ID
4903
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00373373
Link
http://clinicaltrials.gov/show/NCT00373373
Palabras clave
Versiones (3)
- 11/12/13 11/12/13 - Martin Dugas
- 14/4/14 14/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
14 de abril de 2014
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT00373373 Acute Myeloid Leukemia
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
Central nervous system manifestation of AML
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0027763
- SNOMED CT 2011_0131
- 25087005
- LOINC Version 232
- MTHU001437
- 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 III or IV. Active 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
- C1275491
- SNOMED CT 2011_0131
- 420816009
- 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
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0010068
- SNOMED CT 2011_0131
- 53741008
- MedDRA 14.1
- 10068617
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
- 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
- C0003195
- SNOMED CT 2011_0131
- 67507000
- UMLS CUI 2011AA
- C0001645
- SNOMED CT 2011_0131
- 33252009
- LOINC Version 232
- MTHU003324
- UMLS CUI 2011AA
- C0012265
- SNOMED CT 2011_0131
- 796001
- LOINC Version 232
- MTHU001808
Descripción
Chronically impaired renal function (creatinin clearance < 30 ml/min)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0403447
Descripción
Chronic pulmonary disease with relevant hypoxia
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0024115
- SNOMED CT 2011_0131
- 19829001
- MedDRA 14.1
- 10025082
- ICD-10-CM Version 2010
- J98.4
- UMLS CUI 2011AA
- C0242184
- SNOMED CT 2011_0131
- 389086002
- MedDRA 14.1
- 10021143
- CTCAE 1105E
- E13388
Descripción
Inadequate liver function (ALT and AST >= 2.5 x ULN)
Tipo de datos
boolean
Alias
- 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
- C0001899
- SNOMED CT 2011_0131
- 56935002
- MedDRA 14.1
- 10001844
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- MedDRA 14.1
- 10003543
Descripción
Total bilirubin >= 1.5 x ULN
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 79706000
- LOINC Version 232
- 1975-2
Descripción
Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0020538
- SNOMED CT 2011_0131
- 38341003
- MedDRA 14.1
- 10020772
- LOINC Version 232
- MTHU020789
- ICD-10-CM Version 2010
- I10
- ICD-9-CM Version 2011
- 997.91
- CTCAE 1105E
- E13785
Descripción
Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
Descripción
Uncontrolled active infection
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0021311
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
Descripción
Concurrent malignancies other than AML
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
Descripción
Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m2/d cytarabine
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0020402
- SNOMED CT 2011_0131
- 56602009
- UMLS CUI 2011AA
- C0010711
- SNOMED CT 2011_0131
- 89265009
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 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
Descripción
Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0038454
- SNOMED CT 2011_0131
- 230690007
- MedDRA 14.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE 1105E
- E12826
- UMLS CUI 2011AA
- C0034065
- SNOMED CT 2011_0131
- 59282003
- MedDRA 14.1
- 10037377
- ICD-10-CM Version 2010
- I26
- ICD-9-CM Version 2011
- 415.1
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
Descripción
History of organ allograft
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0262926
- SNOMED CT 2011_0131
- 417662000
- LOINC Version 232
- MTHU027722
- UMLS CUI 2011AA
- C0029216
- MedDRA 14.1
- 10061890
- LOINC Version 232
- MTHU000173
Descripción
Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0596087
- SNOMED CT 2011_0131
- 409407003
Descripción
Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205164
- SNOMED CT 2011_0131
- 255603008
- UMLS CUI 2011AA
- C0038895
Descripción
Serious, non-healing wound, ulcer or bone fracture
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205404
- SNOMED CT 2011_0131
- 42745003
- UMLS CUI 2011AA
- C0748826
- ICD-10-CM Version 2010
- L97
- UMLS CUI 2011AA
- C0016658
- SNOMED CT 2011_0131
- 125605004
- MedDRA 14.1
- 10017076
- ICD-10-CM Version 2010
- T14.8
- ICD-9-CM Version 2011
- 800-829.99
- CTCAE 1105E
- E11703
Descripción
Allergy to study medication or excipients in study medication
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 257550005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0013227
Descripción
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C2348568
Descripción
Patients who are not eligible for standard chemotherapy
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1444657
- SNOMED CT 2011_0131
- 410536001
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
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Eligibility
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19032002 (SNOMED CT 2011_0131)
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257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
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