ID
4364
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT01035502
Link
http://clinicaltrials.gov/show/NCT01035502
Stichworte
Versionen (3)
- 07.12.13 07.12.13 - Martin Dugas
- 17.04.14 17.04.14 - Julian Varghese
- 27.09.21 27.09.21 -
Hochgeladen am
7. Dezember 2013
DOI
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Lizenz
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Eligibility NCT01035502 Acute Myeloid Leukemia
Eligibility
- StudyEvent: Eligibility
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Beschreibung
A history of allergic reactions to egg, idarubicin and/or other anthracyclines or other components of the products. A history of allergic reactions to ara-C of CTCAE grade 3 or 4
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1527304
- SNOMED CT 2011_0131
- 421668005
- MedDRA 14.1
- 10001718
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0013710
- SNOMED CT 2011_0131
- 102263004
- UMLS CUI 2011AA
- C0020789
- SNOMED CT 2011_0131
- 372539000
- UMLS CUI 2011AA
- C0282564
- SNOMED CT 2011_0131
- 372540003
- UMLS CUI 2011AA
- C0010711
- SNOMED CT 2011_0131
- 89265009
- UMLS CUI 2011AA
- C1519275
- UMLS CUI 2011AA
- CL427997
Beschreibung
Persistent clinically significant and relevant toxicities from the previous course of chemotherapy
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0205322
- UMLS CUI 2011AA
- C0040539
- UMLS CUI 2011AA
- C1314792
- SNOMED CT 2011_0131
- 134198009
- UMLS CUI 2011AA
- C1514457
Beschreibung
A cancer history, that according to the investigator might confound the assessment of the study endpoints
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C2735088
- LOINC Version 232
- MTHU034770
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C1516048
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C2349179
Beschreibung
Patients with prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 300 mg/m2 according to the following calculation index: X/300 + Y/160 < 1 where X is the doxorubicin or equivalent dose in mg/m2 and Y is the mitoxantrone dose in mg/m2. These calculations are to be used as guidance as there is no maximum cumulative dose defined in the summary of product characteristics (SPC) for idarubicin. The patient should tolerate minimum one course of combination therapy
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- CL426125
- UMLS CUI 2011AA
- C0013089
- SNOMED CT 2011_0131
- 68444001
- LOINC Version 232
- MTHU004184
- UMLS CUI 2011AA
- CL415123
- UMLS CUI 2011AA
- C1441506
- UMLS CUI 2011AA
- C0918012
- UMLS CUI 2011AA
- C0026259
- SNOMED CT 2011_0131
- 386913001
- UMLS CUI 2011AA
- C0220845
- UMLS CUI 2011AA
- C1709515
- UMLS CUI 2011AA
- C0020789
- SNOMED CT 2011_0131
- 372539000
- UMLS CUI 2011AA
- C0556895
- SNOMED CT 2011_0131
- 229554006
Beschreibung
Active heart disease including myocardial infarction within the previous 3 months, symptomatic coronary disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any NYHA grade 3 or 4
Datentyp
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
- 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
- C0231220
- SNOMED CT 2011_0131
- 264931009
- UMLS CUI 2011AA
- C0010068
- SNOMED CT 2011_0131
- 53741008
- MedDRA 14.1
- 10068617
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0003811
- SNOMED CT 2011_0131
- 44808001
- MedDRA 14.1
- 10003119
- ICD-9-CM Version 2011
- 427.9
- UMLS CUI 2011AA
- C0018802
- SNOMED CT 2011_0131
- 42343007
- MedDRA 14.1
- 10007559
- LOINC Version 232
- MTHU020787
- ICD-10-CM Version 2010
- I50.9
- ICD-9-CM Version 2011
- 428.0
- 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
Beschreibung
Known positive status for human immunodeficiency virus (HIV)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0019699
- SNOMED CT 2011_0131
- 165816005
- MedDRA 14.1
- 10020188
- ICD-10-CM Version 2010
- Z21
Beschreibung
Pregnant and nursing patients are excluded because the effects of elacytarabine on a fetus or a nursing child are unknown
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
Beschreibung
Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, or psychiatric illness/social situations that may reduce compliance with study requirements
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0277557
- SNOMED CT 2011_0131
- 88472004
- UMLS CUI 2011AA
- C0021311
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- UMLS CUI 2011AA
- C0851364
- MedDRA 14.1
- 10041244
- UMLS CUI 2011AA
- C0392756
- SNOMED CT 2011_0131
- 260400001
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 405078008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514873
Beschreibung
Patients receiving hydroxyurea within the last 12 hours prior to treatment on this protocol or any other investigational or standard cytotoxic treatment within the last 14 days, except the first remission-induction course
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0020402
- SNOMED CT 2011_0131
- 56602009
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0677881
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C1514832
Beschreibung
Any medical condition, which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0040539
Ähnliche Modelle
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)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C0543478 (UMLS CUI 2011AA)
17964000 (SNOMED CT 2011_0131)
C0175630 (UMLS CUI 2011AA)
65929005 (SNOMED CT 2011_0131)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0205322 (UMLS CUI 2011AA)
CL414320 (UMLS CUI 2011AA)
188737002, 94719007 (SNOMED CT 2011_0131)
10008583 (MedDRA 14.1)
205.3 (ICD-9-CM Version 2011)
C1148554 (UMLS CUI 2011AA)
C1130454 (UMLS CUI 2011AA)
C0449438 (UMLS CUI 2011AA)
263490005 (SNOMED CT 2011_0131)
MTHU015827 (LOINC Version 232)
C2697913 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1442488 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1827388 (UMLS CUI 2011AA)
422512005 (SNOMED CT 2011_0131)
C1828242 (UMLS CUI 2011AA)
422894000 (SNOMED CT 2011_0131)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C0521317 (UMLS CUI 2011AA)
404221001 (SNOMED CT 2011_0131)
10028211 (MedDRA 14.1)
C0013524 (UMLS CUI 2011AA)
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)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (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)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C1707141 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C2348583 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL415062 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
CL414911 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0023418 (UMLS CUI 2011AA)
93143009 (SNOMED CT 2011_0131)
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)
ELG (HL7 V3 2006_05)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL415062 (UMLS CUI 2011AA)
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
CL414911 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1527304 (UMLS CUI 2011AA)
421668005 (SNOMED CT 2011_0131)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
C0013710 (UMLS CUI 2011AA)
102263004 (SNOMED CT 2011_0131)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C1519275 (UMLS CUI 2011AA)
CL427997 (UMLS CUI 2011AA)
C0040539 (UMLS CUI 2011AA)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C1514457 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2349179 (UMLS CUI 2011AA)
CL426125 (UMLS CUI 2011AA)
C0013089 (UMLS CUI 2011AA)
68444001 (SNOMED CT 2011_0131)
MTHU004184 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
C1441506 (UMLS CUI 2011AA)
C0918012 (UMLS CUI 2011AA)
C0026259 (UMLS CUI 2011AA)
386913001 (SNOMED CT 2011_0131)
C0220845 (UMLS CUI 2011AA)
C1709515 (UMLS CUI 2011AA)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0556895 (UMLS CUI 2011AA)
229554006 (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)
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)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
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)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
19032002 (SNOMED CT 2011_0131)
C0277557 (UMLS CUI 2011AA)
88472004 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0851364 (UMLS CUI 2011AA)
10041244 (MedDRA 14.1)
C0392756 (UMLS CUI 2011AA)
260400001 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0677881 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1514832 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)