ID
5123
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT01295307
Link
http://clinicaltrials.gov/show/NCT01295307
Trefwoorden
Versies (3)
- 19-03-13 19-03-13 - Martin Dugas
- 19-04-14 19-04-14 - Julian Varghese
- 20-09-21 20-09-21 -
Geüploaded op
19 april 2014
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Eligibility NCT01295307 Acute Myeloid Leukemia
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Beschrijving
For refractory disease, more than two prior induction chemotherapies or more than one prior salvage chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine >= 5 g/m2).
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1514815
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205448
- SNOMED CT 2011_0131
- 19338005
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C3179010
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0085405
- MedDRA 14.1
- 10068833
- UMLS CUI 2011AA
- C0444956
- SNOMED CT 2011_0131
- 261829003
- UMLS CUI 2011AA
- C0010711
- SNOMED CT 2011_0131
- 89265009
Beschrijving
Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a treatment of first relapse, respond and relapse later on may be included.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0277556
- SNOMED CT 2011_0131
- 58184002
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1254351
- UMLS CUI 2011AA
- CL414898
- UMLS CUI 2011AA
- C2613367
- UMLS CUI 2011AA
- C0004475
- SNOMED CT 2011_0131
- 412329008
- UMLS CUI 2011AA
- C0049065
- SNOMED CT 2011_0131
- 420517007
- UMLS CUI 2011AA
- C0332149
- SNOMED CT 2011_0131
- 371930009
- UMLS CUI 2011AA
- C1302261
- SNOMED CT 2011_0131
- 399223003
Beschrijving
Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARalpha).
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0023487
- SNOMED CT 2011_0131
- 110004001
- MedDRA 14.1
- 10001019
- ICD-10-CM Version 2010
- C92.4
- UMLS CUI 2011AA
- C1515724
- UMLS CUI 2011AA
- CL414625
- UMLS CUI 2011AA
- C1511790
- UMLS CUI 2011AA
- C0279625
Beschrijving
Central nervous system involvement (i.e. WBC >= 5/microL in cerebrospinal fluid with blasts present on cytospin).
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0449389
- SNOMED CT 2011_0131
- 260766009
- UMLS CUI 2011AA
- C0023508
- SNOMED CT 2011_0131
- 767002
- MedDRA 14.1
- 10047939
- UMLS CUI 2011AA
- C1271796
- SNOMED CT 2011_0131
- 391308009
- UMLS CUI 2011AA
- C0150312
- SNOMED CT 2011_0131
- 52101004
- UMLS CUI 2011AA
- C0368761
- SNOMED CT 2011_0131
- 312256009
- LOINC Version 232
- MTHU005201
Beschrijving
Prior allogeneic HCT
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C2242529
- SNOMED CT 2011_0131
- 288556008
- MedDRA 14.1
- 10067862
Beschrijving
Autologous transplantation within 100 days prior to start of study treatment
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0040736
- SNOMED CT 2011_0131
- 53088000
- MedDRA 14.1
- 10064285
- UMLS CUI 2011AA
- C0332285
- SNOMED CT 2011_0131
- 18720000
- UMLS CUI 2011AA
- C1704407
- SNOMED CT 2011_0131
- 420528006
- UMLS CUI 2011AA
- C0439228
- SNOMED CT 2011_0131
- 258703001
- HL7 V3 2006_05
- D
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
Beschrijving
Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of hydroxyurea or low-dose cytarabine.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0920425
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0020402
- SNOMED CT 2011_0131
- 56602009
- UMLS CUI 2011AA
- C0445550
- SNOMED CT 2011_0131
- 262459003
- UMLS CUI 2011AA
- C0010711
- SNOMED CT 2011_0131
- 89265009
Beschrijving
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo transplantation.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205420
- SNOMED CT 2011_0131
- 68405009
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0349410
- SNOMED CT 2011_0131
- 251526004
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- UMLS CUI 2011AA
- C0022658
- SNOMED CT 2011_0131
- 90708001
- MedDRA 14.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
- 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
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0460002
- SNOMED CT 2011_0131
- 91689009
Beschrijving
Patients with known refractoriness to platelet support.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- C0205269
- SNOMED CT 2011_0131
- 20646008
- UMLS CUI 2011AA
- C0005821
- SNOMED CT 2011_0131
- 16378004
- LOINC Version 232
- MTHU002432
- UMLS CUI 2011AA
- C1521721
Beschrijving
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C0026946
- SNOMED CT 2011_0131
- 3218000
- MedDRA 14.1
- 10017533
- ICD-10-CM Version 2010
- B35-B49
- ICD-9-CM Version 2011
- 110-118.99
- UMLS CUI 2011AA
- C0004623
- SNOMED CT 2011_0131
- 87628006
- MedDRA 14.1
- 10060945
- ICD-10-CM Version 2010
- A49.9
- UMLS CUI 2011AA
- C0042769
- SNOMED CT 2011_0131
- 34014006
- MedDRA 14.1
- 10047461
- ICD-10-CM Version 2010
- B34.9
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0021311
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
Beschrijving
Pregnant or lactating patients.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
Beschrijving
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205420
- SNOMED CT 2011_0131
- 68405009
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- 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
- C0221099
- SNOMED CT 2011_0131
- 260379002
- UMLS CUI 2011AA
- C1113679
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0525058
- UMLS CUI 2011AA
- C0459471
- SNOMED CT 2011_0131
- 280452008
- LOINC Version 232
- MTHU003869
- UMLS CUI 2011AA
- C0683954
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- StudyEvent: Eligibility
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10067862 (MedDRA 14.1)
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392521001 (SNOMED CT 2011_0131)
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251526004 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
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90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
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235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0460002 (UMLS CUI 2011AA)
91689009 (SNOMED CT 2011_0131)
116154003 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
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10021789 (MedDRA 14.1)
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10037174 (MedDRA 14.1)
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290-319.99 (ICD-9-CM Version 2011)
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