ID

12303

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)
  1. 11/2/15 11/2/15 -
  2. 11/5/15 11/5/15 -
  3. 11/5/15 11/5/15 -
  4. 11/6/15 11/6/15 -
  5. 11/6/15 11/6/15 -
  6. 12/29/15 12/29/15 -
  7. 2/11/16 2/11/16 -
Uploaded on

November 5, 2015

DOI

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License

Creative Commons BY-NC 3.0
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HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

English

On Study Form

1 forms  
  1. StudyEvent: ODM
    1. On Study Form
Default Itemgroup
Description

Default Itemgroup

Height
Description

Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Diagnosis
Description

Diagnosis

Alias
UMLS CUI-1
C0011900
WHO-AML classification (Appendix A.1, A.2. and A.3)
Description

WHO-AML classification (Appendix A.1, A.2. and A.3)

Data type

text

Alias
UMLS CUI [1,1]
C0043237
UMLS CUI [1,2]
C0023467
UMLS CUI [1,3]
C0008902
FAB type (Appendix A.4)
Description

FAB type (Appendix A.4)

Data type

text

Alias
UMLS CUI [1]
C0457321
History Of Disease And Clincial Status
Description

History Of Disease And Clincial Status

Alias
UMLS CUI-1
C0683519
UMLS CUI-3
C0449440
Prior MDS
Description

MDS

Data type

integer

Alias
UMLS CUI [1]
C0026986
MDS Date of Diagnosis
Description

MDS Date of Diagnosis

Data type

date

Alias
UMLS CUI [1,1]
C0026986
UMLS CUI [1,2]
C2316983
MDS Subtype
Description

MDS Subtype

Data type

integer

Alias
UMLS CUI [1,1]
C0026986
UMLS CUI [1,2]
C0449560
Other hematological disease(> 3 months duration prior to diagnosis disease under study).
Description

Hematological disease

Data type

integer

Alias
UMLS CUI [1]
C0018939
Hematological disease Date of diagnosis
Description

Hematological disease Date of diagnosis

Data type

date

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C2316983
Hematological Disease Specification
Description

Hematological Disease Specification

Data type

text

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C2348235
Other oncological disease
Description

Oncological disease

Data type

integer

Alias
UMLS CUI [1]
C0027651
Oncological disease Date of diagnosis
Description

Oncological disease Date of diagnosis

Data type

date

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2316983
Oncological disease Specification
Description

Oncological disease Specification

Data type

text

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2348235
Chemotherapy/Radiotherapy
Description

Chemotherapy/Radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C1522449
Chemotherapy/Radiotherapy Date or year start
Description

Chemotherapy/Radiotherapy Date or year start

Data type

date

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0011008
Chemotherapy/Radiotherapy Specification
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
Exposure to toxic agents (e.g. insecticide)
Description

Toxic agents

Data type

integer

Alias
UMLS CUI [1]
C0522757
Exposure to Toxic agents since year
Description

Toxic agents

Data type

date

Alias
UMLS CUI [1,1]
C0522757
UMLS CUI [1,2]
C0011008
Toxic agents Specification
Description

Toxic agents Specification

Data type

text

Alias
UMLS CUI [1,1]
C0522757
UMLS CUI [1,2]
C2348235
Existence of one (or more) relatives having previously suffered from AML
Description

Relatives AML

Data type

integer

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C0023467
*Specify family relation
Description

Family relation

Data type

text

Alias
UMLS CUI [1,1]
C0015608
UMLS CUI [1,2]
C0023467
*specify diagnosis
Description

AML Subtype

Data type

text

Alias
UMLS CUI [1,1]
C0449560
UMLS CUI [1,2]
C0023467
*specify age of relative at diagnosis
Description

Relative Age at Diagnosis

Data type

text

Alias
UMLS CUI [1]
C1828181
Extramedullary disease
Description

Extramedullary disease

Data type

integer

Alias
UMLS CUI [1]
C1868812
*Specify site
Description

Specify site

Data type

text

Level of evidence - Physical examination
Description

Physical examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Level of evidence - Radiologically confirmed
Description

Radiologic exam

Data type

integer

Alias
UMLS CUI [1]
C2985535
Level of evidence - Pathologically confirmed
Description

Pathologically confirmed

Data type

integer

Alias
UMLS CUI [1]
C0019638
Lactate dehydrogenase (LDH) (U/L)
Description

LDH

Data type

float

Alias
UMLS CUI [1]
C0202113
Lactate dehydrogenase ULN
Description

LDH ULN

Data type

float

Alias
UMLS CUI [1,1]
C0202113
UMLS CUI [1,2]
C1519815
Bone Marrow Aspirate
Description

Bone Marrow Aspirate

Alias
UMLS CUI-1
C0857285
BM aspirate done
Description

BM aspirate done

Data type

integer

Alias
UMLS CUI [1]
C0857285
Evaluable
Description

Evaluable

Data type

text

Alias
UMLS CUI [1]
M
BM sampling date
Description

BM sampling date

Data type

date

Alias
UMLS CUI [1,1]
C0857285
UMLS CUI [1,2]
C0011008
Cellularity
Description

Cellularity

Data type

integer

Alias
UMLS CUI [1]
C1516377
Blasts
Description

Blasts

Data type

float

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

Promyelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455279
%
Myelocytes
Description

Myelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0369715
%
Metamyelocytes
Description

Metamyelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0229635
%
Neutrophils (segments & bands)
Description

Neutrophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C2238207
%
Monocytes
Description

Monocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Description

Eosinophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0362902
%
Basophils
Description

Basophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200641
%
Erythroblasts
Description

Erythroblasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0014762
%
Lymphocytes
Description

Lymphocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0024264
%
Other*
Description

Other*

Data type

float

Measurement units
  • %
%
*Specify
Description

*Specify

Data type

text

Auer rods
Description

Auer rods

Data type

integer

Alias
UMLS CUI [1]
C0333828
Dyserythropoiesis
Description

Dyserythropoiesis

Data type

integer

Alias
UMLS CUI [1]
C0221143
Dysmegakaryopoiesis
Description

Dysmegakaryopoiesis

Data type

integer

Alias
UMLS CUI [1]
C3700221
Dysgranulopoiesis
Description

Dysgranulopoiesis

Data type

integer

Alias
UMLS CUI [1]
C0312832
Bone Marrow Biopsy
Description

Bone Marrow Biopsy

Alias
UMLS CUI-1
C0005954
BM biopsy done
Description

BM biopsy done

Data type

integer

Alias
UMLS CUI [1]
C0005954
Bone marrow biopsy evaluable
Description

Bone marrow biopsy evaluable

Data type

integer

Alias
UMLS CUI [1]
M
Date of BM biopsy
Description

Date of BM biopsy

Data type

date

Alias
UMLS CUI [1,1]
C0005954
UMLS CUI [1,2]
C0011008
Cellularity
Description

Cellularity

Data type

text

Alias
UMLS CUI [1]
C1561532
Clusters of blasts present
Description

Clusters of blasts present

Data type

boolean

Alias
UMLS CUI [1]
C0368761
Blasts (i.e.leukemic blasts) estimated
Description

Blasts (i.e.leukemic blasts) estimated

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0587348
%
Peripheral blood evaluation
Description

Peripheral blood evaluation

Alias
UMLS CUI-1
C0229664
Peripheral blood evaluation
Description

Peripheral blood evaluation

Data type

integer

Alias
UMLS CUI [1]
C0229664
Blood sampling date
Description

Blood sampling date

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Hemoglobin
Description

Hemoglobin

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0019046
mmol/l
Platelets
Description

Platelets

Data type

float

Measurement units
  • x10^9/l
Alias
UMLS CUI [1]
C0005821
x10^9/l
WBC
Description

WBC

Data type

float

Measurement units
  • x10^9/l
Alias
UMLS CUI [1]
C0023508
x10^9/l
Blasts
Description

Blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0368761
%
Promyelocytes
Description

Promyelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455279
%
Myelocytes
Description

Myelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0369715
%
Metamyelocytes
Description

Metamyelocytes

Data type

float

Alias
UMLS CUI [1]
C0229635
Neutrophils
Description

Neutrophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C2238207
%
Basophils
Description

Basophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200641
%
Lymphocytes
Description

Lymphocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Description

Monocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0026473
%
Other*
Description

Other*

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
M
%
*Specify
Description

*Specify

Data type

text

Erythroblasts
Description

Erythroblasts

Data type

float

Alias
UMLS CUI [1]
C0014762
Auer rods
Description

Auer rods

Data type

integer

Alias
UMLS CUI [1]
C0333828
Did patient start protocol treatment
Description

Did patient start protocol treatment

Data type

boolean

Alias
UMLS CUI [1]
C0040808
Comments
Description

Comments

Data type

text

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Similar models

On Study Form

1 forms
  1. StudyEvent: ODM
    1. On Study Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Default Itemgroup
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item Group
C0011900 (UMLS CUI-1)
WHO-AML classification (Appendix A.1, A.2. and A.3)
Item
WHO-AML classification (Appendix A.1, A.2. and A.3)
text
C0043237 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
Item
FAB type (Appendix A.4)
text
C0457321 (UMLS CUI [1])
FAB type (Appendix A.4)
Code List
FAB type (Appendix A.4)
CL Item
M0  (0)
C0457327 (UMLS CUI-1)
CL Item
M1  (1)
C0457328 (UMLS CUI-1)
CL Item
M2  (2)
C0457352 (UMLS CUI-1)
CL Item
M4  (4)
C0457331 (UMLS CUI-1)
CL Item
M5  (5)
C0457333 (UMLS CUI-1)
CL Item
M6  (6)
C0457336 (UMLS CUI-1)
CL Item
M7  (7)
C0457337 (UMLS CUI-1)
CL Item
RAEB  (8)
C0002894 (UMLS CUI-1)
CL Item
RAEB-t  (9)
C0280028 (UMLS CUI-1)
CL Item
AML, not M3 (10)
C0023467 (UMLS CUI-1)
Item Group
C0683519 (UMLS CUI-1)
C0449440 (UMLS CUI-3)
Item
Prior MDS
integer
C0026986 (UMLS CUI [1])
MDS
Code List
Prior MDS
CL Item
no 1=yes 9=unknown (0)
MDS Date of Diagnosis
Item
date
C0026986 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item
MDS Subtype
integer
C0026986 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
MDS Subtype
Code List
MDS Subtype
CL Item
RCUD  (1)
C2826318 (UMLS CUI-1)
CL Item
RT  (4)
C2826321 (UMLS CUI-1)
CL Item
RAEB1  (7)
C1318550 (UMLS CUI-1)
CL Item
unknown (9)
CL Item
MDS unclassified (10)
C0026986 (UMLS CUI-1)
CL Item
MDS associated with isolated del(5q) (11)
C1292779 (UMLS CUI-1)
CL Item
RA  (2)
C0002893 (UMLS CUI-1)
CL Item
RN (3)
C2826320 (UMLS CUI-1)
CL Item
RARS  (5)
C1264195 (UMLS CUI-1)
CL Item
RCMD (6)
C0796466 (UMLS CUI-1)
CL Item
RAEB2 (8)
C1318551 (UMLS CUI-1)
Item
Other hematological disease(> 3 months duration prior to diagnosis disease under study).
integer
C0018939 (UMLS CUI [1])
Hematological disease
Code List
Other hematological disease(> 3 months duration prior to diagnosis disease under study).
CL Item
no 1=yes 9=unknown (0)
Hematological disease Date of diagnosis
Item
date
C0018939 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Hematological Disease Specification
Item
text
C0018939 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Other oncological disease
integer
C0027651 (UMLS CUI [1])
Oncological disease
Code List
Other oncological disease
CL Item
no 1=yes 9=unknown (0)
Oncological disease Date of diagnosis
Item
Oncological disease Date of diagnosis
date
C0027651 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Oncological disease Specification
Item
text
C0027651 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Chemotherapy/Radiotherapy
Item
Chemotherapy/Radiotherapy
boolean
C3665472 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Chemotherapy/Radiotherapy Date or year start
Item
date
C3665472 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Chemotherapy/Radiotherapy Specification
Item
text
C3665472 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Exposure to toxic agents (e.g. insecticide)
integer
C0522757 (UMLS CUI [1])
toxic agents
Code List
Exposure to toxic agents (e.g. insecticide)
CL Item
no 1=yes 9=unknown (0)
Toxic agents
Item
Exposure to Toxic agents since year
date
C0522757 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Toxic agents Specification
Item
text
C0522757 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Existence of one (or more) relatives having previously suffered from AML
integer
C0080103 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
Relatives AML
Code List
Existence of one (or more) relatives having previously suffered from AML
CL Item
no 1=yes* 9=unknown (0)
Family relation
Item
*Specify family relation
text
C0015608 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
AML Subtype
Item
*specify diagnosis
text
C0449560 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
Relative Age at Diagnosis
Item
*specify age of relative at diagnosis
text
C1828181 (UMLS CUI [1])
Item
Extramedullary disease
integer
C1868812 (UMLS CUI [1])
Extramedullary disease
Code List
Extramedullary disease
CL Item
no (go to box 31)  (0)
CL Item
skin*  (1)
C1123023 (UMLS CUI-1)
CL Item
CNS*  (2)
C3714787 (UMLS CUI-1)
CL Item
liver*  (3)
C0023884 (UMLS CUI-1)
CL Item
spleen*  (4)
C0037993 (UMLS CUI-1)
CL Item
lymphadenopathy*  (5)
C0497156 (UMLS CUI-1)
CL Item
other* (8)
C0205394 (UMLS CUI-1)
Specify site
Item
*Specify site
text
Item
Level of evidence - Physical examination
integer
C0031809 (UMLS CUI [1])
Physical examination
Code List
Level of evidence - Physical examination
CL Item
no 1=yes 9=unknown (0)
Item
Level of evidence - Radiologically confirmed
integer
C2985535 (UMLS CUI [1])
Radiologic exam
Code List
Level of evidence - Radiologically confirmed
CL Item
no 1=yes 9=unknown (0)
Item
Level of evidence - Pathologically confirmed
integer
C0019638 (UMLS CUI [1])
Pathologically confirmed
Code List
Level of evidence - Pathologically confirmed
CL Item
no 1=yes 9=unknown (0)
LDH
Item
Lactate dehydrogenase (LDH) (U/L)
float
C0202113 (UMLS CUI [1])
LDH ULN
Item
Lactate dehydrogenase ULN
float
C0202113 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Item Group
C0857285 (UMLS CUI-1)
Item
BM aspirate done
integer
C0857285 (UMLS CUI [1])
BM aspirate done
Code List
BM aspirate done
CL Item
not done (go to box 33) 1=done (0)
Item
text
M (UMLS CUI [1])
Evaluable
Code List
Evaluable
CL Item
no (go to box 33) 1=yes (0)
BM sampling date
Item
BM sampling date
date
C0857285 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Cellularity
integer
C1516377 (UMLS CUI [1])
Zellularität
Code List
Cellularity
CL Item
low 2=medium 3=high (1)
Blasts
Item
Blasts
float
C1982687 (UMLS CUI [1])
Promyelocytes
Item
Promyelocytes
float
C0455279 (UMLS CUI [1])
Myelocytes
Item
Myelocytes
float
C0369715 (UMLS CUI [1])
Metamyelocytes
Item
Metamyelocytes
float
C0229635 (UMLS CUI [1])
Neutrophils
Item
Neutrophils (segments & bands)
float
C2238207 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0362902 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Erythroblasts
Item
Erythroblasts
float
C0014762 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0024264 (UMLS CUI [1])
Other*
Item
Other*
float
*Specify
Item
text
Item
Auer rods
integer
C0333828 (UMLS CUI [1])
Auer rods
Code List
Auer rods
CL Item
absent (0)
CL Item
present (1)
Item
Dyserythropoiesis
integer
C0221143 (UMLS CUI [1])
Dyserythropoiesis
Code List
Dyserythropoiesis
CL Item
no 1=yes (0)
Item
Dysmegakaryopoiesis
integer
C3700221 (UMLS CUI [1])
Dysmegakaryopoiesis
Code List
Dysmegakaryopoiesis
CL Item
no 1=yes (0)
Item
Dysgranulopoiesis
integer
C0312832 (UMLS CUI [1])
Dysgranulopoiesis
Code List
Dysgranulopoiesis
CL Item
no 1=yes (0)
Item Group
C0005954 (UMLS CUI-1)
Item
integer
C0005954 (UMLS CUI [1])
BM biopsy done
Code List
BM biopsy done
CL Item
not done (go to box 60) 1=done (0)
Item
integer
M (UMLS CUI [1])
Bone marrow biopsy evaluable
Code List
Bone marrow biopsy evaluable
CL Item
no (go to box 60) 1=yes (0)
Date of BM biopsy
Item
date
C0005954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
text
C1561532 (UMLS CUI [1])
Cellularity
Code List
Cellularity
CL Item
low 2=medium 3=high (1)
Clusters of blasts present
Item
boolean
C0368761 (UMLS CUI [1])
Blasts (i.e.leukemic blasts) estimated
Item
float
C0587348 (UMLS CUI [1])
Item Group
C0229664 (UMLS CUI-1)
Item
integer
C0229664 (UMLS CUI [1])
Peripheral blood evaluation
Code List
Peripheral blood evaluation
CL Item
not done 1=done (0)
Blood sampling date
Item
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
WBC
Item
WBC
float
C0023508 (UMLS CUI [1])
Blasts
Item
Blasts
float
C0368761 (UMLS CUI [1])
Promyelocytes
Item
Promyelocytes
float
C0455279 (UMLS CUI [1])
Myelocytes
Item
Myelocytes
float
C0369715 (UMLS CUI [1])
Metamyelocytes
Item
Metamyelocytes
float
C0229635 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C2238207 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Lymphocytes
Item
float
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Other*
Item
float
M (UMLS CUI [1])
*Specify
Item
text
Erythroblasts
Item
Erythroblasts
float
C0014762 (UMLS CUI [1])
Item
Auer rods
integer
C0333828 (UMLS CUI [1])
Auer rods
Code List
Auer rods
CL Item
absent (0)
CL Item
present (1)
Did patient start protocol treatment
Item
Did patient start protocol treatment
boolean
C0040808 (UMLS CUI [1])
Comments
Item
text
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