ID
13496
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)
Keywords
Versions (7)
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- 11/5/15 11/5/15 -
- 11/5/15 11/5/15 -
- 11/6/15 11/6/15 -
- 11/6/15 11/6/15 -
- 12/29/15 12/29/15 -
- 2/11/16 2/11/16 -
Uploaded on
February 11, 2016
DOI
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License
Creative Commons BY-NC 3.0
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On Study Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26
On Study Form
- StudyEvent: ODM
Description
Diagnosis
Alias
- UMLS CUI-1
- C0011900
Description
WHO-AML classification
Data type
text
Alias
- UMLS CUI [1]
- C1301142
Description
FAB type (Appendix A.4)
Data type
text
Alias
- UMLS CUI [1]
- C2984084
Description
History Of Disease And Clincial Status
Alias
- UMLS CUI-1
- C0683519
- UMLS CUI-2
- C0449440
Description
MDS
Data type
integer
Alias
- UMLS CUI [1]
- C3463824
Description
MDS Date of Diagnosis
Data type
date
Alias
- UMLS CUI [1,1]
- C3463824
- UMLS CUI [1,2]
- C2316983
Description
MDS Subtype
Data type
integer
Alias
- UMLS CUI [1,1]
- C3463824
- UMLS CUI [1,2]
- C0449560
Description
Hematological disease
Data type
integer
Alias
- UMLS CUI [1]
- C0018939
Description
Hematological disease Date of diagnosis
Data type
date
Alias
- UMLS CUI [1,1]
- C0018939
- UMLS CUI [1,2]
- C2316983
Description
Hematological Disease Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0018939
- UMLS CUI [1,2]
- C2348235
Description
Oncological disease
Data type
integer
Alias
- UMLS CUI [1]
- C0027651
Description
Oncological disease Date of diagnosis
Data type
date
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C2316983
Description
Oncological disease Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C2348235
Description
Chemotherapy/Radiotherapy
Data type
boolean
Alias
- UMLS CUI [1]
- C3665472
- UMLS CUI [2]
- C1522449
Description
Chemotherapy/Radiotherapy Date or year start
Data type
date
Alias
- UMLS CUI [1,1]
- C3665472
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1522449
- UMLS CUI [2,2]
- C0808070
Description
Chemotherapy/Radiotherapy Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C3665472
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1522449
- UMLS CUI [2,2]
- C2348235
Description
Toxic agents
Data type
integer
Alias
- UMLS CUI [1]
- C0014412
Description
Toxic agents
Data type
date
Alias
- UMLS CUI [1,1]
- C0014412
- UMLS CUI [1,2]
- C0011008
Description
Toxic agents Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0014412
- UMLS CUI [1,2]
- C2348235
Description
Relatives AML
Data type
integer
Alias
- UMLS CUI [1,1]
- C0080103
- UMLS CUI [1,2]
- C0023467
Description
Family relation
Data type
text
Alias
- UMLS CUI [1,1]
- C0015608
- UMLS CUI [1,2]
- C0023467
Description
AML Subtype
Data type
text
Alias
- UMLS CUI [1,1]
- C2984084
- UMLS CUI [1,2]
- C0023467
Description
Relative Age at Diagnosis
Data type
text
Alias
- UMLS CUI [1]
- C1828181
Description
Extramedullary disease
Data type
integer
Alias
- UMLS CUI [1]
- C1868812
Description
Site
Data type
text
Alias
- UMLS CUI [1]
- C0807944
Description
Physical examination
Data type
integer
Alias
- UMLS CUI [1,1]
- C0393009
- UMLS CUI [1,2]
- C0031809
Description
Radiologic exam
Data type
integer
Alias
- UMLS CUI [1,1]
- C0393009
- UMLS CUI [1,2]
- C2985535
Description
Pathologically confirmed
Data type
integer
Alias
- UMLS CUI [1,1]
- C0393009
- UMLS CUI [1,2]
- C0019638
Description
LDH
Data type
float
Alias
- UMLS CUI [1]
- C0202113
Description
LDH ULN
Data type
float
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C1519815
Description
Bone Marrow Aspirate
Alias
- UMLS CUI-1
- C0857285
Description
BM aspirate
Data type
integer
Alias
- UMLS CUI [1]
- C0857285
Description
Evaluable
Data type
text
Alias
- UMLS CUI [1,1]
- C0857285
- UMLS CUI [1,2]
- C0220825
Description
BM sampling date
Data type
date
Alias
- UMLS CUI [1,1]
- C0005953
- UMLS CUI [1,2]
- C0011008
Description
Cellularity
Data type
integer
Alias
- UMLS CUI [1]
- C1516377
Description
Blasts
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C1982687
Description
Promyelocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455279
Description
Myelocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455284
Description
Metamyelocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0229635
Description
Neutrophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200633
Description
Monocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0942447
Description
Eosinophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0945354
Description
Basophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200641
Description
Erythroblasts
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0014762
Description
Lymphocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0942440
Description
Other*
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0205394
Description
*Specify
Data type
text
Alias
- UMLS CUI [1]
- C1521902
Description
Auer rods
Data type
integer
Alias
- UMLS CUI [1]
- C0333828
Description
Dyserythropoiesis
Data type
integer
Alias
- UMLS CUI [1]
- C0221143
Description
Dysmegakaryopoiesis
Data type
integer
Alias
- UMLS CUI [1]
- C3700221
Description
Dysgranulopoiesis
Data type
integer
Alias
- UMLS CUI [1]
- C0312832
Description
Bone Marrow Biopsy
Alias
- UMLS CUI-1
- C0005954
Description
BM biopsy done
Data type
integer
Alias
- UMLS CUI [1]
- C0005954
Description
Evaluable
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005954
- UMLS CUI [1,2]
- C0220825
Description
BM biopsy Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0005954
- UMLS CUI [1,2]
- C0011008
Description
Cellularity
Data type
text
Alias
- UMLS CUI [1]
- C1561532
Description
Clusters of blasts
Data type
boolean
Alias
- UMLS CUI [1]
- C0368761
Description
Blasts (i.e.leukemic blasts) estimated
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0368761
Description
Peripheral blood evaluation
Alias
- UMLS CUI-1
- C0229664
Description
Peripheral blood evaluation
Data type
integer
Alias
- UMLS CUI [1]
- C0229664
Description
Blood sampling date
Data type
date
Alias
- UMLS CUI [1,1]
- C0229664
- UMLS CUI [1,2]
- C0011008
Description
Hemoglobin
Data type
float
Measurement units
- mmol/l
Alias
- UMLS CUI [1]
- C0019046
Description
Platelets
Data type
float
Measurement units
- x10^9/l
Alias
- UMLS CUI [1]
- C0005821
Description
WBC
Data type
float
Measurement units
- x10^9/l
Alias
- UMLS CUI [1]
- C0023508
Description
Blasts
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0523113
Description
Promyelocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455279
Description
Myelocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455284
Description
Metamyelocytes
Data type
float
Alias
- UMLS CUI [1]
- C0229635
Description
Neutrophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200633
Description
Basophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200641
Description
Lymphocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0942440
Description
Monocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0942447
Description
Other*
Data type
float
Measurement units
- %
Description
*Specify
Data type
text
Alias
- UMLS CUI [1]
- C1521902
Description
Erythroblasts
Data type
float
Alias
- UMLS CUI [1]
- C0014762
Description
Auer rods
Data type
integer
Alias
- UMLS CUI [1]
- C0333828
Description
Did patient start protocol treatment
Data type
boolean
Alias
- UMLS CUI [1]
- C0087111
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
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On Study Form
- StudyEvent: ODM
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C2348235 (UMLS CUI [1,2])
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