ID

5065

Description

ODM derived from http://clinicaltrials.gov/show/NCT01011205

Link

http://clinicaltrials.gov/show/NCT01011205

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

April 17, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01011205 Liver Transplantation

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Undergoing orthotopic liver or split liver allograft transplantation
Description

Undergoing orthotopic liver or split liver allograft transplantation

Data type

boolean

Alias
UMLS CUI 2011AA
C0400447
SNOMED CT 2011_0131
174425003
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
CL370605
UMLS CUI 2011AA
C0522536
UMLS CUI 2011AA
C0023911
SNOMED CT 2011_0131
18027006
MedDRA 14.1
10024714
ICD-9-CM Version 2011
50.5
Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study
Description

Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
Description

Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
UMLS CUI 2011AA
C0023884
SNOMED CT 2011_0131
10200004
LOINC Version 232
MTHU002039
UMLS CUI 2011AA
C0597409
Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
Description

Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C0336562
SNOMED CT 2011_0131
3319006
UMLS CUI 2011AA
C0007634
SNOMED CT 2011_0131
118957004
LOINC Version 232
MTHU001933
UMLS CUI 2011AA
C0449913
SNOMED CT 2011_0131
246333005
LOINC Version 232
MTHU025766
Receiving ABO incompatible graft or a graft from a non heart beating donor
Description

Receiving ABO incompatible graft or a graft from a non heart beating donor

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0860218
MedDRA 14.1
10000206
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0027045
UMLS CUI 2011AA
CL414920
Ongoing dosing with systemic corticosteroids
Description

Ongoing dosing with systemic corticosteroids

Data type

boolean

Alias
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
CL421051
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
Subjects with systemic infection requiring treatment except viral hepatitis
Description

Subjects with systemic infection requiring treatment except viral hepatitis

Data type

boolean

Alias
UMLS CUI 2011AA
C0243026
SNOMED CT 2011_0131
91302008
MedDRA 14.1
10040047
ICD-9-CM Version 2011
995.91
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0042721
SNOMED CT 2011_0131
3738000
MedDRA 14.1
10019799
LOINC Version 232
MTHU020837
ICD-10-CM Version 2010
B19
ICD-9-CM Version 2011
070
CTCAE 1105E
E11410
Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:
Description

Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205314
SNOMED CT 2011_0131
7147002
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
CL425202
UMLS CUI 2011AA
C0220630
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
< 3 nodes
Description

< 3 nodes

Data type

boolean

Alias
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0745761
SNOMED CT 2011_0131
428187007
MedDRA 14.1
10049578
no node larger than 5 cm
Description

no node larger than 5 cm

Data type

boolean

Alias
UMLS CUI 2011AA
C0549184
SNOMED CT 2011_0131
260413007
UMLS CUI 2011AA
C0745761
SNOMED CT 2011_0131
428187007
MedDRA 14.1
10049578
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0475210
SNOMED CT 2011_0131
258672001
No metastases (tumor staging)
Description

no metastases

Data type

boolean

Alias
UMLS CUI 2011AA
C0445092
SNOMED CT 2011_0131
261985008
Vascular invasion by tumor absent
Description

no vascular tumoral invasion

Data type

boolean

Alias
UMLS CUI 2011AA
C1264755
SNOMED CT 2011_0131
127494000
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Description

Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1443924
SNOMED CT 2011_0131
409587002
UMLS CUI 2011AA
C0042963
SNOMED CT 2011_0131
249497008
MedDRA 14.1
10047700
LOINC Version 232
MTHU013530
ICD-10-CM Version 2010
R11.1
CTCAE 1105E
E11068
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1268997
SNOMED CT 2011_0131
181244000
UMLS CUI 2011AA
C0024523
SNOMED CT 2011_0131
155841000
ICD-10-CM Version 2010
K90.4
UMLS CUI 2011AA
C0030920
SNOMED CT 2011_0131
13200003
MedDRA 14.1
10034341
ICD-10-CM Version 2010
K27
ICD-9-CM Version 2011
533
Subject or donor known to be HIV positive
Description

Subject or donor known to be HIV positive

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
Description

Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1744706
UMLS CUI 2011AA
C0085149
SNOMED CT 2011_0131
386975001
LOINC Version 232
MTHU001849
UMLS CUI 2011AA
C0003240
SNOMED CT 2011_0131
372480009
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0676831
SNOMED CT 2011_0131
386978004
UMLS CUI 2011AA
C0209368
SNOMED CT 2011_0131
386976000
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
Pregnant woman or breast-feeding mother
Description

Pregnant woman or breast-feeding mother

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0026591
SNOMED CT 2011_0131
72705000
LOINC Version 232
MTHU035602
HL7 V3 2006_05
MTH
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
Description

Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Unlikely to comply with the Visits scheduled in the protocol
Description

Unlikely to comply with the Visits scheduled in the protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C0750558
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0086960
Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
Description

Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator

Data type

boolean

Alias
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0681832
Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
Description

Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1554075
HL7 V3 2006_05
NP
UMLS CUI 2011AA
C1707479
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Description

Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator

Data type

boolean

Alias
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
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
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1522701
UMLS CUI 2011AA
C0009452
SNOMED CT 2011_0131
263536004
LOINC Version 232
MTHU021752
UMLS CUI 2011AA
CL102947
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Undergoing orthotopic liver or split liver allograft transplantation
Item
Undergoing orthotopic liver or split liver allograft transplantation
boolean
C0400447 (UMLS CUI 2011AA)
174425003 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL370605 (UMLS CUI 2011AA)
C0522536 (UMLS CUI 2011AA)
C0023911 (UMLS CUI 2011AA)
18027006 (SNOMED CT 2011_0131)
10024714 (MedDRA 14.1)
50.5 (ICD-9-CM Version 2011)
Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study
Item
Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C1516879 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
Item
Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
boolean
C1514756 (UMLS CUI 2011AA)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C0023884 (UMLS CUI 2011AA)
10200004 (SNOMED CT 2011_0131)
MTHU002039 (LOINC Version 232)
C0597409 (UMLS CUI 2011AA)
Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
Item
Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
boolean
C1514756 (UMLS CUI 2011AA)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0336562 (UMLS CUI 2011AA)
3319006 (SNOMED CT 2011_0131)
C0007634 (UMLS CUI 2011AA)
118957004 (SNOMED CT 2011_0131)
MTHU001933 (LOINC Version 232)
C0449913 (UMLS CUI 2011AA)
246333005 (SNOMED CT 2011_0131)
MTHU025766 (LOINC Version 232)
Receiving ABO incompatible graft or a graft from a non heart beating donor
Item
Receiving ABO incompatible graft or a graft from a non heart beating donor
boolean
C1514756 (UMLS CUI 2011AA)
C0860218 (UMLS CUI 2011AA)
10000206 (MedDRA 14.1)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0027045 (UMLS CUI 2011AA)
CL414920 (UMLS CUI 2011AA)
Ongoing dosing with systemic corticosteroids
Item
Ongoing dosing with systemic corticosteroids
boolean
C0750536 (UMLS CUI 2011AA)
CL421051 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Subjects with systemic infection requiring treatment except viral hepatitis
Item
Subjects with systemic infection requiring treatment except viral hepatitis
boolean
C0243026 (UMLS CUI 2011AA)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0042721 (UMLS CUI 2011AA)
3738000 (SNOMED CT 2011_0131)
10019799 (MedDRA 14.1)
MTHU020837 (LOINC Version 232)
B19 (ICD-10-CM Version 2010)
070 (ICD-9-CM Version 2011)
E11410 (CTCAE 1105E)
Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:
Item
Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
CL415147 (UMLS CUI 2011AA)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
CL425202 (UMLS CUI 2011AA)
C0220630 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
< 3 nodes
Item
< 3 nodes
boolean
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0745761 (UMLS CUI 2011AA)
428187007 (SNOMED CT 2011_0131)
10049578 (MedDRA 14.1)
no node larger than 5 cm
Item
no node larger than 5 cm
boolean
C0549184 (UMLS CUI 2011AA)
260413007 (SNOMED CT 2011_0131)
C0745761 (UMLS CUI 2011AA)
428187007 (SNOMED CT 2011_0131)
10049578 (MedDRA 14.1)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0475210 (UMLS CUI 2011AA)
258672001 (SNOMED CT 2011_0131)
no metastases
Item
No metastases (tumor staging)
boolean
C0445092 (UMLS CUI 2011AA)
261985008 (SNOMED CT 2011_0131)
no vascular tumoral invasion
Item
Vascular invasion by tumor absent
boolean
C1264755 (UMLS CUI 2011AA)
127494000 (SNOMED CT 2011_0131)
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Item
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1443924 (UMLS CUI 2011AA)
409587002 (SNOMED CT 2011_0131)
C0042963 (UMLS CUI 2011AA)
249497008 (SNOMED CT 2011_0131)
10047700 (MedDRA 14.1)
MTHU013530 (LOINC Version 232)
R11.1 (ICD-10-CM Version 2010)
E11068 (CTCAE 1105E)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1268997 (UMLS CUI 2011AA)
181244000 (SNOMED CT 2011_0131)
C0024523 (UMLS CUI 2011AA)
155841000 (SNOMED CT 2011_0131)
K90.4 (ICD-10-CM Version 2010)
C0030920 (UMLS CUI 2011AA)
13200003 (SNOMED CT 2011_0131)
10034341 (MedDRA 14.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
Subject or donor known to be HIV positive
Item
Subject or donor known to be HIV positive
boolean
C0019699 (UMLS CUI 2011AA)
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
Item
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1744706 (UMLS CUI 2011AA)
C0085149 (UMLS CUI 2011AA)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
C0003240 (UMLS CUI 2011AA)
372480009 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0676831 (UMLS CUI 2011AA)
386978004 (SNOMED CT 2011_0131)
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Pregnant woman or breast-feeding mother
Item
Pregnant woman or breast-feeding mother
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0026591 (UMLS CUI 2011AA)
72705000 (SNOMED CT 2011_0131)
MTHU035602 (LOINC Version 232)
MTH (HL7 V3 2006_05)
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
Item
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
boolean
C2348568 (UMLS CUI 2011AA)
Unlikely to comply with the Visits scheduled in the protocol
Item
Unlikely to comply with the Visits scheduled in the protocol
boolean
C0750558 (UMLS CUI 2011AA)
C0525058 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
Item
Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
Item
Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
boolean
C1514756 (UMLS CUI 2011AA)
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C1707479 (UMLS CUI 2011AA)
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Item
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
boolean
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1522701 (UMLS CUI 2011AA)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)
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