ID
43346
Descrizione
ODM derived from http://clinicaltrials.gov/show/NCT00373373
collegamento
http://clinicaltrials.gov/show/NCT00373373
Keywords
versioni (2)
- 14/04/14 14/04/14 - Julian Varghese
- 20/09/21 20/09/21 -
Caricato su
20 settembre 2021
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY 4.0
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Eligibility NCT00373373 Acute Myeloid Leukemia
Eligibility
- StudyEvent: Eligibility
Descrizione
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Descrizione
Central nervous system manifestation of AML
Tipo di dati
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
Descrizione
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 di dati
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
Descrizione
Chronically impaired renal function (creatinin clearance < 30 ml/min)
Tipo di dati
boolean
Alias
- UMLS CUI 2011AA
- C0403447
Descrizione
Chronic pulmonary disease with relevant hypoxia
Tipo di dati
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
Descrizione
Inadequate liver function (ALT and AST >= 2.5 x ULN)
Tipo di dati
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
Descrizione
Total bilirubin >= 1.5 x ULN
Tipo di dati
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 79706000
- LOINC Version 232
- 1975-2
Descrizione
Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
Tipo di dati
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
Descrizione
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 di dati
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
Descrizione
Uncontrolled active infection
Tipo di dati
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
Descrizione
Concurrent malignancies other than AML
Tipo di dati
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
Descrizione
Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m2/d cytarabine
Tipo di dati
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
Descrizione
Known HIV and/or hepatitis C infection
Tipo di dati
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
Descrizione
Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders
Tipo di dati
boolean
Alias
- UMLS CUI 2011AA
- C0007682
- SNOMED CT 2011_0131
- 23853001
- MedDRA 14.1
- 10007943
- ICD-10-CM Version 2010
- G96.9
Descrizione
Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
Tipo di dati
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
Descrizione
Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
Tipo di dati
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
Descrizione
History of organ allograft
Tipo di dati
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
Descrizione
Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
Tipo di dati
boolean
Alias
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0596087
- SNOMED CT 2011_0131
- 409407003
Descrizione
Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
Tipo di dati
boolean
Alias
- UMLS CUI 2011AA
- C0205164
- SNOMED CT 2011_0131
- 255603008
- UMLS CUI 2011AA
- C0038895
Descrizione
Serious, non-healing wound, ulcer or bone fracture
Tipo di dati
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
Descrizione
Allergy to study medication or excipients in study medication
Tipo di dati
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 257550005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0013227
Descrizione
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Tipo di dati
boolean
Alias
- UMLS CUI 2011AA
- C2348568
Descrizione
Patients who are not eligible for standard chemotherapy
Tipo di dati
boolean
Alias
- UMLS CUI 2011AA
- C1444657
- SNOMED CT 2011_0131
- 410536001
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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)
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)
397669002 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
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)
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)
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)
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)
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)
24484000 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
19032002 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
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)
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)
23853001 (SNOMED CT 2011_0131)
10007943 (MedDRA 14.1)
G96.9 (ICD-10-CM Version 2010)
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)
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)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C0596087 (UMLS CUI 2011AA)
409407003 (SNOMED CT 2011_0131)
255603008 (SNOMED CT 2011_0131)
C0038895 (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)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0013227 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)