ID

42900

Beschreibung

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

Link

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

Stichworte

Versionen (2)
  1. 07.03.18 07.03.18 -
  2. 17.09.21 17.09.21 -
Rechteinhaber

Technische Universität Dresden,Dr. Röllig

Hochgeladen am

17. September 2021

DOI

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Lizenz

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

Englisch

Visit Randomization II

12 Formulare  
Cytogenetics
Beschreibung

Cytogenetics

Alias
UMLS CUI-1
C0010802
Randomization number
Beschreibung

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

Datentyp

integer

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

Cytogenetics analysis

Datentyp

integer

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

Number of analyzed metaphases

Datentyp

integer

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

Karyotype

Datentyp

integer

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

Karyotype characteristics

Datentyp

integer

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

Complete

Datentyp

boolean

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

Chromosome aberrations

Alias
UMLS CUI-1
C0008625
High risk aberrations
Beschreibung

High risk aberrations

Datentyp

integer

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

Low risk aberrations

Datentyp

integer

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

Other aberrations

Datentyp

text

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

Further entry

Datentyp

boolean

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

Randomization II

Alias
UMLS CUI-1
C0034656
Date of Randomization II
Beschreibung

Randomization Date

Datentyp

date

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

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

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C1982687
%
The patient is allocated to stratum
Beschreibung

Patient allocation, automatic entry

Datentyp

integer

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

Patient allocation

Datentyp

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.
Beschreibung

Study subject participation status confirmed

Datentyp

boolean

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

Randomization

Datentyp

boolean

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

Randomization result

Datentyp

integer

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

Randomization II Result

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

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

Datentyp

integer

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

Treatment Arm

Datentyp

integer

Alias
UMLS CUI [1]
C1522541
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Visit Randomization II

12 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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