ID

4304

Description

ODM derived from http://clinicaltrials.gov/show/NCT01203228

Link

http://clinicaltrials.gov/show/NCT01203228

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 12/6/13 12/6/13 - Martin Dugas
  3. 9/17/21 9/17/21 -
Uploaded on

December 6, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01203228 Myelodysplastic Syndromes

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 65 Years
Description

age 18 Years to 65 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Disease: Cytologically proven primary or therapy-related myelodysplastic syndrome (MDS), either as
Description

Disease: Cytologically proven primary or therapy-related myelodysplastic syndrome (MDS), either as

Data type

boolean

Alias
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0026986
SNOMED CT 2011_0131
128623006
MedDRA 14.1
10028533
ICD-10-CM Version 2010
D46
ICD-9-CM Version 2011
238.75
CTCAE 1105E
E12552
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1292780
SNOMED CT 2011_0131
128838005
refractory anaemia (RA) according FAB or RA with or without dysplasia according WHO,
Description

refractory anaemia (RA) according FAB or RA with or without dysplasia according WHO,

Data type

boolean

Alias
UMLS CUI 2011AA
C0002893
SNOMED CT 2011_0131
109996008
MedDRA 14.1
10038269
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL421536
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0334044
SNOMED CT 2011_0131
25723000
MedDRA 14.1
10058314
refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with or without dysplasia according WHO,
Description

refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with or without dysplasia according WHO,

Data type

boolean

Alias
UMLS CUI 2011AA
C1264195
SNOMED CT 2011_0131
109998009
MedDRA 14.1
10038272
ICD-10-CM Version 2010
D46.1
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL421536
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0334044
SNOMED CT 2011_0131
25723000
MedDRA 14.1
10058314
refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or RAEB II according WHO,
Description

refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or RAEB II according WHO,

Data type

boolean

Alias
UMLS CUI 2011AA
C0002894
SNOMED CT 2011_0131
398623004
MedDRA 14.1
10038270
ICD-10-CM Version 2010
D46.20
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL421536
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
UMLS CUI 2011AA
C1318550
SNOMED CT 2011_0131
415283002
ICD-10-CM Version 2010
D46.21
UMLS CUI 2011AA
C1318551
SNOMED CT 2011_0131
415284008
ICD-10-CM Version 2010
D46.22
refractory anaemia with excess of blast in transformation (RAEB T) according FAB,
Description

refractory anaemia with excess of blast in transformation (RAEB T) according FAB,

Data type

boolean

Alias
UMLS CUI 2011AA
C0280028
SNOMED CT 2011_0131
110000005
MedDRA 14.1
10054593
ICD-10-CM Version 2010
C92.0
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL421536
CMML (dysplastic type) according WHO,
Description

CMML (dysplastic type) according WHO,

Data type

boolean

Alias
UMLS CUI 2011AA
C0023480
SNOMED CT 2011_0131
127225006
MedDRA 14.1
10009018
ICD-10-CM Version 2010
C93.1
UMLS CUI 2011AA
C0334044
SNOMED CT 2011_0131
25723000
MedDRA 14.1
10058314
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
Secondary Acute Myeloid Leukemia
Description

or secondary acute myeloid leukaemia (sAML).

Data type

boolean

Alias
UMLS CUI 2011AA
C0280449
Blast count < 20 percent in bone marrow with or without chemotherapy at time of transplantation.
Description

Blast count < 20 percent in bone marrow with or without chemotherapy at time of transplantation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0523113
SNOMED CT 2011_0131
104102000
MedDRA 14.1
10061700
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
Patient eligible for standard and dose-reduced conditioning as per local guideline.
Description

Patient eligible for standard and dose-reduced conditioning as per local guideline.

Data type

boolean

Alias
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C1707814
UMLS CUI 2011AA
C0009647
SNOMED CT 2011_0131
78326006
UMLS CUI 2011AA
C0220845
Patient age 18 - 60 years if donor is a HLA-matched unrelated donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed):
Description

Patient age 18 - 60 years if donor is a HLA-matched unrelated donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed):

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C3179133
UMLS CUI 2011AA
C0019728
SNOMED CT 2011_0131
49495002
LOINC Version 232
MTHU033943
UMLS CUI 2011AA
C0019737
SNOMED CT 2011_0131
54481006
LOINC Version 232
MTHU027937
UMLS CUI 2011AA
C0122040
LOINC Version 232
MTHU019559
UMLS CUI 2011AA
C0122020
LOINC Version 232
MTHU019561
Patient age 18 - 65 years if donor is a HLA-matched related donor ((HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed):
Description

Patient age 18 - 65 years if donor is a HLA-matched related donor ((HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed):

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
UMLS CUI 2011AA
CL414920
UMLS CUI 2011AA
C0019728
SNOMED CT 2011_0131
49495002
LOINC Version 232
MTHU033943
UMLS CUI 2011AA
C0019737
SNOMED CT 2011_0131
54481006
LOINC Version 232
MTHU027937
UMLS CUI 2011AA
C0122040
LOINC Version 232
MTHU019559
UMLS CUI 2011AA
C0122020
LOINC Version 232
MTHU019561
No major organ dysfunction.
Description

No major organ dysfunction.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C0277785
SNOMED CT 2011_0131
386585008
Written informed consent of the patient.
Description

Written informed consent of the patient.

Data type

boolean

Alias
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Blasts > 20 % in bone marrow at time of transplantation
Description

Blasts > 20 % in bone marrow at time of transplantation

Data type

boolean

Alias
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C1262102
MedDRA 14.1
10062274
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
No written informed consent.
Description

No written informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C1705492
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
Central nervous system (CNS) involvement status
Description

Central nervous involvement.

Data type

boolean

Alias
UMLS CUI 2011AA
C0449389
SNOMED CT 2011_0131
260766009
Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
Description

Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0860433
MedDRA 14.1
10022997
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
Total bilirubin, SGPT or SGOT > 2 times upper the normal level.
Description

Total bilirubin, SGPT or SGOT > 2 times upper the normal level.

Data type

boolean

Alias
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C1519815
LVEF - Left ventricular ejection fraction
Description

Left ventricular ejection fraction < 30 %.

Data type

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
Creatinine clearance (CrCl) measurement
Description

Creatinine clearance < 30 ml/min.

Data type

boolean

Alias
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
DLCO < 35 % and/or receiving supplementary continuous oxygen.
Description

DLCO < 35 % and/or receiving supplementary continuous oxygen.

Data type

boolean

Alias
UMLS CUI 2011AA
C1516251
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0919655
MedDRA 14.1
10050322
HIV Seropositivity
Description

Positive serology for HIV.

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
Pregnant or lactating women.
Description

Pregnant or lactating women.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
Patients with a life-expectancy of < six months because of another debilitating disease.
Description

Patients with a life-expectancy of < six months because of another debilitating disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1883552
SNOMED CT 2011_0131
260407003
MedDRA 14.1
10011942
ICD-10-CM Version 2010
R53.1
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Serious psychiatric or psychological disorders.
Description

Serious psychiatric or psychological disorders.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
Invasive fungal infection at time of registration.
Description

Invasive fungal infection at time of registration.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
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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 18 Years to 65 Years
Item
age 18 Years to 65 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Disease: Cytologically proven primary or therapy-related myelodysplastic syndrome (MDS), either as
Item
Disease: Cytologically proven primary or therapy-related myelodysplastic syndrome (MDS), either as
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0026986 (UMLS CUI 2011AA)
128623006 (SNOMED CT 2011_0131)
10028533 (MedDRA 14.1)
D46 (ICD-10-CM Version 2010)
238.75 (ICD-9-CM Version 2011)
E12552 (CTCAE 1105E)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1292780 (UMLS CUI 2011AA)
128838005 (SNOMED CT 2011_0131)
refractory anaemia (RA) according FAB or RA with or without dysplasia according WHO,
Item
refractory anaemia (RA) according FAB or RA with or without dysplasia according WHO,
boolean
C0002893 (UMLS CUI 2011AA)
109996008 (SNOMED CT 2011_0131)
10038269 (MedDRA 14.1)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL421536 (UMLS CUI 2011AA)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0334044 (UMLS CUI 2011AA)
25723000 (SNOMED CT 2011_0131)
10058314 (MedDRA 14.1)
refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with or without dysplasia according WHO,
Item
refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with or without dysplasia according WHO,
boolean
C1264195 (UMLS CUI 2011AA)
109998009 (SNOMED CT 2011_0131)
10038272 (MedDRA 14.1)
D46.1 (ICD-10-CM Version 2010)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL421536 (UMLS CUI 2011AA)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0334044 (UMLS CUI 2011AA)
25723000 (SNOMED CT 2011_0131)
10058314 (MedDRA 14.1)
refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or RAEB II according WHO,
Item
refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or RAEB II according WHO,
boolean
C0002894 (UMLS CUI 2011AA)
398623004 (SNOMED CT 2011_0131)
10038270 (MedDRA 14.1)
D46.20 (ICD-10-CM Version 2010)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL421536 (UMLS CUI 2011AA)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C1318550 (UMLS CUI 2011AA)
415283002 (SNOMED CT 2011_0131)
D46.21 (ICD-10-CM Version 2010)
C1318551 (UMLS CUI 2011AA)
415284008 (SNOMED CT 2011_0131)
D46.22 (ICD-10-CM Version 2010)
refractory anaemia with excess of blast in transformation (RAEB T) according FAB,
Item
refractory anaemia with excess of blast in transformation (RAEB T) according FAB,
boolean
C0280028 (UMLS CUI 2011AA)
110000005 (SNOMED CT 2011_0131)
10054593 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL421536 (UMLS CUI 2011AA)
CMML (dysplastic type) according WHO,
Item
CMML (dysplastic type) according WHO,
boolean
C0023480 (UMLS CUI 2011AA)
127225006 (SNOMED CT 2011_0131)
10009018 (MedDRA 14.1)
C93.1 (ICD-10-CM Version 2010)
C0334044 (UMLS CUI 2011AA)
25723000 (SNOMED CT 2011_0131)
10058314 (MedDRA 14.1)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
or secondary acute myeloid leukaemia (sAML).
Item
Secondary Acute Myeloid Leukemia
boolean
C0280449 (UMLS CUI 2011AA)
Blast count < 20 percent in bone marrow with or without chemotherapy at time of transplantation.
Item
Blast count < 20 percent in bone marrow with or without chemotherapy at time of transplantation.
boolean
C0523113 (UMLS CUI 2011AA)
104102000 (SNOMED CT 2011_0131)
10061700 (MedDRA 14.1)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
Patient eligible for standard and dose-reduced conditioning as per local guideline.
Item
Patient eligible for standard and dose-reduced conditioning as per local guideline.
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C2828392 (UMLS CUI 2011AA)
C1707814 (UMLS CUI 2011AA)
C0009647 (UMLS CUI 2011AA)
78326006 (SNOMED CT 2011_0131)
C0220845 (UMLS CUI 2011AA)
Patient age 18 - 60 years if donor is a HLA-matched unrelated donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed):
Item
Patient age 18 - 60 years if donor is a HLA-matched unrelated donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed):
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C3179133 (UMLS CUI 2011AA)
C0019728 (UMLS CUI 2011AA)
49495002 (SNOMED CT 2011_0131)
MTHU033943 (LOINC Version 232)
C0019737 (UMLS CUI 2011AA)
54481006 (SNOMED CT 2011_0131)
MTHU027937 (LOINC Version 232)
C0122040 (UMLS CUI 2011AA)
MTHU019559 (LOINC Version 232)
C0122020 (UMLS CUI 2011AA)
MTHU019561 (LOINC Version 232)
Patient age 18 - 65 years if donor is a HLA-matched related donor ((HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed):
Item
Patient age 18 - 65 years if donor is a HLA-matched related donor ((HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed):
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
CL414920 (UMLS CUI 2011AA)
C0019728 (UMLS CUI 2011AA)
49495002 (SNOMED CT 2011_0131)
MTHU033943 (LOINC Version 232)
C0019737 (UMLS CUI 2011AA)
54481006 (SNOMED CT 2011_0131)
MTHU027937 (LOINC Version 232)
C0122040 (UMLS CUI 2011AA)
MTHU019559 (LOINC Version 232)
C0122020 (UMLS CUI 2011AA)
MTHU019561 (LOINC Version 232)
No major organ dysfunction.
Item
No major organ dysfunction.
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
Written informed consent of the patient.
Item
Written informed consent of the patient.
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Blasts > 20 % in bone marrow at time of transplantation
Item
Blasts > 20 % in bone marrow at time of transplantation
boolean
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C1262102 (UMLS CUI 2011AA)
10062274 (MedDRA 14.1)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
No written informed consent.
Item
No written informed consent.
boolean
C1705492 (UMLS CUI 2011AA)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Central nervous involvement.
Item
Central nervous system (CNS) involvement status
boolean
C0449389 (UMLS CUI 2011AA)
260766009 (SNOMED CT 2011_0131)
Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
Item
Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0860433 (UMLS CUI 2011AA)
10022997 (MedDRA 14.1)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
Total bilirubin, SGPT or SGOT > 2 times upper the normal level.
Item
Total bilirubin, SGPT or SGOT > 2 times upper the normal level.
boolean
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Left ventricular ejection fraction < 30 %.
Item
LVEF - Left ventricular ejection fraction
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
Creatinine clearance < 30 ml/min.
Item
Creatinine clearance (CrCl) measurement
boolean
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
DLCO < 35 % and/or receiving supplementary continuous oxygen.
Item
DLCO < 35 % and/or receiving supplementary continuous oxygen.
boolean
C1516251 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0750536 (UMLS CUI 2011AA)
C0919655 (UMLS CUI 2011AA)
10050322 (MedDRA 14.1)
Positive serology for HIV.
Item
HIV Seropositivity
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
Pregnant or lactating women.
Item
Pregnant or lactating women.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Patients with a life-expectancy of < six months because of another debilitating disease.
Item
Patients with a life-expectancy of < six months because of another debilitating disease.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1883552 (UMLS CUI 2011AA)
260407003 (SNOMED CT 2011_0131)
10011942 (MedDRA 14.1)
R53.1 (ICD-10-CM Version 2010)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Serious psychiatric or psychological disorders.
Item
Serious psychiatric or psychological disorders.
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
Invasive fungal infection at time of registration.
Item
Invasive fungal infection at time of registration.
boolean
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
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