ID
4467
Description
ODM derived from http://clinicaltrials.gov/show/NCT00405743
Link
http://clinicaltrials.gov/show/NCT00405743
Keywords
Versions (3)
- 12/9/13 12/9/13 - Martin Dugas
- 4/15/14 4/15/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
December 9, 2013
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00405743 Hematologic Malignancies
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Description
A history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to CP-4055, i.e., ara-C and/or egg
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0036667
- UMLS CUI 2011AA
- C0205198
- SNOMED CT 2011_0131
- 62105006
- UMLS CUI 2011AA
- C2348205
- UMLS CUI 2011AA
- C0243176
- UMLS CUI 2011AA
- C0205460
- SNOMED CT 2011_0131
- 12893009
- UMLS CUI 2011AA
- C0486616
- LOINC Version 232
- MTHU024868
- UMLS CUI 2011AA
- C1707141
- UMLS CUI 2011AA
- C0010711
- SNOMED CT 2011_0131
- 89265009
- UMLS CUI 2011AA
- C0013710
- SNOMED CT 2011_0131
- 102263004
Description
Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0019699
- SNOMED CT 2011_0131
- 165816005
- MedDRA 14.1
- 10020188
- ICD-10-CM Version 2010
- Z21
- UMLS CUI 2011AA
- C0856706
- MedDRA 14.1
- 10019738
- UMLS CUI 2011AA
- C1112419
- MedDRA 14.1
- 10057394
Description
Pregnant and nursing patients are excluded
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Description
Uncontrolled intercurrent illness
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0277557
- SNOMED CT 2011_0131
- 88472004
Description
Active heart disease
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- ICD-10-CM Version 2010
- I51.9
- ICD-9-CM Version 2011
- 429.9
Description
Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy other than a maximum of 5 g of hydroxyurea to a maximum of 5 days in cycle 1 of therapy
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- CL426127
- UMLS CUI 2011AA
- C1517586
- UMLS CUI 2011AA
- C1511636
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0376545
- SNOMED CT 2011_0131
- 129154003
- MedDRA 14.1
- 10066476
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0806909
- SNOMED CT 2011_0131
- 398303009
- LOINC Version 232
- MTHU008917
- UMLS CUI 2011AA
- C0020402
- SNOMED CT 2011_0131
- 56602009
- UMLS CUI 2011AA
- C0205451
- SNOMED CT 2011_0131
- 34001005
- UMLS CUI 2011AA
- C0439228
- SNOMED CT 2011_0131
- 258703001
- HL7 V3 2006_05
- D
- UMLS CUI 2011AA
- C0439596
- SNOMED CT 2011_0131
- 44180009
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0039798
Description
Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- CL102947
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C1883420
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0040539
Description
Exclusion criteria no. 8 applies only in arm C:
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL425201
Description
Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0020789
- SNOMED CT 2011_0131
- 372539000
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C1705248
- UMLS CUI 2011AA
- C1514468
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0282564
- SNOMED CT 2011_0131
- 372540003
- UMLS CUI 2011AA
- C0003174
- SNOMED CT 2011_0131
- 116283009
- LOINC Version 232
- MTHU015517
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
C0205171 (UMLS CUI 2011AA)
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C1548788 (UMLS CUI 2011AA)
CL426127 (UMLS CUI 2011AA)
C1947911 (UMLS CUI 2011AA)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
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C1518422 (UMLS CUI 2011AA)
C0679106 (UMLS CUI 2011AA)
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79409006 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
C0231175 (UMLS CUI 2011AA)
C1880198 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C2733540 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C1548788 (UMLS CUI 2011AA)
CL426127 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C1947911 (UMLS CUI 2011AA)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
424122007 (SNOMED CT 2011_0131)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0279752 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
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166435006 (SNOMED CT 2011_0131)
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10036577 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
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288556008 (SNOMED CT 2011_0131)
CL414705 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
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CL425201 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
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237679004 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C1707141 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
371150009 (SNOMED CT 2011_0131)
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C2348583 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0439831 (UMLS CUI 2011AA)
255358001 (SNOMED CT 2011_0131)
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385673002 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
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C1518422 (UMLS CUI 2011AA)
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373526007 (SNOMED CT 2011_0131)
255260001 (SNOMED CT 2011_0131)
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58147004 (SNOMED CT 2011_0131)
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261904005 (SNOMED CT 2011_0131)
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27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
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56935002 (SNOMED CT 2011_0131)
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26091008 (SNOMED CT 2011_0131)
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C1554961 (UMLS CUI 2011AA)
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MTHU020170 (LOINC Version 232)
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10024288 (MedDRA 14.1)
C95.9 (ICD-10-CM Version 2010)
208.9 (ICD-9-CM Version 2011)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
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)
C1514756 (UMLS CUI 2011AA)
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392521001 (SNOMED CT 2011_0131)
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T78.40 (ICD-10-CM Version 2010)
C0036667 (UMLS CUI 2011AA)
C0205198 (UMLS CUI 2011AA)
62105006 (SNOMED CT 2011_0131)
C2348205 (UMLS CUI 2011AA)
C0243176 (UMLS CUI 2011AA)
C0205460 (UMLS CUI 2011AA)
12893009 (SNOMED CT 2011_0131)
C0486616 (UMLS CUI 2011AA)
MTHU024868 (LOINC Version 232)
C1707141 (UMLS CUI 2011AA)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0013710 (UMLS CUI 2011AA)
102263004 (SNOMED CT 2011_0131)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
116154003 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
19032002 (SNOMED CT 2011_0131)
C0277557 (UMLS CUI 2011AA)
88472004 (SNOMED CT 2011_0131)
55561003 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
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C1511636 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0376545 (UMLS CUI 2011AA)
129154003 (SNOMED CT 2011_0131)
10066476 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0806909 (UMLS CUI 2011AA)
398303009 (SNOMED CT 2011_0131)
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258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1883420 (UMLS CUI 2011AA)
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15508007 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
C0003174 (UMLS CUI 2011AA)
116283009 (SNOMED CT 2011_0131)
MTHU015517 (LOINC Version 232)