ID

4556

Description

ODM derived from http://clinicaltrials.gov/show/NCT00246974

Link

http://clinicaltrials.gov/show/NCT00246974

Keywords

  1. 12/11/13 12/11/13 - Martin Dugas
Uploaded on

December 11, 2013

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility DRKS00010322 NCT00246974 Bladder Cancer

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age 18 Years and older
Description

age >=18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
Description

Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
CL363966
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Locally advanced or metastatic disease
Description

Locally advanced or metastatic disease

Data type

boolean

Alias
UMLS CUI 2011AA
CL415116
UMLS CUI 2011AA
C0679246
UMLS CUI 2011AA
C0027627
MedDRA 14.1
10027478
At least one measurable lesion as defined by RECIST
Description

At least one measurable lesion as defined by RECIST

Data type

boolean

Alias
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C1709926
Chemotherapy-naiv
Description

Chemotherapy-naiv

Data type

boolean

Alias
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0919936
MedDRA 14.1
10051259
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Previous chemotherapy or other systemic antitumour therapy
Description

Previous chemotherapy or other systemic antitumour therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0920425
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer
Description

Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0346429
SNOMED CT 2011_0131
363500001
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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1554961
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
UMLS CUI 2011AA
CL415116
UMLS CUI 2011AA
C0439801
SNOMED CT 2011_0131
255469002
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age >=18 Years
Item
Age 18 Years and older
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
Item
Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
CL363966 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Locally advanced or metastatic disease
Item
Locally advanced or metastatic disease
boolean
CL415116 (UMLS CUI 2011AA)
C0679246 (UMLS CUI 2011AA)
C0027627 (UMLS CUI 2011AA)
10027478 (MedDRA 14.1)
At least one measurable lesion as defined by RECIST
Item
At least one measurable lesion as defined by RECIST
boolean
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C1709926 (UMLS CUI 2011AA)
Chemotherapy-naiv
Item
Chemotherapy-naiv
boolean
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0919936 (UMLS CUI 2011AA)
10051259 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Previous chemotherapy or other systemic antitumour therapy
Item
Previous chemotherapy or other systemic antitumour therapy
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer
Item
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer
boolean
C0346429 (UMLS CUI 2011AA)
363500001 (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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
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)
CL415116 (UMLS CUI 2011AA)
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial