ID

5101

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT01209286

Link

http://clinicaltrials.gov/show/NCT01209286

Palavras-chave

Versões (3)
  1. 06/12/2013 06/12/2013 - Martin Dugas
  2. 19/04/2014 19/04/2014 - Julian Varghese
  3. 27/09/2021 27/09/2021 -
Transferido a

19 de abril de 2014

DOI

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Licença

Creative Commons BY 4.0
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Eligibility DRKS00003796 NCT01209286 B-ALL

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrição

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Descrição

age at least 18 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
Descrição

Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1292769
SNOMED CT 2011_0131
128823009
MedDRA 14.1
10003890
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0600558
UMLS CUI 2011AA
C0702116
SNOMED CT 2011_0131
9656002
UMLS CUI 2011AA
C1514815
More than 5% blasts in bone marrow
Descrição

More than 5% blasts in bone marrow

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439165
SNOMED CT 2011_0131
118582008
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
ECOG Status <= 2
Descrição

ECOG performance status <= 2

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Life expectancy of >= 12 weeks
Descrição

Life expectancy of >= 12 weeks

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0023671
Ausschlusskriterien
Descrição

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
History or presence of clinically relevant CNS pathology
Descrição

History or presence of clinically relevant CNS pathology

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C1269563
SNOMED CT 2011_0131
278199004
UMLS CUI 2011AA
C0677042
Infiltration of cerebrospinal fluid (CSF) by ALL
Descrição

Infiltration of cerebrospinal fluid (CSF) by ALL

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0332448
SNOMED CT 2011_0131
47351003
UMLS CUI 2011AA
C0007806
SNOMED CT 2011_0131
65216001
LOINC Version 232
MTHU001311
HL7 V3 2006_05
CSF
UMLS CUI 2011AA
C0023449
SNOMED CT 2011_0131
91857003, 128822004
MedDRA 14.1
10060390
ICD-10-CM Version 2010
C91.0
ICD-9-CM Version 2011
204.0
Autologous/allogeneic HSCT within six weeks/three months prior to start of blinatumomab treatment
Descrição

Autologous/allogeneic HSCT within six weeks/three months prior to start of blinatumomab treatment

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1831743
UMLS CUI 2011AA
C2242529
MedDRA 14.1
10067862
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1722284
UMLS CUI 2011AA
C0039798
Active Graft-versus-Host Disease (GvHD)
Descrição

Active Graft-versus-Host Disease (GvHD)

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0018133
SNOMED CT 2011_0131
234646005
MedDRA 14.1
10018651
ICD-10-CM Version 2010
D89.813
ICD-9-CM Version 2011
279.50
Patients with Ph+ ALL eligible for treatment with dasatinib or imatinib
Descrição

Patients with Ph+ ALL eligible for treatment with dasatinib or imatinib

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1960397
SNOMED CT 2011_0131
425688002
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1455147
SNOMED CT 2011_0131
422756008
UMLS CUI 2011AA
C0935989
SNOMED CT 2011_0131
391634008
Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
Descrição

Cancer chemotherapy within two weeks prior to start of blinatumomab treatment

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1722284
UMLS CUI 2011AA
C0039798
Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab treatment
Descrição

Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab treatment

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0021083
SNOMED CT 2011_0131
146638005
UMLS CUI 2011AA
C0732355
SNOMED CT 2011_0131
386919002
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1722284
UMLS CUI 2011AA
C0039798
Infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
Descrição

Infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)

Tipo de dados

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
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
UMLS CUI 2011AA
C0149709
SNOMED CT 2011_0131
165806002
MedDRA 14.1
10019742
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
UMLS CUI 2011AA
C0281863
MedDRA 14.1
10019747
Pregnant or nursing women
Descrição

Pregnant or nursing women

Tipo de dados

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 14.1
10036586
UMLS CUI 2
C0006147
MedDRA 14.1
10006247
SNOMED CT 2011_0131
224526002
Previous treatment with blinatumomab
Descrição

Previous treatment with blinatumomab

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1722284
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
Item
Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
boolean
C1292769 (UMLS CUI 2011AA)
128823009 (SNOMED CT 2011_0131)
10003890 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C0702116 (UMLS CUI 2011AA)
9656002 (SNOMED CT 2011_0131)
C1514815 (UMLS CUI 2011AA)
More than 5% blasts in bone marrow
Item
More than 5% blasts in bone marrow
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439165 (UMLS CUI 2011AA)
118582008 (SNOMED CT 2011_0131)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
ECOG performance status <= 2
Item
ECOG Status <= 2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Life expectancy of >= 12 weeks
Item
Life expectancy of >= 12 weeks
boolean
C0023671 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
History or presence of clinically relevant CNS pathology
Item
History or presence of clinically relevant CNS pathology
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
C0677042 (UMLS CUI 2011AA)
Infiltration of cerebrospinal fluid (CSF) by ALL
Item
Infiltration of cerebrospinal fluid (CSF) by ALL
boolean
C0332448 (UMLS CUI 2011AA)
47351003 (SNOMED CT 2011_0131)
C0007806 (UMLS CUI 2011AA)
65216001 (SNOMED CT 2011_0131)
MTHU001311 (LOINC Version 232)
CSF (HL7 V3 2006_05)
C0023449 (UMLS CUI 2011AA)
91857003, 128822004 (SNOMED CT 2011_0131)
10060390 (MedDRA 14.1)
C91.0 (ICD-10-CM Version 2010)
204.0 (ICD-9-CM Version 2011)
Autologous/allogeneic HSCT within six weeks/three months prior to start of blinatumomab treatment
Item
Autologous/allogeneic HSCT within six weeks/three months prior to start of blinatumomab treatment
boolean
C1831743 (UMLS CUI 2011AA)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1722284 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Active Graft-versus-Host Disease (GvHD)
Item
Active Graft-versus-Host Disease (GvHD)
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0018133 (UMLS CUI 2011AA)
234646005 (SNOMED CT 2011_0131)
10018651 (MedDRA 14.1)
D89.813 (ICD-10-CM Version 2010)
279.50 (ICD-9-CM Version 2011)
Patients with Ph+ ALL eligible for treatment with dasatinib or imatinib
Item
Patients with Ph+ ALL eligible for treatment with dasatinib or imatinib
boolean
C1960397 (UMLS CUI 2011AA)
425688002 (SNOMED CT 2011_0131)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
C1455147 (UMLS CUI 2011AA)
422756008 (SNOMED CT 2011_0131)
C0935989 (UMLS CUI 2011AA)
391634008 (SNOMED CT 2011_0131)
Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
Item
Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
boolean
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1722284 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab treatment
Item
Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab treatment
boolean
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1722284 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
Item
Infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
boolean
C0019693 (UMLS CUI 2011AA)
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)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0149709 (UMLS CUI 2011AA)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
C0281863 (UMLS CUI 2011AA)
10019747 (MedDRA 14.1)
Pregnant or nursing women
Item
Pregnant or nursing women
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 14.1)
224526002 (SNOMED CT 2011_0131)
Previous treatment with blinatumomab
Item
Previous treatment with blinatumomab
boolean
C1514463 (UMLS CUI 2011AA)
C1722284 (UMLS CUI 2011AA)
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