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ID
12155
Description
An open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab plus fludarabine and cyclophosphamide (FCR) versus fludarabine and cyclophosphamide alone (FC) in previously treated patients with CD20 positive B-cell chronic lymphocytic leukemia (CLL). NCT00090051 BO17072
Keywords
Versions (2)
- 10/1/15 10/1/15 -
- 10/28/15 10/28/15 -
Uploaded on
October 1, 2015
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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CLL Follow-Up Month 9 NCT00090051 BO17072
Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072
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Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Date
Item
Date of examination
date
C0011008 (UMLS CUI-1)
normal result
Item
normal result
boolean
CL Item
normocellular (1)
CL Item
hypocellular (2)
CL Item
hypercellular (3)
CL Item
Percentage of bone marrow involved with CLL (1)
CL Item
diffude pattern of involvement (2)
CL Item
nodular pattern of involvement (3)
no involvement
Item
no involvement
boolean
uncertain involvement
Item
Lymphoid nodules in bone marrow?
boolean
Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Code of origin
Item
text
extra nodal or other specification
Item
text
C1517067 (UMLS CUI [1])
Side of lesion
Item
text
C0441987 (UMLS CUI [1])
Dimensions
Item
text
C0439534 (UMLS CUI [1])
Method of assessment
Item
text
C2598110 (UMLS CUI [1])
Other specification
Item
text
Code of origin
Item
text
extra nodal or other specification
Item
text
C1517067 (UMLS CUI [1])
Side of lesion
Item
text
C0441987 (UMLS CUI [1])
Present
Item
Present
boolean
C0150312 (UMLS CUI [1])
Item Group
Liver and spleen examination
C2243078 (UMLS CUI-1)
C2228485 (UMLS CUI-2)
C2228485 (UMLS CUI-2)
Date of Assessment
Item
date
C2985720 (UMLS CUI [1])
CL Item
CT scan (1)
C0040405 (UMLS CUI-1)
CL Item
physical examination (2)
C0031809 (UMLS CUI-1)
CL Item
other (3)
specify other examination
Item
text
Hepatomegaly
Item
Hepatomegaly
boolean
C0019209 (UMLS CUI [1])
Splenomegaly
Item
Splenomegaly
boolean
C0038002 (UMLS CUI [1])
Assessment Date
Item
date
C2985720 (UMLS CUI [1])
New lesions
Item
Are there any new lesions?
boolean
C0221198 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,2])
Non-indicator lesions
Item
Was there unequivocal progression in the size of non-indicator lesions?
boolean
CL Item
complete response (1)
C0677874 (UMLS CUI-1)
CL Item
partial response (2)
C1521726 (UMLS CUI-1)
CL Item
stable disease (3)
C0677946 (UMLS CUI-1)
CL Item
pregressive disease (4)
C1335499 (UMLS CUI-1)
Item
Was complete response confirmed with a bone marrow biopsy?
integer
C0677874 (UMLS CUI [1])
CL Item
yes (1)
CL Item
no (2)
CL Item
not applicable (3)
Item
Is patient in complete remission but has bone marrow nodules that can be identified histologically?
integer
C1521726 (UMLS CUI [1])
Code List
Is patient in complete remission but has bone marrow nodules that can be identified histologically?
CL Item
Percentage of bone marrow involved with CLL (1)
CL Item
diffude pattern of involvement (2)
CL Item
nodular pattern of involvement (3)
Partial response
Item
Does patient fulfill the criteria for a CR but have persistent anemia or thrombocytopenia?
boolean
C1521726 (UMLS CUI [1])