ID

10684

Descripción

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

Palabras clave

Versiones (2)
  1. 19/5/15 19/5/15 -
  2. 8/6/15 8/6/15 - Julian Varghese
Subido en

8 de junio de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0
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CLL Lab NCT00090051 BO17072

Inglés

Laboratories of Chronic lymphocytic leukemia NCT0090051

1 formularios  
Laboratory analysis
Descripción

Laboratory analysis

Sample collection date
Descripción

Sample collection date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0011008
dd/mm/yy
Lab ID number
Descripción

Lab ID number

Tipo de datos

integer

Hematology
Descripción

Hematology

Alias
UMLS CUI-1
C0474523
Hemoglobin
Descripción

Hemoglobin

Tipo de datos

text

Alias
UMLS CUI-1
C0019046
Hematocrit
Descripción

Hematocrit

Tipo de datos

text

Alias
UMLS CUI-1
C0518014
Red Blood Cells
Descripción

Red Blood Cells

Tipo de datos

text

Alias
UMLS CUI-1
C0362910
Leukocytes (total)
Descripción

Leukocytes (total)

Tipo de datos

text

Alias
UMLS CUI-1
C0023508
Neutrophils
Descripción

Neutrophils

Tipo de datos

text

Alias
UMLS CUI-1
C0948762
Basophils
Descripción

Basophils

Tipo de datos

text

Alias
UMLS CUI-1
C0200641
Eosinophils
Descripción

Eosinophils

Tipo de datos

text

Alias
UMLS CUI-1
C0362902
Lymphocytes
Descripción

Lymphocytes

Tipo de datos

text

Alias
UMLS CUI-1
C0024264
Monocytes
Descripción

Monocytes

Tipo de datos

text

Alias
UMLS CUI-1
C0026473
Other cells
Descripción

Other cells

Tipo de datos

text

Platelets
Descripción

Platelets

Tipo de datos

text

Alias
UMLS CUI-1
C0005821
Prothrombin time
Descripción

Prothrombin time

Tipo de datos

text

Alias
UMLS CUI-1
C0033707
Please comment on any abnormal other cells and specify white cell morphology
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI-1
C0947611
indirect/direct
Descripción

indirect/direct

Sample collection date
Descripción

Sample collection date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
dd/mm/yy
Indirect
Descripción

Indirect

Tipo de datos

integer

Direct
Descripción

Direct

Tipo de datos

integer

Blood chemistry
Descripción

Blood chemistry

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

Aspartate transaminase (Serum glutamic oxaloacetic transaminase)

Tipo de datos

text

Alias
UMLS CUI-1
C0242192
Alanine transaminase (Serum glutamate-pyruvate transaminase)
Descripción

Alanine transaminase (Serum glutamate-pyruvate transaminase)

Tipo de datos

text

Alk. phosphatase
Descripción

Alk. phosphatase

Tipo de datos

text

Bilirubin total
Descripción

Bilirubin total

Tipo de datos

text

Alias
UMLS CUI-1
C0201913
Urea (BUN)
Descripción

Urea (BUN)

Tipo de datos

text

Serum creatinine
Descripción

Serum creatinine

Tipo de datos

text

Alias
UMLS CUI-1
C0201976
Estimated creatinine clearance
Descripción

Estimated creatinine clearance

Tipo de datos

text

Alias
UMLS CUI-1
C0373595
Lactate dehydrogenase
Descripción

Lactate dehydrogenase

Tipo de datos

text

Alias
UMLS CUI-1
C0202113
Total protein
Descripción

Total protein

Tipo de datos

text

Alias
UMLS CUI-1
C0555903
Albumin
Descripción

Albumin

Tipo de datos

text

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

Blood glucose (random)

Tipo de datos

text

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

beta-2-microglobulin

Tipo de datos

text

Electrocytes
Descripción

Electrocytes

Sodium
Descripción

Sodium

Tipo de datos

text

Alias
UMLS CUI-1
C0037473
Calcium
Descripción

Calcium

Tipo de datos

text

Alias
UMLS CUI-1
C0006675
Potassium
Descripción

Potassium

Tipo de datos

text

Alias
UMLS CUI-1
C0032821
Phosphate
Descripción

Phosphate

Tipo de datos

text

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

Lymphocyte immunophenotyping (local lab)

Sample collection date
Descripción

Sample collection date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
dd/mm/yy
Lymphocytes
Descripción

Lymphocytes

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI-1
C0024264
%
Monocytes
Descripción

Monocytes

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI-1
C0026473
%
Neutrophils
Descripción

Neutrophils

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI-1
C0027950
%
Lymphocyte immunophenotyping (local lab)
Descripción

Lymphocyte immunophenotyping (local lab)

Immunophenotyping
Descripción

Immunophenotyping

Tipo de datos

text

Unidades de medida
  • %
Alias
UMLS CUI-1
C0079611
Lab parameter
Descripción

Lab parameter

Tipo de datos

text

Comments
Descripción

Comments

Tipo de datos

text

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

Blood sampling for molecular analyses

Sample number 101
Descripción

Sample number 101

Tipo de datos

text

Alias
UMLS CUI-1
C0370003
UMLS CUI-2
C0600091
Sample Collection Date
Descripción

Sample Collection Date

Tipo de datos

date

Alias
UMLS CUI-1
C1302413
Comments
Descripción

Comments

Tipo de datos

text

Alias
UMLS CUI-1
C0947611
Blood sampling for VH mutation status and chromosome abnormalities
Descripción

Blood sampling for VH mutation status and chromosome abnormalities

Sample number 401
Descripción

Sample number 401

Tipo de datos

text

Alias
UMLS CUI-1
C0370003
UMLS CUI-2
C0600091
Sample Collection Date
Descripción

Sample Collection Date

Tipo de datos

date

Alias
UMLS CUI-1
C1302413
Bone marrow examination
Descripción

Bone marrow examination

Alias
UMLS CUI-1
C0005957
Date of examination
Descripción

Date of examination

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI-1
C0011008
UMLS CUI-2
C0005957
dd/mm/yy
Result of Bone marrow examination
Descripción

Result of Bone marrow examination

Alias
UMLS CUI-1
C0427694
normal result
Descripción

normal result

Tipo de datos

boolean

Alias
UMLS CUI-1
C1335065
abnormal result
Descripción

abnormal result

Tipo de datos

integer

Alias
UMLS CUI-1
C0741594
Is bone marrow involved with CLL?
Descripción

Is bone marrow involved with CLL?

Percentage of bone marrow involvement
Descripción

Percentage of bone marrow involvement

Tipo de datos

text

Alias
UMLS CUI-1
C1517677
no involvement
Descripción

no involvement

Tipo de datos

boolean

Lymphoid nodules in bone marrow?
Descripción

uncertain involvement

Tipo de datos

boolean

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Similar models

Laboratories of Chronic lymphocytic leukemia NCT0090051

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
C0033707 (UMLS CUI-1)
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
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
Item Group
Electrocytes
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)
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
Immunophenotyping
text
C0079611 (UMLS CUI-1)
Lab value
Code List
Immunophenotyping
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 101
text
C0370003 (UMLS CUI-1)
C0600091 (UMLS CUI-2)
Sample number
Code List
Sample number 101
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)
Item Group
Blood sampling for VH mutation status and chromosome abnormalities
Item
Sample number 401
text
C0370003 (UMLS CUI-1)
C0600091 (UMLS CUI-2)
Sample number
Code List
Sample number 401
CL Item
Sample collection date (1)
CL Item
Remarks (2)
Sample Collection Date
Item
Sample Collection Date
date
C1302413 (UMLS CUI-1)
Item Group
Bone marrow examination
C0005957 (UMLS CUI-1)
Date
Item
Date of examination
date
C0011008 (UMLS CUI-1)
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)
Item
abnormal result
integer
C0741594 (UMLS CUI-1)
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
C1517677 (UMLS CUI-1)
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
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