Eligibility NCT00682396 Myelodysplastic Syndrome
ODM derived from http://clinicaltrials.gov/show/NCT00682396

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 18 Years to 65 Years
Item
Alter 18 bis 65 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Disease: cytologically proven
Item
Disease: cytologically proven
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)
primary or therapy related myelodysplastic syndrome (MDS) either as
Item
primary or therapy related myelodysplastic syndrome (MDS) either as
boolean
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)
C0680240 (UMLS CUI 2011AA)
CL421536 (UMLS CUI 2011AA)
C0002893 (UMLS CUI 2011AA)
109996008 (SNOMED CT 2011_0131)
10038269 (MedDRA 14.1)
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)
C0680240 (UMLS CUI 2011AA)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
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)
C0680240 (UMLS CUI 2011AA)
CL421536 (UMLS CUI 2011AA)
C1264195 (UMLS CUI 2011AA)
109998009 (SNOMED CT 2011_0131)
10038272 (MedDRA 14.1)
D46.1 (ICD-10-CM Version 2010)
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)
C0680240 (UMLS CUI 2011AA)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
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)
C0680240 (UMLS CUI 2011AA)
CL421536 (UMLS CUI 2011AA)
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)
C0680240 (UMLS CUI 2011AA)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
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)
C0680240 (UMLS CUI 2011AA)
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)
C0680240 (UMLS CUI 2011AA)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
or secondary acute myeloid leukaemia (sAML)
Item
sekundäre akute myeloische Leukämie
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
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C2828392 (UMLS CUI 2011AA)
C0392756 (UMLS CUI 2011AA)
260400001 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0009647 (UMLS CUI 2011AA)
78326006 (SNOMED CT 2011_0131)
CL415116 (UMLS CUI 2011AA)
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)
CL414920 (UMLS CUI 2011AA)
C1315037 (UMLS CUI 2011AA)
MTHU000083 (LOINC Version 232)
C1708943 (UMLS CUI 2011AA)
CL414700 (UMLS CUI 2011AA)
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)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1881865 (UMLS CUI 2011AA)
C1524004 (UMLS CUI 2011AA)
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)
CL414920 (UMLS CUI 2011AA)
C1315037 (UMLS CUI 2011AA)
MTHU000083 (LOINC Version 232)
C1708943 (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)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0003320 (UMLS CUI 2011AA)
7120007 (SNOMED CT 2011_0131)
MTHU007668 (LOINC Version 232)
C1881865 (UMLS CUI 2011AA)
C1524004 (UMLS CUI 2011AA)
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
C0021430 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Blasts >20% in bone marrow at time of transplantation
Item
Blasts >20% in bone marrow at time of transplantation
boolean
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
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
C0021430 (UMLS CUI 2011AA)
central nervous involvement
Item
Zentralnervensystembeteiligung, Status
boolean
C0007682 (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)
C1518422 (UMLS CUI 2011AA)
C0205343 (UMLS CUI 2011AA)
35174006 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
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)
C0205172 (UMLS CUI 2011AA)
242762006 (SNOMED CT 2011_0131)
C1948050 (UMLS CUI 2011AA)
CL384738 (UMLS CUI 2011AA)
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
N (HL7 V3 2006_05)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
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
Kreatinin-Clearance
boolean
C0201976 (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)
C2348609 (UMLS CUI 2011AA)
C0750536 (UMLS CUI 2011AA)
C0030054 (UMLS CUI 2011AA)
24099007 (SNOMED CT 2011_0131)
MTHU002757 (LOINC Version 232)
Positive serology for HIV
Item
Positive serology for HIV
boolean
C0242089 (UMLS CUI 2011AA)
168276008 (SNOMED CT 2011_0131)
10050409 (MedDRA 14.1)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
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 < 6 months because of another debilitating disease
Item
patients with a life-expectancy of < 6 months because of another debilitating disease
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0547044 (UMLS CUI 2011AA)
263796003 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
CL420107 (UMLS CUI 2011AA)
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)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)