ID

4441

Description

ODM derived from http://clinicaltrials.gov/show/NCT00684619

Link

http://clinicaltrials.gov/show/NCT00684619

Keywords

Versions (1)
  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00684619 T-ALL, T-NHL (Lymphoblastic)

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
T-ALL, T-NHL
Description

T-ALL, T-NHL

Data type

boolean

Alias
UMLS CUI 2011AA
C1961099
SNOMED CT 2011_0131
277575008
MedDRA 14.1
10042987
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0079772
SNOMED CT 2011_0131
109978004
MedDRA 14.1
10042971
cytological treatment failure / relapse
Description

cytological treatment failure / relapse

Data type

boolean

Alias
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0231174
SNOMED CT 2011_0131
76797004
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
molecular treatment failure / relapse
Description

molecular treatment failure / relapse

Data type

boolean

Alias
UMLS CUI 2011AA
CL414625
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0231174
SNOMED CT 2011_0131
76797004
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
no promising therapy alternatives with approved medication available
Description

no promising therapy alternatives with approved medication available

Data type

boolean

Alias
UMLS CUI 2011AA
C1555307
HL7 V3 2006_05
PRMS
UMLS CUI 2011AA
C0554849
SNOMED CT 2011_0131
309846006
UMLS CUI 2011AA
C1523987
UMLS CUI 2011AA
C1706842
UMLS CUI 2011AA
C0013227
no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
Description

no CNS-manifestation, requiring intrathecal therapy or CNS-radiation

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1269563
SNOMED CT 2011_0131
278199004
UMLS CUI 2011AA
C0205319
SNOMED CT 2011_0131
250255003
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205527
SNOMED CT 2011_0131
72607000
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1269563
SNOMED CT 2011_0131
278199004
UMLS CUI 2011AA
C0851346
SNOMED CT 2011_0131
82107009
LOINC Version 232
MTHU026213
no convulsive disease or neurotoxicity > grade III in patients history
Description

no convulsive disease or neurotoxicity > grade III in patients history

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0234972
MedDRA 14.1
10010924
ICD-10-CM Version 2010
R56.9
UMLS CUI 2011AA
C0235032
SNOMED CT 2011_0131
19466003
MedDRA 14.1
10029350
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C0450094
UMLS CUI 2011AA
C0679831
LOINC Version 232
MTHU016351
written informed consent
Description

written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
no cytostatic therapy in the last 10 days
Description

no cytostatic therapy in the last 10 days

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0010858
SNOMED CT 2011_0131
373221003
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205456
SNOMED CT 2011_0131
3445001
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
no pregnancy or breastfeeding
Description

no pregnancy or breastfeeding

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Contraception, Birth control
Description

effective contraception

Data type

boolean

Alias
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
recovery of toxicities of previous chemotherapy - except leukemia-related changes like bone marrow suppression or pathological transaminases in liver manifestation
Description

recovery of toxicities of previous chemotherapy - except leukemia-related changes like bone marrow suppression or pathological transaminases in liver manifestation

Data type

boolean

Alias
UMLS CUI 2011AA
C2004454
UMLS CUI 2011AA
C0040539
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0023418
SNOMED CT 2011_0131
93143009
MedDRA 14.1
10024288
ICD-10-CM Version 2010
C95.9
ICD-9-CM Version 2011
208.9
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0280962
UMLS CUI 2011AA
C1521733
SNOMED CT 2011_0131
29458008
UMLS CUI 2011AA
C0002594
SNOMED CT 2011_0131
130093006
UMLS CUI 2011AA
C0023884
SNOMED CT 2011_0131
10200004
LOINC Version 232
MTHU002039
UMLS CUI 2011AA
C0205319
SNOMED CT 2011_0131
250255003
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Severe psychiatric illness
Description

Severe psychiatric illness

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
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
uncontrolled or severe cardiac disease or infection
Description

uncontrolled or severe cardiac disease or infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C1096253
MedDRA 14.1
10054212
active secondary neoplasms - except skin cancer (no melanoma)
Description

active secondary neoplasms - except skin cancer (no melanoma)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C2939419
SNOMED CT 2011_0131
128462008
MedDRA 14.1
10061289
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
T-ALL, T-NHL
Item
T-ALL, T-NHL
boolean
C1961099 (UMLS CUI 2011AA)
277575008 (SNOMED CT 2011_0131)
10042987 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0079772 (UMLS CUI 2011AA)
109978004 (SNOMED CT 2011_0131)
10042971 (MedDRA 14.1)
cytological treatment failure / relapse
Item
cytological treatment failure / relapse
boolean
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0231174 (UMLS CUI 2011AA)
76797004 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
molecular treatment failure / relapse
Item
molecular treatment failure / relapse
boolean
CL414625 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0231174 (UMLS CUI 2011AA)
76797004 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
no promising therapy alternatives with approved medication available
Item
no promising therapy alternatives with approved medication available
boolean
C1555307 (UMLS CUI 2011AA)
PRMS (HL7 V3 2006_05)
C0554849 (UMLS CUI 2011AA)
309846006 (SNOMED CT 2011_0131)
C1523987 (UMLS CUI 2011AA)
C1706842 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
Item
no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
boolean
C1518422 (UMLS CUI 2011AA)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
C0205319 (UMLS CUI 2011AA)
250255003 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0205527 (UMLS CUI 2011AA)
72607000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
C0851346 (UMLS CUI 2011AA)
82107009 (SNOMED CT 2011_0131)
MTHU026213 (LOINC Version 232)
no convulsive disease or neurotoxicity > grade III in patients history
Item
no convulsive disease or neurotoxicity > grade III in patients history
boolean
C1518422 (UMLS CUI 2011AA)
C0234972 (UMLS CUI 2011AA)
10010924 (MedDRA 14.1)
R56.9 (ICD-10-CM Version 2010)
C0235032 (UMLS CUI 2011AA)
19466003 (SNOMED CT 2011_0131)
10029350 (MedDRA 14.1)
CL384738 (UMLS CUI 2011AA)
C0450094 (UMLS CUI 2011AA)
C0679831 (UMLS CUI 2011AA)
MTHU016351 (LOINC Version 232)
written informed consent
Item
written informed consent
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
no cytostatic therapy in the last 10 days
Item
no cytostatic therapy in the last 10 days
boolean
C1518422 (UMLS CUI 2011AA)
C0010858 (UMLS CUI 2011AA)
373221003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0205456 (UMLS CUI 2011AA)
3445001 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
no pregnancy or breastfeeding
Item
no pregnancy or breastfeeding
boolean
C1518422 (UMLS CUI 2011AA)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
effective contraception
Item
Contraception, Birth control
boolean
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
recovery of toxicities of previous chemotherapy - except leukemia-related changes like bone marrow suppression or pathological transaminases in liver manifestation
Item
recovery of toxicities of previous chemotherapy - except leukemia-related changes like bone marrow suppression or pathological transaminases in liver manifestation
boolean
C2004454 (UMLS CUI 2011AA)
C0040539 (UMLS CUI 2011AA)
C1514457 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
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)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0280962 (UMLS CUI 2011AA)
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C0002594 (UMLS CUI 2011AA)
130093006 (SNOMED CT 2011_0131)
C0023884 (UMLS CUI 2011AA)
10200004 (SNOMED CT 2011_0131)
MTHU002039 (LOINC Version 232)
C0205319 (UMLS CUI 2011AA)
250255003 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Severe psychiatric illness
Item
Severe psychiatric illness
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
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)
uncontrolled or severe cardiac disease or infection
Item
uncontrolled or severe cardiac disease or infection
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C1096253 (UMLS CUI 2011AA)
10054212 (MedDRA 14.1)
active secondary neoplasms - except skin cancer (no melanoma)
Item
active secondary neoplasms - except skin cancer (no melanoma)
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C2939419 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
10061289 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
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