ID

3712

Description

ODM derived from http://clinicaltrials.gov/show/NCT01246752

Link

http://clinicaltrials.gov/show/NCT01246752

Keywords

Versions (1)
  1. 2/22/13 2/22/13 - Martin Dugas
Uploaded on

February 22, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00005726 NCT01246752 Leukemia, Myeloid, Acute

German English

Eligibility

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

Inclusion Criteria

age 18 Years to 60 Years
Description

age 18 Years to 60 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
AML in first remission
Description

AML in first remission

Data type

boolean

Alias
UMLS CUI 2011AA
C0153886
SNOMED CT 2011_0131
91860005
MedDRA 14.1
10000881
ICD-10-CM Version 2010
C92.01
ICD-9-CM Version 2011
205.01
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
cytological standard risk, i.e. karyotype not listed under exclusion criteria
Description

cytological standard risk, i.e. karyotype not listed under exclusion criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C1261273
LOINC Version 232
MTHU014085
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
C0745732
Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)
Description

Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205396
SNOMED CT 2011_0131
7882003
LOINC Version 232
MTHU014964
UMLS CUI 2011AA
C0019721
SNOMED CT 2011_0131
47038001
LOINC Version 232
MTHU018438
UMLS CUI 2011AA
C0205280
SNOMED CT 2011_0131
20323000
UMLS CUI 2011AA
C0037047
SNOMED CT 2011_0131
375005
LOINC Version 232
MTHU016169
HL7 V3 2006_05
SIB
UMLS CUI 2011AA
C0019627
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
UMLS CUI 2011AA
CL414920
UMLS CUI 2011AA
C3179133
UMLS CUI 2011AA
C0002085
SNOMED CT 2011_0131
9109004
UMLS CUI 2011AA
C1708943
UMLS CUI 2011AA
C2735717
LOINC Version 232
57290-9
UMLS CUI 2011AA
C2735718
LOINC Version 232
57291-7
UMLS CUI 2011AA
C2735725
LOINC Version 232
57297-4
UMLS CUI 2011AA
C2735721
LOINC Version 232
57293-3
UMLS CUI 2011AA
C2735726
LOINC Version 232
57299-0
medically fit for allogeneic stem cell transplantation
Description

medically fit for allogeneic stem cell transplantation

Data type

boolean

Alias
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0424576
SNOMED CT 2011_0131
102499006
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
CR / CRi after induction therapy
Description

CR / CRi after induction therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1514832
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
C0205257
SNOMED CT 2011_0131
255599008
UMLS CUI 2011AA
C0229601
UMLS CUI 2011AA
C2004454
Exclusion Criteria
Description

Exclusion Criteria

core-binding factor leukemia (t(8;21), inv16)
Description

core-binding factor leukemia (t(8;21), inv16)

Data type

boolean

Alias
UMLS CUI 2011AA
C0212320
UMLS CUI 2011AA
C0023418
SNOMED CT 2011_0131
93143009
MedDRA 14.1
10024288
ICD-10-CM Version 2010
C95.9
ICD-9-CM Version 2011
208.9
Acute Promyelocytic Leukemia
Description

acute promyelocytic leukemia (t(15;17)

Data type

boolean

Alias
UMLS CUI 2011AA
C0023487
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
Complex Karyotype
Description

complex aberrant karyotype

Data type

boolean

Alias
UMLS CUI 2011AA
CL429691
karyotypes: -7, -5, del5q, t(3;3), t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration
Description

karyotypes: -7, -5, del5q, t(3;3), t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration

Data type

boolean

Alias
UMLS CUI 2011AA
C1261273
LOINC Version 232
MTHU014085
UMLS CUI 2011AA
C0008625
UMLS CUI 2011AA
C0432412
SNOMED CT 2011_0131
205649008
MedDRA 14.1
10053871
LOINC Version 232
MTHU010203
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0008625
pregnancy / nursing
Description

pregnancy / nursing

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Non-compliant
Description

non-compliance

Data type

boolean

Alias
UMLS CUI 2011AA
C0457432
SNOMED CT 2011_0131
258143003
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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 18 Years to 60 Years
Item
age 18 Years to 60 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
AML in first remission
Item
AML in first remission
boolean
C0153886 (UMLS CUI 2011AA)
91860005 (SNOMED CT 2011_0131)
10000881 (MedDRA 14.1)
C92.01 (ICD-10-CM Version 2010)
205.01 (ICD-9-CM Version 2011)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
cytological standard risk, i.e. karyotype not listed under exclusion criteria
Item
cytological standard risk, i.e. karyotype not listed under exclusion criteria
boolean
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C2828392 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C1261273 (UMLS CUI 2011AA)
MTHU014085 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
C0745732 (UMLS CUI 2011AA)
Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)
Item
Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)
boolean
C0205396 (UMLS CUI 2011AA)
7882003 (SNOMED CT 2011_0131)
MTHU014964 (LOINC Version 232)
C0019721 (UMLS CUI 2011AA)
47038001 (SNOMED CT 2011_0131)
MTHU018438 (LOINC Version 232)
C0205280 (UMLS CUI 2011AA)
20323000 (SNOMED CT 2011_0131)
C0037047 (UMLS CUI 2011AA)
375005 (SNOMED CT 2011_0131)
MTHU016169 (LOINC Version 232)
SIB (HL7 V3 2006_05)
C0019627 (UMLS CUI 2011AA)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
CL414920 (UMLS CUI 2011AA)
C3179133 (UMLS CUI 2011AA)
C0002085 (UMLS CUI 2011AA)
9109004 (SNOMED CT 2011_0131)
C1708943 (UMLS CUI 2011AA)
C2735717 (UMLS CUI 2011AA)
57290-9 (LOINC Version 232)
C2735718 (UMLS CUI 2011AA)
57291-7 (LOINC Version 232)
C2735725 (UMLS CUI 2011AA)
57297-4 (LOINC Version 232)
C2735721 (UMLS CUI 2011AA)
57293-3 (LOINC Version 232)
C2735726 (UMLS CUI 2011AA)
57299-0 (LOINC Version 232)
medically fit for allogeneic stem cell transplantation
Item
medically fit for allogeneic stem cell transplantation
boolean
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0424576 (UMLS CUI 2011AA)
102499006 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
CR / CRi after induction therapy
Item
CR / CRi after induction therapy
boolean
C1514832 (UMLS CUI 2011AA)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
C0229601 (UMLS CUI 2011AA)
C2004454 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
core-binding factor leukemia (t(8;21), inv16)
Item
core-binding factor leukemia (t(8;21), inv16)
boolean
C0212320 (UMLS CUI 2011AA)
C0023418 (UMLS CUI 2011AA)
93143009 (SNOMED CT 2011_0131)
10024288 (MedDRA 14.1)
C95.9 (ICD-10-CM Version 2010)
208.9 (ICD-9-CM Version 2011)
acute promyelocytic leukemia (t(15;17)
Item
Acute Promyelocytic Leukemia
boolean
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
complex aberrant karyotype
Item
Complex Karyotype
boolean
CL429691 (UMLS CUI 2011AA)
karyotypes: -7, -5, del5q, t(3;3), t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration
Item
karyotypes: -7, -5, del5q, t(3;3), t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration
boolean
C1261273 (UMLS CUI 2011AA)
MTHU014085 (LOINC Version 232)
C0008625 (UMLS CUI 2011AA)
C0432412 (UMLS CUI 2011AA)
205649008 (SNOMED CT 2011_0131)
10053871 (MedDRA 14.1)
MTHU010203 (LOINC Version 232)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0008625 (UMLS CUI 2011AA)
pregnancy / nursing
Item
pregnancy / nursing
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
non-compliance
Item
Non-compliant
boolean
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
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