ID

3748

Description

ODM derived from http://clinicaltrials.gov/show/NCT01185223

Link

http://clinicaltrials.gov/show/NCT01185223

Keywords

Versions (1)
  1. 3/19/13 3/19/13 - Martin Dugas
Uploaded on

March 19, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01185223 Allogeneic Stem Cell Transplantation

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patient following allogeneic SCT
Description

Patient following allogeneic SCT

Data type

boolean

Alias
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
Description

Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT

Data type

boolean

Alias
UMLS CUI 2011AA
C0439615
SNOMED CT 2011_0131
255217005
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0010825
SNOMED CT 2011_0131
407444007
MedDRA 14.1
10009701
LOINC Version 232
MTHU033986
UMLS CUI 2011AA
C0032520
SNOMED CT 2011_0131
258066000
MedDRA 14.1
10050967
UMLS CUI 2011AA
C0369083
SNOMED CT 2011_0131
121109001
LOINC Version 232
MTHU011613
UMLS CUI 2011AA
C0005768
UMLS CUI 2011AA
C0082181
UMLS CUI 2011AA
C1510438
SNOMED CT 2011_0131
272392009
Absolute neutrophil count (ANC) >=1000 cells/microL on 2 consecutive follow-ups within 10 days before randomization
Description

Absolute neutrophil count (ANC) >=1000 cells/microL on 2 consecutive follow-ups within 10 days before randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C1707491
UMLS CUI 2011AA
C1522577
Patient has a creatinine clearance of >=25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
Description

Patient has a creatinine clearance of >=25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,

Data type

boolean

Alias
UMLS CUI 2011AA
C2711451
SNOMED CT 2011_0131
442407001
UMLS CUI 2011AA
C1272745
SNOMED CT 2011_0131
385633008
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2
Description

None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2

Data type

boolean

Alias
UMLS CUI 2011AA
C0549184
SNOMED CT 2011_0131
260413007
UMLS CUI 2011AA
C0521362
LOINC Version 232
MTHU031867
UMLS CUI 2011AA
C0018133
SNOMED CT 2011_0131
234646005
MedDRA 14.1
10018651
ICD-10-CM Version 2010
D89.813
ICD-9-CM Version 2011
279.50
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
Exclusion Criteria
Description

Exclusion Criteria

Patient has a suspected or diagnosed CMV disease
Description

Patient has a suspected or diagnosed CMV disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0010825
SNOMED CT 2011_0131
407444007
MedDRA 14.1
10009701
LOINC Version 232
MTHU033986
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
Patient has received syngeneic SCT
Description

Patient has received syngeneic SCT

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C2985487
Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
Description

Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C1514468
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
Body weight (observable entity)
Description

Patient with a body weight <50 kg or >95 kg,

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
Description

Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0010825
SNOMED CT 2011_0131
407444007
MedDRA 14.1
10009701
LOINC Version 232
MTHU033986
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C0001367
SNOMED CT 2011_0131
372729009
LOINC Version 232
MTHU006764
UMLS CUI 2011AA
C0249458
SNOMED CT 2011_0131
96098007
UMLS CUI 2011AA
C0209227
SNOMED CT 2011_0131
387557001
Patient who has participated in this study before,
Description

Patient who has participated in this study before,

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:
Description

Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:

Data type

boolean

Alias
UMLS CUI 2011AA
C0853697
MedDRA 14.1
10029366
CTCAE 1105E
E12198
UMLS CUI 2011AA
C0040034
SNOMED CT 2011_0131
302215000
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE 1105E
E12207
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
C1883713
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
The ANC is <1000 cells/microL on 2 consecutive follow-ups, or
Description

The ANC is <1000 cells/microL on 2 consecutive follow-ups, or

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C1707491
UMLS CUI 2011AA
C1522577
A platelet count of >=25000/microL can not be achieved/maintained with platelet transfusions
Description

A platelet count of >=25000/microL can not be achieved/maintained with platelet transfusions

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0086818
SNOMED CT 2011_0131
12719002
MedDRA 14.1
10035543
ICD-9-CM Version 2011
99.05
UMLS CUI 2011AA
C1272276
SNOMED CT 2011_0131
390801001
A hemoglobin level of >=8g/dL can not be achieved/maintained by red blood cell transfusions
Description

A hemoglobin level of >=8g/dL can not be achieved/maintained by red blood cell transfusions

Data type

boolean

Alias
UMLS CUI 2011AA
C0518015
MedDRA 14.1
10018876
UMLS CUI 2011AA
C0086252
SNOMED CT 2011_0131
116863004
UMLS CUI 2011AA
C1272276
SNOMED CT 2011_0131
390801001
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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
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patient following allogeneic SCT
Item
Patient following allogeneic SCT
boolean
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
Item
Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
boolean
C0439615 (UMLS CUI 2011AA)
255217005 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0032520 (UMLS CUI 2011AA)
258066000 (SNOMED CT 2011_0131)
10050967 (MedDRA 14.1)
C0369083 (UMLS CUI 2011AA)
121109001 (SNOMED CT 2011_0131)
MTHU011613 (LOINC Version 232)
C0005768 (UMLS CUI 2011AA)
C0082181 (UMLS CUI 2011AA)
C1510438 (UMLS CUI 2011AA)
272392009 (SNOMED CT 2011_0131)
Absolute neutrophil count (ANC) >=1000 cells/microL on 2 consecutive follow-ups within 10 days before randomization
Item
Absolute neutrophil count (ANC) >=1000 cells/microL on 2 consecutive follow-ups within 10 days before randomization
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1707491 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
Patient has a creatinine clearance of >=25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
Item
Patient has a creatinine clearance of >=25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
boolean
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
C1272745 (UMLS CUI 2011AA)
385633008 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2
Item
None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2
boolean
C0549184 (UMLS CUI 2011AA)
260413007 (SNOMED CT 2011_0131)
C0521362 (UMLS CUI 2011AA)
MTHU031867 (LOINC Version 232)
C0018133 (UMLS CUI 2011AA)
234646005 (SNOMED CT 2011_0131)
10018651 (MedDRA 14.1)
D89.813 (ICD-10-CM Version 2010)
279.50 (ICD-9-CM Version 2011)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
Item Group
Exclusion Criteria
Patient has a suspected or diagnosed CMV disease
Item
Patient has a suspected or diagnosed CMV disease
boolean
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
Patient has received syngeneic SCT
Item
Patient has received syngeneic SCT
boolean
C1514756 (UMLS CUI 2011AA)
C2985487 (UMLS CUI 2011AA)
Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
Item
Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
boolean
C1514756 (UMLS CUI 2011AA)
C1517586 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
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)
Patient with a body weight <50 kg or >95 kg,
Item
Body weight (observable entity)
boolean
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
Item
Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
boolean
C1514756 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0001367 (UMLS CUI 2011AA)
372729009 (SNOMED CT 2011_0131)
MTHU006764 (LOINC Version 232)
C0249458 (UMLS CUI 2011AA)
96098007 (SNOMED CT 2011_0131)
C0209227 (UMLS CUI 2011AA)
387557001 (SNOMED CT 2011_0131)
Patient who has participated in this study before,
Item
Patient who has participated in this study before,
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:
Item
Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:
boolean
C0853697 (UMLS CUI 2011AA)
10029366 (MedDRA 14.1)
E12198 (CTCAE 1105E)
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
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)
C1883713 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
The ANC is <1000 cells/microL on 2 consecutive follow-ups, or
Item
The ANC is <1000 cells/microL on 2 consecutive follow-ups, or
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1707491 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
A platelet count of >=25000/microL can not be achieved/maintained with platelet transfusions
Item
A platelet count of >=25000/microL can not be achieved/maintained with platelet transfusions
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0086818 (UMLS CUI 2011AA)
12719002 (SNOMED CT 2011_0131)
10035543 (MedDRA 14.1)
99.05 (ICD-9-CM Version 2011)
C1272276 (UMLS CUI 2011AA)
390801001 (SNOMED CT 2011_0131)
A hemoglobin level of >=8g/dL can not be achieved/maintained by red blood cell transfusions
Item
A hemoglobin level of >=8g/dL can not be achieved/maintained by red blood cell transfusions
boolean
C0518015 (UMLS CUI 2011AA)
10018876 (MedDRA 14.1)
C0086252 (UMLS CUI 2011AA)
116863004 (SNOMED CT 2011_0131)
C1272276 (UMLS CUI 2011AA)
390801001 (SNOMED CT 2011_0131)
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