Eligibility NCT00373373 Acute Myeloid Leukemia

ODM derived from http://clinicaltrials.gov/show/NCT00373373

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age >= 61 Years
Item
age >= 61 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
Item
Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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)
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
C0280449 (UMLS CUI 2011AA)
Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells, with the exception of AML FAB M6, where >= 30% of non-erythroid cells must be leukemic blasts
Item
Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells, with the exception of AML FAB M6, where >= 30% of non-erythroid cells must be leukemic blasts
boolean
C0005954 (UMLS CUI 2011AA)
234326005 (SNOMED CT 2011_0131)
10004737 (MedDRA 14.1)
41.31 (ICD-9-CM Version 2011)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
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)
CL421536 (UMLS CUI 2011AA)
Age >= 61 years
Item
Age >= 61 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
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 Sorafenib treatment and for at least 3 months after the last administration of Sorafenib
Item
Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the Sorafenib treatment and for at least 3 months after the last administration of Sorafenib
boolean
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Central nervous system manifestation of AML
Item
Central nervous system manifestation of AML
boolean
C0027763 (UMLS CUI 2011AA)
25087005 (SNOMED CT 2011_0131)
MTHU001437 (LOINC Version 232)
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 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)
Item
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)
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)
C1275491 (UMLS CUI 2011AA)
420816009 (SNOMED CT 2011_0131)
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)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
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)
C0003195 (UMLS CUI 2011AA)
67507000 (SNOMED CT 2011_0131)
C0001645 (UMLS CUI 2011AA)
33252009 (SNOMED CT 2011_0131)
MTHU003324 (LOINC Version 232)
C0012265 (UMLS CUI 2011AA)
796001 (SNOMED CT 2011_0131)
MTHU001808 (LOINC Version 232)
Chronically impaired renal function (creatinin clearance < 30 ml/min)
Item
Chronically impaired renal function (creatinin clearance < 30 ml/min)
boolean
C0403447 (UMLS CUI 2011AA)
Chronic pulmonary disease with relevant hypoxia
Item
Chronic pulmonary disease with relevant hypoxia
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0242184 (UMLS CUI 2011AA)
389086002 (SNOMED CT 2011_0131)
10021143 (MedDRA 14.1)
E13388 (CTCAE 1105E)
Inadequate liver function (ALT and AST >= 2.5 x ULN)
Item
Inadequate liver function (ALT and AST >= 2.5 x ULN)
boolean
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
10001844 (MedDRA 14.1)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
10003543 (MedDRA 14.1)
Total bilirubin >= 1.5 x ULN
Item
Total bilirubin >= 1.5 x ULN
boolean
C1278039 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
Item
Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
boolean
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
Item
Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
Uncontrolled active infection
Item
Uncontrolled active infection
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Concurrent malignancies other than AML
Item
Concurrent malignancies other than AML
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m2/d cytarabine
Item
Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m2/d cytarabine
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
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 CNS disease, including primary or metastatic brain tumors, seizure disorders
Item
Evidence or 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)
Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
Item
Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
boolean
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (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)
History of organ allograft
Item
History of organ allograft
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
Item
Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
boolean
C0013227 (UMLS CUI 2011AA)
C0596087 (UMLS CUI 2011AA)
409407003 (SNOMED CT 2011_0131)
Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
Item
Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
boolean
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
Serious, non-healing wound, ulcer or bone fracture
Item
Serious, non-healing wound, ulcer or bone fracture
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0748826 (UMLS CUI 2011AA)
L97 (ICD-10-CM Version 2010)
C0016658 (UMLS CUI 2011AA)
125605004 (SNOMED CT 2011_0131)
10017076 (MedDRA 14.1)
T14.8 (ICD-10-CM Version 2010)
800-829.99 (ICD-9-CM Version 2011)
E11703 (CTCAE 1105E)
Allergy to study medication or excipients in study medication
Item
Allergy to study medication or excipients in study medication
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0013227 (UMLS CUI 2011AA)
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Item
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
boolean
C2348568 (UMLS CUI 2011AA)
Patients who are not eligible for standard chemotherapy
Item
Patients who are not eligible for standard chemotherapy
boolean
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)

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