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ID
12259
Beschrijving
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: Registration and Randomization Form
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Versies (5)
- 29-10-15 29-10-15 -
- 23-11-15 23-11-15 -
- 18-12-15 18-12-15 -
- 11-02-16 11-02-16 -
- 20-09-21 20-09-21 -
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29 oktober 2015
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Creative Commons BY-NC 3.0
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Registration and Randomization Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26
Registration and Randomization Form
- StudyEvent: ODM
Similar models
Registration and Randomization Form
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Caller
Item
Caller
text
C0557514 (UMLS CUI [1])
Responsible physician
Item
Responsible physician
text
C1273518 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
Date of written Informed Consent
Item
Date of written Informed Consent
date
C2985782 (UMLS CUI [1])
Date of diagnosis of AML or MDS
Item
Date of diagnosis of AML or MDS
date
C2316983 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C2316983 (UMLS CUI [2,1])
C0026986 (UMLS CUI [2,2])
C0023467 (UMLS CUI [1,2])
C2316983 (UMLS CUI [2,1])
C0026986 (UMLS CUI [2,2])
Approach for future research
Item
Approach for future research
boolean
Keeping body material up to 15 years after trial for additional future research
Item
boolean
Taking extra bone marrow, blood and saliva for additional research
Item
boolean
Item
AML or MDS diagnosis (see protocol appendix A1-3)
text
C0011900 (UMLS CUI [1])
Code List
AML or MDS diagnosis (see protocol appendix A1-3)
CL Item
AML (1)
CL Item
RAEB (2)
CL Item
Leukemia with abiguous lineage (3)
IPSS-R risk score
Item
integer
C2827405 (UMLS CUI [1])
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
Sampled BM/PB samples for analysis and MRD evaluation
text
C0005953 (UMLS CUI [1])
C0032105 (UMLS CUI [2])
C2238270 (UMLS CUI [3])
C0032105 (UMLS CUI [2])
C2238270 (UMLS CUI [3])
Code List
Sampled BM/PB samples for analysis and MRD evaluation
CL Item
no (0)
CL Item
yes (1)
CL Item
dry tap (2)
Blood sampling
Item
date
C0005834 (UMLS CUI [1])
Creatinine, Serum
Item
Serum creatinine
float
C0201976 (UMLS CUI [1])
GFR
Item
GFR
float
C1316377 (UMLS CUI [1])
Bilirubin
Item
float
C0005437 (UMLS CUI [1])
Bilirubin ULN
Item
float
C0005437 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
ALT ULN
Item
ALT (SGPT) ULN
float
C0376147 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C0151420 (UMLS CUI [1])
Ability and willingness to adhere to lenalidomide pregnancy prevention program
Item
Ability and willingness to adhere to lenalidomide pregnancy prevention program
boolean
C0086286 (UMLS CUI [1])
Previous therapy with lenalidomide
Item
boolean
C2114510 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
C1144149 (UMLS CUI [1,2])
Acute promyelocytic leukemia
Item
Acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1])
Myeloproliferative neoplasia
Item
boolean
C0027022 (UMLS CUI [1])
Previous treatment for AML or high risk MDS, except hydroxyurea
Item
boolean
Concurrent history of active malignancy in two past years prior to diagnosis (except for basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix)
Item
Concurrent history of active malignancy in two past years prior to diagnosis (except for basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix)
boolean
C0006826 (UMLS CUI [1])
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
Item
boolean
Cardiac dysfunction (see protocol section 8.1.2)
Item
boolean
C3277906 (UMLS CUI [1])
Hypersensitivity to the active substance or to any of the excipients of the drug product
Item
boolean
C0020517 (UMLS CUI [1])
Pregnant or lactating females
Item
boolean
C2828358 (UMLS CUI [1,1])
C0549206 (UMLS CUI [1,2])
C0549206 (UMLS CUI [1,2])
Unwilling or not capable to use effective means of birth control
Item
boolean
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Item
boolean
Date of Randomization
Item
Date of Randomization
date
Patient study number
Item
integer
C1830427 (UMLS CUI [1])
CL Item
Arm A: induction chemotherapy without Lenalidomide (1)
CL Item
Arm B: induction chemotherapy with Lenalidomide 20mg (2)
CL Item
Arm B: induction chemotherapy with Lenalidomide 15mg (5)
CL Item
Arm B: induction chemotherapy with Lenalidomide 10mg (6)