	7	161147	7	110428138
Eye pruritus	33.85	14.02	4	161150	32771	110395374
Alpha 1 foetoprotein increased	33.83	14.02	19	161135	845	110427300
Encephalopathy	33.74	14.02	218	160936	80837	110347308
Bacterial abdominal infection	33.73	14.02	9	161145	45	110428100
Limb discomfort	33.54	14.02	9	161145	40845	110387300
Neurosensory hypoacusis	33.49	14.02	13	161141	244	110427901
Staphylococcal infection	33.46	14.02	195	160959	69749	110358396
Cervix neoplasm	33.32	14.02	12	161142	181	110427964
Retinitis	33.25	14.02	4	161150	32323	110395822
Wernicke's encephalopathy	33.21	14.02	8	161146	24	110428121
Metastases to pleura	33.10	14.02	26	161128	2037	110426108
Papillary thyroid cancer	33.08	14.02	30	161124	2864	110425281
Unevaluable event	32.90	14.02	23	161131	59204	110368941
Nasal abscess	32.85	14.02	12	161142	189	110427956
Plasma cell leukaemia	32.82	14.02	26	161128	2062	110426083
Anisometropia	32.73	14.02	10	161144	87	110428058
Carbohydrate antigen 19-9 increased	32.54	14.02	16	161138	540	110427605
Acoustic stimulation tests abnormal	32.49	14.02	8	161146	27	110428118
Gene mutation	32.42	14.02	32	161122	3397	110424748
Melanoderma	31.98	14.02	15	161139	455	110427690
Mesenteric abscess	31.97	14.02	11	161143	144	110428001
Cervix carcinoma recurrent	31.95	14.02	9	161145	57	110428088
Adrenocorticotropic hormone deficiency	31.82	14.02	26	161128	2156	110425989
Taste disorder	31.80	14.02	29	161125	65358	110362787
Blood HIV RNA increased	31.75	14.02	26	161128	2162	110425983
Accidental overdose	31.73	14.02	18	161136	51816	110376329
Myasthenia gravis crisis	31.59	14.02	24	161130	1790	110426355
Device issue	31.57	14.02	6	161148	34529	110393616
Aortitis	31.48	14.02	25	161129	1990	110426155
Sinus disorder	31.42	14.02	5	161149	32723	110395422
Blood pressure diastolic decreased	31.22	14.02	7	161147	35878	110392267
Sleep apnoea syndrome	31.21	14.02	10	161144	40437	110387708
Eye disorder	31.20	14.02	3	161151	28903	110399242
Hypovolaemic shock	31.19	14.02	67	161087	14516	110413629
Clostridium bacteraemia	31.16	14.02	15	161139	483	110427662
Haematochezia	31.14	14.02	77	161077	115447	110312698
Flagellate dermatitis	31.13	14.02	13	161141	297	110427848
Ileus	31.00	14.02	107	161047	30622	110397523
Procedural pain	30.82	14.02	7	161147	35558	110392587
Paraneoplastic syndrome	30.81	14.02	21	161133	1321	110426824
Sinus congestion	30.76	14.02	4	161150	30455	110397690
Immune-mediated encephalitis	30.64	14.02	20	161134	1170	110426975
Rib fracture	30.59	14.02	6	161148	33764	110394381
Axillary vein thrombosis	30.41	14.02	17	161137	749	110427396
Gastrointestinal anastomotic leak	30.39	14.02	17	161137	750	110427395
Metastatic lymphoma	30.36	14.02	16	161138	626	110427519
Hip fracture	30.30	14.02	7	161147	35144	110393001
Acne	30.27	14.02	6	161148	33514	110394631
Gastrointestinal fungal infection	30.15	14.02	17	161137	762	110427383
Urinary tract toxicity	30.13	14.02	7	161147	17	110428128
Acute myocardial infarction	29.93	14.02	217	160937	83560	110344585
Emotional distress	29.79	14.02	14	161140	44833	110383312
Ovarian cancer recurrent	29.79	14.02	16	161138	651	110427494
Subclavian vein thrombosis	29.74	14.02	28	161126	2804	110425341
Myelitis transverse	29.65	14.02	26	161128	2375	110425770
Intervertebral disc protrusion	29.57	14.02	3	161151	27695	110400450
Mesenteric artery thrombosis	29.51	14.02	18	161136	935	110427210
Dry eye	29.27	14.02	23	161131	55770	110372375
EGFR gene mutation	29.24	14.02	15	161139	555	110427590
Labelled drug-drug interaction medication error	29.23	14.02	4	161150	29298	110398847
Nephrolithiasis	29.18	14.02	32	161122	66180	110361965
Fluid intake reduced	29.14	14.02	43	161111	6943	110421202
Coronary artery disease	29.08	14.02	37	161117	71653	110356492
Granulocytopenia	29.04	14.02	60	161094	12655	110415490
Diaphragm muscle weakness	29.02	14.02	11	161143	193	110427952
Nephritis bacterial	28.91	14.02	8	161146	47	110428098
Radiotherapy	28.85	14.02	21	161133	1467	110426678
Panic attack	28.76	14.02	4	161150	28936	110399209
Lung cancer metastatic	28.74	14.02	33	161121	4165	110423980
Irritability	28.70	14.02	17	161137	47792	110380353
Cholelithiasis	28.68	14.02	30	161124	63392	110364753
Dyskinesia	28.55	14.02	20	161134	51426	110376719
Cerebellar haemangioma	28.53	14.02	9	161145	88	110428057
Agitation	28.45	14.02	78	161076	112973	110315172
Hyperadrenocorticism	28.44	14.02	15	161139	588	110427557
Blood creatine phosphokinase increased	28.33	14.02	39	161115	73038	110355107
Abdominal distension	28.25	14.02	145	161009	174958	110253187
Blood test abnormal	28.25	14.02	4	161150	28550	110399595
Treatment failure	28.16	14.02	263	160891	276971	110151174
Fanconi syndrome acquired	28.11	14.02	28	161126	3006	110425139
Superior mesenteric artery syndrome	28.07	14.02	11	161143	212	110427933
Traumatic lung injury	28.07	14.02	26	161128	2551	110425594
Hallucination, auditory	27.82	14.02	3	161151	26394	110401751
Refeeding syndrome	27.74	14.02	11	161143	219	110427926
Hyperhidrosis	27.53	14.02	160	160994	187138	110241007
Tendonitis	27.40	14.02	3	161151	26080	110402065
Adverse reaction	27.36	14.02	5	161149	29589	110398556
Testicular malignant teratoma	27.33	14.02	6	161148	10	110428135
Biliary obstruction	27.31	14.02	37	161117	5521	110422624
Visceral venous thrombosis	27.31	14.02	7	161147	29	110428116
Skin exfoliation	27.26	14.02	54	161100	87597	110340548
Tumour thrombosis	27.09	14.02	12	161142	318	110427827
Tubulointerstitial nephritis	27.05	14.02	153	161001	54131	110374014
Rectal haemorrhage	27.03	14.02	87	161067	119746	110308399
Paraesthesia	26.95	14.02	265	160889	276256	110151889
Multiple sclerosis	26.88	14.02	3	161151	25695	110402450
Cystitis	26.87	14.02	34	161120	66002	110362143
Therapy cessation	26.86	14.02	16	161138	44841	110383304
Blood glucose increased	26.66	14.02	101	161053	132395	110295750
Hepatic candidiasis	26.57	14.02	9	161145	112	110428033
Extrapyramidal disorder	26.42	14.02	5	161149	28862	110399283
Gastric disorder	26.18	14.02	8	161146	33349	110394796
Malignant pleural effusion	26.06	14.02	31	161123	4062	110424083
Staphylococcus test positive	26.02	14.02	42	161112	7328	110420817
Transient ischaemic attack	25.97	14.02	33	161121	63949	110364196
Plasma cells increased	25.94	14.02	9	161145	121	110428024
Iron deficiency anaemia	25.82	14.02	7	161147	31552	110396593
Urinary tract infection	25.75	14.02	328	160826	325954	110102191
Myoclonus	25.74	14.02	8	161146	32990	110395155
Pain in jaw	25.73	14.02	22	161132	51155	110376990
Systemic infection	25.63	14.02	49	161105	9770	110418375
Medulloblastoma recurrent	25.55	14.02	10	161144	192	110427953
BK virus infection	25.53	14.02	58	161096	13048	110415097
Immune-mediated adrenal insuficiency	25.51	14.02	21	161133	1759	110426386
Erythropenia	25.51	14.02	13	161141	474	110427671
Melanosis	25.47	14.02	8	161146	77	110428068
Acute monocytic leukaemia	25.40	14.02	14	161140	600	110427545
Recurrent cancer	25.29	14.02	28	161126	3395	110424750
Failure to thrive	25.26	14.02	59	161095	13515	110414630
Myeloid leukaemia	25.25	14.02	16	161138	889	110427256
Blood glucose decreased	25.16	14.02	6	161148	29482	110398663
Wound evisceration	25.10	14.02	9	161145	134	110428011
Blood magnesium decreased	25.05	14.02	75	161079	19921	110408224
Hepatotoxicity	24.86	14.02	168	160986	63232	110364913
Oesophageal squamous cell carcinoma metastatic	24.73	14.02	5	161149	4	110428141
Granulocyte-colony stimulating factor level increased	24.73	14.02	5	161149	4	110428141
Optic atrophy	24.72	14.02	24	161130	2497	110425648
Diabetes mellitus	24.68	14.02	69	161085	99312	110328833
Poisoning	24.68	14.02	6	161148	29099	110399046
Chemotherapeutic drug level increased	24.66	14.02	13	161141	509	110427636
Acute coronary syndrome	24.65	14.02	82	161072	23030	110405115
Primitive neuroectodermal tumour	24.63	14.02	7	161147	46	110428099
Metastases to the mediastinum	24.61	14.02	15	161139	778	110427367
Delirium	24.61	14.02	107	161047	134918	110293227
Aggression	24.60	14.02	30	161124	59180	110368965
Stress cardiomyopathy	24.44	14.02	64	161090	15742	110412403
Testicular cancer metastatic	24.43	14.02	8	161146	89	110428056
Crying	24.41	14.02	4	161150	25624	110402521
Thrombotic thrombocytopenic purpura	24.39	14.02	40	161114	7071	110421074
Hypopituitarism	24.32	14.02	31	161123	4359	110423786
Cytomegalovirus infection	24.26	14.02	149	161005	54295	110373850
Retinopathy	24.10	14.02	31	161123	4398	110423747
Depressed mood	24.03	14.02	32	161122	60777	110367368
Renal tubular injury	23.97	14.02	26	161128	3082	110425063
Tumour associated fever	23.92	14.02	17	161137	1144	110427001
Metastases to spine	23.91	14.02	34	161120	5309	110422836
Haematoma	23.90	14.02	30	161124	58446	110369699
Vascular pseudoaneurysm	23.87	14.02	30	161124	4160	110423985
Hypercalcaemia of malignancy	23.76	14.02	13	161141	549	110427596
Cerebral venous sinus thrombosis	23.70	14.02	25	161129	2870	110425275
Pneumocystis jirovecii pneumonia	23.69	14.02	124	161030	42611	110385534
Blood culture positive	23.68	14.02	45	161109	8931	110419214
Ejection fraction decreased	23.62	14.02	120	161034	40760	110387385
Fibrosis	23.58	14.02	41	161113	7601	110420544
Respiratory alkalosis	23.55	14.02	35	161119	5686	110422459
Thrombocytosis	23.52	14.02	49	161105	10395	110417750
RUNX1 gene mutation	23.43	14.02	7	161147	56	110428089
Hypersomnia	23.38	14.02	6	161148	28055	110400090
Sopor	23.38	14.02	12	161142	36534	110391611
Product substitution issue	23.36	14.02	3	161151	23058	110405087
International normalised ratio increased	23.26	14.02	58	161096	86714	110341431
Gastrointestinal obstruction	23.24	14.02	22	161132	2218	110425927
Lymphadenopathy mediastinal	23.23	14.02	34	161120	5450	110422695
Movement disorder	23.22	14.02	12	161142	36392	110391753
Pulmonary artery thrombosis	23.17	14.02	19	161135	1583	110426562
Myocarditis	23.15	14.02	96	161058	29959	110398186
Chromaturia	23.12	14.02	7	161147	29353	110398792
Obstructive airways disorder	23.00	14.02	20	161134	46129	110382016
Cough	22.99	14.02	505	160649	461136	109967009
Surgery	22.97	14.02	16	161138	41267	110386878
Hyperthyroidism	22.96	14.02	94	161060	29167	110398978
Sneezing	22.81	14.02	9	161145	31975	110396170
Clostridium colitis	22.59	14.02	26	161128	3289	110424856
Lung abscess	22.58	14.02	32	161122	4980	110423165
Peritoneal gliomatosis	22.53	14.02	5	161149	9	110428136
Non-small cell lung cancer	22.46	14.02	41	161113	7894	110420251
Immune-mediated hyperthyroidism	22.41	14.02	13	161141	615	110427530
Dysstasia	22.37	14.02	10	161144	32976	110395169
Acute promyelocytic leukaemia	22.35	14.02	20	161134	1876	110426269
Pulmonary fistula	22.32	14.02	8	161146	119	110428026
Disturbance in attention	22.16	14.02	35	161119	61960	110366185
Left ventricular dysfunction	22.14	14.02	80	161074	23413	110404732
Unmasking of previously unidentified disease	22.13	14.02	24	161130	2844	110425301
Chemotherapy	22.12	14.02	21	161133	2125	110426020
Autoimmune hypothyroidism	22.10	14.02	12	161142	499	110427646
Ear pain	22.08	14.02	27	161127	53199	110374946
Arteritis	22.04	14.02	16	161138	1113	110427032
Cancer with a high tumour mutational burden	22.01	14.02	6	161148	33	110428112
Tracheal stenosis	21.98	14.02	13	161141	638	110427507
Hepatic mass	21.92	14.02	24	161130	2874	110425271
Gastroenteritis viral	21.92	14.02	9	161145	31217	110396928
Aortic embolus	21.87	14.02	7	161147	72	110428073
Radiotherapy to bone	21.86	14.02	5	161149	11	110428134
Dysphonia	21.75	14.02	49	161105	75880	110352265
Epilepsy	21.74	14.02	74	161080	100135	110328010
Respiratory distress	21.58	14.02	173	160981	68701	110359444
KMT2A gene mutation	21.57	14.02	6	161148	36	110428109
Radiotherapy to lung	21.56	14.02	5	161149	12	110428133
Ovarian vein thrombosis	21.37	14.02	7	161147	78	110428067
Streptococcal bacteraemia	21.32	14.02	30	161124	4639	110423506
Renal-limited thrombotic microangiopathy	21.32	14.02	12	161142	536	110427609
Skin haemorrhage	21.29	14.02	5	161149	24822	110403323
Feeding disorder	21.21	14.02	74	161080	21288	110406857
Hyperlipidaemia	21.16	14.02	13	161141	35835	110392310
Necrotising oesophagitis	21.12	14.02	18	161136	1582	110426563
Restless legs syndrome	21.03	14.02	5	161149	24621	110403524
Eustachian tube dysfunction	21.00	14.02	13	161141	693	110427452
Mediastinitis	21.00	14.02	17	161137	1391	110426754
Treatment noncompliance	20.99	14.02	47	161107	72943	110355202
Malignant ascites	20.98	14.02	17	161137	1393	110426752
Body temperature decreased	20.98	14.02	14	161140	36921	110391224
Toxic leukoencephalopathy	20.96	14.02	18	161136	1599	110426546
Cannabinoid hyperemesis syndrome	20.90	14.02	7	161147	84	110428061
Rash pruritic	20.89	14.02	73	161081	97996	110330149
Myocardial necrosis marker increased	20.87	14.02	27	161127	3853	110424292
Candida pneumonia	20.86	14.02	15	161139	1028	110427117
Haemoperitoneum	20.81	14.02	32	161122	5356	110422789
Adenocarcinoma gastric	20.78	14.02	20	161134	2059	110426086
Metastases to abdominal cavity	20.78	14.02	14	161140	864	110427281
Mood swings	20.78	14.02	4	161150	22808	110405337
Hypochloraemia	20.76	14.02	26	161128	3592	110424553
Varicella zoster virus infection	20.75	14.02	35	161119	6333	110421812
Hyperpyrexia	20.73	14.02	40	161114	8029	110420116
Chest pain	20.72	14.02	405	160749	375970	110052175
Tumour invasion	20.66	14.02	12	161142	569	110427576
Full blood count abnormal	20.66	14.02	31	161123	56021	110372124
Renal tubular dysfunction	20.60	14.02	14	161140	876	110427269
Uterine atrophy	20.51	14.02	5	161149	16	110428129
Viral load increased	20.48	14.02	25	161129	3365	110424780
Metastases to bladder	20.46	14.02	10	161144	333	110427812
Amputation stump pain	20.42	14.02	6	161148	45	110428100
Muscle twitching	20.42	14.02	9	161145	29926	110398219
Infected neoplasm	20.40	14.02	12	161142	583	110427562
Glaucoma	20.40	14.02	4	161150	22513	110405632
Organising pneumonia	20.34	14.02	56	161098	14187	110413958
Pneumonia	20.30	14.02	1511	159643	875203	109552942
Metastases to kidney	20.25	14.02	12	161142	591	110427554
Alveolar soft part sarcoma	20.25	14.02	7	161147	93	110428052
Capillary leak syndrome	20.17	14.02	30	161124	4878	110423267
Breast cancer	20.08	14.02	16	161138	38526	110389619
Delusion	19.95	14.02	5	161149	23750	110404395
Chest discomfort	19.84	14.02	160	160994	173688	110254457
Klebsiella test positive	19.81	14.02	21	161133	2425	110425720
B-cell lymphoma refractory	19.78	14.02	8	161146	168	110427977
Hypovolaemia	19.75	14.02	73	161081	21601	110406544
Inferior vena caval occlusion	19.72	14.02	7	161147	101	110428044
Laryngeal pain	19.68	14.02	33	161121	5942	110422203
Embryonal rhabdomyosarcoma	19.66	14.02	6	161148	52	110428093
Transitional cell carcinoma recurrent	19.65	14.02	5	161149	20	110428125
Vertigo	19.64	14.02	63	161091	86807	110341338
Necrotising colitis	19.60	14.02	18	161136	1747	110426398
Chromosomal deletion	19.56	14.02	8	161146	173	110427972
Secondary adrenocortical insufficiency	19.52	14.02	28	161126	4406	110423739
Eosinophilia	19.51	14.02	34	161120	57902	110370243
Lung adenocarcinoma	19.49	14.02	43	161111	9488	110418657
Chylothorax	19.48	14.02	15	161139	1141	110427004
Heart rate irregular	19.45	14.02	13	161141	34261	110393884
Thrombocytopenia neonatal	19.45	14.02	5	161149	21	110428124
Oral fungal infection	19.43	14.02	28	161126	4424	110423721
Hot flush	19.42	14.02	42	161112	65994	110362151
Portal vein thrombosis	19.39	14.02	36	161118	7022	110421123
Dysgeusia	19.38	14.02	171	160983	69814	110358331
Maternal death affecting foetus	19.36	14.02	4	161150	4	110428141
Vibrio vulnificus infection	19.36	14.02	4	161150	4	110428141
Trigeminal nerve paresis	19.36	14.02	4	161150	4	110428141
Anti-Muellerian hormone level decreased	19.29	14.02	7	161147	108	110428037
Venous thrombosis	19.26	14.02	40	161114	8465	110419680
Nail pigmentation	19.25	14.02	10	161144	380	110427765
Pneumonia fungal	19.11	14.02	56	161098	14698	110413447
Mental disorder	19.11	14.02	17	161137	38774	110389371
Median nerve injury	19.08	14.02	5	161149	23	110428122
Sinus polyp	19.07	14.02	12	161142	659	110427486
Iliac artery occlusion	19.05	14.02	10	161144	388	110427757
Carcinoembryonic antigen increased	19.00	14.02	22	161132	2802	110425343
Hepatic steatosis	18.99	14.02	26	161128	48805	110379340
Adenoviral hepatitis	18.98	14.02	14	161140	998	110427147
Jaw operation	18.89	14.02	13	161141	831	110427314
Gastrointestinal ischaemia	18.78	14.02	11	161143	530	110427615
General physical health deterioration	18.75	14.02	778	160376	424517	110003628
BRAF gene mutation	18.72	14.02	6	161148	62	110428083
Hernia	18.67	14.02	3	161151	19497	110408648
Purulent pericarditis	18.67	14.02	7	161147	119	110428026
Kidney infection	18.59	14.02	7	161147	25592	110402553
Enterocolitis infectious	18.58	14.02	24	161130	3420	110424725
Trismus	18.57	14.02	34	161120	6562	110421583
Mucosal toxicity	18.51	14.02	12	161142	694	110427451
Enterococcus test positive	18.50	14.02	22	161132	2882	110425263
Ulcer haemorrhage	18.48	14.02	5	161149	22566	110405579
Abdominal neoplasm	18.43	14.02	12	161142	699	110427446
Toxocariasis	18.42	14.02	5	161149	27	110428118
Tooth disorder	18.42	14.02	10	161144	29499	110398646
Carotid artery dissection	18.39	14.02	10	161144	417	110427728
Metastases to retroperitoneum	18.37	14.02	10	161144	418	110427727
Joint effusion	18.35	14.02	4	161150	20901	110407244
Metastases to abdominal wall	18.34	14.02	8	161146	204	110427941
Upper limb fracture	18.32	14.02	4	161150	20884	110407261
Testicular germ cell cancer metastatic	18.30	14.02	6	161148	67	110428078
Blood iron decreased	18.30	14.02	3	161151	19211	110408934
Ureteric compression	18.27	14.02	9	161145	305	110427840
Haematopoietic stem cell mobilisation	18.26	14.02	10	161144	423	110427722
Fistula of small intestine	18.23	14.02	14	161140	1061	110427084
Sweat gland tumour	18.18	14.02	11	161143	563	110427582
Neutropenic infection	18.11	14.02	23	161131	3222	110424923
Spinal stenosis	18.10	14.02	3	161151	19053	110409092
Immunosuppression	18.05	14.02	62	161092	17697	110410448
Chronic sinusitis	17.99	14.02	7	161147	25077	110403068
Bacterial sepsis	17.98	14.02	44	161110	10382	110417763
Mydriasis	17.96	14.02	5	161149	22152	110405993
Glycosylated haemoglobin increased	17.94	14.02	6	161148	23613	110404532
Klebsiella infection	17.90	14.02	67	161087	19942	110408203
Gastroenteritis sapovirus	17.78	14.02	8	161146	220	110427925
Apparent mineralocorticoid excess	17.76	14.02	6	161148	74	110428071
Cardiac tamponade	17.71	14.02	46	161108	11261	110416884
Injection site rash	17.70	14.02	6	161148	23413	110404732
Haemoglobin abnormal	17.61	14.02	40	161114	8998	110419147
Impaired quality of life	17.56	14.02	11	161143	30006	110398139
Brachiocephalic vein thrombosis	17.54	14.02	9	161145	333	110427812
Vitamin D deficiency	17.44	14.02	3	161151	18549	110409596
Drug level decreased	17.44	14.02	3	161151	18545	110409600
Abnormal DNA methylation	17.43	14.02	4	161150	9	110428136
Ganglioneuroma	17.39	14.02	7	161147	145	110428000
Anaplastic lymphoma kinase gene mutation	17.39	14.02	7	161147	145	110428000
Paraneoplastic dermatomyositis	17.36	14.02	8	161146	233	110427912
Poor venous access	17.33	14.02	7	161147	24515	110403630
Endothelial dysfunction	17.27	14.02	9	161145	344	110427801
Pharyngeal stenosis	17.20	14.02	5	161149	36	110428109
Vascular injury	17.17	14.02	14	161140	1157	110426988
Subcutaneous emphysema	17.16	14.02	20	161134	2564	110425581
Cardiac pseudoaneurysm	17.14	14.02	6	161148	83	110428062
Post procedural diarrhoea	17.11	14.02	10	161144	480	110427665
Peripheral blood stem cell apheresis	17.09	14.02	7	161147	152	110427993
Pneumonia adenoviral	17.08	14.02	11	161143	629	110427516
Abnormal behaviour	17.06	14.02	19	161135	39020	110389125
Asthenia	17.05	14.02	1194	159960	687805	109740340
Liver function test abnormal	17.03	14.02	48	161106	68902	110359243
Leukaemic lymphoma	17.01	14.02	6	161148	85	110428060
Hyperbilirubinaemia	17.00	14.02	89	161065	30582	110397563
Device malfunction	16.94	14.02	8	161146	25550	110402595
Small intestinal perforation	16.92	14.02	26	161128	4350	110423795
Parasitic pneumonia	16.85	14.02	5	161149	39	110428106
Azoospermia	16.84	14.02	8	161146	250	110427895
Retinal ischaemia	16.83	14.02	13	161141	994	110427151
Bronchiectasis	16.80	14.02	17	161137	36476	110391669
Blood loss anaemia	16.76	14.02	3	161151	18022	110410123
Carpal tunnel syndrome	16.73	14.02	6	161148	22604	110405541
Sputum discoloured	16.68	14.02	10	161144	27935	110400210
Parathyroid tumour malignant	16.64	14.02	7	161147	163	110427982
Pneumonia escherichia	16.63	14.02	14	161140	1210	110426935
Cholangitis infective	16.63	14.02	12	161142	827	110427318
Laboratory test abnormal	16.61	14.02	24	161130	44055	110384090
Metapneumovirus bronchiolitis	16.60	14.02	4	161150	12	110428133
Bile duct cancer recurrent	16.60	14.02	4	161150	12	110428133
DNA mismatch repair protein gene mutation	16.60	14.02	4	161150	12	110428133
Deafness congenital	16.60	14.02	3	161151	0	110428145
Gingivitis ulcerative	16.56	14.02	10	161144	510	110427635
Hepatic failure	16.55	14.02	163	160991	68576	110359569
Enterococcal bacteraemia	16.54	14.02	26	161128	4435	110423710
Blood pressure immeasurable	16.51	14.02	19	161135	2404	110425741
Oesophageal squamous cell carcinoma	16.49	14.02	10	161144	514	110427631
Thymus enlargement	16.48	14.02	7	161147	167	110427978
Paranoia	16.45	14.02	6	161148	22368	110405777
Depressed level of consciousness	16.45	14.02	96	161058	112182	110315963
Angina pectoris	16.41	14.02	42	161112	62253	110365892
Ureteric dilatation	16.38	14.02	8	161146	266	110427879
Myositis	16.37	14.02	89	161065	31027	110397118
Duodenal ulcer	16.36	14.02	64	161090	19450	110408695
Retroperitoneal neoplasm	16.32	14.02	5	161149	44	110428101
Sarcomatoid carcinoma	16.32	14.02	5	161149	44	110428101
Retroperitoneal neoplasm metastatic	16.22	14.02	5	161149	45	110428100
Enterococcal sepsis	16.20	14.02	22	161132	3290	110424855
Enterobacter bacteraemia	16.16	14.02	15	161139	1475	110426670
Biliary tract infection	16.14	14.02	16	161138	1708	110426437
Myasthenic syndrome	16.12	14.02	14	161140	1262	110426883
Pelvic venous thrombosis	16.08	14.02	20	161134	2744	110425401
Fistula	16.07	14.02	54	161100	15245	110412900
Intestinal metastasis	16.06	14.02	10	161144	539	110427606
Systemic candida	16.06	14.02	41	161113	9933	110418212
Cerebral artery occlusion	16.04	14.02	17	161137	1963	110426182
Pneumonia aspiration	15.99	14.02	185	160969	81048	110347097
Metastases to thorax	15.95	14.02	8	161146	282	110427863
Pericardial effusion	15.94	14.02	140	161014	57077	110371068
Skin ulcer	15.94	14.02	44	161110	63601	110364544
Middle insomnia	15.94	14.02	5	161149	20497	110407648
Right ventricular failure	15.90	14.02	9	161145	25945	110402200
Immune-mediated thyroiditis	15.86	14.02	13	161141	1083	110427062
Transplant rejection	15.81	14.02	8	161146	24559	110403586
Mucosal erosion	15.74	14.02	20	161134	2804	110425341
Noctiphobia	15.72	14.02	4	161150	16	110428129
Oroticaciduria	15.72	14.02	4	161150	16	110428129
Hepatic artery occlusion	15.64	14.02	6	161148	109	110428036
Nervous system disorder	15.54	14.02	89	161065	31632	110396513
Cytomegalovirus chorioretinitis	15.54	14.02	33	161121	7095	110421050
Feeling hot	15.52	14.02	74	161080	91032	110337113
Pneumomediastinum	15.51	14.02	27	161127	5009	110423136
Mucosal pain	15.49	14.02	5	161149	53	110428092
Poor quality sleep	15.47	14.02	11	161143	28066	110400079
Dementia	15.46	14.02	14	161140	31659	110396486
Atelectasis	15.44	14.02	99	161055	36613	110391532
Hypoxia	15.44	14.02	270	160884	129245	110298900
Non-small cell lung cancer metastatic	15.42	14.02	14	161140	1338	110426807
Spinal column injury	15.41	14.02	18	161136	2313	110425832
Candida test positive	15.40	14.02	14	161140	1341	110426804
Facial paralysis	15.36	14.02	73	161081	24141	110404004
Streptococcus test positive	15.34	14.02	19	161135	2595	110425550
Marchiafava-Bignami disease	15.34	14.02	4	161150	18	110428127
Gastroenteritis pseudomonas	15.32	14.02	5	161149	55	110428090
Hypoglossal nerve paresis	15.29	14.02	6	161148	116	110428029
Central nervous system necrosis	15.29	14.02	9	161145	438	110427707
Mood altered	15.27	14.02	6	161148	21369	110406776
Blood chloride decreased	15.23	14.02	38	161116	9077	110419068
Squamous cell carcinoma of the cervix	15.21	14.02	8	161146	312	110427833
Electrocardiogram ST segment depression	15.18	14.02	28	161126	5433	110422712
Rotator cuff syndrome	15.18	14.02	3	161151	16791	110411354
Paraesthesia oral	15.14	14.02	16	161138	33655	110394490
Device related sepsis	15.07	14.02	34	161120	7613	110420532
Femur fracture	15.06	14.02	26	161128	44443	110383702
Tonic clonic movements	15.04	14.02	20	161134	2932	110425213
White blood cell disorder	15.02	14.02	23	161131	3836	110424309
Thyroiditis	14.99	14.02	31	161123	6542	110421603
Morphoea	14.97	14.02	10	161144	608	110427537
Haemorrhoids	14.90	14.02	18	161136	35654	110392491
Retinal toxicity	14.80	14.02	15	161139	1644	110426501
Intestinal infarction	14.75	14.02	14	161140	1416	110426729
Computerised tomogram abnormal	14.68	14.02	23	161131	3913	110424232
Papilloedema	14.67	14.02	33	161121	7376	110420769
Musculoskeletal discomfort	14.66	14.02	8	161146	23530	110404615
Colony stimulating factor therapy	14.63	14.02	10	161144	632	110427513
Fracture	14.62	14.02	9	161145	24779	110403366
Coma	14.61	14.02	106	161048	117763	110310382
Skin discolouration	14.58	14.02	31	161123	49015	110379130
Sarcoma	14.58	14.02	12	161142	1005	110427140
Adenocarcinoma	14.58	14.02	24	161130	4256	110423889
Superior vena cava occlusion	14.55	14.02	7	161147	225	110427920
Procedural vomiting	14.55	14.02	12	161142	1008	110427137
Radiculopathy	14.53	14.02	5	161149	19331	110408814
Eye swelling	14.53	14.02	16	161138	33032	110395113
Neuroectodermal neoplasm	14.53	14.02	4	161150	23	110428122
Pharyngeal erosion	14.52	14.02	3	161151	3	110428142
Immune-mediated adverse reaction	14.49	14.02	15	161139	1685	110426460
Duodenal perforation	14.47	14.02	19	161135	2751	110425394
Myocardial infarction	14.45	14.02	195	160959	191888	110236257
Laryngeal oedema	14.45	14.02	39	161115	9768	110418377
Vaginitis gardnerella	14.43	14.02	5	161149	67	110428078
Pelvic fluid collection	14.42	14.02	12	161142	1021	110427124
Tumour rupture	14.38	14.02	10	161144	650	110427495
Campylobacter test positive	14.37	14.02	6	161148	137	110428008
Dystonia	14.36	14.02	10	161144	25795	110402350
Polyneuropathy in malignant disease	14.34	14.02	9	161145	492	110427653
Bradycardia	14.33	14.02	151	161003	155366	110272779
Embolism venous	14.28	14.02	26	161128	4997	110423148
Skin fissures	14.26	14.02	9	161145	24449	110403696
Laryngeal cancer stage IV	14.24	14.02	4	161150	25	110428120
Incorrect product administration duration	14.24	14.02	6	161148	20492	110407653
Immune-mediated arthritis	14.20	14.02	10	161144	663	110427482
Motor dysfunction	14.20	14.02	9	161145	24397	110403748
Dyspnoea exertional	14.18	14.02	91	161063	103969	110324176
Metastases to chest wall	14.16	14.02	10	161144	666	110427479
Photosensitivity reaction	14.13	14.02	10	161144	25579	110402566
Meningitis tuberculous	14.12	14.02	13	161141	1265	110426880
Stent malfunction	14.10	14.02	5	161149	72	110428073
Visceral leishmaniasis	14.09	14.02	15	161139	1741	110426404
Oesophageal squamous cell carcinoma recurrent	14.06	14.02	3	161151	4	110428141
Oesophageal prosthesis insertion	14.06	14.02	3	161151	4	110428141
Sepsis pasteurella	14.06	14.02	3	161151	4	110428141

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01XA01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Platinum compounds
FDA EXT	N0000175073	Platinum-containing Compounds
FDA EPC	N0000175413	Platinum-based Drug
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D003432	Cross-Linking Reagents
MeSH PA	D007202	Indicators and Reagents
MeSH PA	D011838	Radiation-Sensitizing Agents
CHEBI has role	CHEBI:25435	mutagen
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:38068	antimalarial
CHEBI has role	CHEBI:47868	photosensitizing agent
CHEBI has role	CHEBI:50684	cross-linking reagent
CHEBI has role	CHEBI:50902	genotoxin
CHEBI has role	CHEBI:50909	nephrotoxic agent
CHEBI has role	CHEBI:50919	antiemetic
CHEBI has role	CHEBI:67079	anti-inflammatory agent
CHEBI has role	CHEBI:68495	apoptosis inducer
CHEBI has role	CHEBI:75835	anti-anaemic agent
CHEBI has role	CHEBI:173085	ferroptosis inducer
CHEBI has role	CHEBI:231911	renoprotective agent
CHEBI has role	CHEBI:233423	antifibrotic agent

Related Drugs by ATC class:

L01XA Platinum compounds 3 drugs

carboplatin oxaliplatin satraplatin

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

Disease	Relation	SNOMED_ID	DOID
Malignant tumor of ovary	indication	363443007	DOID:2394
Ovarian Germ Cell Tumor Carcinoma	indication
Testicular Germ Cell Tumor	indication
Invasive Bladder Malignancy	indication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN	Ki	5.95	CHEMBL
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN	Ki	5.37	CHEMBL
Canalicular multispecific organic anion transporter 1	Transporter	Q92887	MRP2_HUMAN			WOMBAT-PK
Adenosine receptor A3	GPCR	P0DMS8	AA3R_HUMAN	Ki	5.62	DRUG MATRIX
Multidrug resistance-associated protein 6	Transporter	O95255	MRP6_HUMAN			WOMBAT-PK
Multidrug resistance-associated protein 5	Transporter	O15440	MRP5_HUMAN			WOMBAT-PK
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN	IC50	5.58	DRUG MATRIX
Tyrosine-protein kinase Lck	Kinase	P06239	LCK_HUMAN	IC50	4.64	DRUG MATRIX
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN	IC50	5.32	DRUG MATRIX
C-X-C chemokine receptor type 2	GPCR	P25025	CXCR2_HUMAN	Ki	5.02	DRUG MATRIX
Thromboxane-A synthase	Enzyme	P24557	THAS_HUMAN	IC50	5.03	DRUG MATRIX
C-C chemokine receptor type 2	GPCR	P41597	CCR2_HUMAN	Ki	5.15	DRUG MATRIX
Mitogen-activated protein kinase 3	Kinase	P27361	MK03_HUMAN	IC50	5.34	DRUG MATRIX
Melanocortin receptor 5	GPCR	P33032	MC5R_HUMAN	Ki	5.22	DRUG MATRIX
Sodium/potassium-transporting ATPase subunit alpha-2	Ion channel		AT1A2_PIG	IC50	5.03	DRUG MATRIX

External reference:

ID	Source
D00275	KEGG_DRUG
4018139	VUID
N0000146476	NUI
4018139	VANDF
C0008838	UMLSCUI
CHEBI:27899	CHEBI
CPT	PDB_CHEM_ID
CHEMBL11359	ChEMBL_ID
DB00515	DRUGBANK_ID
5343	IUPHAR_LIGAND_ID
4426	INN_ID
Q20Q21Q62J	UNII
5460033	PUBCHEM_CID
2555	RXNORM
31747	MMSL
4456	MMSL
d00195	MMSL
002641	NDDF
387318005	SNOMEDCT_US
57066004	SNOMEDCT_US
D002945	MESH_DESCRIPTOR_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9504	INJECTION	1 mg	INTRAVENOUS	ANDA	19 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9505	INJECTION	1 mg	INTRAVENOUS	ANDA	19 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5747	INJECTION, SOLUTION	50 mg	INTRAVENOUS	ANDA	26 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5748	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	16729-288	INJECTION	1 mg	INTRAVENOUS	ANDA	26 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	25021-253	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	21 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	44567-509	INJECTION, SOLUTION	1 mg	INTRAVENOUS	NDA	19 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	44567-510	INJECTION, SOLUTION	1 mg	INTRAVENOUS	NDA	19 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	44567-511	INJECTION, SOLUTION	1 mg	INTRAVENOUS	NDA	19 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	44567-530	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6277	INJECTION, SOLUTION	50 mg	INTRAVENOUS	Unapproved drug for use in drug shortage	2 sections
CISplatin	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6279	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	20 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	63323-103	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	65219-359	INJECTION, SOLUTION	1 mg	INTRAVENOUS	Unapproved drug for use in drug shortage	2 sections
Cisplatin	HUMAN PRESCRIPTION DRUG LABEL	1	68001-283	INJECTION	1 mg	INTRAVENOUS	ANDA	26 sections
CISPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	68001-608	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
CISPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	68001-609	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
CISPLATIN	Human Prescription Drug Label	1	68083-162	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
CISPLATIN	Human Prescription Drug Label	1	68083-163	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
CISPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	72266-252	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections
CISPLATIN	HUMAN PRESCRIPTION DRUG LABEL	1	72266-253	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	13 sections

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

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: