Visit date
Item
Date of visit
date
C1320303 (UMLS CUI-1)
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Randomization number
Item
Randomization number
integer
C2986235 (UMLS CUI [1])
Item
Treatment arm
integer
C1522541 (UMLS CUI [1])
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
integer
C0746919 (UMLS CUI [1])
Participation in pharmacokinetic sampling
Item
Participation in pharmacokinetic sampling
boolean
C0031328 (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])
Hemoglobin
Item
Hemoglobin
integer
C0019046 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
integer
C0518014 (UMLS CUI [1])
RBC
Item
Red Blood Cells
integer
C0362910 (UMLS CUI [1])
Leukocytes
Item
Leukocytes (total)
integer
C0023508 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
integer
C0948762 (UMLS CUI [1])
Basophils
Item
Basophils
integer
C0200641 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
integer
C0362902 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
integer
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes
integer
C0026473 (UMLS CUI [1])
Other cells
Item
Other cells
integer
Platelets
Item
Platelets
integer
C0005821 (UMLS CUI [1])
Prothrombin time
Item
Prothrombin time
integer
C0491338 (UMLS CUI [1])
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)
integer
C0004002 (UMLS CUI [1])
ALT (SGPT)
Item
Alanine transaminase (Serum glutamate-pyruvate transaminase)
integer
C0001899 (UMLS CUI [1])
Alk. phosphatase
Item
Alk. phosphatase
integer
C0002059 (UMLS CUI [1])
Bilirubin total
Item
Bilirubin total
integer
C0201913 (UMLS CUI [1])
Urea (BUN)
Item
Urea (BUN)
integer
C0523961 (UMLS CUI [1])
Serum creatinine
Item
Serum creatinine
integer
C0201976 (UMLS CUI [1])
LDH
Item
Lactate dehydrogenase
integer
C0202113 (UMLS CUI [1])
Total protein
Item
Total protein
integer
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
integer
C0201838 (UMLS CUI [1])
Blood glucose
Item
Blood glucose (random)
integer
C0202042 (UMLS CUI [1])
beta-2-microglobulin
Item
beta-2-microglobulin
integer
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
C0393022 (UMLS CUI [1])
Interrupted infusion
Item
Interrupted infusion
boolean
C0574032 (UMLS CUI [1])
Reason of interruption
Item
Reason of interruption
text
C3538832 (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
C0574032 (UMLS CUI [1])
Reason of incomplete infusion
Item
Reason of incomplete infusion
text
C0205257 (UMLS CUI [1])
Delay of Fludarabine medication
Item
Delay of Fludarabine medication
boolean
C0059985 (UMLS CUI [1])
Item
Reason for delay
integer
C1298642 (UMLS CUI [1])
Code List
Reason for delay
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
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])
Item
Reason for dose adjustment
integer
C2826286 (UMLS CUI [1])
Code List
Reason for dose adjustment
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])
Item
Reson for delay
integer
C1298642 (UMLS CUI [1])
Code List
Reson for delay
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])
Item
Reason for dose adjustment
integer
C2826286 (UMLS CUI [1])
Code List
Reason for dose adjustment
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])