ID

4450

Description

ODM derived from http://clinicaltrials.gov/show/NCT00717366

Link

http://clinicaltrials.gov/show/NCT00717366

Keywords

Versions (1)
  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00006414 NCT00717366 Anemia

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 5 Years to 17 Years
Description

age 5 Years to 17 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
children aged 5-17 years with clinically stable chronic renal anemia
Description

children aged 5-17 years with clinically stable chronic renal anemia

Data type

boolean

Alias
UMLS CUI 2011AA
C0008059
SNOMED CT 2011_0131
67822003
HL7 V3 2006_05
CHILD
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C1142276
MedDRA 14.1
10058132
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
hemodialysis for >=8 weeks
Description

hemodialysis for >=8 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0019004
SNOMED CT 2011_0131
302497006
MedDRA 14.1
10018875
ICD-10-CM Version 2010
E71.43
ICD-9-CM Version 2011
39.95
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
intravenous stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa for >= 8 weeks before screening
Description

intravenous stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa for >= 8 weeks before screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0348016
SNOMED CT 2011_0131
255560000
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0024501
UMLS CUI 2011AA
C0357126
SNOMED CT 2011_0131
386947003
UMLS CUI 2011AA
C0357131
SNOMED CT 2011_0131
396043004
UMLS CUI 2011AA
C0937950
SNOMED CT 2011_0131
385608005
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
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
C1409616
stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa with no more than one dose change <=25% during the 2 weeks of screening.
Description

stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa with no more than one dose change <=25% during the 2 weeks of screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0024501
UMLS CUI 2011AA
C0357126
SNOMED CT 2011_0131
386947003
UMLS CUI 2011AA
C0357131
SNOMED CT 2011_0131
396043004
UMLS CUI 2011AA
C0937950
SNOMED CT 2011_0131
385608005
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C1409616
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening
Description

overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0175566
SNOMED CT 2011_0131
56116003
UMLS CUI 2011AA
C0017181
SNOMED CT 2011_0131
74474003
MedDRA 14.1
10017955
ICD-10-CM Version 2010
K92.2
ICD-9-CM Version 2011
578
UMLS CUI 2011AA
C1970394
UMLS CUI 2011AA
C1555447
HL7 V3 2006_05
MEDNEC
UMLS CUI 2011AA
C1879316
SNOMED CT 2011_0131
5447007
MedDRA 14.1
10066152
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
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
C1409616
red blood cell transfusions within 8 weeks before screening
Description

red blood cell transfusions within 8 weeks before screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0086252
SNOMED CT 2011_0131
116863004
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
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
C1409616
active malignant disease.
Description

active malignant disease.

Data type

boolean

Alias
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
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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 5 Years to 17 Years
Item
age 5 Years to 17 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
children aged 5-17 years with clinically stable chronic renal anemia
Item
children aged 5-17 years with clinically stable chronic renal anemia
boolean
C0008059 (UMLS CUI 2011AA)
67822003 (SNOMED CT 2011_0131)
CHILD (HL7 V3 2006_05)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1142276 (UMLS CUI 2011AA)
10058132 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
hemodialysis for >=8 weeks
Item
hemodialysis for >=8 weeks
boolean
C0019004 (UMLS CUI 2011AA)
302497006 (SNOMED CT 2011_0131)
10018875 (MedDRA 14.1)
E71.43 (ICD-10-CM Version 2010)
39.95 (ICD-9-CM Version 2011)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
intravenous stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa for >= 8 weeks before screening
Item
intravenous stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa for >= 8 weeks before screening
boolean
C0348016 (UMLS CUI 2011AA)
255560000 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0024501 (UMLS CUI 2011AA)
C0357126 (UMLS CUI 2011AA)
386947003 (SNOMED CT 2011_0131)
C0357131 (UMLS CUI 2011AA)
396043004 (SNOMED CT 2011_0131)
C0937950 (UMLS CUI 2011AA)
385608005 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (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)
C1409616 (UMLS CUI 2011AA)
stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa with no more than one dose change <=25% during the 2 weeks of screening.
Item
stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa with no more than one dose change <=25% during the 2 weeks of screening.
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0024501 (UMLS CUI 2011AA)
C0357126 (UMLS CUI 2011AA)
386947003 (SNOMED CT 2011_0131)
C0357131 (UMLS CUI 2011AA)
396043004 (SNOMED CT 2011_0131)
C0937950 (UMLS CUI 2011AA)
385608005 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening
Item
overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening
boolean
C0175566 (UMLS CUI 2011AA)
56116003 (SNOMED CT 2011_0131)
C0017181 (UMLS CUI 2011AA)
74474003 (SNOMED CT 2011_0131)
10017955 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
578 (ICD-9-CM Version 2011)
C1970394 (UMLS CUI 2011AA)
C1555447 (UMLS CUI 2011AA)
MEDNEC (HL7 V3 2006_05)
C1879316 (UMLS CUI 2011AA)
5447007 (SNOMED CT 2011_0131)
10066152 (MedDRA 14.1)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (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)
C1409616 (UMLS CUI 2011AA)
red blood cell transfusions within 8 weeks before screening
Item
red blood cell transfusions within 8 weeks before screening
boolean
C0086252 (UMLS CUI 2011AA)
116863004 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (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)
C1409616 (UMLS CUI 2011AA)
active malignant disease.
Item
active malignant disease.
boolean
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)
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