ID

43346

Description

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

Link

http://clinicaltrials.gov/show/NCT00373373

Keywords

Versions (2)
  1. 4/14/14 4/14/14 - Julian Varghese
  2. 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 NCT00373373 Acute Myeloid Leukemia

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age >= 61 Years
Description

age >= 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 and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
Description

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)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
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
C0023487
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
UMLS CUI 2011AA
C0280449
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0005954
SNOMED CT 2011_0131
234326005
MedDRA 14.1
10004737
ICD-9-CM Version 2011
41.31
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
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
CL421536
Age >= 61 years
Description

Age >= 61 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
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 Sorafenib treatment and for at least 3 months after the last administration of Sorafenib
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Central nervous system manifestation of AML
Description

Central nervous system manifestation of AML

Data type

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
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)
Description

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)

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
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
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
Chronic pulmonary disease with relevant hypoxia
Description

Chronic pulmonary disease with relevant hypoxia

Data type

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
Inadequate liver function (ALT and AST >= 2.5 x ULN)
Description

Inadequate liver function (ALT and AST >= 2.5 x ULN)

Data type

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
Total bilirubin >= 1.5 x ULN
Description

Total bilirubin >= 1.5 x ULN

Data type

boolean

Alias
UMLS CUI 2011AA
C1278039
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
Description

Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg

Data type

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

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

Data type

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
Uncontrolled active infection
Description

Uncontrolled active infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
Concurrent malignancies other than AML
Description

Concurrent malignancies other than AML

Data type

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

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

Data type

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
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 CNS disease, including primary or metastatic brain tumors, seizure disorders
Description

Evidence or 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
Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
Description

Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry

Data type

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
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
History of organ allograft
Description

History of organ allograft

Data type

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
Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
Description

Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg

Data type

boolean

Alias
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0596087
SNOMED CT 2011_0131
409407003
Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
Description

Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose

Data type

boolean

Alias
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0038895
Serious, non-healing wound, ulcer or bone fracture
Description

Serious, non-healing wound, ulcer or bone fracture

Data type

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
Allergy to study medication or excipients in study medication
Description

Allergy to study medication or excipients in study medication

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0013227
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Description

Investigational drug therapy outside of this trial during or within 4 weeks of study entry

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Patients who are not eligible for standard chemotherapy
Description

Patients who are not eligible for standard chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
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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 >= 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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