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ID
44634
Beschreibung
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
Stichworte
Versionen (2)
- 28.10.15 28.10.15 -
- 27.09.21 27.09.21 -
Hochgeladen am
27. September 2021
DOI
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Lizenz
Creative Commons BY-NC 3.0
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CLL Cycle 2 FCR vs FC BO17072 NCT00090051
Chemotherapy Cycle 2 of Chronic Lymphocytic Leukemia NCT00090051 BO17072
Ähnliche Modelle
Chemotherapy Cycle 2 of Chronic Lymphocytic Leukemia NCT00090051 BO17072
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Weight
Item
Weight
float
C0005910 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI-1)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI-1)
Blood pressure
Item
systolic
integer
C0871470 (UMLS CUI-1)
Blood pressure
Item
diastolic
integer
C0428883 (UMLS CUI-1)
Pulse rate
Item
Pulse rate
integer
C0232117 (UMLS CUI-1)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI-1)
Night sweats
Item
Night sweats
boolean
C0028081 (UMLS CUI-1)
Weight loss
Item
Weight loss
boolean
C1262477 (UMLS CUI-1)
CL Item
normal (1)
C0205307 (UMLS CUI-1)
CL Item
abnormal (2)
C0205161 (UMLS CUI-1)
CL Item
"If abnormal: Post Baseline adverse change in patient’s state is to be recorded on an “Adverse event“ page in case of abnormalities not related to CLL. Record spleen and liver examination and CLL related lesions in the tumor assessment section, if changed as compared to previous examination." (3)
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
C0393022 (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
C3840932 (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
Infusion completed
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
C3840932 (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])