ID

13943

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

Keywords

Versions (1)
  1. 3/17/16 3/17/16 -
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March 17, 2016

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License

Creative Commons BY-NC 3.0
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Second Follow-up LenaMain-Study

English

Second Follow-Up

1 forms  
  1. StudyEvent: ODM
    1. Second Follow-Up
Follow-Up
Description

Follow-Up

Date of visit
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Patient Vital Status
Description

Patient Status

Data type

text

Alias
UMLS CUI [1]
C3846084
Myeloma: lines of treatment
Description

Myeloma: lines of treatment

Data type

text

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0040808
Secondary disease occurred?
Description

Secondary disease

Data type

boolean

Alias
UMLS CUI [1]
C0277555
Secondary disease: please specify
Description

Secondary disease

Data type

text

Alias
UMLS CUI [1]
C0277555
Has a progressive disease been diagnosed?
Description

Did the patient suffer progress during the study,prior to this visit?

Data type

boolean

Alias
UMLS CUI [1]
C1335499
Response
Description

Response

Data type

integer

Alias
UMLS CUI [1]
C0521982
Survival Status
Description

Survival Status

Survival Status
Description

Survival Status

Data type

integer

Alias
UMLS CUI [1]
C1148433
Date of death
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Death certificate available?
Description

Death certificate

Data type

boolean

Alias
UMLS CUI [1]
C0011066
Autopsy performed?
Description

Autopsy

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Cause of death
Description

Cause of death

Data type

integer

Alias
UMLS CUI [1]
C0007465
Other cause of death:please specify
Description

Cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
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Similar models

Second Follow-Up

1 forms
  1. StudyEvent: ODM
    1. Second Follow-Up
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Follow-Up
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Patient Vital Status
text
C3846084 (UMLS CUI [1])
Patient Status
Code List
Patient Vital Status
CL Item
Alive (0)
CL Item
Dead (1)
Myeloma: lines of treatment
Item
Myeloma: lines of treatment
text
C0026764 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
Secondary disease
Item
Secondary disease occurred?
boolean
C0277555 (UMLS CUI [1])
Secondary disease
Item
Secondary disease: please specify
text
C0277555 (UMLS CUI [1])
Progressive disease
Item
Has a progressive disease been diagnosed?
boolean
C1335499 (UMLS CUI [1])
Item
Response
integer
C0521982 (UMLS CUI [1])
Response
Code List
Response
CL Item
sCR (0)
CL Item
CR (1)
CL Item
vgPR (2)
CL Item
PR (3)
CL Item
SD (5)
CL Item
PD (6)
Item Group
Survival Status
Item
Survival Status
integer
C1148433 (UMLS CUI [1])
Survival Status
Code List
Survival Status
CL Item
alive (0)
CL Item
dead (1)
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Death certificate
Item
Death certificate available?
boolean
C0011066 (UMLS CUI [1])
Autopsy
Item
Autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Item
Cause of death
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
Cause of death
CL Item
malignant disease (1)
CL Item
side effect (2)
CL Item
infection (3)
CL Item
second neoplasm (4)
CL Item
cardiovascular disease (5)
CL Item
other chronic comorbidity (6)
CL Item
other comorbidity (7)
CL Item
unknown (8)
CL Item
progressive disease (9)
Cause of death
Item
Other cause of death:please specify
text
C0007465 (UMLS CUI [1])
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