ID

13905

Description

A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

Mots-clés

Versions (1)
  1. 15/03/2016 15/03/2016 -
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15 mars 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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Laboratory results LenaMain-Study

Anglais

Laboratory results

1 Formulaires  
  1. StudyEvent: ODM
    1. Laboratory results
Protein electrophoresis
Description

Protein electrophoresis

Albumin
Description

Albumin

Type de données

float

Unités de mesure
  • g/dL
Alias
UMLS CUI [1]
C0201838
g/dL
Total Protein in 24h urine
Description

Total Protein

Type de données

float

Unités de mesure
  • mg/24h
Alias
UMLS CUI [1]
C0428541
mg/24h
Total Serum Protein
Description

Total Serum Protein

Type de données

float

Unités de mesure
  • g/dl
Alias
UMLS CUI [1]
C0036836
g/dl
Beta-globulin
Description

Beta-globulin

Type de données

float

Unités de mesure
  • g/dL
Alias
UMLS CUI [1]
C0005157
g/dL
Gamma-Globulin measurement
Description

Gamma-Globulin

Type de données

float

Unités de mesure
  • g/dL
Alias
UMLS CUI [1]
C0860681
g/dL
Beta and gamma globulin total
Description

Please give the sum only, if stated in the lab sheet

Type de données

float

Unités de mesure
  • g/dL
Alias
UMLS CUI [1]
C1717622
g/dL
Serum immunofixation
Description

Serum immunofixation

Type de données

integer

Alias
UMLS CUI [1]
C1271678
Comment on serum immunofixation
Description

Comment

Type de données

text

Alias
UMLS CUI [1]
C0947611
Urine immunofixation
Description

Urine immunofixation

Type de données

integer

Alias
UMLS CUI [1]
C1271641
Comment on urine immunofixation
Description

Comment

Type de données

text

Alias
UMLS CUI [1]
C0947611
IgA measurement
Description

IgA

Type de données

float

Unités de mesure
  • mg/dl
Alias
UMLS CUI [1]
C0202083
mg/dl
IgD measurement
Description

IgD

Type de données

float

Unités de mesure
  • mg/dl
Alias
UMLS CUI [1]
C0577612
mg/dl
IgG measurement
Description

IgG

Type de données

float

Unités de mesure
  • mg/dl
Alias
UMLS CUI [1]
C0202087
mg/dl
Immunoglobulin M measurement
Description

IgM

Type de données

float

Unités de mesure
  • mg/dl
Alias
UMLS CUI [1]
C0202084
mg/dl
FLC kappa measurement
Description

FLC kappa

Type de données

float

Unités de mesure
  • mg/l
Alias
UMLS CUI [1]
C3274397
mg/l
Kappa
Description

Kappa

Type de données

integer

Alias
UMLS CUI [1]
C0439099
FLC lambda measurement
Description

FLC lambda

Type de données

float

Unités de mesure
  • mg/l
Alias
UMLS CUI [1]
C3274399
mg/l
Lambda
Description

Lambda

Type de données

integer

Alias
UMLS CUI [1]
C1706314
Kappa/lambda quotient
Description

Kappa/lambda quotient

Type de données

integer

Alias
UMLS CUI [1]
C1168398
Hematology
Description

Hematology

Erythrocytes
Description

Erythrocytes

Type de données

float

Unités de mesure
  • Mio/μl
Alias
UMLS CUI [1]
C0014772
Mio/μl
Hemoglobin
Description

Hemoglobin

Type de données

float

Unités de mesure
  • g/dl
Alias
UMLS CUI [1]
C0518015
g/dl
Hematocrit
Description

Hematocrit

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C0518014
%
Mean Corpuscular Volume
Description

MCV

Type de données

float

Unités de mesure
  • fl
Alias
UMLS CUI [1]
C1948043
fl
MCH
Description

MCH

Type de données

float

Unités de mesure
  • pg
Alias
UMLS CUI [1]
C0369183
pg
Mean corpuscular hemoglobin concentration
Description

MCHC

Type de données

float

Unités de mesure
  • g Hb/dL Ery
Alias
UMLS CUI [1]
C0474535
g Hb/dL Ery
Leukocytes
Description

Leukocytes

Type de données

float

Unités de mesure
  • 1000/μl
Alias
UMLS CUI [1]
C0023508
1000/μl
Leukocytes (total)
Description

Leukocytes

Type de données

integer

Alias
UMLS CUI [1]
C1271681
Platelet count
Description

Platelets

Type de données

float

Unités de mesure
  • 1000/μl
Alias
UMLS CUI [1]
C0005821
1000/μl
Neutrophils percentage
Description

Neutrophils percentage

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C2238207
%
Neutrophils
Description

Neutrophils

Type de données

float

Unités de mesure
  • abs.
Alias
UMLS CUI [1]
C0948762
abs.
Eosinophils percentage
Description

Eosinophils percentage

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C2228144
%
Basophils percentage
Description

Basophils percentage

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C2237945
%
Monocytes percentage
Description

Monocytes percentage

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C2237144
%
Lymphocytes percentage
Description

Lymphocytes percentage

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C2200256
%
Neutrophils
Description

Neutrophils

Type de données

float

Unités de mesure
  • 1000/μl
Alias
UMLS CUI [1]
C0200633
1000/μl
Serum chemistry
Description

Serum chemistry

Sodium
Description

Sodium

Type de données

float

Unités de mesure
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Potassium
Description

Potassium

Type de données

float

Unités de mesure
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Calcium
Description

Calcium

Type de données

float

Unités de mesure
  • mmol/l
Alias
UMLS CUI [1]
C0201925
mmol/l
Glucose
Description

Glucose

Type de données

float

Unités de mesure
  • mg/dl
Alias
UMLS CUI [1]
C0202042
mg/dl
Alkaline Phosphatase
Description

Alkaline Phosphatase

Type de données

float

Unités de mesure
  • U/l
Alias
UMLS CUI [1]
C0002059
U/l
Bilirubin
Description

Bilirubin

Type de données

float

Unités de mesure
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
AST (SGOT)
Description

AST

Type de données

float

Unités de mesure
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
ALT
Description

ALT

Type de données

float

Unités de mesure
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
Gamma GT
Description

Gamma GT

Type de données

float

Unités de mesure
  • U/l
Alias
UMLS CUI [1]
C0202035
U/l
Lactate Dehydrogenase (LDH) (U/l)
Description

LDH

Type de données

float

Alias
UMLS CUI [1]
C0202113
Urea
Description

Urea

Type de données

float

Unités de mesure
  • mg/dl
Alias
UMLS CUI [1]
C0523961
mg/dl
CRP
Description

CRP

Type de données

float

Unités de mesure
  • md/dl
Alias
UMLS CUI [1]
C0201657
md/dl
Serum Creatinine
Description

Serum Creatinine

Type de données

float

Unités de mesure
  • mg/dl
Alias
UMLS CUI [1]
C0201976
mg/dl
Creatinine Clearance
Description

Creatinine Clearance

Type de données

float

Unités de mesure
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
Pregnancy test
Description

Pregnancy test

Is the subject of childbearing potential?
Description

Childbearing potential

Type de données

boolean

Alias
UMLS CUI [1]
C3831118
Pregnancy test result
Description

PREGNANCY TEST

Type de données

integer

Alias
UMLS CUI [1]
C0032976
Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
Description

Menstruation

Type de données

integer

Alias
UMLS CUI [1]
C0025344
Retour au début de la page

Similar models

Laboratory results

1 Formulaires
  1. StudyEvent: ODM
    1. Laboratory results
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Protein electrophoresis
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total Protein
Item
Total Protein in 24h urine
float
C0428541 (UMLS CUI [1])
Total Serum Protein
Item
Total Serum Protein
float
C0036836 (UMLS CUI [1])
Beta-globulin
Item
Beta-globulin
float
C0005157 (UMLS CUI [1])
Gamma-Globulin
Item
Gamma-Globulin measurement
float
C0860681 (UMLS CUI [1])
Beta and gamma globulin total
Item
Beta and gamma globulin total
float
C1717622 (UMLS CUI [1])
Item
Serum immunofixation
integer
C1271678 (UMLS CUI [1])
Serum immunofixation
Code List
Serum immunofixation
CL Item
positive (1)
CL Item
negative (2)
Comment
Item
Comment on serum immunofixation
text
C0947611 (UMLS CUI [1])
Item
Urine immunofixation
integer
C1271641 (UMLS CUI [1])
Urine immunofixation
Code List
Urine immunofixation
CL Item
positive (1)
CL Item
negative (2)
Comment
Item
Comment on urine immunofixation
text
C0947611 (UMLS CUI [1])
IgA
Item
IgA measurement
float
C0202083 (UMLS CUI [1])
IgD
Item
IgD measurement
float
C0577612 (UMLS CUI [1])
IgG
Item
IgG measurement
float
C0202087 (UMLS CUI [1])
IgM
Item
Immunoglobulin M measurement
float
C0202084 (UMLS CUI [1])
FLC kappa
Item
FLC kappa measurement
float
C3274397 (UMLS CUI [1])
Kappa
Item
Kappa
integer
C0439099 (UMLS CUI [1])
FLC lambda
Item
FLC lambda measurement
float
C3274399 (UMLS CUI [1])
Lambda
Item
Lambda
integer
C1706314 (UMLS CUI [1])
Kappa/lambda quotient
Item
Kappa/lambda quotient
integer
C1168398 (UMLS CUI [1])
Item Group
Hematology
Erythrocytes
Item
Erythrocytes
float
C0014772 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0518015 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
MCV
Item
Mean Corpuscular Volume
float
C1948043 (UMLS CUI [1])
MCH
Item
MCH
float
C0369183 (UMLS CUI [1])
MCHC
Item
Mean corpuscular hemoglobin concentration
float
C0474535 (UMLS CUI [1])
Leukocytes
Item
Leukocytes
float
C0023508 (UMLS CUI [1])
Leukocytes
Item
Leukocytes (total)
integer
C1271681 (UMLS CUI [1])
Platelets
Item
Platelet count
float
C0005821 (UMLS CUI [1])
Neutrophils percentage
Item
Neutrophils percentage
float
C2238207 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0948762 (UMLS CUI [1])
Eosinophils percentage
Item
Eosinophils percentage
float
C2228144 (UMLS CUI [1])
Basophils percentage
Item
Basophils percentage
float
C2237945 (UMLS CUI [1])
Monocytes percentage
Item
Monocytes percentage
float
C2237144 (UMLS CUI [1])
Lymphocytes percentage
Item
Lymphocytes percentage
float
C2200256 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1])
Item Group
Serum chemistry
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0002059 (UMLS CUI [1])
Bilirubin
Item
Bilirubin
float
C0005437 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
Gamma GT
Item
Gamma GT
float
C0202035 (UMLS CUI [1])
LDH
Item
Lactate Dehydrogenase (LDH) (U/l)
float
C0202113 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
CRP
Item
CRP
float
C0201657 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
Item Group
Pregnancy test
Childbearing potential
Item
Is the subject of childbearing potential?
boolean
C3831118 (UMLS CUI [1])
Item
Pregnancy test result
integer
C0032976 (UMLS CUI [1])
PREGNANCY TEST
Code List
Pregnancy test result
CL Item
positive (1)
CL Item
negative (2)
Item
Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
integer
C0025344 (UMLS CUI [1])
Menstruation
Code List
Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
CL Item
No menstruation (0)
CL Item
Yes (1)
CL Item
No (2)
Retour au début de la page 

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