ID
43346
Description
ODM derived from http://clinicaltrials.gov/show/NCT00373373
Link
http://clinicaltrials.gov/show/NCT00373373
Keywords
Versions (2)
- 4/14/14 4/14/14 - Julian Varghese
- 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
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
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
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
Description
Chronically impaired renal function (creatinin clearance < 30 ml/min)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0403447
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Description
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2348568
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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Eligibility
- StudyEvent: Eligibility
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