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ID
4715
Description
ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00050999
Link
http://clinicaltrials.gov/ct2/show/record/NCT00050999
Keywords
Versions (3)
- 11/14/11 11/14/11 -
- 3/23/14 3/23/14 - Martin Dugas
- 4/11/14 4/11/14 - Julian Varghese
Uploaded on
March 23, 2014
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00050999 T-Cell Lymphoma
Eligibility NCT00050999
- StudyEvent: Eligibility
Description
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Similar models
Eligibility NCT00050999
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Age
Item
18 Years and older
boolean
C0001779 (UMLS CUI-1)
CTCL
Item
Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab
boolean
C0079773 (UMLS CUI-1)
Prior CTCL therapy
Item
Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy
boolean
C0039798 (UMLS CUI-1)
C0079773 (UMLS CUI-2)
C0079773 (UMLS CUI-2)
Interleukin-2 receptor expression
Item
Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry
boolean
C0034819 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
C0017262 (UMLS CUI-2)
Disease stage
Item
Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months. Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
boolean
C0699749 (UMLS CUI-1)
Other diseases
Item
No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. No systemic infections
boolean
C2359476 (UMLS CUI-1)
Willingness
Item
Willingness to be randomized to a placebo treatment only arm
boolean
C1516879 (UMLS CUI-1)
C0599724 (UMLS CUI-2)
C0599724 (UMLS CUI-2)
CL Item
ECOG 0 (0)
CL Item
ECOG 1 (1)
Previous trials
Item
Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
boolean
C0422740 (UMLS CUI-1)