ID

44173

Description

ODM derived from http://clinicaltrials.gov/show/NCT00717470

Link

http://clinicaltrials.gov/show/NCT00717470

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00717470 Kidney 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
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
Description

End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)

Data type

boolean

Alias
UMLS CUI 2011AA
C1261469
SNOMED CT 2011_0131
46177005
ICD-9-CM Version 2011
585.6
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
UMLS CUI 2011AA
C0597409
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C0745777
UMLS CUI 2011AA
C0018129
SNOMED CT 2011_0131
72627004
MedDRA 14.1
10044439
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
Description

Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
UMLS CUI 2011AA
C0006629
SNOMED CT 2011_0131
261244009
UMLS CUI 2011AA
CL414920
UMLS CUI 2011AA
C0348050
SNOMED CT 2011_0131
105456007
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1315037
LOINC Version 232
MTHU000083
UMLS CUI 2011AA
C0205280
SNOMED CT 2011_0131
20323000
UMLS CUI 2011AA
C1524057
SNOMED CT 2011_0131
7883008
UMLS CUI 2011AA
C0344389
SNOMED CT 2011_0131
112143006
Female subject of childbearing potential must have a negative serum 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 pregnancy test at enrollment and must agree to maintain effective birth control during the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Receiving or having previously received an organ transplant other than a kidney
Description

Receiving or having previously received an organ transplant other than a kidney

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0022646
SNOMED CT 2011_0131
64033007
LOINC Version 232
MTHU002935
Cold ischemia time of the donor kidney > 30 hours
Description

Cold ischemia time of the donor kidney > 30 hours

Data type

boolean

Alias
UMLS CUI 2011AA
C1563922
LOINC Version 232
MTHU020173
UMLS CUI 2011AA
C1720476
SNOMED CT 2011_0131
420970005
UMLS CUI 2011AA
C0439227
SNOMED CT 2011_0131
258702006
HL7 V3 2006_05
HR, h
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
Description

Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0425583
SNOMED CT 2011_0131
248646004
LOINC Version 232
MTHU002606
UMLS CUI 2011AA
CL414920
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0683312
LOINC Version 232
MTHU018876
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C2349954
UMLS CUI 2011AA
C1521721
UMLS CUI 2011AA
CL370104
UMLS CUI 2011AA
C0018790
SNOMED CT 2011_0131
410429000
MedDRA 14.1
10007515
ICD-10-CM Version 2010
I46
ICD-9-CM Version 2011
427.5
CTCAE 1105E
E10101
Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels >= 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
Description

Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels >= 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
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
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
CL414623
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
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C2825164
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
UMLS CUI 2011AA
C1112419
MedDRA 14.1
10057394
UMLS CUI 2011AA
CL414920
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
Description

Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C1705294
UMLS CUI 2011AA
CL419320
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
108807002
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
Description

Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
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
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0009450
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
C0205177
SNOMED CT 2011_0131
55561003
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
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
Subject or donor known to be HIV positive
Description

Subject or donor known to be HIV positive

Data type

boolean

Alias
UMLS CUI 1
C0019699
UMLS CUI 1*1
C0681850
UMLS CUI 1*2
C0013018
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
CL407060
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
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
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

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
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
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
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
CL407060
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
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0009566
SNOMED CT 2011_0131
116223007
LOINC Version 232
MTHU008883
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)
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
Item
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
boolean
C1261469 (UMLS CUI 2011AA)
46177005 (SNOMED CT 2011_0131)
585.6 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
CL414904 (UMLS CUI 2011AA)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
C0597409 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0745777 (UMLS CUI 2011AA)
C0018129 (UMLS CUI 2011AA)
72627004 (SNOMED CT 2011_0131)
10044439 (MedDRA 14.1)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
Item
Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
boolean
C1514756 (UMLS CUI 2011AA)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
C0006629 (UMLS CUI 2011AA)
261244009 (SNOMED CT 2011_0131)
CL414920 (UMLS CUI 2011AA)
C0348050 (UMLS CUI 2011AA)
105456007 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1315037 (UMLS CUI 2011AA)
MTHU000083 (LOINC Version 232)
C0205280 (UMLS CUI 2011AA)
20323000 (SNOMED CT 2011_0131)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
C0344389 (UMLS CUI 2011AA)
112143006 (SNOMED CT 2011_0131)
Female subject of childbearing potential must have a negative serum 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 pregnancy test at enrollment and must agree to maintain effective birth control during the study
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Receiving or having previously received an organ transplant other than a kidney
Item
Receiving or having previously received an organ transplant other than a kidney
boolean
C1514756 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
Cold ischemia time of the donor kidney > 30 hours
Item
Cold ischemia time of the donor kidney > 30 hours
boolean
C1563922 (UMLS CUI 2011AA)
MTHU020173 (LOINC Version 232)
C1720476 (UMLS CUI 2011AA)
420970005 (SNOMED CT 2011_0131)
C0439227 (UMLS CUI 2011AA)
258702006 (SNOMED CT 2011_0131)
HR, h (HL7 V3 2006_05)
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
Item
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
boolean
C1514756 (UMLS CUI 2011AA)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0425583 (UMLS CUI 2011AA)
248646004 (SNOMED CT 2011_0131)
MTHU002606 (LOINC Version 232)
CL414920 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0683312 (UMLS CUI 2011AA)
MTHU018876 (LOINC Version 232)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C2349954 (UMLS CUI 2011AA)
C1521721 (UMLS CUI 2011AA)
CL370104 (UMLS CUI 2011AA)
C0018790 (UMLS CUI 2011AA)
410429000 (SNOMED CT 2011_0131)
10007515 (MedDRA 14.1)
I46 (ICD-10-CM Version 2010)
427.5 (ICD-9-CM Version 2011)
E10101 (CTCAE 1105E)
Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels >= 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
Item
Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels >= 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0549178 (UMLS CUI 2011AA)
CL414623 (UMLS CUI 2011AA)
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)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
CL384738 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
C2825164 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
CL414920 (UMLS CUI 2011AA)
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
Item
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
boolean
C1514873 (UMLS CUI 2011AA)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C1705294 (UMLS CUI 2011AA)
CL419320 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0003250 (UMLS CUI 2011AA)
108807002 (SNOMED CT 2011_0131)
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
Item
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
boolean
C1514873 (UMLS CUI 2011AA)
C0549178 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
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
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0009450 (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)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
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)
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)
Subject or donor known to be HIV positive
Item
Subject or donor known to be HIV positive
boolean
C0019699 (UMLS CUI 1)
C0681850 (UMLS CUI 1*1)
C0013018 (UMLS CUI 1*2)
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)
CL407060 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
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
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
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)
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
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (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
CL407060 (UMLS CUI 2011AA)
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)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0009566 (UMLS CUI 2011AA)
116223007 (SNOMED CT 2011_0131)
MTHU008883 (LOINC Version 232)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)
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