ID
5146
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT01404741
Länk
http://clinicaltrials.gov/show/NCT01404741
Nyckelord
Versioner (3)
- 2013-04-17 2013-04-17 - Martin Dugas
- 2014-04-20 2014-04-20 - Julian Varghese
- 2021-09-20 2021-09-20 -
Uppladdad den
20 april 2014
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT01404741 Myelodysplastic Syndrome
Eligibility
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Beskrivning
Blasts > 30 % in bone marrow at time of diagnosis
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0368761
- SNOMED CT 2011_0131
- 312256009
- LOINC Version 232
- MTHU005201
- UMLS CUI 2011AA
- C0205217
- HL7 V3 2006_05
- U
- UMLS CUI 2011AA
- CL343029
- HL7 V3 2006_05
- %
- UMLS CUI 2011AA
- C0005953
- SNOMED CT 2011_0131
- 14016003
- LOINC Version 232
- MTHU016536
Beskrivning
Central nervous involvement
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0007682
- SNOMED CT 2011_0131
- 260766009
Beskrivning
Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
Datatyp
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
Beskrivning
Total bilirubin, SGPT or SGOT >= 3 times upper the normal level
Datatyp
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
Beskrivning
Left ventricular ejection fraction < 30 %
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0428772
- SNOMED CT 2011_0131
- 250908004
- MedDRA 14.1
- 10069170
Beskrivning
Creatinine clearance < 30 ml/min
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
Beskrivning
DLCO < 35 % and/or receiving supplementary continuous oxygen
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1516251
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0750536
- UMLS CUI 2011AA
- C0919655
- MedDRA 14.1
- 10050322
Beskrivning
Pregnant or breastfeeding female subject
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0015780
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C0681850
Beskrivning
Patients with a life-expectancy of < six months because of another debilitating disease
Datatyp
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
- 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
Beskrivning
Serious psychiatric or psychological disorders
Datatyp
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
Beskrivning
Uncontrolled invasive fungal infection at time of registration
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- 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
Beskrivning
Known positive for HIV or acute infectious hepatitis, type A, B or C
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0019699
- SNOMED CT 2011_0131
- 165816005
- MedDRA 14.1
- 10020188
- ICD-10-CM Version 2010
- Z21
- UMLS CUI 2011AA
- C0019159
- SNOMED CT 2011_0131
- 40468003
- MedDRA 14.1
- 10019780
- UMLS CUI 2011AA
- C0019163
- SNOMED CT 2011_0131
- 66071002
- MedDRA 14.1
- 10019731
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
Beskrivning
Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study
Datatyp
boolean
Alias
- 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
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0023636
- UMLS CUI 2011AA
- C0013230
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Eligibility
- StudyEvent: Eligibility
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79036002 (SNOMED CT 2011_0131)
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
51117008 (SNOMED CT 2011_0131)
C0232164 (UMLS CUI 2011AA)
86185002 (SNOMED CT 2011_0131)
C0232174 (UMLS CUI 2011AA)
70822001 (SNOMED CT 2011_0131)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
CL343029 (UMLS CUI 2011AA)
% (HL7 V3 2006_05)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
260766009 (SNOMED CT 2011_0131)
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)
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)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C1514756 (UMLS CUI 2011AA)
C0750536 (UMLS CUI 2011AA)
C0919655 (UMLS CUI 2011AA)
10050322 (MedDRA 14.1)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0681850 (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)
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)
42745003 (SNOMED CT 2011_0131)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
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290-319.99 (ICD-9-CM Version 2011)
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165816005 (SNOMED CT 2011_0131)
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10019780 (MedDRA 14.1)
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10019731 (MedDRA 14.1)
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110465008 (SNOMED CT 2011_0131)
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