Information:
Fel:
ID
13482
Beskrivning
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: Hematological Evaluation Form
Nyckelord
Versioner (3)
- 2015-11-10 2015-11-10 -
- 2015-12-23 2015-12-23 -
- 2016-02-11 2016-02-11 -
Uppladdad den
11 februari 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Hematological Evaluation Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26
Hematological Evaluation Form
- StudyEvent: ODM
Similar models
Hematological Evaluation Form
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
CL Item
induction cycle I (1)
C3179010 (UMLS CUI-1)
CL Item
induction cycle II (2)
C3179010 (UMLS CUI-1)
CL Item
post induction cycle III (3)
C0687676 (UMLS CUI-1)
C3179010 (UMLS CUI-2)
C3179010 (UMLS CUI-2)
CL Item
autoHSCT (4)
C0194037 (UMLS CUI-1)
CL Item
alloHSCT (5)
C1705576 (UMLS CUI-1)
CL Item
observation/maintenance (1-6) (11-16)
C0481504 (UMLS CUI-1)
C0700325 (UMLS CUI-3)
C0700325 (UMLS CUI-3)
Number of platelet transfusions
Item
Number of platelet transfusions
float
C0086818 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
Date last platelet transfusion
Item
Date last platelet transfusion
date
C0086818 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Red Blood Cell Transfusion
Item
Number of RBC transfusions
float
C0086252 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
Date of last RBC transfusion
Item
Date of last RBC transfusion
date
C0086252 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Hematological Evaluations
C0018941 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
Item
Hematological Evaluation at
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
CL Item
Start of treatment (1)
CL Item
First evaluation ANC < 0.5 x 109/L (2)
C1882078 (UMLS CUI-1)
CL Item
First evaluation ANC ≥ 0,5 x 109/L (3)
C1882078 (UMLS CUI-1)
CL Item
First evaluation ANC ≥ 1,0 x 109/L (4)
C1882078 (UMLS CUI-1)
CL Item
If not ≥ 1,0 x 109/L, last ANC before next treatment (5)
CL Item
If not ≥ 1,0 x 109/L, last ANC before end of protocol (6)
CL Item
First evaluation platelets < 50 x 109/L (7)
C1882407 (UMLS CUI-1)
CL Item
First evaluation platelets ≥ 50 x 109/L (8)
C1882407 (UMLS CUI-1)
CL Item
First evaluation platelets ≥ 100 x 109/L (9)
C1882407 (UMLS CUI-1)
CL Item
If not ≥ 100 x 109/L, last platelets before next treatment (10)
CL Item
If not ≥ 100 x 109/L, last platelets before end of protocol (11)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Blasts
Item
Blasts
float
C1982687 (UMLS CUI [1])
Neutrophil count
Item
ANC
float
C0948762 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])