ID

13952

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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Creative Commons BY-NC 3.0
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Adverse events LenaMain-Study

English

Adverse Events CTC

1 forms  
  1. StudyEvent: ODM
    1. Adverse Events CTC
Adverse Events
Description

Adverse Events

Consecutive number of adverse event
Description

Number

Data type

integer

Alias
UMLS CUI [1,1]
C0750480
UMLS CUI [1,2]
C0877248
CTC classification?
Description

CTC classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0008902
Version CTC
Description

Version CTC

Data type

integer

Alias
UMLS CUI [1,1]
C0808391
UMLS CUI [1,2]
C1516728
CTCAE category
Description

CTCAE category

Data type

text

Alias
UMLS CUI [1]
C1879645
Category ID
Description

Category ID

Data type

integer

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0600091
Adverse event CTC term (superordinate)
Description

Adverse event CTC term

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1705313
Adverse event CTC subordinate term
Description

Adverse event CTC subordinate term

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2983704
UMLS CUI [1,3]
C1705313
Meddra Low Level Term
Description

Meddra Low Level Term

Data type

text

Alias
UMLS CUI [1]
C2347090
MedDRA Low Level Term Code
Description

MedDRA Low Level Term Code

Data type

text

Alias
UMLS CUI [1]
C3898442
MedDRA Low Level Term ID
Description

MedDRA Low Level Term ID

Data type

integer

Alias
UMLS CUI [1,1]
C2347090
UMLS CUI [1,2]
C0600091
Common Toxicity Criteria Adverse Event Grade
Description

CTC Adverse Event Grade

Data type

integer

Alias
UMLS CUI [1]
C2985911
Please describe the AE
Description

one AE per consecutive number

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse event severity
Description

Adverse event severity

Data type

text

Alias
UMLS CUI [1]
C1710066
Adverse Event Start Date
Description

Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1]
C2697888
Adverse event start time
Description

Adverse event start time

Data type

time

Alias
UMLS CUI [1]
C2697889
Adverse Event End Date
Description

Adverse Event End Date

Data type

date

Alias
UMLS CUI [1]
C2697886
Adverse event end time
Description

Adverse event end time

Data type

time

Alias
UMLS CUI [1]
C2826658
Adverse event ongoing?
Description

Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826663
Was the AE serious?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Causality with trial substance
Description

Causality

Data type

text

Alias
UMLS CUI [1]
C1547657
Actions taken with study medication
Description

Actions taken with study medication

Data type

integer

Alias
UMLS CUI [1]
C1704758
Adverse Event Outcome
Description

Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Adverse event treatment
Description

Adverse Event Treatment

Data type

text

Alias
UMLS CUI [1]
C2981656
Please specify treatment given for this adverse event
Description

Adverse event treatment

Data type

text

Alias
UMLS CUI [1]
C2981656
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Similar models

Adverse Events CTC

1 forms
  1. StudyEvent: ODM
    1. Adverse Events CTC
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Events
Number
Item
Consecutive number of adverse event
integer
C0750480 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
CTC classification
Item
CTC classification?
boolean
C1516728 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Version CTC
Item
Version CTC
integer
C0808391 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
CTCAE category
Item
CTCAE category
text
C1879645 (UMLS CUI [1])
Category ID
Item
Category ID
integer
C0683312 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Adverse event CTC term
Item
Adverse event CTC term (superordinate)
text
C0877248 (UMLS CUI [1,1])
C1705313 (UMLS CUI [1,2])
Adverse event CTC subordinate term
Item
Adverse event CTC subordinate term
text
C0877248 (UMLS CUI [1,1])
C2983704 (UMLS CUI [1,2])
C1705313 (UMLS CUI [1,3])
Meddra Low Level Term
Item
Meddra Low Level Term
text
C2347090 (UMLS CUI [1])
MedDRA Low Level Term Code
Item
MedDRA Low Level Term Code
text
C3898442 (UMLS CUI [1])
MedDRA Low Level Term ID
Item
MedDRA Low Level Term ID
integer
C2347090 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
CTC Adverse Event Grade
Item
Common Toxicity Criteria Adverse Event Grade
integer
C2985911 (UMLS CUI [1])
Adverse Event
Item
Please describe the AE
text
C0877248 (UMLS CUI [1])
Item
Adverse event severity
text
C1710066 (UMLS CUI [1])
Adverse event severity
Code List
Adverse event severity
CL Item
minor (1)
CL Item
moderate (2)
CL Item
severe (3)
Adverse Event Start Date
Item
Adverse Event Start Date
date
C2697888 (UMLS CUI [1])
Adverse event start time
Item
Adverse event start time
time
C2697889 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
Adverse event end time
Item
Adverse event end time
time
C2826658 (UMLS CUI [1])
Ongoing
Item
Adverse event ongoing?
boolean
C2826663 (UMLS CUI [1])
Serious Adverse Event
Item
Was the AE serious?
boolean
C1519255 (UMLS CUI [1])
Item
Causality with trial substance
text
C1547657 (UMLS CUI [1])
Causality
Code List
Causality with trial substance
CL Item
confirmed (1)
CL Item
probable (2)
CL Item
possible (3)
CL Item
unlikely (4)
CL Item
no causality (5)
CL Item
cannot be assessed (6)
Item
Actions taken with study medication
integer
C1704758 (UMLS CUI [1])
Actions taken with study medication
Code List
Actions taken with study medication
CL Item
dose increased (1)
CL Item
dose unchanged (2)
CL Item
dose decreased (3)
CL Item
medication paused (4)
CL Item
medication discontinued (5)
CL Item
not applicable (6)
CL Item
unknown (7)
Item
Adverse Event Outcome
integer
C1705586 (UMLS CUI [1])
AdverseEventOutcome
Code List
Adverse Event Outcome
CL Item
Recovered (1)
CL Item
Subsiding (2)
CL Item
Alive With Sequelae (3)
CL Item
Ongoing (4)
CL Item
Death (5)
CL Item
Unknown (6)
Item
Adverse event treatment
text
C2981656 (UMLS CUI [1])
Adverse Event Treatment
Code List
Adverse event treatment
CL Item
none (0)
CL Item
with medication (1)
CL Item
transfusion (2)
CL Item
hospitalized (3)
CL Item
other(please specify) (4)
Adverse event treatment
Item
Please specify treatment given for this adverse event
text
C2981656 (UMLS CUI [1])
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