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ID
12152
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 NCT00090051 BO17072
Follow-Up Study completion Chronic Lymphocytic Leukemia NCT00090051 BO17072
Similar models
Follow-Up Study completion Chronic Lymphocytic Leukemia NCT00090051 BO17072
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Info
Item
text
Item Group
Bone marrow sampling for molecular response
C0005953 (UMLS CUI-1)
Date of 1st confirmation
Item
Date of 1st confimation
date
Remarks of 1st confirmation
Item
text
Date of 2nd confirmation
Item
Date of 2nd confirmation
date
Remarks of 2nd confirmation
Item
text
Item Group
Blood sampling for molecular response
C0005953 (UMLS CUI-1)
Date of 1st confimation
Item
Date of 1st confirmation
date
Remarks of 1st confirmation
Item
text
Date of 2nd confirmation
Item
Date of 2nd confirmation
date
Remarks of 2nd confirmation
Item
text
Completion
Item
Did the patient complete the study up to the end of 5 year follow-up?
boolean
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1])
Study completion
Item
Did the patient complete the study up to the end of the treatment phase?
boolean
CL Item
adverse event/intercurrent illness (1)
CL Item
death (complete death page) (2)
CL Item
insufficient therapeutic response (3)
CL Item
failure to return (4)
CL Item
did not cooperate/withdrew consent (5)
CL Item
administrative/other (6)
Specify violation of selection criteria
Item
text
Specify other protocol violation
Item
text
Specify other reason
Item
text
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,2])
CL Item
alive (1)
CL Item
death (2)
CL Item
lost to follow-up (3)
Date of Death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Date of last contact
Item
Date last contact
date
C0805839 (UMLS CUI [1])
CL Item
progressive disease (1)
CL Item
other (2)
CL Item
not known (3)
Specify other cause of death
Item
Specify other cause of death
text
C0007465 (UMLS CUI [1])
Item
Did the patient’s disease progress after coming off study?
integer
C0242656 (UMLS CUI [1])
CL Item
yes (1)
CL Item
no (2)
CL Item
not known (3)
CL Item
not applicable (progressive disease already documented) (4)
Date of progressive disease
Item
Date of progressive disease
date
C1335499 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])