ID

42813

Description

ODM derived from http://clinicaltrials.gov/show/NCT00598442

Link

http://clinicaltrials.gov/show/NCT00598442

Keywords

Versions (2)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00598442 Chronic Renal Failure

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
Chronic Renal Failure with an estimated glomerular filtration rate < 60 mL/min/1.73m2 and not expected to begin dialysis for at least 12 weeks.
Description

Chronic Renal Failure with an estimated glomerular filtration rate < 60 mL/min/1.73m2 and not expected to begin dialysis for at least 12 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C0022661
SNOMED CT 2011_0131
90688005
MedDRA 14.1
10038444
ICD-10-CM Version 2010
N18.9
ICD-9-CM Version 2011
585.6
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0750572
SNOMED CT 2011_0131
414135002
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1517001
UMLS CUI 2011AA
CL414705
UMLS CUI 2011AA
C0011946
SNOMED CT 2011_0131
108241001
MedDRA 14.1
10061105
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Two consecutive Hgb values >=8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization.
Description

Two consecutive Hgb values >=8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C1707491
UMLS CUI 2011AA
C0518015
MedDRA 14.1
10018876
UMLS CUI 2011AA
C1522609
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
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
C0034656
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Females who are pregnant or breast-feeding.
Description

Females who are pregnant or breast-feeding.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
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
Treatment with an ESA in the 12 weeks prior to randomization.
Description

Treatment with an ESA in the 12 weeks prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2917382
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
C0034656
Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecule.
Description

Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecule.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
CL415164
HL7 V3 2006_05
OINT
UMLS CUI 2011AA
C2917382
UMLS CUI 2011AA
C1518896
UMLS CUI 2011AA
C2825025
UMLS CUI 2011AA
C0032483
SNOMED CT 2011_0131
8030004
UMLS CUI 2011AA
C0567416
SNOMED CT 2011_0131
290005005
Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
Description

Prior chronic hemodialysis or chronic peritoneal dialysis treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1740835
MedDRA 14.1
10066622
UMLS CUI 2011AA
C0455150
SNOMED CT 2011_0131
225230008
UMLS CUI 2011AA
C0039798
Known bleeding or coagulation disorder.
Description

Known bleeding or coagulation disorder.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C1458140
SNOMED CT 2011_0131
248250000
MedDRA 14.1
10005134
UMLS CUI 2011AA
C0005779
SNOMED CT 2011_0131
64779008
MedDRA 14.1
10009802
ICD-10-CM Version 2010
D68.9
Known hematologic disease or cause of anemia other than renal disease.
Description

Known hematologic disease or cause of anemia other than renal disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
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
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C0002871
SNOMED CT 2011_0131
271737000
MedDRA 14.1
10002034
LOINC Version 232
MTHU020823
ICD-10-CM Version 2010
D64.9
ICD-9-CM Version 2011
285.9
CTCAE 1105E
E10010
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
Poorly controlled hypertension.
Description

Poorly controlled hypertension.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205169
SNOMED CT 2011_0131
556001
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0020538
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
Evidence of active malignancy within one year prior to randomization
Description

Evidence of active malignancy within one year prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
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
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
A scheduled kidney transplant.
Description

A scheduled kidney transplant.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
Back to the top of the page

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)
Chronic Renal Failure with an estimated glomerular filtration rate < 60 mL/min/1.73m2 and not expected to begin dialysis for at least 12 weeks.
Item
Chronic Renal Failure with an estimated glomerular filtration rate < 60 mL/min/1.73m2 and not expected to begin dialysis for at least 12 weeks.
boolean
C0022661 (UMLS CUI 2011AA)
90688005 (SNOMED CT 2011_0131)
10038444 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
585.6 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0750572 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
C1517001 (UMLS CUI 2011AA)
CL414705 (UMLS CUI 2011AA)
C0011946 (UMLS CUI 2011AA)
108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Two consecutive Hgb values >=8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization.
Item
Two consecutive Hgb values >=8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization.
boolean
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1707491 (UMLS CUI 2011AA)
C0518015 (UMLS CUI 2011AA)
10018876 (MedDRA 14.1)
C1522609 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (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)
C0034656 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Females who are pregnant or breast-feeding.
Item
Females who are pregnant or breast-feeding.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Treatment with an ESA in the 12 weeks prior to randomization.
Item
Treatment with an ESA in the 12 weeks prior to randomization.
boolean
C0039798 (UMLS CUI 2011AA)
C2917382 (UMLS CUI 2011AA)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecule.
Item
Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecule.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
CL415164 (UMLS CUI 2011AA)
OINT (HL7 V3 2006_05)
C2917382 (UMLS CUI 2011AA)
C1518896 (UMLS CUI 2011AA)
C2825025 (UMLS CUI 2011AA)
C0032483 (UMLS CUI 2011AA)
8030004 (SNOMED CT 2011_0131)
C0567416 (UMLS CUI 2011AA)
290005005 (SNOMED CT 2011_0131)
Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
Item
Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1740835 (UMLS CUI 2011AA)
10066622 (MedDRA 14.1)
C0455150 (UMLS CUI 2011AA)
225230008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Known bleeding or coagulation disorder.
Item
Known bleeding or coagulation disorder.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
Known hematologic disease or cause of anemia other than renal disease.
Item
Known hematologic disease or cause of anemia other than renal disease.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
CL411789 (UMLS CUI 2011AA)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
Poorly controlled hypertension.
Item
Poorly controlled hypertension.
boolean
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
Evidence of active malignancy within one year prior to randomization
Item
Evidence of active malignancy within one year prior to randomization
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (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)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
A scheduled kidney transplant.
Item
A scheduled kidney transplant.
boolean
C0086960 (UMLS CUI 2011AA)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial