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ID
12146
Descripción
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
Palabras clave
Versiones (2)
- 30/9/15 30/9/15 -
- 28/10/15 28/10/15 -
Subido en
30 de septiembre de 2015
DOI
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Licencia
Creative Commons BY-NC 3.0 Legacy
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CLL Cycle 3-6 FCR vs FC NCT00090051 BO17072
Chemotherapy Cycle 3-6 of Chronic Lymphocytic Leukemia NCT00090051 BO17072
Similar models
Chemotherapy Cycle 3-6 of Chronic Lymphocytic Leukemia NCT00090051 BO17072
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Info
Item
Rituximab should be administered on the same day as Fludarabine and Cyclophosphamide administration.
text
Delay of Rituximab medication
Item
Was administration of Rituximab delayed?
boolean
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Date of first dose
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Start time of first dose
Item
Start time of first dose
time
C1301880 (UMLS CUI [1])
End time of first dose
Item
End time of first dose
time
C1522314 (UMLS CUI [1])
Actual Dose of Rituximab
Item
Actual Dose of Rituximab
float
C0178602 (UMLS CUI [1,1])
C0732355 (UMLS CUI [1,2])
C0732355 (UMLS CUI [1,2])
Interrupted infusion
Item
Interrupted infusion
boolean
C0443239 (UMLS CUI [1])
Reason of interruption
Item
Reason of interruption
text
C102703 (UMLS CUI [1])
Decrease of infusion rate
Item
Decrease of infusion rate
boolean
C2964135 (UMLS CUI [1])
Reason of decrease
Item
Reason of decrease
text
C0547047 (UMLS CUI [1])
Completion of infusion
Item
Completion of infusion
boolean
C0205197 (UMLS CUI [1])
Reason of incomplete infusion
Item
Reason of incomplete infusion
text
C0205257 (UMLS CUI [1])
Info
Item
Rituximab should be administered on the same day as Fludarabine and Cyclophosphamide
text
Lymphocyte count
Item
Does the patient have a lymphocyte count of > 25x10e9/L?
boolean
C0200635 (UMLS CUI [1])
Dosage splitting
Item
Is the Rituximab dose being split over 2 days?
boolean
Delay of Rituximab medication
Item
Delay of Rituximab medication
boolean
C0393022 (UMLS CUI [1])
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual Dose
float
C3174092 (UMLS CUI [1])
Infusion interrupted
Item
Infusion interrupted
boolean
C1512900 (UMLS CUI [1])
Specify reason
Item
Specify reason
text
C0566251 (UMLS CUI [1])
Decrease of infusion rate
Item
boolean
C2964135 (UMLS CUI [1])
Specify reason
Item
Specify reason
text
C0566251 (UMLS CUI [1])
Infusion completed
Item
Infusion completed
boolean
C0574032 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
Specify Reason
Item
Specify Reason
text
C0566251 (UMLS CUI [1])
Delay of Rituximab medication
Item
Delay of Rituximab medication
boolean
C0393022 (UMLS CUI [1])
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual Dose
float
C3174092 (UMLS CUI [1])
Infusion interrupted
Item
boolean
C1512900 (UMLS CUI [1])
Specify reason
Item
text
C0566251 (UMLS CUI [1])
Decrease of infusion rate
Item
boolean
C2964135 (UMLS CUI [1])
Specify reason
Item
text
C0566251 (UMLS CUI [1])
Infusion completed
Item
boolean
C0574032 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
Specify Reason
Item
text
C0566251 (UMLS CUI [1])
Delay of Fludarabine medication
Item
boolean
C0059985 (UMLS CUI [1])
CL Item
laboratory (1)
CL Item
adverse event (2)
CL Item
other (3)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Date
Item
date
C0011008 (UMLS CUI [1])
Start time
Item
time
C1301880 (UMLS CUI [1])
End time
Item
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual dose
float
C3174092 (UMLS CUI [1])
Dose adjustment
Item
boolean
C2826232 (UMLS CUI [1])
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Delay of Cyclophosphamide
Item
Delay of Cyclophosphamide
boolean
C0010583 (UMLS CUI [1])
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual dose
float
C3174092 (UMLS CUI [1])
Dose adjustment
Item
Dose adjustment
boolean
C2826232 (UMLS CUI [1])
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])