ID

13482

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: Hematological Evaluation Form

Keywords

Versions (3)
  1. 11/10/15 11/10/15 -
  2. 12/23/15 12/23/15 -
  3. 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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Hematological Evaluation Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

English

Hematological Evaluation Form

1 forms  
Form Relation
Description

Form Relation

Form related to
Description

Form related to

Data type

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348792
Supportive Care
Description

Supportive Care

Alias
UMLS CUI-1
C0344211
Number of platelet transfusions
Description

Number of platelet transfusions

Data type

float

Alias
UMLS CUI [1,1]
C0086818
UMLS CUI [1,2]
C0750480
Date last platelet transfusion
Description

Date last platelet transfusion

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0086818
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Number of RBC transfusions
Description

Red Blood Cell Transfusion

Data type

float

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0750480
Date of last RBC transfusion
Description

Date of last RBC transfusion

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Hematological Evaluations
Description

Hematological Evaluations

Alias
UMLS CUI-1
C0018941
UMLS CUI-2
C0220825
Hematological Evaluation at
Description

Evaluation to be performed at

Data type

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348792
Date
Description

Date

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0011008
dd/mm/yyyy
Blasts
Description

Blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C1982687
%
ANC
Description

Neutrophil count

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0948762
10^9/L
Platelets
Description

Platelets

Data type

float

Measurement units
  • 10^9/l
Alias
UMLS CUI [1]
C0005821
10^9/l
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Similar models

Hematological Evaluation Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item
Form related to
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Form related to
Code List
Form related to
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)
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)
Item Group
C0344211 (UMLS CUI-1)
Number of platelet transfusions
Item
Number of platelet transfusions
float
C0086818 (UMLS CUI [1,1])
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])
Red Blood Cell Transfusion
Item
Number of RBC transfusions
float
C0086252 (UMLS CUI [1,1])
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])
Item Group
Hematological Evaluations
C0018941 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Item
Hematological Evaluation at
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Evaluation to be performed at
Code List
Hematological Evaluation at
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])
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