ID

12320

Description

Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score> 4.5) Description of Form: End of Protocol Form

Keywords

  1. 11/9/15 11/9/15 -
  2. 12/28/15 12/28/15 -
  3. 2/11/16 2/11/16 -
Uploaded on

November 9, 2015

DOI

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License

Creative Commons BY-NC 3.0

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End of Protocol Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

End of Protocol Form

  1. StudyEvent: ODM
    1. End of Protocol Form
Default Itemgroup
Description

Default Itemgroup

Date when taken off protocol
Description

Off Protocol Date

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C2985813
dd/mm/yyyy
Reason for going off protocol
Description

Off protocol reason

Data type

integer

Alias
UMLS CUI [1]
C2985814
*Specify
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Comments
Description

Comments

Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611

Similar models

End of Protocol Form

  1. StudyEvent: ODM
    1. End of Protocol Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Off Protocol Date
Item
Date when taken off protocol
date
C2985813 (UMLS CUI [1])
Item
Reason for going off protocol
integer
C2985814 (UMLS CUI [1])
Code List
Reason for going off protocol
CL Item
no CR(i) after cycle II (1)
C3844738 (UMLS CUI-1)
CL Item
excessive drug toxicity* (2)
C0013221 (UMLS CUI-1)
CL Item
hypoplastic bone marrow abnormalities (3)
C1855710 (UMLS CUI-1)
CL Item
death (4)
C1306577 (UMLS CUI-1)
CL Item
relapse after initial CR (5)
C0035020 (UMLS CUI-1)
CL Item
no compliance of the patient / refusal of treatment (6)
C0040809 (UMLS CUI-1)
CL Item
patient not eligible for 2nd randomization* (7)
C2919401 (UMLS CUI-1)
CL Item
pregnancy (8)
C0032961 (UMLS CUI-1)
CL Item
other* (88)
C0205394 (UMLS CUI-1)
Specify
Item
*Specify
text
C1521902 (UMLS CUI [1])
Item Group
Comments
Item
text
C0947611 (UMLS CUI [1])

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