ID
12824
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) Form Description: Second Randomization Form
Keywords
Versions (3)
- 11/9/15 11/9/15 -
- 12/28/15 12/28/15 -
- 2/11/16 2/11/16 -
Uploaded on
December 28, 2015
DOI
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License
Creative Commons BY-NC 3.0
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Second Randomization Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26
Second Randomization Form
- StudyEvent: ODM
Description
Eligibility (See Protocol Section 8)
Alias
- UMLS CUI-1
- C1516637
Description
Patient in CR(i)
Data type
integer
Alias
- UMLS CUI [1]
- C1704632
Description
Neutrophil count
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0027950
Description
Platelets
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0005821
Description
Creatinine Clearance
Data type
float
Measurement units
- mL/min
Alias
- UMLS CUI [1]
- C0373595
Description
Bilirubin
Data type
float
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Description
Bilirubin, Total ULN
Data type
float
Measurement units
- mg/dL
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519815
Description
AST
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
AST ULN
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519815
Description
ALT
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
ALT ULN
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1519815
Description
Severe cardiac dysfunction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3277906
Description
Severe pulmonary dysfunction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1709770
- UMLS CUI [1,3]
- C0205082
Description
Severe neurological or psychiatric disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0027765
Description
Active infections
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3714514
Description
Previous serious toxicities related to the use of lenalidomide
Data type
integer
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1144149
Description
CMV reactivation, which is not responsive to first line valganciclovir
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0010825
- UMLS CUI [1,2]
- C1142560
- UMLS CUI [1,3]
- C0909381
Description
Data from HOVON data center
Similar models
Second Randomization Form
- StudyEvent: ODM
C0808070 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C3277906 (UMLS CUI [1,2])
C1709770 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0027765 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,2])
C1144149 (UMLS CUI [1,2])
C1142560 (UMLS CUI [1,2])
C0909381 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1144149 (UMLS CUI-2)