ID

42900

Beskrivning

Randomized Comparison Between Two Dose Levels of Daunorubicin and Between One Versus Two Cycles of Induction Therapy for Adult Patients With Acute Myeloid Leukemia <=60 Years. See: https://www.clinicaltrials.gov/ct2/show/NCT02140242 Copyright Holder: PD Dr. med. Christoph Röllig, MSc Source:PD Dr. med. Christoph Röllig, MSc Universitätsklinikum Dresden

Länk

https://www.clinicaltrials.gov/ct2/show/NCT02140242

Nyckelord

Versioner (2)
  1. 07-03-18 07-03-18 -
  2. 17-09-21 17-09-21 -
Rättsinnehavare

Technische Universität Dresden,Dr. Röllig

Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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26496_Daunorubicin Acute Myeloid Leukemia NCT02140242

Engelsk

Visit Randomization II

12 Formulär  
Cytogenetics
Beskrivning

Cytogenetics

Alias
UMLS CUI-1
C0010802
Randomization number
Beskrivning

2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I)

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0034656
Cytogenetics analysis
Beskrivning

Cytogenetics analysis

Datatyp

integer

Alias
UMLS CUI [1]
C0752095
Total Number of analyzed metaphases
Beskrivning

Number of analyzed metaphases

Datatyp

integer

Alias
UMLS CUI [1,1]
C1621812
UMLS CUI [1,2]
C0260877
UMLS CUI [1,3]
C0449788
Karyotype
Beskrivning

Karyotype

Datatyp

integer

Alias
UMLS CUI [1,1]
C1261273
UMLS CUI [1,2]
C0678257
If karyotype is not normal, which characteristics apply?
Beskrivning

Karyotype characteristics

Datatyp

integer

Alias
UMLS CUI [1,1]
C1261273
UMLS CUI [1,2]
C0008625
Have you marked all karyotype characteristics?
Beskrivning

Complete

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205197
UMLS CUI [1,2]
C1511726
Chromosome aberrations
Beskrivning

Chromosome aberrations

Alias
UMLS CUI-1
C0008625
High risk aberrations
Beskrivning

High risk aberrations

Datatyp

integer

Alias
UMLS CUI [1,1]
C0008625
UMLS CUI [1,2]
C0684030
Low risk aberrations
Beskrivning

Low risk aberrations

Datatyp

integer

Alias
UMLS CUI [1,1]
C0008625
UMLS CUI [1,2]
C3538919
Other aberrations, please specify
Beskrivning

Other aberrations

Datatyp

text

Alias
UMLS CUI [1,1]
C0008625
UMLS CUI [1,2]
C0205394
Further entry
Beskrivning

Further entry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705654
UMLS CUI [1,2]
C1517331
Randomization II
Beskrivning

Randomization II

Alias
UMLS CUI-1
C0034656
Date of Randomization II
Beskrivning

Randomization Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0034656
Percentage of blasts:
Beskrivning

(locally assessed in bone marrow at visit 7) xxx . x

Datatyp

float

Måttenheter
  • %
Alias
UMLS CUI [1]
C1982687
%
The patient is allocated to stratum
Beskrivning

Patient allocation, automatic entry

Datatyp

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C1706778
UMLS CUI [1,3]
C0004374
The patient is allocated to stratum
Beskrivning

Patient allocation

Datatyp

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C1706778
UMLS CUI [1,3]
C0175674
By signing the “Rando II” form the local investigator has confirmed, that the patient can proceed to Randomization II.
Beskrivning

Study subject participation status confirmed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0750484
The patient shall now be randomized
Beskrivning

Randomization

Datatyp

boolean

Alias
UMLS CUI [1]
C0034656
Result NON automatic randomization II
Beskrivning

Randomization result

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1522541
Randomization II Result
Beskrivning

Randomization II Result

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C1274040
Randomization number
Beskrivning

2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0034656
Assigned Treatment Arm
Beskrivning

Treatment Arm

Datatyp

integer

Alias
UMLS CUI [1]
C1522541
Tillbaka till toppen

Similar models

Visit Randomization II

12 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Cytogenetics
C0010802 (UMLS CUI-1)
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item
Cytogenetics analysis
integer
C0752095 (UMLS CUI [1])
Cytogenetics analysis
Code List
Cytogenetics analysis
CL Item
Not done (1)
CL Item
Failed (e.g. technical problems, EDTA conditioned) (2)
CL Item
Failure (bad morphology, no proliferation) (3)
CL Item
Done (4)
Number of analyzed metaphases
Item
Total Number of analyzed metaphases
integer
C1621812 (UMLS CUI [1,1])
C0260877 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Item
Karyotype
integer
C1261273 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Karyotype
Code List
Karyotype
CL Item
Normal karyotype (1)
CL Item
Abnormal karyotype (2)
Item
If karyotype is not normal, which characteristics apply?
integer
C1261273 (UMLS CUI [1,1])
C0008625 (UMLS CUI [1,2])
Karyotype characteristics
Code List
If karyotype is not normal, which characteristics apply?
CL Item
high risk aberrations (1)
CL Item
low risk aberrations (2)
Complete
Item
Have you marked all karyotype characteristics?
boolean
C0205197 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Item Group
Chromosome aberrations
C0008625 (UMLS CUI-1)
Item
High risk aberrations
integer
C0008625 (UMLS CUI [1,1])
C0684030 (UMLS CUI [1,2])
High risk aberrations
Code List
High risk aberrations
CL Item
-5 (1)
C0439075 (UMLS CUI-1)
(Comment:en)
CL Item
-7 (2)
C3846158 (UMLS CUI-1)
(Comment:en)
CL Item
abnl(17p) (3)
C0796349 (UMLS CUI-1)
(Comment:en)
CL Item
del(5q) (4)
C1521461 (UMLS CUI-1)
(Comment:en)
CL Item
inv(3)(q21q26.2) (5)
C1515666 (UMLS CUI-1)
(Comment:en)
CL Item
t(3;3)(q21;q26.2) (6)
C1515764 (UMLS CUI-1)
(Comment:en)
CL Item
t(6;9) (q23;q34) (7)
C1515781 (UMLS CUI-1)
(Comment:en)
CL Item
t(v;11)(v;q23) (8)
C1515714 (UMLS CUI-1)
(Comment:en)
CL Item
complex karyotype (≥ 3 aberrations) (9)
C3273253 (UMLS CUI-1)
(Comment:en)
Item
Low risk aberrations
integer
C0008625 (UMLS CUI [1,1])
C3538919 (UMLS CUI [1,2])
Low risk aberrations
Code List
Low risk aberrations
CL Item
inv(16) (1)
C3897144 (UMLS CUI-1)
(Comment:en)
CL Item
t(8;21) (2)
C3897139 (UMLS CUI-1)
(Comment:en)
CL Item
t(16;16) (3)
C4287945 (UMLS CUI-1)
(Comment:en)
CL Item
other aberrations (4)
C0008625 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
(Comment:en)
Other aberrations
Item
Other aberrations, please specify
text
C0008625 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Further entry
Item
Further entry
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
Item Group
Randomization II
C0034656 (UMLS CUI-1)
Randomization Date
Item
Date of Randomization II
date
C0011008 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Bone marrow Blasts
Item
Percentage of blasts:
float
C1982687 (UMLS CUI [1])
Item
The patient is allocated to stratum
integer
C1522541 (UMLS CUI [1,1])
C1706778 (UMLS CUI [1,2])
C0004374 (UMLS CUI [1,3])
Patient allocation, automatic entry
Code List
The patient is allocated to stratum
CL Item
non high risk (1)
CL Item
high risk (2)
Item
The patient is allocated to stratum
integer
C1522541 (UMLS CUI [1,1])
C1706778 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Patient allocation, automatic entry
Code List
The patient is allocated to stratum
CL Item
non high risk (1)
CL Item
high risk (2)
Study subject participation status confirmed
Item
By signing the “Rando II” form the local investigator has confirmed, that the patient can proceed to Randomization II.
boolean
C2348568 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Randomization
Item
The patient shall now be randomized
boolean
C0034656 (UMLS CUI [1])
Randomization result
Item
Result NON automatic randomization II
integer
C0034656 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
Item Group
Randomization II Result
C0034656 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item
Assigned Treatment Arm
integer
C1522541 (UMLS CUI [1])
Treatment Arm
Code List
Assigned Treatment Arm
CL Item
45 mg/m2 Daunorubicin day 3-5 during second induction (1)
CL Item
no second induction (2)
CL Item
60 mg/m2 Daunorubicin day 3-5 during second induction (3)
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