ID

12291

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)

Nyckelord

  1. 2015-11-02 2015-11-02 -
  2. 2015-11-05 2015-11-05 -
  3. 2015-11-05 2015-11-05 -
  4. 2015-11-06 2015-11-06 -
  5. 2015-11-06 2015-11-06 -
  6. 2015-12-29 2015-12-29 -
  7. 2016-02-11 2016-02-11 -
Uppladdad den

2 november 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

On Study Form

  1. StudyEvent: ODM
    1. On Study Form
Default Itemgroup
Beskrivning

Default Itemgroup

Height
Beskrivning

Height

Datatyp

float

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Diagnosis
Beskrivning

Diagnosis

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

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

Datatyp

text

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

FAB type (Appendix A.4)

Datatyp

text

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

History Of Disease And Clincial Status

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

MDS

Datatyp

integer

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

MDS Date of Diagnosis

Datatyp

date

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

MDS Subtype

Datatyp

integer

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

Hematological disease

Datatyp

integer

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

Hematological disease Date of diagnosis

Datatyp

date

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

Hematological Disease Specification

Datatyp

text

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

Oncological disease

Datatyp

integer

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

Oncological disease Date of diagnosis

Datatyp

date

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

Oncological disease Specification

Datatyp

text

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

Chemotherapy/Radiotherapy

Datatyp

boolean

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

Chemotherapy/Radiotherapy Date or year start

Datatyp

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
Beskrivning

Chemotherapy/Radiotherapy Specification

Datatyp

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)
Beskrivning

Toxic agents

Datatyp

integer

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

Toxic agents

Datatyp

date

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

Toxic agents Specification

Datatyp

text

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

Relatives AML

Datatyp

integer

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

Family relation

Datatyp

text

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

AML Subtype

Datatyp

text

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

Relative Age at Diagnosis

Datatyp

text

Alias
UMLS CUI [1]
C1828181
Extramedullary disease
Beskrivning

Extramedullary disease

Datatyp

integer

Alias
UMLS CUI [1]
C1868812
*Specify site
Beskrivning

Specify site

Datatyp

text

Level of evidence - Physical examination
Beskrivning

Physical examination

Datatyp

integer

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

Radiologic exam

Datatyp

integer

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

Pathologically confirmed

Datatyp

integer

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

LDH

Datatyp

float

Alias
UMLS CUI [1]
C0202113
Lactate dehydrogenase ULN
Beskrivning

LDH ULN

Datatyp

float

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

Bone Marrow Aspirate

Alias
UMLS CUI-1
C0857285
BM aspirate done
Beskrivning

BM aspirate done

Datatyp

integer

Alias
UMLS CUI [1]
C0857285
Evaluable
Beskrivning

Evaluable

Datatyp

text

Alias
UMLS CUI [1]
M
BM sampling date
Beskrivning

BM sampling date

Datatyp

date

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

Cellularity

Datatyp

integer

Alias
UMLS CUI [1]
C1516377
Blasts
Beskrivning

Blasts

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C1982687
%
Promyelocytes
Beskrivning

Promyelocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0455279
%
Myelocytes
Beskrivning

Myelocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0369715
%
Metamyelocytes
Beskrivning

Metamyelocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0229635
%
Neutrophils (segments & bands)
Beskrivning

Neutrophils

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C2238207
%
Monocytes
Beskrivning

Monocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Beskrivning

Eosinophils

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0362902
%
Basophils
Beskrivning

Basophils

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200641
%
Erythroblasts
Beskrivning

Erythroblasts

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0014762
%
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0024264
%
Other*
Beskrivning

Other*

Datatyp

float

Måttenheter
  • %
%
*Specify
Beskrivning

*Specify

Datatyp

text

Auer rods
Beskrivning

Auer rods

Datatyp

integer

Alias
UMLS CUI [1]
C0333828
Dyserythropoiesis
Beskrivning

Dyserythropoiesis

Datatyp

integer

Alias
UMLS CUI [1]
C0221143
Dysmegakaryopoiesis
Beskrivning

Dysmegakaryopoiesis

Datatyp

integer

Alias
UMLS CUI [1]
C3700221
Dysgranulopoiesis
Beskrivning

Dysgranulopoiesis

Datatyp

integer

Alias
UMLS CUI [1]
C0312832
Bone Marrow Biopsy
Beskrivning

Bone Marrow Biopsy

Alias
UMLS CUI-1
C0005954
BM biopsy done
Beskrivning

BM biopsy done

Datatyp

integer

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

Bone marrow biopsy evaluable

Datatyp

integer

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

Date of BM biopsy

Datatyp

date

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

Cellularity

Datatyp

text

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

Clusters of blasts present

Datatyp

boolean

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

Blasts (i.e.leukemic blasts) estimated

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0587348
%
Peripheral blood evaluation
Beskrivning

Peripheral blood evaluation

Alias
UMLS CUI-1
C0229664
Peripheral blood evaluation
Beskrivning

Peripheral blood evaluation

Datatyp

integer

Alias
UMLS CUI [1]
C0229664
Blood sampling date
Beskrivning

Blood sampling date

Datatyp

date

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

Hemoglobin

Datatyp

float

Måttenheter
  • mmol/l
Alias
UMLS CUI [1]
C0019046
mmol/l
Platelets
Beskrivning

Platelets

Datatyp

float

Måttenheter
  • x10^9/l
Alias
UMLS CUI [1]
C0005821
x10^9/l
WBC
Beskrivning

WBC

Datatyp

float

Måttenheter
  • x10^9/l
Alias
UMLS CUI [1]
C0023508
x10^9/l
Blasts
Beskrivning

Blasts

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0368761
%
Promyelocytes
Beskrivning

Promyelocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0455279
%
Myelocytes
Beskrivning

Myelocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0369715
%
Metamyelocytes
Beskrivning

Metamyelocytes

Datatyp

float

Alias
UMLS CUI [1]
C0229635
Neutrophils
Beskrivning

Neutrophils

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C2238207
%
Basophils
Beskrivning

Basophils

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200641
%
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Beskrivning

Monocytes

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C0026473
%
Other*
Beskrivning

Other*

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
M
%
*Specify
Beskrivning

*Specify

Datatyp

text

Erythroblasts
Beskrivning

Erythroblasts

Datatyp

float

Alias
UMLS CUI [1]
C0014762
Auer rods
Beskrivning

Auer rods

Datatyp

integer

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

Did patient start protocol treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0040808
Comments
Beskrivning

Comments

Datatyp

text

Similar models

On Study Form

  1. StudyEvent: ODM
    1. On Study Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Code List
FAB type (Appendix A.4)
CL Item
M0 1=M1 2=M2 4=M4 5=M5 6=M6 7=M7 8=RAEB 9=RAEB-t 10=AML, not M3 (0)
Item Group
C0683519 (UMLS CUI-1)
C0449440 (UMLS CUI-3)
Item
Prior MDS
integer
C0026986 (UMLS CUI [1])
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])
Code List
MDS Subtype
CL Item
RCUD 2= RA 3= RN (1)
CL Item
RT 5=RARS 6=RCMD (4)
CL Item
RAEB1 8=RAEB2 (7)
CL Item
unknown (9)
CL Item
MDS unclassified (10)
CL Item
MDS associated with isolated del(5q) (11)
Item
Other hematological disease(> 3 months duration prior to diagnosis disease under study).
integer
C0018939 (UMLS CUI [1])
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])
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])
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])
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
integer
C1868812 (UMLS CUI [1])
Code List
Extramedullary disease
CL Item
no (go to box 31) 1=skin* 2=CNS* 3=liver* 4=spleen* 5=lymphadenopathy* 8=other* (0)
Specify site
Item
*Specify site
text
Item
Level of evidence - Physical examination
integer
C0031809 (UMLS CUI [1])
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])
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])
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])
Code List
BM aspirate done
CL Item
not done (go to box 33) 1=done (0)
Item
text
M (UMLS CUI [1])
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])
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])
Code List
Auer rods
CL Item
absent (0)
CL Item
present (1)
Item
Dyserythropoiesis
integer
C0221143 (UMLS CUI [1])
Code List
Dyserythropoiesis
CL Item
no 1=yes (0)
Item
Dysmegakaryopoiesis
integer
C3700221 (UMLS CUI [1])
Code List
Dysmegakaryopoiesis
CL Item
no 1=yes (0)
Item
Dysgranulopoiesis
integer
C0312832 (UMLS CUI [1])
Code List
Dysgranulopoiesis
CL Item
no 1=yes (0)
Item Group
C0005954 (UMLS CUI-1)
Item
integer
C0005954 (UMLS CUI [1])
Code List
BM biopsy done
CL Item
not done (go to box 60) 1=done (0)
Item
integer
M (UMLS CUI [1])
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])
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])
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])
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

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial