ID

10227

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 (2)
  1. 2015-05-19 2015-05-19 -
  2. 2015-06-08 2015-06-08 - Julian Varghese
Uppladdad den

19 maj 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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CLL Lab NCT00090051 BO17072

Engelsk

Laboratories of Chronic lymphocytic leukemia NCT0090051

1 Formulär  
Laboratory analysis
Beskrivning

Laboratory analysis

Sample collection date
Beskrivning

Sample collection date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0011008
dd/mm/yy
Lab ID number
Beskrivning

Lab ID number

Datatyp

integer

Hematology
Beskrivning

Hematology

Alias
UMLS CUI-1
C0474523
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

text

Alias
UMLS CUI-1
C0019046
Hematocrit
Beskrivning

Hematocrit

Datatyp

text

Alias
UMLS CUI-1
C0518014
Red Blood Cells
Beskrivning

Red Blood Cells

Datatyp

text

Alias
UMLS CUI-1
C0362910
Leukocytes (total)
Beskrivning

Leukocytes (total)

Datatyp

text

Alias
UMLS CUI-1
C0023508
Neutrophils
Beskrivning

Neutrophils

Datatyp

text

Alias
UMLS CUI-1
C0948762
Basophils
Beskrivning

Basophils

Datatyp

text

Alias
UMLS CUI-1
C0200641
Eosinophils
Beskrivning

Eosinophils

Datatyp

text

Alias
UMLS CUI-1
C0362902
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

text

Alias
UMLS CUI-1
C0024264
Monocytes
Beskrivning

Monocytes

Datatyp

text

Alias
UMLS CUI-1
C0026473
Other cells
Beskrivning

Other cells

Datatyp

text

Platelets
Beskrivning

Platelets

Datatyp

text

Alias
UMLS CUI-1
C0005821
Prothrombin time
Beskrivning

Prothrombin time

Datatyp

text

Alias
UMLS CUI-1
C1274040
UMLS CUI-2
C0033707
UMLS CUI-3
C0022885
UMLS CUI-4
C1522609
Please comment on any abnormal other cells and specify white cell morphology
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI-1
C0947611
indirect/direct
Beskrivning

indirect/direct

Sample collection date
Beskrivning

Sample collection date

Datatyp

date

Måttenheter
  • dd/mm/yy
dd/mm/yy
Indirect
Beskrivning

Indirect

Datatyp

integer

Direct
Beskrivning

Direct

Datatyp

integer

Blood chemistry
Beskrivning

Blood chemistry

Alias
UMLS CUI-1
C0005774
Aspartate transaminase (Serum glutamic oxaloacetic transaminase)
Beskrivning

Aspartate transaminase (Serum glutamic oxaloacetic transaminase)

Datatyp

text

Alias
UMLS CUI-1
C0205054
UMLS CUI-2
C0242192
UMLS CUI-3
C0022877
UMLS CUI-4
C0205370
UMLS CUI-5
C1522609
Alanine transaminase (Serum glutamate-pyruvate transaminase)
Beskrivning

Alanine transaminase (Serum glutamate-pyruvate transaminase)

Datatyp

text

Alk. phosphatase
Beskrivning

Alk. phosphatase

Datatyp

text

Bilirubin total
Beskrivning

Bilirubin total

Datatyp

text

Alias
UMLS CUI-1
C0201913
Urea (BUN)
Beskrivning

Urea (BUN)

Datatyp

text

Serum creatinine
Beskrivning

Serum creatinine

Datatyp

text

Alias
UMLS CUI-1
C0201976
Estimated creatinine clearance
Beskrivning

Estimated creatinine clearance

Datatyp

text

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1274040
UMLS CUI-3
C0373595
UMLS CUI-4
C0750572
UMLS CUI-5
C1522609
Lactate dehydrogenase
Beskrivning

Lactate dehydrogenase

Datatyp

text

Alias
UMLS CUI-1
C0202113
Total protein
Beskrivning

Total protein

Datatyp

text

Alias
UMLS CUI-1
C0555903
Albumin
Beskrivning

Albumin

Datatyp

text

Alias
UMLS CUI-1
C0201838
Blood glucose (random)
Beskrivning

Blood glucose (random)

Datatyp

text

Alias
UMLS CUI-1
C0202042
beta-2-microglobulin
Beskrivning

beta-2-microglobulin

Datatyp

text

Electrocytes
Beskrivning

Electrocytes

Sodium
Beskrivning

Sodium

Datatyp

text

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1274040
UMLS CUI-3
C0037473
UMLS CUI-4
C0013832
UMLS CUI-5
C1522609
Calcium
Beskrivning

Calcium

Datatyp

text

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0006675
UMLS CUI-3
C1274040
UMLS CUI-4
C0013832
UMLS CUI-5
C1522609
Potassium
Beskrivning

Potassium

Datatyp

text

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1274040
UMLS CUI-3
C0013832
UMLS CUI-4
C0032821
UMLS CUI-5
C1522609
Phosphate
Beskrivning

Phosphate

Datatyp

text

Alias
UMLS CUI-1
C0523826
Lymphocyte immunophenotyping (local lab)
Beskrivning

Lymphocyte immunophenotyping (local lab)

Sample collection date
Beskrivning

Sample collection date

Datatyp

date

Måttenheter
  • dd/mm/yy
dd/mm/yy
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI-1
C0024264
%
Monocytes
Beskrivning

Monocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI-1
C0026473
%
Neutrophils
Beskrivning

Neutrophils

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI-1
C0027950
%
Lymphocyte immunophenotyping (local lab)
Beskrivning

Lymphocyte immunophenotyping (local lab)

Lab value
Beskrivning

Lab value

Datatyp

text

Måttenheter
  • %
Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C0022885
UMLS CUI-3
C1522609
Lab parameter
Beskrivning

Lab parameter

Datatyp

text

Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI-1
C0947611
Blood sampling for molecular analyses
Beskrivning

Blood sampling for molecular analyses

Sample number
Beskrivning

Sample number 101

Datatyp

text

Alias
UMLS CUI-1
C0237753
UMLS CUI-2
C0370003
Blood sampling for VH mutation status and chromosome abnormalities
Beskrivning

Blood sampling for VH mutation status and chromosome abnormalities

Sample number 401
Beskrivning

Sample number 401

Datatyp

text

Bone marrow examination
Beskrivning

Bone marrow examination

Alias
UMLS CUI-1
C0005957
Date of examination
Beskrivning

Date of examination

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI-1
C0011008
dd/mm/yy
Result of Bone marrow examination
Beskrivning

Result of Bone marrow examination

normal result
Beskrivning

normal result

Datatyp

boolean

abnormal result
Beskrivning

abnormal result

Datatyp

integer

Is bone marrow involved with CLL?
Beskrivning

Is bone marrow involved with CLL?

Percentage of bone marrow involvement
Beskrivning

Percentage of bone marrow involvement

Datatyp

text

no involvement
Beskrivning

no involvement

Datatyp

boolean

Lymphoid nodules in bone marrow?
Beskrivning

uncertain involvement

Datatyp

boolean

Tillbaka till toppen

Similar models

Laboratories of Chronic lymphocytic leukemia NCT0090051

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Laboratory analysis
Date
Item
Sample collection date
date
C0022885 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Lab ID number
Item
Lab ID number
integer
Item Group
Hematology
C0474523 (UMLS CUI-1)
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)
Comment
Item
Please comment on any abnormal other cells and specify white cell morphology
text
C0947611 (UMLS CUI-1)
Item Group
indirect/direct
Date
Item
Sample collection date
date
Item
Indirect
integer
Indirect
Code List
Indirect
CL Item
negative (1)
CL Item
positive (2)
Item
Direct
integer
Indirect
Code List
Direct
CL Item
negative (1)
CL Item
positive (2)
Item Group
Blood chemistry
C0005774 (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)
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
C0022885 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0373595 (UMLS CUI-3)
C0750572 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
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
Item Group
Electrocytes
Sodium
Item
Sodium
text
C0022885 (UMLS CUI-1)
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)
Potassium
Item
Potassium
text
C0022885 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
C0032821 (UMLS CUI-4)
C1522609 (UMLS CUI-5)
Phosphate
Item
Phosphate
text
C0523826 (UMLS CUI-1)
Item Group
Lymphocyte immunophenotyping (local lab)
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)
Item Group
Lymphocyte immunophenotyping (local lab)
Item
Lab value
text
C0022877 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1522609 (UMLS CUI-3)
Lab value
Code List
Lab value
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)
Item
Lab parameter
text
Lab parameter
Code List
Lab parameter
CL Item
gated (1)
CL Item
total (2)
Comments
Item
Comments
text
C0947611 (UMLS CUI-1)
Item Group
Blood sampling for molecular analyses
Item
Sample number
text
C0237753 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
Sample number
Code List
Sample number
CL Item
Sample collection date (1)
CL Item
Remarks (2)
Item Group
Blood sampling for VH mutation status and chromosome abnormalities
Item
Sample number 401
text
Sample number
Code List
Sample number 401
CL Item
Sample collection date (1)
CL Item
Remarks (2)
Item Group
Bone marrow examination
C0005957 (UMLS CUI-1)
Date
Item
Date of examination
date
C0011008 (UMLS CUI-1)
Item Group
Result of Bone marrow examination
normal result
Item
normal result
boolean
Item
abnormal result
integer
abnormal result
Code List
abnormal result
CL Item
normocellular (1)
CL Item
hypocellular (2)
CL Item
hypercellular (3)
Item Group
Is bone marrow involved with CLL?
Item
Percentage of bone marrow involvement
text
Percentage of bone marrow involvement
Code List
Percentage of bone marrow involvement
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
Tillbaka till toppen 

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