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ID
10684
Beschrijving
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
Trefwoorden
Versies (2)
- 19-05-15 19-05-15 -
- 08-06-15 08-06-15 - Julian Varghese
Geüploaded op
8 juni 2015
DOI
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Licentie
Creative Commons BY-NC 3.0
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CLL Lab NCT00090051 BO17072
Laboratories of Chronic lymphocytic leukemia NCT0090051
- StudyEvent: ODM
Similar models
Laboratories of Chronic lymphocytic leukemia NCT0090051
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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
C0033707 (UMLS CUI-1)
Comment
Item
Please comment on any abnormal other cells and specify white cell morphology
text
C0947611 (UMLS CUI-1)
Date
Item
Sample collection date
date
CL Item
negative (1)
CL Item
positive (2)
CL Item
negative (1)
CL Item
positive (2)
AST (SGOT)
Item
Aspartate transaminase (Serum glutamic oxaloacetic transaminase)
text
C0242192 (UMLS CUI-1)
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)
Estimated creatinine clearance
Item
Estimated creatinine clearance
text
C0373595 (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
C0037473 (UMLS CUI-1)
Calcium
Item
Calcium
text
C0006675 (UMLS CUI-1)
Potassium
Item
Potassium
text
C0032821 (UMLS CUI-1)
Phosphate
Item
Phosphate
text
C0523826 (UMLS CUI-1)
Date
Item
Sample collection date
date
Lymphocytes
Item
Lymphocytes
float
C0024264 (UMLS CUI-1)
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI-1)
Neutrophils
Item
Neutrophils
float
C0027950 (UMLS CUI-1)
CL Item
CD3+ (1)
CL Item
CD5+/CD19 (2)
CL Item
CD19+ (3)
CL Item
CD5+/CD20 (4)
CL Item
CD20+ (5)
CL Item
CD79b (6)
CL Item
CD23 (7)
CL Item
CD38 (8)
CL Item
FMC7/lgG1 (SMIG) weak (9)
CL Item
kappa (10)
CL Item
lambda (11)
CL Item
gated (1)
CL Item
total (2)
Comments
Item
Comments
text
C0947611 (UMLS CUI-1)
CL Item
Sample collection date (1)
CL Item
Remarks (2)
Sample Collection Date
Item
Sample Collection Date
date
C1302413 (UMLS CUI-1)
Comments
Item
text
C0947611 (UMLS CUI-1)
CL Item
Sample collection date (1)
CL Item
Remarks (2)
Sample Collection Date
Item
Sample Collection Date
date
C1302413 (UMLS CUI-1)
Date
Item
Date of examination
date
C0011008 (UMLS CUI-1)
C0005957 (UMLS CUI-2)
C0005957 (UMLS CUI-2)
Item Group
Result of Bone marrow examination
C0427694 (UMLS CUI-1)
normal result
Item
normal result
boolean
C1335065 (UMLS CUI-1)
CL Item
normocellular (1)
CL Item
hypocellular (2)
CL Item
hypercellular (3)
Item
Percentage of bone marrow involvement
text
C1517677 (UMLS CUI-1)
CL Item
Percentage of bone marrow involved with CLL (1)
CL Item
diffude pattern of involvement (2)
CL Item
nodular pattern of involvement (3)
no involvement
Item
no involvement
boolean
uncertain involvement
Item
Lymphoid nodules in bone marrow?
boolean