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ID
12232
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)
- 30-09-15 30-09-15 -
- 27-10-15 27-10-15 -
Geüploaded op
27 oktober 2015
DOI
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Licentie
Creative Commons BY-NC 3.0
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CLL Lab BO17072 NCT00090051
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
C0011008 (UMLS CUI [1])
Lab ID number
Item
Lab ID number
integer
C1114691 (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])
Date
Item
Sample collection date
date
C1549498 (UMLS CUI [1])
CL Item
negative (1)
C0430263 (UMLS CUI-1)
CL Item
positive (2)
C0151570 (UMLS CUI-1)
CL Item
negative (1)
C0430263 (UMLS CUI-1)
CL Item
positive (2)
C0151570 (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
text
C0201913 (UMLS CUI-1)
Urea (BUN)
Item
Urea (BUN)
integer
C0523961 (UMLS CUI [1])
Serum creatinine
Item
Serum creatinine
integer
C0201976 (UMLS CUI [1])
Estimated creatinine clearance
Item
Estimated creatinine clearance
integer
C0373595 (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
C0201910 (UMLS CUI [1])
Sodium
Item
Sodium
integer
C0337443 (UMLS CUI [1])
Calcium
Item
Calcium
integer
C0201925 (UMLS CUI [1])
Potassium
Item
Potassium
integer
C0202194 (UMLS CUI [1])
Phosphate
Item
Phosphate
integer
C0523826 (UMLS CUI [1])
Date
Item
Sample collection date
date
C0011008 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0948762 (UMLS CUI [1])
Item
Lymphocyte immunophenotyping Lab value
integer
C0079718 (UMLS CUI [1])
CL Item
CD3+ (1)
C1267816 (UMLS CUI-1)
CL Item
CD5+/CD19 (2)
C0487156 (UMLS CUI-1)
CL Item
CD19+ (3)
C0108748 (UMLS CUI-1)
CL Item
CD5+/CD20 (4)
C1267847 (UMLS CUI-1)
CL Item
CD20+ (5)
C0054946 (UMLS CUI-1)
CL Item
CD79b (6)
C0104979 (UMLS CUI-1)
CL Item
CD23 (7)
C0123242 (UMLS CUI-1)
CL Item
CD38 (8)
C0075742 (UMLS CUI-1)
CL Item
FMC7/lgG1 (SMIG) weak (9)
C0675491 (UMLS CUI-1)
CL Item
kappa (10)
C0439099 (UMLS CUI-1)
CL Item
lambda (11)
C1706314 (UMLS CUI-1)
Item
Lymphocyte immunophenotyping Lab parameter
integer
C0079718 (UMLS CUI [1])
CL Item
gated (1)
C0444699 (UMLS CUI-1)
CL Item
total (2)
C0439810 (UMLS CUI-1)
Comments
Item
Comments
text
C0947611 (UMLS CUI-1)
CL Item
Sample collection date (1)
C1317250 (UMLS CUI-1)
CL Item
Remarks (2)
C0947611 (UMLS CUI-1)
CL Item
Sample collection date (1)
C1317250 (UMLS CUI-1)
CL Item
Remarks (2)
C0947611 (UMLS CUI-1)
Date
Item
Date of examination
date
C2826643 (UMLS CUI [1])
Result of Bone marrow examination normal result
Item
Result of Bone marrow examination normal result
boolean
C0427695 (UMLS CUI [1])
Item
Result of Bone marrow examination abnormal result
integer
C0427696 (UMLS CUI [1])
CL Item
normocellular (1)
C2960424 (UMLS CUI-1)
CL Item
hypocellular (2)
C1855710 (UMLS CUI-1)
CL Item
hypercellular (3)
C0542080 (UMLS CUI-1)
Item
Percentage of bone marrow involvement
integer
C1517677 (UMLS CUI [1])
CL Item
Percentage of bone marrow involved with CLL (1)
C1517677 (UMLS CUI-1)
CL Item
diffuse pattern of involvement (2)
C0205219 (UMLS CUI-1)
CL Item
nodular pattern of involvement (3)
C1334972 (UMLS CUI-1)
no involvement
Item
no involvement
boolean
C1517677 (UMLS CUI [1])
Lymphoid nodules in bone marrow?
Item
Lymphoid nodules in bone marrow?
boolean
C3807548 (UMLS CUI [1])