ID

43377

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00560794

Link

http://clinicaltrials.gov/show/NCT00560794

Stichworte

  1. 10.12.13 10.12.13 - Martin Dugas
  2. 14.04.14 14.04.14 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility NCT00560794 Acute Lymphoblastic Leukemia

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschreibung

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Beschreibung

age at least 18 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
Beschreibung

B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.

Datentyp

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
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
C0205488
SNOMED CT 2011_0131
57407000
UMLS CUI 2011AA
CL414625
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0231174
SNOMED CT 2011_0131
76797004
UMLS CUI 2011AA
C0702116
SNOMED CT 2011_0131
9656002
UMLS CUI 2011AA
C1708063
Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level 10-4.
Beschreibung

Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level 10-4.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0005516
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0242596
UMLS CUI 2011AA
C0004891
SNOMED CT 2011_0131
56564003
LOINC Version 232
MTHU021298
UMLS CUI 2011AA
C1511790
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
CL370615
UMLS CUI 2011AA
C1511695
UMLS CUI 2011AA
C0021027
SNOMED CT 2011_0131
399771004
HL7 V3 2006_05
14
UMLS CUI 2011AA
C0524889
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C1510438
SNOMED CT 2011_0131
272392009
UMLS CUI 2011AA
C0036667
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C0392762
SNOMED CT 2011_0131
30766002
ECOG Status < 2
Beschreibung

ECOG Performance Status < 2

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Ability to understand and willingness to sign a written informed consent
Beschreibung

Ability to understand and willingness to sign a written informed consent

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Signed and dated written informed consent is available
Beschreibung

Signed and dated written informed consent is available

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Ausschlusskriterien
Beschreibung

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Current extra medullar involvement
Beschreibung

Current extra medullar involvement

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1517060
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
Beschreibung

History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0007682
SNOMED CT 2011_0131
23853001
MedDRA 14.1
10007943
ICD-10-CM Version 2010
G96.9
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0149931
SNOMED CT 2011_0131
37796009
MedDRA 14.1
10027599
ICD-10-CM Version 2010
G43
ICD-9-CM Version 2011
346
UMLS CUI 2011AA
C0018681
SNOMED CT 2011_0131
25064002
MedDRA 14.1
10019211
LOINC Version 232
MTHU020860
ICD-10-CM Version 2010
R51
ICD-9-CM Version 2011
784.0
CTCAE 1105E
E12678
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
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
Current infiltration of cerebrospinal fluid by ALL
Beschreibung

Current infiltration of cerebrospinal fluid by ALL

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
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
History of or current autoimmune disease
Beschreibung

History of or current autoimmune disease

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0004364
SNOMED CT 2011_0131
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE 1105E
E11258
Autologous stem cell transplantation within 6 weeks prior to study entry
Beschreibung

Autologous stem cell transplantation within 6 weeks prior to study entry

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1831743
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
C2348558
Any prior allogeneic stem cell transplantation
Beschreibung

Any prior allogeneic stem cell transplantation

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2242529
Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
Beschreibung

Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
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
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0205527
SNOMED CT 2011_0131
72607000
UMLS CUI 2011AA
C0199176
SNOMED CT 2011_0131
360271000
MedDRA 14.1
10036898
UMLS CUI 2011AA
C1708745
UMLS CUI 2011AA
C0677908
SNOMED CT 2011_0131
314122007
UMLS CUI 2011AA
C0042672
SNOMED CT 2011_0131
61864009
UMLS CUI 2011AA
C0000618
SNOMED CT 2011_0131
386835005
LOINC Version 232
MTHU002562
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
Radiotherapy within 4 weeks prior to study treatment
Beschreibung

Radiotherapy within 4 weeks prior to study treatment

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0034619
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
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
Beschreibung

Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
UMLS CUI 2011AA
C0732355
SNOMED CT 2011_0131
386919002
UMLS CUI 2011AA
C0383429
SNOMED CT 2011_0131
391864003
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
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
Beschreibung

Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0021027
SNOMED CT 2011_0131
399771004
HL7 V3 2006_05
14
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1705957
Presence of human anti-murine antibodies (HAMA)
Beschreibung

Presence of human anti-murine antibodies (HAMA)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C1291910
SNOMED CT 2011_0131
115628002
LOINC Version 232
MTHU003865
Abnormal bone marrow, renal or hepatic function
Beschreibung

Abnormal bone marrow, renal or hepatic function

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205161
SNOMED CT 2011_0131
263654008
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0151746
SNOMED CT 2011_0131
39539005
MedDRA 14.1
10013902
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
Indication for a hypercoagulative state
Beschreibung

Indication for a hypercoagulative state

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0398623
MedDRA 14.1
10020608
History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ
Beschreibung

History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
CL411789
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
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
Beschreibung

Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0750729
SNOMED CT 2011_0131
288524001
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
Beschreibung

Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
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
C0151317
SNOMED CT 2011_0131
177010002
UMLS CUI 2011AA
C0019169
SNOMED CT 2011_0131
81665004
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
Beschreibung

Pregnant or nursing women

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter
Beschreibung

Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004

Ähnliche Modelle

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
Item
B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
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)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
CL414625 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0231174 (UMLS CUI 2011AA)
76797004 (SNOMED CT 2011_0131)
C0702116 (UMLS CUI 2011AA)
9656002 (SNOMED CT 2011_0131)
C1708063 (UMLS CUI 2011AA)
Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level 10-4.
Item
Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level 10-4.
boolean
C0005516 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
C0242596 (UMLS CUI 2011AA)
C0004891 (UMLS CUI 2011AA)
56564003 (SNOMED CT 2011_0131)
MTHU021298 (LOINC Version 232)
C1511790 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
CL370615 (UMLS CUI 2011AA)
C1511695 (UMLS CUI 2011AA)
C0021027 (UMLS CUI 2011AA)
399771004 (SNOMED CT 2011_0131)
14 (HL7 V3 2006_05)
C0524889 (UMLS CUI 2011AA)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C1510438 (UMLS CUI 2011AA)
272392009 (SNOMED CT 2011_0131)
C0036667 (UMLS CUI 2011AA)
C1524031 (UMLS CUI 2011AA)
C0392762 (UMLS CUI 2011AA)
30766002 (SNOMED CT 2011_0131)
ECOG Performance Status < 2
Item
ECOG Status < 2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Ability to understand and willingness to sign a written informed consent
Item
Ability to understand and willingness to sign a written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Signed and dated written informed consent is available
Item
Signed and dated written informed consent is available
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Current extra medullar involvement
Item
Current extra medullar involvement
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1517060 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
Item
History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0007682 (UMLS CUI 2011AA)
23853001 (SNOMED CT 2011_0131)
10007943 (MedDRA 14.1)
G96.9 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0149931 (UMLS CUI 2011AA)
37796009 (SNOMED CT 2011_0131)
10027599 (MedDRA 14.1)
G43 (ICD-10-CM Version 2010)
346 (ICD-9-CM Version 2011)
C0018681 (UMLS CUI 2011AA)
25064002 (SNOMED CT 2011_0131)
10019211 (MedDRA 14.1)
MTHU020860 (LOINC Version 232)
R51 (ICD-10-CM Version 2010)
784.0 (ICD-9-CM Version 2011)
E12678 (CTCAE 1105E)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
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)
Current infiltration of cerebrospinal fluid by ALL
Item
Current infiltration of cerebrospinal fluid by ALL
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
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)
History of or current autoimmune disease
Item
History of or current autoimmune disease
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
Autologous stem cell transplantation within 6 weeks prior to study entry
Item
Autologous stem cell transplantation within 6 weeks prior to study entry
boolean
C1831743 (UMLS CUI 2011AA)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Any prior allogeneic stem cell transplantation
Item
Any prior allogeneic stem cell transplantation
boolean
C2242529 (UMLS CUI 2011AA)
Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
Item
Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
boolean
C0392920 (UMLS CUI 2011AA)
150415003 (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)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205527 (UMLS CUI 2011AA)
72607000 (SNOMED CT 2011_0131)
C0199176 (UMLS CUI 2011AA)
360271000 (SNOMED CT 2011_0131)
10036898 (MedDRA 14.1)
C1708745 (UMLS CUI 2011AA)
C0677908 (UMLS CUI 2011AA)
314122007 (SNOMED CT 2011_0131)
C0042672 (UMLS CUI 2011AA)
61864009 (SNOMED CT 2011_0131)
C0000618 (UMLS CUI 2011AA)
386835005 (SNOMED CT 2011_0131)
MTHU002562 (LOINC Version 232)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
Radiotherapy within 4 weeks prior to study treatment
Item
Radiotherapy within 4 weeks prior to study treatment
boolean
C0034619 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
Item
Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
boolean
C0039798 (UMLS CUI 2011AA)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)
C0383429 (UMLS CUI 2011AA)
391864003 (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)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
Item
Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0021027 (UMLS CUI 2011AA)
399771004 (SNOMED CT 2011_0131)
14 (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1705957 (UMLS CUI 2011AA)
Presence of human anti-murine antibodies (HAMA)
Item
Presence of human anti-murine antibodies (HAMA)
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C1291910 (UMLS CUI 2011AA)
115628002 (SNOMED CT 2011_0131)
MTHU003865 (LOINC Version 232)
Abnormal bone marrow, renal or hepatic function
Item
Abnormal bone marrow, renal or hepatic function
boolean
C0205161 (UMLS CUI 2011AA)
263654008 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0151746 (UMLS CUI 2011AA)
39539005 (SNOMED CT 2011_0131)
10013902 (MedDRA 14.1)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
Indication for a hypercoagulative state
Item
Indication for a hypercoagulative state
boolean
CL335836 (UMLS CUI 2011AA)
C0398623 (UMLS CUI 2011AA)
10020608 (MedDRA 14.1)
History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ
Item
History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
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)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
Item
Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0750729 (UMLS CUI 2011AA)
288524001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
Item
Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
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)
C0151317 (UMLS CUI 2011AA)
177010002 (SNOMED CT 2011_0131)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
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
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter
Item
Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
CL414906 (UMLS CUI 2011AA)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video