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12303
Beschreibung
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)
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Hochgeladen am
5. November 2015
DOI
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Creative Commons BY-NC 3.0
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HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26
Ähnliche Modelle
On Study Form
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 1=yes 9=unknown (0)
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 1=yes 9=unknown (0)
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 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])
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 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])
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])
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])
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 1=yes 9=unknown (0)
CL Item
no 1=yes 9=unknown (0)
Item
Level of evidence - Pathologically confirmed
integer
C0019638 (UMLS CUI [1])
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])
C1519815 (UMLS CUI [1,2])
CL Item
not done (go to box 33) 1=done (0)
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])
C0011008 (UMLS CUI [1,2])
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
CL Item
absent (0)
CL Item
present (1)
CL Item
no 1=yes (0)
CL Item
no 1=yes (0)
CL Item
no 1=yes (0)
CL Item
not done (go to box 60) 1=done (0)
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])
C0011008 (UMLS CUI [1,2])
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])
CL Item
not done 1=done (0)
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