ID

12232

Description

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

Keywords

Versions (2)
  1. 9/30/15 9/30/15 -
  2. 10/27/15 10/27/15 -
Uploaded on

October 27, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

CLL Lab BO17072 NCT00090051

English

Laboratories of Chronic lymphocytic leukemia NCT0090051

1 forms  
Laboratory analysis
Description

Laboratory analysis

Sample collection date
Description

Sample collection date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Lab ID number
Description

Lab ID number

Data type

integer

Alias
UMLS CUI [1]
C1114691
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Hemoglobin
Description

Hemoglobin

Data type

integer

Alias
UMLS CUI [1]
C0019046
Hematocrit
Description

Hematocrit

Data type

integer

Alias
UMLS CUI [1]
C0518014
Red Blood Cells
Description

Red Blood Cells

Data type

integer

Alias
UMLS CUI [1]
C0362910
Leukocytes (total)
Description

Leukocytes (total)

Data type

integer

Alias
UMLS CUI [1]
C0023508
Neutrophils
Description

Neutrophils

Data type

integer

Alias
UMLS CUI [1]
C0948762
Basophils
Description

Basophils

Data type

integer

Alias
UMLS CUI [1]
C0200641
Eosinophils
Description

Eosinophils

Data type

integer

Alias
UMLS CUI [1]
C0362902
Lymphocytes
Description

Lymphocytes

Data type

integer

Alias
UMLS CUI [1]
C0024264
Monocytes
Description

Monocytes

Data type

integer

Alias
UMLS CUI [1]
C0026473
Other cells
Description

Other cells

Data type

integer

Platelets
Description

Platelets

Data type

integer

Alias
UMLS CUI [1]
C0005821
Prothrombin time
Description

Prothrombin time

Data type

integer

Alias
UMLS CUI [1]
C0491338
Please comment on any abnormal other cells and specify white cell morphology
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Coombs tests indirect/direct
Description

Coombs tests indirect/direct

Sample collection date
Description

Sample collection date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C1549498
dd/mm/yy
Indirect Coombs tests
Description

Indirect Coombs tests

Data type

integer

Alias
UMLS CUI [1]
C0430262
Direct Coombs tests
Description

Direct Coombs tests

Data type

integer

Alias
UMLS CUI [1]
C0151569
Blood chemistry
Description

Blood chemistry

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

Aspartate transaminase (Serum glutamic oxaloacetic transaminase)

Data type

integer

Alias
UMLS CUI [1]
C0004002
Alanine transaminase (Serum glutamate-pyruvate transaminase)
Description

Alanine transaminase (Serum glutamate-pyruvate transaminase)

Data type

integer

Alias
UMLS CUI [1]
C0001899
Alk. phosphatase
Description

Alk. phosphatase

Data type

integer

Alias
UMLS CUI [1]
C0002059
Bilirubin total
Description

Bilirubin total

Data type

text

Alias
UMLS CUI-1
C0201913
Urea (BUN)
Description

Urea (BUN)

Data type

integer

Alias
UMLS CUI [1]
C0523961
Serum creatinine
Description

Serum creatinine

Data type

integer

Alias
UMLS CUI [1]
C0201976
Estimated creatinine clearance
Description

Estimated creatinine clearance

Data type

integer

Alias
UMLS CUI [1]
C0373595
Lactate dehydrogenase
Description

Lactate dehydrogenase

Data type

integer

Alias
UMLS CUI [1]
C0202113
Total protein
Description

Total protein

Data type

integer

Alias
UMLS CUI [1]
C0555903
Albumin
Description

Albumin

Data type

integer

Alias
UMLS CUI [1]
C0201838
Blood glucose (random)
Description

Blood glucose (random)

Data type

integer

Alias
UMLS CUI [1]
C0202042
beta-2-microglobulin
Description

beta-2-microglobulin

Data type

integer

Alias
UMLS CUI [1]
C0201910
Electrocytes
Description

Electrocytes

Sodium
Description

Sodium

Data type

integer

Alias
UMLS CUI [1]
C0337443
Calcium
Description

Calcium

Data type

integer

Alias
UMLS CUI [1]
C0201925
Potassium
Description

Potassium

Data type

integer

Alias
UMLS CUI [1]
C0202194
Phosphate
Description

Phosphate

Data type

integer

Alias
UMLS CUI [1]
C0523826
Lymphocyte immunophenotyping (local lab)
Description

Lymphocyte immunophenotyping (local lab)

Sample collection date
Description

Sample collection date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Lymphocytes
Description

Lymphocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200635
%
Monocytes
Description

Monocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0026473
%
Neutrophils
Description

Neutrophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0948762
%
Lymphocyte immunophenotyping (local lab)
Description

Lymphocyte immunophenotyping (local lab)

Lymphocyte immunophenotyping Lab value
Description

Lymphocyte immunophenotyping Lab value

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0079718
Lymphocyte immunophenotyping Lab parameter
Description

Lymphocyte immunophenotyping Lab parameter

Data type

integer

Alias
UMLS CUI [1]
C0079718
Comments
Description

Comments

Data type

text

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

Blood sampling for molecular analyses

Sample number
Description

Sample number 101

Data type

integer

Alias
UMLS CUI [1]
C0370003
Blood sampling for VH mutation status and chromosome abnormalities
Description

Blood sampling for VH mutation status and chromosome abnormalities

Sample number 401
Description

Sample number 401

Data type

integer

Bone marrow examination
Description

Bone marrow examination

Alias
UMLS CUI-1
C0005957
Date of examination
Description

Date of examination

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C2826643
dd/mm/yy
Result of Bone marrow examination
Description

Result of Bone marrow examination

Result of Bone marrow examination normal result
Description

Result of Bone marrow examination normal result

Data type

boolean

Alias
UMLS CUI [1]
C0427695
Result of Bone marrow examination abnormal result
Description

Result of Bone marrow examination abnormal result

Data type

integer

Alias
UMLS CUI [1]
C0427696
Is bone marrow involved with CLL?
Description

Is bone marrow involved with CLL?

Percentage of bone marrow involvement
Description

Percentage of bone marrow involvement

Data type

integer

Alias
UMLS CUI [1]
C1517677
no involvement
Description

no involvement

Data type

boolean

Alias
UMLS CUI [1]
C1517677
Lymphoid nodules in bone marrow?
Description

Lymphoid nodules in bone marrow?

Data type

boolean

Alias
UMLS CUI [1]
C3807548
Back to the top of the page

Similar models

Laboratories of Chronic lymphocytic leukemia NCT0090051

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Laboratory analysis
Date
Item
Sample collection date
date
C0011008 (UMLS CUI [1])
Lab ID number
Item
Lab ID number
integer
C1114691 (UMLS CUI [1])
Item Group
Hematology
C0474523 (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])
Item Group
Coombs tests indirect/direct
Date
Item
Sample collection date
date
C1549498 (UMLS CUI [1])
Item
Indirect Coombs tests
integer
C0430262 (UMLS CUI [1])
Indirect
Code List
Indirect Coombs tests
CL Item
negative (1)
C0430263 (UMLS CUI-1)
CL Item
positive (2)
C0151570 (UMLS CUI-1)
Item
Direct Coombs tests
integer
C0151569 (UMLS CUI [1])
Indirect
Code List
Direct Coombs tests
CL Item
negative (1)
C0430263 (UMLS CUI-1)
CL Item
positive (2)
C0151570 (UMLS CUI-1)
Item Group
Blood chemistry
C0005774 (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])
Item Group
Electrocytes
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])
Item Group
Lymphocyte immunophenotyping (local lab)
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 Group
Lymphocyte immunophenotyping (local lab)
Item
Lymphocyte immunophenotyping Lab value
integer
C0079718 (UMLS CUI [1])
Lab value
Code List
Lymphocyte immunophenotyping Lab value
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])
Lab parameter
Code List
Lymphocyte immunophenotyping Lab parameter
CL Item
gated (1)
C0444699 (UMLS CUI-1)
CL Item
total (2)
C0439810 (UMLS CUI-1)
Comments
Item
Comments
text
C0947611 (UMLS CUI-1)
Item Group
Blood sampling for molecular analyses
Item
Sample number
integer
C0370003 (UMLS CUI [1])
Sample number
Code List
Sample number
CL Item
Sample collection date (1)
C1317250 (UMLS CUI-1)
CL Item
Remarks (2)
C0947611 (UMLS CUI-1)
Item Group
Blood sampling for VH mutation status and chromosome abnormalities
Item
Sample number 401
integer
Sample number
Code List
Sample number 401
CL Item
Sample collection date (1)
C1317250 (UMLS CUI-1)
CL Item
Remarks (2)
C0947611 (UMLS CUI-1)
Item Group
Bone marrow examination
C0005957 (UMLS CUI-1)
Date
Item
Date of examination
date
C2826643 (UMLS CUI [1])
Item Group
Result of Bone marrow examination
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])
abnormal result
Code List
Result of Bone marrow examination abnormal result
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 Group
Is bone marrow involved with CLL?
Item
Percentage of bone marrow involvement
integer
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)
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial