ID

43506

Description

ODM derived from http://clinicaltrials.gov/show/NCT00915252

Link

http://clinicaltrials.gov/show/NCT00915252

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - 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 NCT00915252 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 61 Years
Description

age at least 61 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with newly diagnosed AML (except APL) according to the FAB or WHO classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML).
Description

Patients with newly diagnosed AML (except APL) according to the FAB or WHO classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML).

Data type

boolean

Alias
UMLS CUI 2011AA
C1518321
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
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0023487
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
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
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0280449
Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells or differential blood count must contain >= 20% blasts. In AML FAB M6 >= 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be < 20%.
Description

Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells or differential blood count must contain >= 20% blasts. In AML FAB M6 >= 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be < 20%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0857285
MedDRA 14.1
10005981
UMLS CUI 2011AA
C0005954
SNOMED CT 2011_0131
234326005
MedDRA 14.1
10004737
ICD-9-CM Version 2011
41.31
UMLS CUI 2011AA
C1332570
UMLS CUI 2011AA
C0443199
SNOMED CT 2011_0131
263735002
UMLS CUI 2011AA
C0005771
SNOMED CT 2011_0131
88308000
MedDRA 14.1
10064196
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
UMLS CUI 2011AA
C0457336
SNOMED CT 2011_0131
278172001
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1257751
SNOMED CT 2011_0131
414128005
LOINC Version 232
MTHU030086
UMLS CUI 2011AA
C2697913
UMLS CUI 2011AA
C0008625
UMLS CUI 2011AA
C1709707
Informed consent, personally signed and dated to participate in the study
Description

Informed consent, personally signed and dated to participate in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the 5-azacytidine treatment and for at least 3 months after the last administration of 5-azacytidine.
Description

Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the 5-azacytidine treatment and for at least 3 months after the last administration of 5-azacytidine.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C0004475
SNOMED CT 2011_0131
412329008
UMLS CUI 2011AA
C0039798
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patients who are not eligible for standard chemotherapy as described in chapter 5.2 and 5.3
Description

Patients who are not eligible for standard chemotherapy as described in chapter 5.2 and 5.3

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1555471
HL7 V3 2006_05
NELG
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
Hyperleukocytosis (leukocytes > 20,000/microliter) at study entry. These patients should be treated with hydroxyurea or receive leukocytapheresis treatment (if leukocytes > 100,000/microliter) according to routine practice and entered into the study when leukocyte counts below 20,000/microliter are reached. This applies only for the controlled part of the study.
Description

Hyperleukocytosis (leukocytes > 20,000/microliter) at study entry. These patients should be treated with hydroxyurea or receive leukocytapheresis treatment (if leukocytes > 100,000/microliter) according to routine practice and entered into the study when leukocyte counts below 20,000/microliter are reached. This applies only for the controlled part of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0442802
SNOMED CT 2011_0131
260378005
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0023416
SNOMED CT 2011_0131
77257005
MedDRA 14.1
10051524
ICD-9-CM Version 2011
99.72
Patients with initial hyperleukocytosis above 20,000/microliter can only be enrolled into the controlled part of the study, but not in the run-in dose finding part.
Description

Patients with initial hyperleukocytosis above 20,000/microliter can only be enrolled into the controlled part of the study, but not in the run-in dose finding part.

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C0442802
SNOMED CT 2011_0131
260378005
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C1292711
SNOMED CT 2011_0131
123005000
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Known central nervous system manifestation of AML
Description

Known central nervous system manifestation of AML

Data type

boolean

Alias
UMLS CUI 2011AA
C1269563
SNOMED CT 2011_0131
278199004
UMLS CUI 2011AA
C0205319
SNOMED CT 2011_0131
250255003
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
Cardiac Disease: Heart failure NYHA class 3 or 4. Unstable coronary artery disease (MI more than 6 months prior to study entry is permitted). Serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Description

Cardiac Disease: Heart failure NYHA class 3 or 4. Unstable coronary artery disease (MI more than 6 months prior to study entry is permitted). Serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)

Data type

boolean

Alias
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0085612
SNOMED CT 2011_0131
44103008
MedDRA 14.1
10047281
ICD-10-CM Version 2010
I49.01
CTCAE 1105E
E10230
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0003195
SNOMED CT 2011_0131
67507000
UMLS CUI 2011AA
C0039798
Chronically impaired renal function (creatinin clearance < 30 ml / min)
Description

Chronically impaired renal function (creatinin clearance < 30 ml / min)

Data type

boolean

Alias
UMLS CUI 2011AA
C0403447
Inadequate liver function (ALT and AST >= 2.5 x ULN) if not caused by leukemic infiltration
Description

Inadequate liver function (ALT and AST >= 2.5 x ULN) if not caused by leukemic infiltration

Data type

boolean

Alias
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
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
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C0162679
SNOMED CT 2011_0131
446688004
MedDRA 14.1
10069360
Total bilirubin >= 1.5 x ULN if not caused by leukemic infiltration
Description

Total bilirubin >= 1.5 x ULN if not caused by leukemic infiltration

Data type

boolean

Alias
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C0162679
SNOMED CT 2011_0131
446688004
MedDRA 14.1
10069360
Known HIV and/or hepatitis C infection
Description

Known HIV and/or hepatitis C 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
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
Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
Description

Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1458140
SNOMED CT 2011_0131
248250000
MedDRA 14.1
10005134
UMLS CUI 2011AA
C0005779
SNOMED CT 2011_0131
64779008
MedDRA 14.1
10009802
ICD-10-CM Version 2010
D68.9
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
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
Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
Description

Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders

Data type

boolean

Alias
UMLS CUI 2011AA
C0007682
SNOMED CT 2011_0131
23853001
MedDRA 14.1
10007943
ICD-10-CM Version 2010
G96.9
UMLS CUI 2011AA
C0750974
UMLS CUI 2011AA
C0036525
SNOMED CT 2011_0131
77879006
MedDRA 14.1
10027474
UMLS CUI 2011AA
C0006118
SNOMED CT 2011_0131
126952004
MedDRA 14.1
10061019
ICD-9-CM Version 2011
239.6
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
Uncontrolled active infection
Description

Uncontrolled active infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0009450
Concurrent malignancies other than AML with an estimated life expectancy of < 2 years
Description

Concurrent malignancies other than AML with an estimated life expectancy of < 2 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
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
CL411789
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
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
History of organ allograft
Description

History of organ allograft

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C0040739
Hypersensitivity to cytarabine (not including drug fever or exanthema), daunorubicin, azacytidine or mannitol
Description

Hypersensitivity to cytarabine (not including drug fever or exanthema), daunorubicin, azacytidine or mannitol

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0011015
SNOMED CT 2011_0131
372715008
UMLS CUI 2011AA
C0004475
SNOMED CT 2011_0131
412329008
UMLS CUI 2011AA
C0024730
SNOMED CT 2011_0131
387168006
LOINC Version 232
MTHU015736
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C1320835
SNOMED CT 2011_0131
95908009
MedDRA 14.1
10013697
UMLS CUI 2011AA
C0458082
SNOMED CT 2011_0131
278993004
UMLS CUI 2011AA
C0015230
SNOMED CT 2011_0131
112625008
MedDRA 14.1
10037844
LOINC Version 232
MTHU015064
ICD-10-CM Version 2010
R21
ICD-9-CM Version 2011
782.1
Previous treatment of AML except hydroxyurea and up to 2 days of <=100 mg/m2/d cytarabine
Description

Previous treatment of AML except hydroxyurea and up to 2 days of <=100 mg/m2/d cytarabine

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
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
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
Previous therapy with 5-azacytidine (i.e. for an antecedent myelodysplastic syndrome)
Description

Previous therapy with 5-azacytidine (i.e. for an antecedent myelodysplastic syndrome)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0004475
SNOMED CT 2011_0131
412329008
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
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
Patients with investigational drug therapy outside of this trial during or within 4 weeks of study entry should be discussed with the study office whether study participation is possible
Description

Patients with investigational drug therapy outside of this trial during or within 4 weeks of study entry should be discussed with the study office whether study participation is possible

Data type

boolean

Alias
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C2584313
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
Description

Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0034866
LOINC Version 232
MTHU036724
HL7 V3 2006_05
RMD
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0231347
SNOMED CT 2011_0131
45704003
UMLS CUI 2011AA
C2348563
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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 61 Years
Item
age at least 61 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with newly diagnosed AML (except APL) according to the FAB or WHO classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML).
Item
Patients with newly diagnosed AML (except APL) according to the FAB or WHO classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML).
boolean
C1518321 (UMLS CUI 2011AA)
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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (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)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0280449 (UMLS CUI 2011AA)
Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells or differential blood count must contain >= 20% blasts. In AML FAB M6 >= 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be < 20%.
Item
Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells or differential blood count must contain >= 20% blasts. In AML FAB M6 >= 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be < 20%.
boolean
C0857285 (UMLS CUI 2011AA)
10005981 (MedDRA 14.1)
C0005954 (UMLS CUI 2011AA)
234326005 (SNOMED CT 2011_0131)
10004737 (MedDRA 14.1)
41.31 (ICD-9-CM Version 2011)
C1332570 (UMLS CUI 2011AA)
C0443199 (UMLS CUI 2011AA)
263735002 (SNOMED CT 2011_0131)
C0005771 (UMLS CUI 2011AA)
88308000 (SNOMED CT 2011_0131)
10064196 (MedDRA 14.1)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0457336 (UMLS CUI 2011AA)
278172001 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1257751 (UMLS CUI 2011AA)
414128005 (SNOMED CT 2011_0131)
MTHU030086 (LOINC Version 232)
C2697913 (UMLS CUI 2011AA)
C0008625 (UMLS CUI 2011AA)
C1709707 (UMLS CUI 2011AA)
Informed consent, personally signed and dated to participate in the study
Item
Informed consent, personally signed and dated to participate in the study
boolean
C0021430 (UMLS CUI 2011AA)
Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the 5-azacytidine treatment and for at least 3 months after the last administration of 5-azacytidine.
Item
Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the 5-azacytidine treatment and for at least 3 months after the last administration of 5-azacytidine.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C1516879 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0004475 (UMLS CUI 2011AA)
412329008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients who are not eligible for standard chemotherapy as described in chapter 5.2 and 5.3
Item
Patients who are not eligible for standard chemotherapy as described in chapter 5.2 and 5.3
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1555471 (UMLS CUI 2011AA)
NELG (HL7 V3 2006_05)
C2828392 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
Hyperleukocytosis (leukocytes > 20,000/microliter) at study entry. These patients should be treated with hydroxyurea or receive leukocytapheresis treatment (if leukocytes > 100,000/microliter) according to routine practice and entered into the study when leukocyte counts below 20,000/microliter are reached. This applies only for the controlled part of the study.
Item
Hyperleukocytosis (leukocytes > 20,000/microliter) at study entry. These patients should be treated with hydroxyurea or receive leukocytapheresis treatment (if leukocytes > 100,000/microliter) according to routine practice and entered into the study when leukocyte counts below 20,000/microliter are reached. This applies only for the controlled part of the study.
boolean
C0442802 (UMLS CUI 2011AA)
260378005 (SNOMED CT 2011_0131)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0023416 (UMLS CUI 2011AA)
77257005 (SNOMED CT 2011_0131)
10051524 (MedDRA 14.1)
99.72 (ICD-9-CM Version 2011)
Patients with initial hyperleukocytosis above 20,000/microliter can only be enrolled into the controlled part of the study, but not in the run-in dose finding part.
Item
Patients with initial hyperleukocytosis above 20,000/microliter can only be enrolled into the controlled part of the study, but not in the run-in dose finding part.
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0442802 (UMLS CUI 2011AA)
260378005 (SNOMED CT 2011_0131)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C1516879 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C1292711 (UMLS CUI 2011AA)
123005000 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Known central nervous system manifestation of AML
Item
Known central nervous system manifestation of AML
boolean
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
C0205319 (UMLS CUI 2011AA)
250255003 (SNOMED CT 2011_0131)
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)
Cardiac Disease: Heart failure NYHA class 3 or 4. Unstable coronary artery disease (MI more than 6 months prior to study entry is permitted). Serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Item
Cardiac Disease: Heart failure NYHA class 3 or 4. Unstable coronary artery disease (MI more than 6 months prior to study entry is permitted). Serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
boolean
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
C1514873 (UMLS CUI 2011AA)
C0003195 (UMLS CUI 2011AA)
67507000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Chronically impaired renal function (creatinin clearance < 30 ml / min)
Item
Chronically impaired renal function (creatinin clearance < 30 ml / min)
boolean
C0403447 (UMLS CUI 2011AA)
Inadequate liver function (ALT and AST >= 2.5 x ULN) if not caused by leukemic infiltration
Item
Inadequate liver function (ALT and AST >= 2.5 x ULN) if not caused by leukemic infiltration
boolean
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (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)
C1518422 (UMLS CUI 2011AA)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0162679 (UMLS CUI 2011AA)
446688004 (SNOMED CT 2011_0131)
10069360 (MedDRA 14.1)
Total bilirubin >= 1.5 x ULN if not caused by leukemic infiltration
Item
Total bilirubin >= 1.5 x ULN if not caused by leukemic infiltration
boolean
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0162679 (UMLS CUI 2011AA)
446688004 (SNOMED CT 2011_0131)
10069360 (MedDRA 14.1)
Known HIV and/or hepatitis C infection
Item
Known HIV and/or hepatitis C 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)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
Item
Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
C1518422 (UMLS CUI 2011AA)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
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)
Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
Item
Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
boolean
C0007682 (UMLS CUI 2011AA)
23853001 (SNOMED CT 2011_0131)
10007943 (MedDRA 14.1)
G96.9 (ICD-10-CM Version 2010)
C0750974 (UMLS CUI 2011AA)
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
C0006118 (UMLS CUI 2011AA)
126952004 (SNOMED CT 2011_0131)
10061019 (MedDRA 14.1)
239.6 (ICD-9-CM Version 2011)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
Uncontrolled active infection
Item
Uncontrolled active infection
boolean
C0009450 (UMLS CUI 2011AA)
Concurrent malignancies other than AML with an estimated life expectancy of < 2 years
Item
Concurrent malignancies other than AML with an estimated life expectancy of < 2 years
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (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)
CL411789 (UMLS CUI 2011AA)
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)
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
History of organ allograft
Item
History of organ allograft
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0040739 (UMLS CUI 2011AA)
Hypersensitivity to cytarabine (not including drug fever or exanthema), daunorubicin, azacytidine or mannitol
Item
Hypersensitivity to cytarabine (not including drug fever or exanthema), daunorubicin, azacytidine or mannitol
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0011015 (UMLS CUI 2011AA)
372715008 (SNOMED CT 2011_0131)
C0004475 (UMLS CUI 2011AA)
412329008 (SNOMED CT 2011_0131)
C0024730 (UMLS CUI 2011AA)
387168006 (SNOMED CT 2011_0131)
MTHU015736 (LOINC Version 232)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C1320835 (UMLS CUI 2011AA)
95908009 (SNOMED CT 2011_0131)
10013697 (MedDRA 14.1)
C0458082 (UMLS CUI 2011AA)
278993004 (SNOMED CT 2011_0131)
C0015230 (UMLS CUI 2011AA)
112625008 (SNOMED CT 2011_0131)
10037844 (MedDRA 14.1)
MTHU015064 (LOINC Version 232)
R21 (ICD-10-CM Version 2010)
782.1 (ICD-9-CM Version 2011)
Previous treatment of AML except hydroxyurea and up to 2 days of <=100 mg/m2/d cytarabine
Item
Previous treatment of AML except hydroxyurea and up to 2 days of <=100 mg/m2/d cytarabine
boolean
C1514463 (UMLS CUI 2011AA)
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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
Previous therapy with 5-azacytidine (i.e. for an antecedent myelodysplastic syndrome)
Item
Previous therapy with 5-azacytidine (i.e. for an antecedent myelodysplastic syndrome)
boolean
C1514463 (UMLS CUI 2011AA)
C0004475 (UMLS CUI 2011AA)
412329008 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (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)
Patients with investigational drug therapy outside of this trial during or within 4 weeks of study entry should be discussed with the study office whether study participation is possible
Item
Patients with investigational drug therapy outside of this trial during or within 4 weeks of study entry should be discussed with the study office whether study participation is possible
boolean
C0013230 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2584313 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
Item
Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0231347 (UMLS CUI 2011AA)
45704003 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
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