ID
5043
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00915252
Link
http://clinicaltrials.gov/show/NCT00915252
Palabras clave
Versiones (3)
- 9/12/13 9/12/13 - Martin Dugas
- 17/4/14 17/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
17 de abril de 2014
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT00915252 Acute Myeloid Leukemia
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
Patients who are not eligible for standard chemotherapy as described in chapter 5.2 and 5.3
Tipo de datos
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
Descripción
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.
Tipo de datos
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
Descripción
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.
Tipo de datos
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
Descripción
Known central nervous system manifestation of AML
Tipo de datos
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
Descripción
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)
Tipo de datos
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
Descripción
Chronically impaired renal function (creatinin clearance < 30 ml / min)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0403447
Descripción
Inadequate liver function (ALT and AST >= 2.5 x ULN) if not caused by leukemic infiltration
Tipo de datos
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
Descripción
Total bilirubin >= 1.5 x ULN if not caused by leukemic infiltration
Tipo de datos
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
Descripción
Known HIV and/or hepatitis C infection
Tipo de datos
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
Descripción
Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
Tipo de datos
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
Descripción
Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
Tipo de datos
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
Descripción
Uncontrolled active infection
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0009450
Descripción
Concurrent malignancies other than AML with an estimated life expectancy of < 2 years
Tipo de datos
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
Descripción
History of organ allograft
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0178784
- LOINC Version 232
- MTHU020170
- UMLS CUI 2011AA
- C0522536
Descripción
Hypersensitivity to cytarabine (not including drug fever or exanthema), daunorubicin, azacytidine or mannitol
Tipo de datos
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
Descripción
Previous treatment of AML except hydroxyurea and up to 2 days of <=100 mg/m2/d cytarabine
Tipo de datos
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
Descripción
Previous therapy with 5-azacytidine (i.e. for an antecedent myelodysplastic syndrome)
Tipo de datos
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
- C0026986
- 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
Descripción
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
Tipo de datos
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
Descripción
Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
Tipo de datos
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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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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99.72 (ICD-9-CM Version 2011)
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C0442802 (UMLS CUI 2011AA)
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345.9 (ICD-9-CM Version 2011)
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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)
392521001 (SNOMED CT 2011_0131)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0522536 (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)
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)
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)
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)
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)