ID

43491

Description

ODM derived from http://clinicaltrials.gov/show/NCT00867672

Link

http://clinicaltrials.gov/show/NCT00867672

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00000733 NCT00867672 Acute Myeloid Leukemia

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 60 Years
Description

age at least 60 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients older than 60 years with acute myeloid leukemia according to FAB (> 30 % bone marrow blasts) not qualifying for, or not consenting to, standard induction chemotherapy or immediate allografting
Description

Patients older than 60 years with acute myeloid leukemia according to FAB (> 30 % bone marrow blasts) not qualifying for, or not consenting to, standard induction chemotherapy or immediate allografting

Data type

boolean

Alias
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL421536
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0205253
SNOMED CT 2011_0131
88694003
UMLS CUI 2011AA
C0040739
Life expectancy > 3 months with successful treatment
Description

Life expectancy > 3 months with successful treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
C0039798
Performance status ECOG 0, 1, 2
Description

Performance status ECOG 0, 1, 2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
Age-adjusted normal cardiac, kidney, liver function (creatinine < 1.5 mg/dl unless leukemia-related, total bilirubin < 2.0 of upper normal limits)
Description

Age-adjusted normal cardiac, kidney, liver function (creatinine < 1.5 mg/dl unless leukemia-related, total bilirubin < 2.0 of upper normal limits)

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0456081
SNOMED CT 2011_0131
410617001
UMLS CUI 2011AA
C0205307
SNOMED CT 2011_0131
17621005
HL7 V3 2006_05
N
UMLS CUI 2011AA
C0232164
SNOMED CT 2011_0131
86185002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0010294
SNOMED CT 2011_0131
15373003
MedDRA 14.1
10011358
LOINC Version 232
38483-4
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C1519815
Patients with >50 000 leukocytes/µl in whom initial cytoreduction according to protocol is effective
Description

Patients with >50 000 leukocytes/µl in whom initial cytoreduction according to protocol is effective

Data type

boolean

Alias
UMLS CUI 2011AA
C0023516
SNOMED CT 2011_0131
52501007
MedDRA 14.1
10047955
LOINC Version 232
MTHU001946
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C0392756
SNOMED CT 2011_0131
260400001
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C0566588
SNOMED CT 2011_0131
289172004
UMLS CUI 2011AA
C1704419
SNOMED CT 2011_0131
254648000
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
AML of FAB subtype M3
Description

AML of FAB subtype M3

Data type

boolean

Alias
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C0457329
SNOMED CT 2011_0131
278165002
Previous induction-type chemotherapy for MDS or AML
Description

Previous induction-type chemotherapy for MDS or AML

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C3463824
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
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
Previous treatment with DAC, 5-azacytidine, VPA or another HDAC inhibitor, or ATRA
Description

Previous treatment with DAC, 5-azacytidine, VPA or another HDAC inhibitor, or ATRA

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0049065
SNOMED CT 2011_0131
420517007
UMLS CUI 2011AA
C0004475
SNOMED CT 2011_0131
412329008
UMLS CUI 2011AA
C0042291
SNOMED CT 2011_0131
13965000
LOINC Version 232
MTHU005126
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1512474
SNOMED CT 2011_0131
423081009
UMLS CUI 2011AA
C0040845
SNOMED CT 2011_0131
54972005
low-dose chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan) within 8 weeks prior to DAC treatment, except for cytoreduction of leukocytosis >50 000/µl according to protocol
Description

low-dose chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan) within 8 weeks prior to DAC treatment, except for cytoreduction of leukocytosis >50 000/µl according to protocol

Data type

boolean

Alias
UMLS CUI 2011AA
CL388412
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C0025241
SNOMED CT 2011_0131
387297002
Patients with > 50 000 leukocytes/µl in whom initial cytoreduction according to protocol is ineffective
Description

Patients with > 50 000 leukocytes/µl in whom initial cytoreduction according to protocol is ineffective

Data type

boolean

Alias
UMLS CUI 2011AA
C0023516
SNOMED CT 2011_0131
52501007
MedDRA 14.1
10047955
LOINC Version 232
MTHU001946
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C0392756
SNOMED CT 2011_0131
260400001
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C0566588
SNOMED CT 2011_0131
289172004
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1704419
SNOMED CT 2011_0131
254648000
Treatment with cytokines within previous 4 weeks
Description

Treatment with cytokines within previous 4 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0079189
SNOMED CT 2011_0131
75777003
LOINC Version 232
MTHU018469
Concomitant use of any other investigational drug
Description

Concomitant use of any other investigational drug

Data type

boolean

Alias
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
Other malignancy that is not in remission (previous chemotherapy for other malignancies is not an exclusion criteria)
Description

Other malignancy that is not in remission (previous chemotherapy for other malignancies is not an exclusion criteria)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0544452
SNOMED CT 2011_0131
277022003
Cardiac insufficiency NYHA IV
Description

Cardiac insufficiency NYHA IV

Data type

boolean

Alias
UMLS CUI 2011AA
C1319796
Human immunodeficiency virus infection
Description

HIV infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
Other uncontrolled active infection
Description

Other uncontrolled active infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
Psychiatric disorder that interferes with treatment
Description

Psychiatric disorder that interferes with treatment

Data type

boolean

Alias
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
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0039798
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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 at least 60 Years
Item
age at least 60 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients older than 60 years with acute myeloid leukemia according to FAB (> 30 % bone marrow blasts) not qualifying for, or not consenting to, standard induction chemotherapy or immediate allografting
Item
Patients older than 60 years with acute myeloid leukemia according to FAB (> 30 % bone marrow blasts) not qualifying for, or not consenting to, standard induction chemotherapy or immediate allografting
boolean
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL421536 (UMLS CUI 2011AA)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C1548788 (UMLS CUI 2011AA)
C2828392 (UMLS CUI 2011AA)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0205253 (UMLS CUI 2011AA)
88694003 (SNOMED CT 2011_0131)
C0040739 (UMLS CUI 2011AA)
Life expectancy > 3 months with successful treatment
Item
Life expectancy > 3 months with successful treatment
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Performance status ECOG 0, 1, 2
Item
Performance status ECOG 0, 1, 2
boolean
C1520224 (UMLS CUI 2011AA)
Age-adjusted normal cardiac, kidney, liver function (creatinine < 1.5 mg/dl unless leukemia-related, total bilirubin < 2.0 of upper normal limits)
Item
Age-adjusted normal cardiac, kidney, liver function (creatinine < 1.5 mg/dl unless leukemia-related, total bilirubin < 2.0 of upper normal limits)
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0456081 (UMLS CUI 2011AA)
410617001 (SNOMED CT 2011_0131)
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
N (HL7 V3 2006_05)
C0232164 (UMLS CUI 2011AA)
86185002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
Patients with >50 000 leukocytes/µl in whom initial cytoreduction according to protocol is effective
Item
Patients with >50 000 leukocytes/µl in whom initial cytoreduction according to protocol is effective
boolean
C0023516 (UMLS CUI 2011AA)
52501007 (SNOMED CT 2011_0131)
10047955 (MedDRA 14.1)
MTHU001946 (LOINC Version 232)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0392756 (UMLS CUI 2011AA)
260400001 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
AML of FAB subtype M3
Item
AML of FAB subtype M3
boolean
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C0457329 (UMLS CUI 2011AA)
278165002 (SNOMED CT 2011_0131)
Previous induction-type chemotherapy for MDS or AML
Item
Previous induction-type chemotherapy for MDS or AML
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C3463824 (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)
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
Previous treatment with DAC, 5-azacytidine, VPA or another HDAC inhibitor, or ATRA
Item
Previous treatment with DAC, 5-azacytidine, VPA or another HDAC inhibitor, or ATRA
boolean
C1514463 (UMLS CUI 2011AA)
C0049065 (UMLS CUI 2011AA)
420517007 (SNOMED CT 2011_0131)
C0004475 (UMLS CUI 2011AA)
412329008 (SNOMED CT 2011_0131)
C0042291 (UMLS CUI 2011AA)
13965000 (SNOMED CT 2011_0131)
MTHU005126 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1512474 (UMLS CUI 2011AA)
423081009 (SNOMED CT 2011_0131)
C0040845 (UMLS CUI 2011AA)
54972005 (SNOMED CT 2011_0131)
low-dose chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan) within 8 weeks prior to DAC treatment, except for cytoreduction of leukocytosis >50 000/µl according to protocol
Item
low-dose chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan) within 8 weeks prior to DAC treatment, except for cytoreduction of leukocytosis >50 000/µl according to protocol
boolean
CL388412 (UMLS CUI 2011AA)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0025241 (UMLS CUI 2011AA)
387297002 (SNOMED CT 2011_0131)
Patients with > 50 000 leukocytes/µl in whom initial cytoreduction according to protocol is ineffective
Item
Patients with > 50 000 leukocytes/µl in whom initial cytoreduction according to protocol is ineffective
boolean
C0023516 (UMLS CUI 2011AA)
52501007 (SNOMED CT 2011_0131)
10047955 (MedDRA 14.1)
MTHU001946 (LOINC Version 232)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0392756 (UMLS CUI 2011AA)
260400001 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
Treatment with cytokines within previous 4 weeks
Item
Treatment with cytokines within previous 4 weeks
boolean
C0039798 (UMLS CUI 2011AA)
C0079189 (UMLS CUI 2011AA)
75777003 (SNOMED CT 2011_0131)
MTHU018469 (LOINC Version 232)
Concomitant use of any other investigational drug
Item
Concomitant use of any other investigational drug
boolean
CL415222 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
Other malignancy that is not in remission (previous chemotherapy for other malignancies is not an exclusion criteria)
Item
Other malignancy that is not in remission (previous chemotherapy for other malignancies is not an exclusion criteria)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1518422 (UMLS CUI 2011AA)
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
Cardiac insufficiency NYHA IV
Item
Cardiac insufficiency NYHA IV
boolean
C1319796 (UMLS CUI 2011AA)
HIV infection
Item
Human immunodeficiency virus infection
boolean
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Other uncontrolled active infection
Item
Other uncontrolled active infection
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Psychiatric disorder that interferes with treatment
Item
Psychiatric disorder that interferes with treatment
boolean
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)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
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