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ID
12305
Descripción
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) Documentation part: On Study Form
Palabras clave
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Subido en
5 de noviembre de 2015
DOI
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Licencia
Creative Commons BY-NC 3.0
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On Study Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26
Similar models
On Study Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Height
Item
Height
float
C0005890 (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])
C0023467 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
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)
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
MDS Date of Diagnosis
Item
date
C0026986 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
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])
Code List
Other hematological disease(> 3 months duration prior to diagnosis disease under study).
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
Hematological disease Date of diagnosis
Item
date
C0018939 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
Hematological Disease Specification
Item
text
C0018939 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
Oncological disease Date of diagnosis
Item
Oncological disease Date of diagnosis
date
C0027651 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
Oncological disease Specification
Item
text
C0027651 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Chemotherapy/Radiotherapy
Item
Chemotherapy/Radiotherapy
boolean
C3665472 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
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])
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])
C2348235 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
Toxic agents
Item
Exposure to Toxic agents since year
date
C0522757 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Toxic agents Specification
Item
text
C0522757 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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])
C0023467 (UMLS CUI [1,2])
Code List
Existence of one (or more) relatives having previously suffered from AML
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
Family relation
Item
*Specify family relation
text
C0015608 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,2])
AML Subtype
Item
*specify diagnosis
text
C0449560 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,2])
Relative Age at Diagnosis
Item
*specify age of relative at diagnosis
text
C1828181 (UMLS CUI [1])
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
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
Item
Level of evidence - Pathologically confirmed
integer
C0019638 (UMLS CUI [1])
CL Item
no (0)
CL Item
yes (1)
CL Item
unknown (9)
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])
C1519815 (UMLS CUI [1,2])
CL Item
not done (go to box 33) (0)
CL Item
done (1)
Item
Evaluable
text
C3258067 (UMLS CUI [1,1])
C0857285 (UMLS CUI [1,2])
C1271729 (UMLS CUI [2])
C0857285 (UMLS CUI [1,2])
C1271729 (UMLS CUI [2])
CL Item
no (go to box 33) (0)
CL Item
yes (1)
BM sampling date
Item
BM sampling date
date
C0857285 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
low (1)
CL Item
medium (2)
CL Item
high (3)
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
CL Item
absent (0)
CL Item
present (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
CL Item
not done (go to box 60) (0)
CL Item
done (1)
Item
Bone marrow biopsy evaluable
integer
C3258067 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,2])
CL Item
no (go to box 60) (0)
CL Item
yes (1)
Date of BM biopsy
Item
date
C0005954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
low (1)
CL Item
medium (2)
CL Item
high (3)
Clusters of blasts present
Item
boolean
C0368761 (UMLS CUI [1])
Blasts (i.e.leukemic blasts) estimated
Item
float
C0587348 (UMLS CUI [1])
CL Item
not done (0)
CL Item
done (1)
Blood sampling date
Item
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
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