ID
4264
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00770445
Link
http://clinicaltrials.gov/show/NCT00770445
Palabras clave
Versiones (3)
- 6/12/13 6/12/13 - Martin Dugas
- 16/4/14 16/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
6 de diciembre de 2013
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00770445 Diabetes Mellitus
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
Has a history of type 1 diabetes mellitus.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0011854
- SNOMED CT 2011_0131
- 46635009
- MedDRA 14.1
- 10067584
- LOINC Version 232
- MTHU020217
- ICD-10-CM Version 2010
- E10
Descripción
Has uncontrolled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 95mmHg) or change of antihypertensive treatment within the last 2 weeks.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1868885
- MedDRA 14.1
- 10066860
- UMLS CUI 2011AA
- C0871470
- SNOMED CT 2011_0131
- 271649006
- UMLS CUI 2011AA
- C0428883
- SNOMED CT 2011_0131
- 271650006
- UMLS CUI 2011AA
- C0392747
- SNOMED CT 2011_0131
- 243326001
- UMLS CUI 2011AA
- C0585941
- SNOMED CT 2011_0131
- 308116003
Descripción
Has acute infections.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0275518
- SNOMED CT 2011_0131
- 63171007
Descripción
Has anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
Descripción
Has a history of severe or multiple allergies.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0455609
- SNOMED CT 2011_0131
- 161614004
Descripción
History of drug or alcohol abuse in the past 5 years
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1299544
- SNOMED CT 2011_0131
- 371435006
- UMLS CUI 2011AA
- C0221628
- SNOMED CT 2011_0131
- 371434005
Descripción
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (Alanine Aminotransferase and/or Aspartate Aminotransferase > 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, Glomerular Filtration Rate < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0007222
- SNOMED CT 2011_0131
- 105980002
- MedDRA 14.1
- 10007649
- ICD-9-CM Version 2011
- 429.2
- UMLS CUI 2011AA
- C1319793
- SNOMED CT 2011_0131
- 420300004
- MedDRA 14.1
- 10064079
- UMLS CUI 2011AA
- C1319794
- SNOMED CT 2011_0131
- 421704003
- MedDRA 14.1
- 10064080
- UMLS CUI 2011AA
- C1319795
- SNOMED CT 2011_0131
- 420913000
- MedDRA 14.1
- 10064081
- UMLS CUI 2011AA
- C1319796
- SNOMED CT 2011_0131
- 422293003
- MedDRA 14.1
- 10064082
- UMLS CUI 2011AA
- C0035204
- SNOMED CT 2011_0131
- 50043002
- MedDRA 14.1
- 10038683
- ICD-10-CM Version 2010
- J98.9
- ICD-9-CM Version 2011
- 519.9
- UMLS CUI 2011AA
- C0017178
- SNOMED CT 2011_0131
- 119292006
- MedDRA 14.1
- 10017944
- UMLS CUI 2011AA
- C1869009
- MedDRA 14.1
- 20000005
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C0022658
- SNOMED CT 2011_0131
- 90708001
- MedDRA 14.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C0017654
- SNOMED CT 2011_0131
- 80274001
- MedDRA 14.1
- 10018355
- UMLS CUI 2011AA
- C2711451
- SNOMED CT 2011_0131
- 442407001
- UMLS CUI 2011AA
- C0027765
- SNOMED CT 2011_0131
- 118940003
- MedDRA 14.1
- 10029202
- ICD-10-CM Version 2010
- G98.8
- ICD-9-CM Version 2011
- 349.9
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- UMLS CUI 2011AA
- C0018939
- SNOMED CT 2011_0131
- 191124002
- MedDRA 14.1
- 10061590
- ICD-10-CM Version 2010
- D75.9
- ICD-9-CM Version 2011
- 289.9
Descripción
History of macular edema.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0271051
- SNOMED CT 2011_0131
- 37231002
- MedDRA 14.1
- 10025415
Descripción
State after kidney transplantation.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0231290
- SNOMED CT 2011_0131
- 237679004
- UMLS CUI 2011AA
- C0022671
- SNOMED CT 2011_0131
- 70536003
- MedDRA 14.1
- 10038533
- ICD-9-CM Version 2011
- 55.6
Descripción
Serum potassium > 5.5 mmol/L.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0302353
- SNOMED CT 2011_0131
- 271236005
- MedDRA 14.1
- 10040376
Descripción
History of primary hyperaldosteronism.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1384514
- SNOMED CT 2011_0131
- 190507007
- MedDRA 14.1
- 10036692
- ICD-10-CM Version 2010
- E26.01
- ICD-9-CM Version 2011
- 255.12
Descripción
Acute myocardial infarction, open heart surgery or cerebral event (stroke/ Transitory Ischemic Attack) within the previous 12 months.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0155626
- SNOMED CT 2011_0131
- 57054005
- MedDRA 14.1
- 10000891
- ICD-10-CM Version 2010
- I21
- ICD-9-CM Version 2011
- 410
- UMLS CUI 2011AA
- C0189745
- SNOMED CT 2011_0131
- 2598006
- MedDRA 14.1
- 10048935
- UMLS CUI 2011AA
- C0228174
- SNOMED CT 2011_0131
- 372073000
- UMLS CUI 2011AA
- C0441471
- SNOMED CT 2011_0131
- 272379006
- LOINC Version 232
- MTHU019184
- UMLS CUI 2011AA
- C0038454
- SNOMED CT 2011_0131
- 230690007
- MedDRA 14.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE 1105E
- E12826
- UMLS CUI 2011AA
- C0007787
- SNOMED CT 2011_0131
- 266257000
- MedDRA 14.1
- 10044390
- LOINC Version 232
- MTHU020810
- ICD-10-CM Version 2010
- G45.9
- ICD-9-CM Version 2011
- 435.9
- CTCAE 1105E
- E12834
Descripción
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1554075
- HL7 V3 2006_05
- NP
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0033080
- SNOMED CT 2011_0131
- 16076005
- UMLS CUI 2011AA
- C1360419
- UMLS CUI 2011AA
- C0013231
- SNOMED CT 2011_0131
- 329505003, 80288002
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0013175
- SNOMED CT 2011_0131
- 185922005
Descripción
Pre-treatment with gemfibrozil within the last 12 weeks.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1882440
- UMLS CUI 2011AA
- C0017245
- SNOMED CT 2011_0131
- 35282000
- LOINC Version 232
- MTHU002557
Descripción
Pre-treatment with rifampicin within the last 12 weeks.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1882440
- UMLS CUI 2011AA
- C0035608
- SNOMED CT 2011_0131
- 387159009
- LOINC Version 232
- MTHU008474
Descripción
Treatment with thiazolidinediones within the past 3 months.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C1257987
- SNOMED CT 2011_0131
- 109086001
Descripción
If statin therapy applicable: Change of medication within the last 4 weeks.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0750557
- UMLS CUI 2011AA
- C0360714
- SNOMED CT 2011_0131
- 372912004
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C1706839
- UMLS CUI 2011AA
- C0580105
- SNOMED CT 2011_0131
- 182838006
Descripción
Has used non-steroidal anti-inflammatory agents including low dose ASA or Cox-2-inhibitors if therapy has been initiated within the last 4 weeks.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0003211
- SNOMED CT 2011_0131
- 16403005, 372665008
- UMLS CUI 2011AA
- C0721444
- UMLS CUI 2011AA
- C1257954
- SNOMED CT 2011_0131
- 387050005
- UMLS CUI 2011AA
- C1517741
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Descripción
Treatment with any other investigational drug within 4 weeks before trial entry.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
Descripción
Any elective surgery during study participation.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0206058
- SNOMED CT 2011_0131
- 274075007
- MedDRA 14.1
- 10058829
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
Descripción
Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0020615
- SNOMED CT 2011_0131
- 302866003
- MedDRA 14.1
- 10020993
- ICD-10-CM Version 2010
- E16.2
- ICD-9-CM Version 2011
- 251.2
- CTCAE 1105E
- E12322
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1554196
- HL7 V3 2006_05
- ENC
Descripción
History of dehydration, precoma diabeticorum or shock or diabetic ketoacidosis within the past year prior to screening visit.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0011175
- SNOMED CT 2011_0131
- 34095006
- MedDRA 14.1
- 10012174
- LOINC Version 232
- MTHU020843
- ICD-10-CM Version 2010
- E86.0
- ICD-9-CM Version 2011
- 276.51
- CTCAE 1105E
- E12258
- UMLS CUI 2011AA
- C0241863
- MedDRA 14.1
- 10012641
- UMLS CUI 2011AA
- C1142529
- MedDRA 14.1
- 10058705
- UMLS CUI 2011AA
- C0851302
- SNOMED CT 2011_0131
- 360546002
- MedDRA 14.1
- 10040576
- UMLS CUI 2011AA
- C0011880
- SNOMED CT 2011_0131
- 420422005
- MedDRA 14.1
- 10012671
- ICD-9-CM Version 2011
- 250.1
Descripción
Acute or scheduled investigation with iodine containing radiopaque material.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0430007
- UMLS CUI 2011AA
- C0021968
- SNOMED CT 2011_0131
- 325330005
- LOINC Version 232
- MTHU009375
- UMLS CUI 2011AA
- C0332256
- SNOMED CT 2011_0131
- 42504009
- UMLS CUI 2011AA
- C0302587
- UMLS CUI 2011AA
- C0520510
- SNOMED CT 2011_0131
- 260769002
- LOINC Version 232
- MTHU013790
- HL7 V3 2006_05
- MAT
Descripción
Uncontrolled unstable angina pectoris.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0002965
- SNOMED CT 2011_0131
- 4557003
- MedDRA 14.1
- 10002388
- ICD-10-CM Version 2010
- I20.0
- ICD-9-CM Version 2011
- 411.1
Descripción
Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0262926
- SNOMED CT 2011_0131
- 417662000
- LOINC Version 232
- MTHU027722
- UMLS CUI 2011AA
- C0031046
- SNOMED CT 2011_0131
- 3238004
- MedDRA 14.1
- 10034484
- CTCAE 1105E
- E10180
- UMLS CUI 2011AA
- C0027059
- SNOMED CT 2011_0131
- 50920009
- MedDRA 14.1
- 10028606
- ICD-10-CM Version 2010
- I51.4
- ICD-9-CM Version 2011
- 429.0
- CTCAE 1105E
- E10157
- UMLS CUI 2011AA
- C0014118
- SNOMED CT 2011_0131
- 56819008
- MedDRA 14.1
- 10014665
- ICD-9-CM Version 2011
- 424.90
- UMLS CUI 2011AA
- C0034065
- SNOMED CT 2011_0131
- 59282003
- MedDRA 14.1
- 10037377
- ICD-10-CM Version 2010
- I26
- ICD-9-CM Version 2011
- 415.1
- UMLS CUI 2011AA
- C0003507
- SNOMED CT 2011_0131
- 60573004
- MedDRA 14.1
- 10002918
- UMLS CUI 2011AA
- C0003486
- SNOMED CT 2011_0131
- 67362008
- MedDRA 14.1
- 10002882
- ICD-10-CM Version 2010
- I71.9
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- StudyEvent: Eligibility
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255.12 (ICD-9-CM Version 2011)
57054005 (SNOMED CT 2011_0131)
10000891 (MedDRA 14.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
C0189745 (UMLS CUI 2011AA)
2598006 (SNOMED CT 2011_0131)
10048935 (MedDRA 14.1)
C0228174 (UMLS CUI 2011AA)
372073000 (SNOMED CT 2011_0131)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
NP (HL7 V3 2006_05)
C0013227 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C1360419 (UMLS CUI 2011AA)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0013175 (UMLS CUI 2011AA)
185922005 (SNOMED CT 2011_0131)
C0017245 (UMLS CUI 2011AA)
35282000 (SNOMED CT 2011_0131)
MTHU002557 (LOINC Version 232)
C0035608 (UMLS CUI 2011AA)
387159009 (SNOMED CT 2011_0131)
MTHU008474 (LOINC Version 232)
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
C0360714 (UMLS CUI 2011AA)
372912004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1706839 (UMLS CUI 2011AA)
C0580105 (UMLS CUI 2011AA)
182838006 (SNOMED CT 2011_0131)
16403005, 372665008 (SNOMED CT 2011_0131)
C0721444 (UMLS CUI 2011AA)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
274075007 (SNOMED CT 2011_0131)
10058829 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
24484000 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
392521001 (SNOMED CT 2011_0131)
C0011175 (UMLS CUI 2011AA)
34095006 (SNOMED CT 2011_0131)
10012174 (MedDRA 14.1)
MTHU020843 (LOINC Version 232)
E86.0 (ICD-10-CM Version 2010)
276.51 (ICD-9-CM Version 2011)
E12258 (CTCAE 1105E)
C0241863 (UMLS CUI 2011AA)
10012641 (MedDRA 14.1)
C1142529 (UMLS CUI 2011AA)
10058705 (MedDRA 14.1)
C0851302 (UMLS CUI 2011AA)
360546002 (SNOMED CT 2011_0131)
10040576 (MedDRA 14.1)
C0011880 (UMLS CUI 2011AA)
420422005 (SNOMED CT 2011_0131)
10012671 (MedDRA 14.1)
250.1 (ICD-9-CM Version 2011)
C0021968 (UMLS CUI 2011AA)
325330005 (SNOMED CT 2011_0131)
MTHU009375 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0302587 (UMLS CUI 2011AA)
C0520510 (UMLS CUI 2011AA)
260769002 (SNOMED CT 2011_0131)
MTHU013790 (LOINC Version 232)
MAT (HL7 V3 2006_05)
19032002 (SNOMED CT 2011_0131)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0031046 (UMLS CUI 2011AA)
3238004 (SNOMED CT 2011_0131)
10034484 (MedDRA 14.1)
E10180 (CTCAE 1105E)
C0027059 (UMLS CUI 2011AA)
50920009 (SNOMED CT 2011_0131)
10028606 (MedDRA 14.1)
I51.4 (ICD-10-CM Version 2010)
429.0 (ICD-9-CM Version 2011)
E10157 (CTCAE 1105E)
C0014118 (UMLS CUI 2011AA)
56819008 (SNOMED CT 2011_0131)
10014665 (MedDRA 14.1)
424.90 (ICD-9-CM Version 2011)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
C0003507 (UMLS CUI 2011AA)
60573004 (SNOMED CT 2011_0131)
10002918 (MedDRA 14.1)
C0003486 (UMLS CUI 2011AA)
67362008 (SNOMED CT 2011_0131)
10002882 (MedDRA 14.1)
I71.9 (ICD-10-CM Version 2010)