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ID
12240
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
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Versies (2)
- 30-09-15 30-09-15 -
- 28-10-15 28-10-15 -
Geüploaded op
28 oktober 2015
DOI
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Licentie
Creative Commons BY-NC 3.0
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CLL Tumor assessment FCR vs FC BO17072 NCT00090051
Tumor assessment of Chronic Lymphocytic Leukemia NCT00090051 BO17072
Similar models
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
Code of origin
integer
C2986125 (UMLS CUI [1])
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
Code of origin
integer
C2986125 (UMLS CUI [1])
extra nodal or other specification
Item
text
C1517067 (UMLS CUI [1])
Side of lesion
Item
text
C0441987 (UMLS CUI [1])
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)
C0205394 (UMLS CUI-1)
specify other examination
Item
specify other examination
text
C0582103 (UMLS CUI [1])
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
Code of origin
text
C2986125 (UMLS CUI [1])
extra nodal or other specification
Item
extra nodal or other specification
integer
C1517067 (UMLS CUI [1])
Side of lesion
Item
Side of lesion
integer
C1285236 (UMLS CUI [1])
Dimensions
Item
Dimensions
integer
C0439534 (UMLS CUI [1])
Method of assessment
Item
Method of assessment
integer
C2598110 (UMLS CUI [1])
Other specification
Item
Other specification
integer
C2348235 (UMLS CUI [1])
Code of origin
Item
text
extra nodal or other specification
Item
text
C1517067 (UMLS CUI [1])
Side of lesion
Item
Side of lesion
integer
C1285236 (UMLS CUI [1])
Presence
Item
Presence
boolean
C0150312 (UMLS CUI [1])
Item Group
Liver and spleen examination after Cycle 3 and 6
Date of Assessment
Item
Date of Assessment
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)
C0205394 (UMLS CUI-1)
specify other examination
Item
specify other examination
text
C0260879 (UMLS CUI [1])
Hepatomegaly
Item
Hepatomegaly
boolean
C0019209 (UMLS CUI [1])
CL Item
no change (1)
C0442739 (UMLS CUI-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)
C0442739 (UMLS CUI-1)
CL Item
decrease (2)
C0547047 (UMLS CUI-1)
CL Item
increase (3)
C0442805 (UMLS CUI-1)
Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
New lesions
Item
Are there any new lesions?
boolean
C0221198 (UMLS CUI [1])
Non-indicator lesions
Item
Was there unequivocal progression in the size of non-indicator lesions?
boolean
C3272925 (UMLS CUI [1])
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
C0741008 (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)
C1705108 (UMLS CUI-1)
CL Item
no (2)
C1298908 (UMLS CUI-1)
CL Item
not applicable (3)
C1272460 (UMLS CUI-1)
Item
Is patient in complete remission but has bone marrow nodules that can be identified histologically?
integer
C0229654 (UMLS CUI [1])
Code List
Is patient in complete remission but has bone marrow nodules that can be identified histologically?
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
no (2)
C1298908 (UMLS CUI-1)
CL Item
not applicable (3)
C1272460 (UMLS CUI-1)
Partial response
Item
Does patient fulfill the criteria for a CR but have persistent anemia or thrombocytopenia?
boolean
C0741008 (UMLS CUI [1])