ID

13949

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 (2)
  1. 3/17/16 3/17/16 -
  2. 3/17/16 3/17/16 -
Uploaded on

March 17, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Concomitant medication LenaMain-Study

English

Concomitant Medication

1 forms  
  1. StudyEvent: ODM
    1. Concomitant Medication
Concomitant medication
Description

Concomitant medication

Consecutive number
Description

Number

Data type

integer

Alias
UMLS CUI [1]
C0750480
Concomitant medication use indication
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
Concomitant agent name or generic substance
Description

Concomitant Agent

Data type

text

Alias
UMLS CUI [1]
C2347852
Please specify medication dose per day or Therapy
Description

Concomitant Agent

Data type

text

Alias
UMLS CUI [1]
C2347852
Frequency of intake
Description

Concomitant agent

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439603
Application route
Description

Application route

Data type

integer

Alias
UMLS CUI [1]
C0013153
Concomitant Medication Start Date
Description

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Concomitant medication end date
Description

Concomitant medication end date

Data type

date

Alias
UMLS CUI [1]
C2826744
Has concomitant medication been subject to change?
Description

Concomitant agent

Data type

integer

Alias
UMLS CUI [1]
C2347852
Please specify reason for changes of concomitant medication
Description

Concomitant Agent

Data type

text

Alias
UMLS CUI [1]
C2347852
Concomitant Medication ongoing after end of trial
Description

Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant Medication

1 forms
  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant medication
Number
Item
Consecutive number
integer
C0750480 (UMLS CUI [1])
Indication
Item
Concomitant medication use indication
text
C2826696 (UMLS CUI [1])
Concomitant Agent
Item
Concomitant agent name or generic substance
text
C2347852 (UMLS CUI [1])
Concomitant Agent
Item
Please specify medication dose per day or Therapy
text
C2347852 (UMLS CUI [1])
Concomitant agent
Item
Frequency of intake
text
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Item
Application route
integer
C0013153 (UMLS CUI [1])
Application route
Code List
Application route
CL Item
1 oral (1)
CL Item
nasal (2)
CL Item
iv (3)
CL Item
sc (4)
CL Item
transdermally (5)
CL Item
rectal (6)
CL Item
inhalatively (7)
Concomitant Medication Start Date
Item
Concomitant Medication Start Date
date
C2826734 (UMLS CUI [1])
Concomitant medication end date
Item
Concomitant medication end date
date
C2826744 (UMLS CUI [1])
Item
Has concomitant medication been subject to change?
integer
C2347852 (UMLS CUI [1])
Concomitant agent
Code List
Has concomitant medication been subject to change?
CL Item
No change in medication dose (1)
CL Item
Dose reduction (2)
CL Item
Dose increased (3)
Concomitant Agent
Item
Please specify reason for changes of concomitant medication
text
C2347852 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Concomitant Medication ongoing after end of trial
boolean
C2826666 (UMLS CUI [1])
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