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
C0024554 (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)
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)
C0522536 (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)
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)
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)