ID
12824
Beschrijving
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
Trefwoorden
Versies (3)
- 09-11-15 09-11-15 -
- 28-12-15 28-12-15 -
- 11-02-16 11-02-16 -
Geüploaded op
28 december 2015
DOI
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Licentie
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
Beschrijving
Eligibility (See Protocol Section 8)
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Patient in CR(i)
Datatype
integer
Alias
- UMLS CUI [1]
- C1704632
Beschrijving
Neutrophil count
Datatype
float
Maateenheden
- 10^9/L
Alias
- UMLS CUI [1]
- C0027950
Beschrijving
Platelets
Datatype
float
Maateenheden
- 10^9/L
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
Creatinine Clearance
Datatype
float
Maateenheden
- mL/min
Alias
- UMLS CUI [1]
- C0373595
Beschrijving
Bilirubin
Datatype
float
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Bilirubin, Total ULN
Datatype
float
Maateenheden
- mg/dL
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519815
Beschrijving
AST
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
AST ULN
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519815
Beschrijving
ALT
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
ALT ULN
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1519815
Beschrijving
Severe cardiac dysfunction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3277906
Beschrijving
Severe pulmonary dysfunction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C1709770
- UMLS CUI [1,3]
- C0205082
Beschrijving
Severe neurological or psychiatric disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0027765
Beschrijving
Active infections
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C3714514
Beschrijving
Previous serious toxicities related to the use of lenalidomide
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1144149
Beschrijving
CMV reactivation, which is not responsive to first line valganciclovir
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0010825
- UMLS CUI [1,2]
- C1142560
- UMLS CUI [1,3]
- C0909381
Beschrijving
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)