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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
Versions (3)
- 11/9/15 11/9/15 -
- 12/28/15 12/28/15 -
- 2/11/16 2/11/16 -
Uploaded on
November 9, 2015
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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
Similar models
End of Protocol Form
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Off Protocol Date
Item
Date when taken off protocol
date
C2985813 (UMLS CUI [1])
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])
Comments
Item
text
C0947611 (UMLS CUI [1])