ID
4516
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT00630864
Länk
http://clinicaltrials.gov/show/NCT00630864
Nyckelord
Versioner (2)
- 2013-12-10 2013-12-10 - Martin Dugas
- 2021-09-17 2021-09-17 -
Uppladdad den
10 december 2013
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT00630864 Transthyretin-associated Amyloidosis With Polyneuropathy
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beskrivning
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as > 3-4 times/month (ibuprofen and nimesulide will be permitted).
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0003211
- SNOMED CT 2011_0131
- 16403005
- UMLS CUI 2011AA
- C1704788
- UMLS CUI 2011AA
- C1632851
- SNOMED CT 2011_0131
- 417929005
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C1524004
- UMLS CUI 2011AA
- C0593507
- SNOMED CT 2011_0131
- 387207008
- LOINC Version 232
- MTHU004262
- UMLS CUI 2011AA
- C0132515
Beskrivning
Patient has primary or secondary amyloidosis.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0268381
- SNOMED CT 2011_0131
- 23132008
- MedDRA 14.1
- 10036673
- UMLS CUI 2011AA
- C0221014
- SNOMED CT 2011_0131
- 281034005
- MedDRA 14.1
- 10039811
- ICD-10-CM Version 2010
- E85.3
Beskrivning
Patient has TTR-associated amyloidosis with V30M mutation.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0032923
- SNOMED CT 2011_0131
- 37959007
- LOINC Version 232
- MTHU004200
- UMLS CUI 2011AA
- C0332281
- SNOMED CT 2011_0131
- 47429007
- UMLS CUI 2011AA
- C0002726
- SNOMED CT 2011_0131
- 17602002
- MedDRA 14.1
- 10002022
- LOINC Version 232
- E85
- ICD-10-CM Version 2010
- 277.3
- UMLS CUI 2011AA
- C1867806
- UMLS CUI 2011AA
- C0026882
- SNOMED CT 2011_0131
- 55446002
Beskrivning
If female, patient is pregnant or breast feeding.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0015780
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Beskrivning
Patient has received prior liver transplantation.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0023911
- SNOMED CT 2011_0131
- 18027006
- MedDRA 14.1
- 10024714
- ICD-9-CM Version 2011
- 50.5
Beskrivning
Patient is expected to undergo liver transplantation within 12 months after enrollment.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1517001
- UMLS CUI 2011AA
- C0023911
- SNOMED CT 2011_0131
- 18027006
- MedDRA 14.1
- 10024714
- ICD-9-CM Version 2011
- 50.5
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
- UMLS CUI 2011AA
- C0231290
- SNOMED CT 2011_0131
- 237679004
- UMLS CUI 2011AA
- C1516879
Beskrivning
Patient with positive results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV).
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0149709
- SNOMED CT 2011_0131
- 165806002
- MedDRA 14.1
- 10019742
- UMLS CUI 2011AA
- C0281863
- MedDRA 14.1
- 10019747
- UMLS CUI 2011AA
- C0019699
- SNOMED CT 2011_0131
- 165816005
- MedDRA 14.1
- 10020188
- ICD-10-CM Version 2010
- Z21
Beskrivning
Patient has renal insufficiency (creatinine clearance < 30 ml/min).
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1565489
- MedDRA 14.1
- 10038474
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
Beskrivning
Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) > 2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0151766
- SNOMED CT 2011_0131
- 166603001
- MedDRA 14.1
- 10024690
- ICD-10-CM Version 2010
- R94.5
- ICD-9-CM Version 2011
- 794.8
- 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
- C1632851
- SNOMED CT 2011_0131
- 417929005
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- C0205476
- SNOMED CT 2011_0131
- 74188005
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- CL102947
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C0392756
- SNOMED CT 2011_0131
- 260400001
- UMLS CUI 2011AA
- C0232741
- SNOMED CT 2011_0131
- 79036002
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0023895
- SNOMED CT 2011_0131
- 235856003
- MedDRA 14.1
- 10024670
- ICD-10-CM Version 2010
- K76.9
- ICD-9-CM Version 2011
- 573.9
Beskrivning
Patient has a New York Heart Association (NYHA) Functional Classification >= III.
Datatyp
boolean
Alias
- 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
Beskrivning
Patient has other causes of sensorimotor neuropathy (B12 deficiency, Diabetes Mellitus, HIV treated with retroviral medications, thyroid disorders, alcohol abuse, and chronic inflammatory diseases).
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1112256
- MedDRA 14.1
- 10056673
- UMLS CUI 2011AA
- C1314792
- SNOMED CT 2011_0131
- 134198009
- UMLS CUI 2011AA
- C0042847
- SNOMED CT 2011_0131
- 190634004
- MedDRA 14.1
- 10047609
- ICD-10-CM Version 2010
- E53.8
- UMLS CUI 2011AA
- C0011849
- SNOMED CT 2011_0131
- 191044006
- UMLS CUI 2011AA
- C0019682
- SNOMED CT 2011_0131
- 19030005
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- CL106887
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0040128
- SNOMED CT 2011_0131
- 14304000
- MedDRA 14.1
- 10043709
- ICD-10-CM Version 2010
- E00-E07
- ICD-9-CM Version 2011
- 240-246.99
- UMLS CUI 2011AA
- C0085762
- SNOMED CT 2011_0131
- 15167005
- MedDRA 14.1
- 10001584
- LOINC Version 232
- LP36309-0
- ICD-10-CM Version 2010
- F10.1
- ICD-9-CM Version 2011
- 305.0
- UMLS CUI 2011AA
- C1290886
- SNOMED CT 2011_0131
- 128294001
Beskrivning
Patient has prior non-amyloid cardiac disease such as: myocardial infarction due to obstructive coronary artery disease, active non-amyloid cardiomyopathy (e.g., symptomatic left ventricular dysfunction from any cause other than amyloid, patients with a primary diagnosis of symptomatic valvular heart disease)
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0002716
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C0028778
- SNOMED CT 2011_0131
- 26036001
- MedDRA 14.1
- 10061876
- UMLS CUI 2011AA
- C0010068
- SNOMED CT 2011_0131
- 53741008
- MedDRA 14.1
- 10068617
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0002716
- UMLS CUI 2011AA
- CL411823
- SNOMED CT 2011_0131
- 85898001
- MedDRA 14.1
- 10007636
- ICD-10-CM Version 2010
- I42.9
- ICD-9-CM Version 2011
- 425
- UMLS CUI 2011AA
- C0231220
- SNOMED CT 2011_0131
- 264931009
- UMLS CUI 2011AA
- C0242698
- MedDRA 14.1
- 10049694
- UMLS CUI 2011AA
- C1314792
- SNOMED CT 2011_0131
- 134198009
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0002716
- UMLS CUI 2011AA
- C0801658
- LOINC Version 232
- 18630-4
- UMLS CUI 2011AA
- C0231220
- SNOMED CT 2011_0131
- 264931009
- UMLS CUI 2011AA
- C0026265
- SNOMED CT 2011_0131
- 11851006
- MedDRA 14.1
- 10061532
- ICD-9-CM Version 2011
- 424.0
- CTCAE 1105E
- E10134
Beskrivning
Patient has a co-morbidity anticipated to limit survival to < 12 months.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0009488
- UMLS CUI 2011AA
- C0679106
- UMLS CUI 2011AA
- C2349209
- UMLS CUI 2011AA
- C0220921
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
Beskrivning
Patient has received an investigational drug/device and/or participated in another clinical investigational study within 60 days before Baseline (Day 0).
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C2346570
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C1517586
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0205448
- SNOMED CT 2011_0131
- 19338005
- 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
- C1442488
- UMLS CUI 2011AA
- C0439228
- SNOMED CT 2011_0131
- 258703001
- HL7 V3 2006_05
- D
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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273546003 (SNOMED CT 2011_0131)
248152002 (SNOMED CT 2011_0131)
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76498008 (SNOMED CT 2011_0131)
C0015787 (UMLS CUI 2011AA)
169549004 (SNOMED CT 2011_0131)
10056199 (MedDRA 14.1)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
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260676000 (SNOMED CT 2011_0131)
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19338005 (SNOMED CT 2011_0131)
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260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL424941 (UMLS CUI 2011AA)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
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C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
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237679004 (SNOMED CT 2011_0131)
CL421124 (UMLS CUI 2011AA)
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248152002 (SNOMED CT 2011_0131)
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262043009 (SNOMED CT 2011_0131)
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C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
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237679004 (SNOMED CT 2011_0131)
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C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1829817 (UMLS CUI 2011AA)
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277.3 (ICD-10-CM Version 2010)
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10024714 (MedDRA 14.1)
50.5 (ICD-9-CM Version 2011)
C0023911 (UMLS CUI 2011AA)
18027006 (SNOMED CT 2011_0131)
10024714 (MedDRA 14.1)
50.5 (ICD-9-CM Version 2011)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C0281863 (UMLS CUI 2011AA)
10019747 (MedDRA 14.1)
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
10038474 (MedDRA 14.1)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
166603001 (SNOMED CT 2011_0131)
10024690 (MedDRA 14.1)
R94.5 (ICD-10-CM Version 2010)
794.8 (ICD-9-CM Version 2011)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1632851 (UMLS CUI 2011AA)
417929005 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
CL420107 (UMLS CUI 2011AA)
C0392756 (UMLS CUI 2011AA)
260400001 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
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235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
10056673 (MedDRA 14.1)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0042847 (UMLS CUI 2011AA)
190634004 (SNOMED CT 2011_0131)
10047609 (MedDRA 14.1)
E53.8 (ICD-10-CM Version 2010)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
CL106887 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0040128 (UMLS CUI 2011AA)
14304000 (SNOMED CT 2011_0131)
10043709 (MedDRA 14.1)
E00-E07 (ICD-10-CM Version 2010)
240-246.99 (ICD-9-CM Version 2011)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C1290886 (UMLS CUI 2011AA)
128294001 (SNOMED CT 2011_0131)
288556008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0002716 (UMLS CUI 2011AA)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
CL420107 (UMLS CUI 2011AA)
C0028778 (UMLS CUI 2011AA)
26036001 (SNOMED CT 2011_0131)
10061876 (MedDRA 14.1)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0002716 (UMLS CUI 2011AA)
CL411823 (UMLS CUI 2011AA)
85898001 (SNOMED CT 2011_0131)
10007636 (MedDRA 14.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0242698 (UMLS CUI 2011AA)
10049694 (MedDRA 14.1)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0002716 (UMLS CUI 2011AA)
C0801658 (UMLS CUI 2011AA)
18630-4 (LOINC Version 232)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0026265 (UMLS CUI 2011AA)
11851006 (SNOMED CT 2011_0131)
10061532 (MedDRA 14.1)
424.0 (ICD-9-CM Version 2011)
E10134 (CTCAE 1105E)
C0679106 (UMLS CUI 2011AA)
C2349209 (UMLS CUI 2011AA)
C0220921 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1517586 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)