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Information:
Fel:
ID
12136
Beskrivning
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
Nyckelord
Versioner (4)
- 2015-09-30 2015-09-30 -
- 2015-09-30 2015-09-30 -
- 2015-10-28 2015-10-28 -
- 2021-09-27 2021-09-27 -
Uppladdad den
30 september 2015
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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CLL Cycle 1 FCR vs FC NCT00090051 BO17072
Chemotherapy Cycle 1 of Chronic Lymphocytic Leukemia NCT00090051 BO17072
Similar models
Chemotherapy Cycle 1 of Chronic Lymphocytic Leukemia NCT00090051 BO17072
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI-1)
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0011008 (UMLS CUI-2)
Randomization number
Item
Randomization number
text
C0237753 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
C0034656 (UMLS CUI-2)
CL Item
FCR (1)
C1880650 (UMLS CUI-1)
CL Item
FC (2)
C0280920 (UMLS CUI-1)
No treatment
Item
Reason why randomized but not treated
text
C0746919 (UMLS CUI-1)
Participation in pharmacokinetic sampling
Item
Participation in pharmacokinetic sampling
boolean
C0679823 (UMLS CUI-1)
C0870078 (UMLS CUI-2)
C0031328 (UMLS CUI-3)
C0870078 (UMLS CUI-2)
C0031328 (UMLS CUI-3)
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
C0043096 (UMLS CUI-1)
General physical examination
Item
Perform a standard physical examination but specify only abnormalities not related to CLL.
text
C0031809 (UMLS CUI-1)
Date
Item
Date ECG performed
date
C0011008 (UMLS CUI-1)
Abnormalities in the ECG
Item
Are there any abnormalities noted in the ECG?
boolean
C1623258 (UMLS CUI-1)
Abnormalities
Item
Specification of abnormalities
text
ECG
Item
Was ECG performed?
boolean
C1623258 (UMLS CUI [1])
Date
Item
Sample collection date
date
C0022885 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0011008 (UMLS CUI-2)
Lab ID number
Item
Lab ID number
integer
Hemoglobin
Item
Hemoglobin
text
C0019046 (UMLS CUI-1)
Hematocrit
Item
Hematocrit
text
C0518014 (UMLS CUI-1)
RBC
Item
Red Blood Cells
text
C0362910 (UMLS CUI-1)
Leukocytes
Item
Leukocytes (total)
text
C0023508 (UMLS CUI-1)
Neutrophils
Item
Neutrophils
text
C0948762 (UMLS CUI-1)
Basophils
Item
Basophils
text
C0200641 (UMLS CUI-1)
Eosinophils
Item
Eosinophils
text
C0362902 (UMLS CUI-1)
Lymphocytes
Item
Lymphocytes
text
C0024264 (UMLS CUI-1)
Monocytes
Item
Monocytes
text
C0026473 (UMLS CUI-1)
Other cells
Item
Other cells
text
Platelets
Item
Platelets
text
C0005821 (UMLS CUI-1)
Prothrombin time
Item
Prothrombin time
text
C1274040 (UMLS CUI-1)
C0033707 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C1522609 (UMLS CUI-4)
C0033707 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C1522609 (UMLS CUI-4)
Comment
Item
Please comment on any abnormal other cells and specify white cell morphology
text
C0947611 (UMLS CUI-1)
AST (SGOT)
Item
Aspartate transaminase (Serum glutamic oxaloacetic transaminase)
text
C0205054 (UMLS CUI-1)
C0242192 (UMLS CUI-2)
C0022877 (UMLS CUI-3)
C0205370 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
C0242192 (UMLS CUI-2)
C0022877 (UMLS CUI-3)
C0205370 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
ALT (SGPT)
Item
Alanine transaminase (Serum glutamate-pyruvate transaminase)
text
Alk. phosphatase
Item
Alk. phosphatase
text
Bilirubin total
Item
Bilirubin total
text
C0201913 (UMLS CUI-1)
Urea (BUN)
Item
Urea (BUN)
text
Serum creatinine
Item
Serum creatinine
text
C0201976 (UMLS CUI-1)
LDH
Item
Lactate dehydrogenase
text
C0202113 (UMLS CUI-1)
Total protein
Item
Total protein
text
C0555903 (UMLS CUI-1)
Albumin
Item
Albumin
text
C0201838 (UMLS CUI-1)
Blood glucose
Item
Blood glucose (random)
text
C0202042 (UMLS CUI-1)
beta-2-microglobulin
Item
beta-2-microglobulin
text
Sodium
Item
Sodium
text
C0022885 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0037473 (UMLS CUI-3)
C0013832 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
C1274040 (UMLS CUI-2)
C0037473 (UMLS CUI-3)
C0013832 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
Calcium
Item
Calcium
text
C0022885 (UMLS CUI-1)
C0006675 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
C0013832 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
C0006675 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
C0013832 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
Potassium
Item
Potassium
text
C0022885 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0032821 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
C1274040 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0032821 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
Phosphate
Item
Phosphate
text
C0523826 (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)
C0732355 (UMLS CUI-2)
C0732355 (UMLS CUI-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])
Delay of Fludarabine medication
Item
boolean
C0059985 (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
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])