ID

13924

Beschrijving

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

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Versies (1)
  1. 17-03-16 17-03-16 -
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17 maart 2016

DOI

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Creative Commons BY-NC 3.0
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Third Consolidation Cycle 2.week LenaMain-Study

Engels

Third Consolidation Cycle

1 Formulieren  
2. Weekly control visit (large)
Beschrijving

2. Weekly control visit (large)

Date of visit
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Prior trial substance dosage
Beschrijving

Trial substance dosage

Datatype

integer

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0178602
New trial substance dosage
Beschrijving

Trial substance dosage

Datatype

integer

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0178602
Please specify reason for dose reduction
Beschrijving

Dosage reduction

Datatype

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0547047
Did any Adverse Events occur?
Beschrijving

Adverse Events

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Laboratory:Hematology
Beschrijving

Laboratory:Hematology

Erythrocytes
Beschrijving

Erythrocytes

Datatype

float

Maateenheden
  • Mio/μl
Alias
UMLS CUI [1]
C0014772
Mio/μl
Hemoglobin
Beschrijving

Hemoglobin

Datatype

float

Maateenheden
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Hematocrit
Beschrijving

Hematocrit

Datatype

float

Maateenheden
  • %
Alias
UMLS CUI [1]
C0518014
%
Mean Corpuscular Volume
Beschrijving

MCV

Datatype

float

Maateenheden
  • fl
Alias
UMLS CUI [1]
C1948043
fl
MCH
Beschrijving

MCH

Datatype

float

Maateenheden
  • pg
Alias
UMLS CUI [1]
C0369183
pg
Mean corpuscular hemoglobin concentration
Beschrijving

MCHC

Datatype

float

Maateenheden
  • g Hb/dL Ery
Alias
UMLS CUI [1]
C0474535
g Hb/dL Ery
Leukocytes
Beschrijving

Leukocytes

Datatype

float

Maateenheden
  • 1000/μl
Alias
UMLS CUI [1]
C0023508
1000/μl
Leukocytes (total)
Beschrijving

Leukocytes

Datatype

integer

Alias
UMLS CUI [1]
C1271681
Platelet count
Beschrijving

Platelets

Datatype

float

Maateenheden
  • 1000/uL
Alias
UMLS CUI [1]
C0005821
1000/uL
Neutrophils percentage
Beschrijving

Neutrophils percentage

Datatype

float

Maateenheden
  • %
Alias
UMLS CUI [1]
C2238207
%
Neutrophils
Beschrijving

Neutrophils

Datatype

float

Maateenheden
  • abs.
Alias
UMLS CUI [1]
C0948762
abs.
Eosinophils percentage
Beschrijving

Eosinophils percentage

Datatype

float

Maateenheden
  • %
Alias
UMLS CUI [1]
C2228144
%
Basophils percentage
Beschrijving

Basophils percentage

Datatype

float

Maateenheden
  • %
Alias
UMLS CUI [1]
C2237945
%
Monocytes percentage
Beschrijving

Monocytes percentage

Datatype

float

Maateenheden
  • %
Alias
UMLS CUI [1]
C2237144
%
Lymphocytes percentage
Beschrijving

Lymphocytes percentage

Datatype

float

Maateenheden
  • %
Alias
UMLS CUI [1]
C2200256
%
Neutrophils
Beschrijving

Neutrophils

Datatype

float

Maateenheden
  • 1000/μl
Alias
UMLS CUI [1]
C0200633
1000/μl
Laboratory:serum chemistry
Beschrijving

Laboratory:serum chemistry

Sodium
Beschrijving

Sodium

Datatype

float

Maateenheden
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Potassium
Beschrijving

Potassium

Datatype

float

Maateenheden
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Calcium
Beschrijving

Calcium

Datatype

float

Maateenheden
  • mmol/l
Alias
UMLS CUI [1]
C0201925
mmol/l
Glucose
Beschrijving

Glucose

Datatype

float

Maateenheden
  • mg/dl
Alias
UMLS CUI [1]
C0202042
mg/dl
Alkaline Phosphatase
Beschrijving

Alkaline Phosphatase

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Bilirubin
Beschrijving

Bilirubin

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
AST (SGOT)
Beschrijving

AST

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
ALT
Beschrijving

ALT

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
Gamma GT
Beschrijving

Gamma GT

Datatype

float

Maateenheden
  • U/l
Alias
UMLS CUI [1]
C0202035
U/l
Lactate Dehydrogenase (LDH)
Beschrijving

LDH

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0202113
U/L
Urea
Beschrijving

Urea

Datatype

float

Maateenheden
  • mg/dl
Alias
UMLS CUI [1]
C0523961
mg/dl
CRP
Beschrijving

CRP

Datatype

float

Maateenheden
  • md/dl
Alias
UMLS CUI [1]
C0201657
md/dl
Serum creatinine
Beschrijving

Creatinine, Serum

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Creatinine Clearance
Beschrijving

Creatinine Clearance

Datatype

float

Maateenheden
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
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Similar models

Third Consolidation Cycle

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
2. Weekly control visit (large)
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Item
Prior trial substance dosage
integer
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Trial substance dosage
Code List
Prior trial substance dosage
CL Item
25 mg (1)
CL Item
15 mg (2)
CL Item
10 mg (3)
CL Item
5 mg (4)
CL Item
20 mg (5)
Item
New trial substance dosage
integer
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Trial substance dosage
Code List
New trial substance dosage
CL Item
25 mg (1)
CL Item
15 mg (2)
CL Item
10 mg (3)
CL Item
5 mg (4)
CL Item
20 mg (5)
Dosage reduction
Item
Please specify reason for dose reduction
text
C0178602 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Adverse Events
Item
Did any Adverse Events occur?
boolean
C0877248 (UMLS CUI [1])
Item Group
Laboratory:Hematology
Erythrocytes
Item
Erythrocytes
float
C0014772 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (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
Laboratory: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
C0201850 (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)
float
C0202113 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
CRP
Item
CRP
float
C0201657 (UMLS CUI [1])
Creatinine, Serum
Item
Serum creatinine
float
C0201976 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
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