ID

42773

Description

ODM derived from http://clinicaltrials.gov/show/NCT00391287

Link

http://clinicaltrials.gov/show/NCT00391287

Keywords

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

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00391287 Pure Red-Cell Aplasia

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
Patients with established CRF as an indication for the treatment of anemia
Description

Patients with established CRF as an indication for the treatment of anemia

Data type

boolean

Alias
UMLS CUI 2011AA
C0443211
SNOMED CT 2011_0131
263748003
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
CL335836
UMLS CUI 2011AA
C0039798
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
Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin product by the s.c. route of administration
Description

Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin product by the s.c. route of administration

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0014822
SNOMED CT 2011_0131
111167001
LOINC Version 232
MTHU004935
UMLS CUI 2011AA
C1522438
SNOMED CT 2011_0131
34206005
HL7 V3 2006_05
SubcutaneousRoute
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year
Description

Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year

Data type

boolean

Alias
UMLS CUI 2011AA
C0332148
SNOMED CT 2011_0131
2931005
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1522438
SNOMED CT 2011_0131
34206005
HL7 V3 2006_05
SubcutaneousRoute
UMLS CUI 2011AA
C0014822
SNOMED CT 2011_0131
111167001
LOINC Version 232
MTHU004935
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients with a history of pure red cell aplasia or aplastic anemia
Description

Patients with a history of pure red cell aplasia or aplastic anemia

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0034902
SNOMED CT 2011_0131
50715003
MedDRA 14.1
10002965
UMLS CUI 2011AA
C0002874
SNOMED CT 2011_0131
306058006
MedDRA 14.1
10002967
ICD-10-CM Version 2010
D61.9
ICD-9-CM Version 2011
284.9
Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment
Description

Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0596545
UMLS CUI 2011AA
C1705492
UMLS CUI 2011AA
C0681841
LOINC Version 232
MTHU013812
UMLS CUI 2011AA
C1517945
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1280500
SNOMED CT 2011_0131
253861007
UMLS CUI 2011AA
C0376541
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1516879
Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy)
Description

Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy)

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0376541
UMLS CUI 2011AA
C0039798
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
C0438286
SNOMED CT 2011_0131
266721009
MedDRA 14.1
10063670
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1280519
SNOMED CT 2011_0131
255403003
Patients with a history of EPO antibodies prior to enrollment
Description

Patients with a history of EPO antibodies prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0014822
SNOMED CT 2011_0131
111167001
LOINC Version 232
MTHU004935
UMLS CUI 2011AA
C0003241
SNOMED CT 2011_0131
68498002
LOINC Version 232
MTHU003502
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to >15 mg/day prednisolone
Description

Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to >15 mg/day prednisolone

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C0085149
SNOMED CT 2011_0131
386975001
LOINC Version 232
MTHU001849
UMLS CUI 2011AA
C0072980
SNOMED CT 2011_0131
387014003
LOINC Version 232
MTHU013897
UMLS CUI 2011AA
C0026933
SNOMED CT 2011_0131
409330005
UMLS CUI 2011AA
C0209368
SNOMED CT 2011_0131
386976000
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0032950
SNOMED CT 2011_0131
116601002
LOINC Version 232
MTHU003522
Subjects whose first s.c. exposure to any erythropoietin product was >1 year prior to enrollment
Description

Subjects whose first s.c. exposure to any erythropoietin product was >1 year prior to enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C1522438
SNOMED CT 2011_0131
34206005
HL7 V3 2006_05
SubcutaneousRoute
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0014822
SNOMED CT 2011_0131
111167001
LOINC Version 232
MTHU004935
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
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
C1516879
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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)
Patients with established CRF as an indication for the treatment of anemia
Item
Patients with established CRF as an indication for the treatment of anemia
boolean
C0443211 (UMLS CUI 2011AA)
263748003 (SNOMED CT 2011_0131)
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)
CL335836 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
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)
Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin product by the s.c. route of administration
Item
Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin product by the s.c. route of administration
boolean
C1514756 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0014822 (UMLS CUI 2011AA)
111167001 (SNOMED CT 2011_0131)
MTHU004935 (LOINC Version 232)
C1522438 (UMLS CUI 2011AA)
34206005 (SNOMED CT 2011_0131)
SubcutaneousRoute (HL7 V3 2006_05)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year
Item
Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year
boolean
C0332148 (UMLS CUI 2011AA)
2931005 (SNOMED CT 2011_0131)
C0549178 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C1522438 (UMLS CUI 2011AA)
34206005 (SNOMED CT 2011_0131)
SubcutaneousRoute (HL7 V3 2006_05)
C0014822 (UMLS CUI 2011AA)
111167001 (SNOMED CT 2011_0131)
MTHU004935 (LOINC Version 232)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients with a history of pure red cell aplasia or aplastic anemia
Item
Patients with a history of pure red cell aplasia or aplastic anemia
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0034902 (UMLS CUI 2011AA)
50715003 (SNOMED CT 2011_0131)
10002965 (MedDRA 14.1)
C0002874 (UMLS CUI 2011AA)
306058006 (SNOMED CT 2011_0131)
10002967 (MedDRA 14.1)
D61.9 (ICD-10-CM Version 2010)
284.9 (ICD-9-CM Version 2011)
Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment
Item
Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment
boolean
C0596545 (UMLS CUI 2011AA)
C1705492 (UMLS CUI 2011AA)
C0681841 (UMLS CUI 2011AA)
MTHU013812 (LOINC Version 232)
C1517945 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1280500 (UMLS CUI 2011AA)
253861007 (SNOMED CT 2011_0131)
C0376541 (UMLS CUI 2011AA)
C0549178 (UMLS CUI 2011AA)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy)
Item
Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy)
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0376541 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
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)
C0438286 (UMLS CUI 2011AA)
266721009 (SNOMED CT 2011_0131)
10063670 (MedDRA 14.1)
CL414904 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1280519 (UMLS CUI 2011AA)
255403003 (SNOMED CT 2011_0131)
Patients with a history of EPO antibodies prior to enrollment
Item
Patients with a history of EPO antibodies prior to enrollment
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0014822 (UMLS CUI 2011AA)
111167001 (SNOMED CT 2011_0131)
MTHU004935 (LOINC Version 232)
C0003241 (UMLS CUI 2011AA)
68498002 (SNOMED CT 2011_0131)
MTHU003502 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to >15 mg/day prednisolone
Item
Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to >15 mg/day prednisolone
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0085149 (UMLS CUI 2011AA)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
C0026933 (UMLS CUI 2011AA)
409330005 (SNOMED CT 2011_0131)
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
CL415123 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
Subjects whose first s.c. exposure to any erythropoietin product was >1 year prior to enrollment
Item
Subjects whose first s.c. exposure to any erythropoietin product was >1 year prior to enrollment
boolean
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C1522438 (UMLS CUI 2011AA)
34206005 (SNOMED CT 2011_0131)
SubcutaneousRoute (HL7 V3 2006_05)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0014822 (UMLS CUI 2011AA)
111167001 (SNOMED CT 2011_0131)
MTHU004935 (LOINC Version 232)
CL384738 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (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)
C1516879 (UMLS CUI 2011AA)
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