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ID
12139
Beschrijving
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). FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients NCT00090051 Roche BO17072
Trefwoorden
Versies (2)
- 30-09-15 30-09-15 -
- 28-10-15 28-10-15 -
Geüploaded op
30 september 2015
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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CLL Tumor assessment FCR vs FC NCT00090051 BO17072
Tumor assessment of Chronic Lymphocytic Leukemia NCT00090051 BO17072
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Tumor assessment of Chronic Lymphocytic Leukemia NCT00090051 BO17072
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
Presence
Item
Presence
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])
CL Item
no change (1)
CL Item
decrease (2)
C0547047 (UMLS CUI-1)
CL Item
increase (3)
C0442805 (UMLS CUI-1)
Splenomegaly
Item
boolean
C0038002 (UMLS CUI [1])
CL Item
no change (1)
CL Item
decrease (2)
C0547047 (UMLS CUI-1)
CL Item
increase (3)
C0442805 (UMLS CUI-1)
Item Group
Response assessment
C0332307 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
C0871261 (UMLS CUI-2)
Assessment Date
Item
Date of Assessment
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)
Partial response
Item
Does patient fulfill the criteria for a CR but have persistent anemia or thrombocytopenia?
boolean
C1521726 (UMLS CUI [1])
Item Group
Response assessment
C0332307 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
C0871261 (UMLS CUI-2)
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
yes (1)
CL Item
no (2)
CL Item
not applicable (3)
Partial response
Item
Does patient fulfill the criteria for a CR but have persistent anemia or thrombocytopenia?
boolean
C1521726 (UMLS CUI [1])