ID

44274

Description

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 further details on: https://www.clinicaltrials.gov/ct2/show/NCT02140242 Principal Investigator: PD Dr. med. Christoph Röllig, MSc Source:PD Dr. med. Christoph Röllig, MSc Universitätsklinikum Dresden

Link

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

Keywords

Versions (3)
  1. 10/24/17 10/24/17 - Julian Varghese
  2. 4/23/19 4/23/19 - Sarah Riepenhausen
  3. 9/20/21 9/20/21 -
Copyright Holder

PD Dr. med. Christoph Röllig, MSc

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Daunorubicin Acute Myeloid Leukemia NCT02140242

English

Visit Registration/Randomization I

12 forms  
Randomization I
Description

Randomization I

Alias
UMLS CUI-1
C0034656
Local trial center number
Description

local trial center number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient inclusion number
Description

inclusion number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Treatment arm part I
Description

treatment arm

Data type

integer

Alias
UMLS CUI [1]
C1522541
Randomization number
Description

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

Data type

integer

Alias
UMLS CUI [1]
C2986235
Registration
Description

Registration

Alias
UMLS CUI-1
C1514821
Local trial center number
Description

local trial center number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Registration date
Description

Registration date

Data type

date

Alias
UMLS CUI [1]
C2985881
Registration date confirmed
Description

confirm registration date

Data type

boolean

Alias
UMLS CUI [1,1]
C2985881
UMLS CUI [1,2]
C0750484
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Age at study inclusion in years
Description

Age

Data type

integer

Alias
UMLS CUI [1]
C0001779
Sex
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Inclusion/Exclusion Criteria
Description

Inclusion/Exclusion Criteria

Alias
UMLS CUI-1
C1516637
The patient fulfills all criteria for inclusion and no criterion for exclusion
Description

Eligibility criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
The patient has been informed comprehensively about the clinical trial and has consented to participate on date
Description

Informed consent date

Data type

date

Alias
UMLS CUI [1]
C2985782
By signing the “patient registration / Rando I” form the local investigator has confirmed, that the patient can participate in the trial.
Description

Study subject participation status confirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0750484
Patient inclusion number
Description

inclusion number

Data type

integer

Alias
UMLS CUI [1]
C2348585
The patient shall now be randomized
Description

Randomization

Data type

boolean

Alias
UMLS CUI [1]
C0034656
Result NON automatic randomization I
Description

Randomization result

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1522541
Randomization number
Description

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

Data type

integer

Alias
UMLS CUI [1]
C2986235
SAL Registry
Description

SAL Registry

Alias
UMLS CUI-1
C0034975
The patient has consented to the documentation of his/ her data in the German or the Czech AML registry.
Description

Informed consent registries

Data type

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0034975
Registry Number
Description

Registry Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0034975
UMLS CUI [1,2]
C1300638
Number in GERMAN SAL-AML Registry
Description

Register - SAL - Hospital-Nr. (xxx) - Pat.-Nr. (xxx) - ID (xxxx)

Data type

text

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0034975
UMLS CUI [1,3]
C1549709
Number in CZECH CELL-AML Registry
Description

D T L - (xxx) - (xxx)

Data type

text

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0034975
UMLS CUI [1,3]
C1549709
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Similar models

Visit Registration/Randomization I

12 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Randomization I
C0034656 (UMLS CUI-1)
local trial center number
Item
Local trial center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
inclusion number
Item
Patient inclusion number
integer
C2348585 (UMLS CUI [1])
treatment arm
Item
Treatment arm part I
integer
C1522541 (UMLS CUI [1])
Randomization number
Item
Randomization number
integer
C2986235 (UMLS CUI [1])
Item Group
Registration
C1514821 (UMLS CUI-1)
local trial center number
Item
Local trial center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Registration date
Item
Registration date
date
C2985881 (UMLS CUI [1])
confirm registration date
Item
Registration date confirmed
boolean
C2985881 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Age
Item
Age at study inclusion in years
integer
C0001779 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Female (1)
CL Item
Male (2)
Item Group
Inclusion/Exclusion Criteria
C1516637 (UMLS CUI-1)
Eligibility criteria
Item
The patient fulfills all criteria for inclusion and no criterion for exclusion
boolean
C1516637 (UMLS CUI [1])
Informed consent date
Item
The patient has been informed comprehensively about the clinical trial and has consented to participate on date
date
C2985782 (UMLS CUI [1])
Study subject participation status confirmed
Item
By signing the “patient registration / Rando I” form the local investigator has confirmed, that the patient can participate in the trial.
boolean
C2348568 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
inclusion number
Item
Patient inclusion number
integer
C2348585 (UMLS CUI [1])
Randomization
Item
The patient shall now be randomized
boolean
C0034656 (UMLS CUI [1])
Randomization result
Item
Result NON automatic randomization I
integer
C0034656 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
Randomization number
Item
Randomization number
integer
C2986235 (UMLS CUI [1])
Item Group
SAL Registry
C0034975 (UMLS CUI-1)
Item
The patient has consented to the documentation of his/ her data in the German or the Czech AML registry.
integer
C0021430 (UMLS CUI [1,1])
C0034975 (UMLS CUI [1,2])
Informed consent registries
Code List
The patient has consented to the documentation of his/ her data in the German or the Czech AML registry.
CL Item
No or unknown (1)
CL Item
Yes. Consent to participate. (2)
Item
Registry Number
integer
C0034975 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Registry Numbers
Code List
Registry Number
CL Item
GERMAN SAL-AML Registry (1)
CL Item
CZECH CELL-AML Registry (2)
Registry Number AML Registry
Item
Number in GERMAN SAL-AML Registry
text
C0023467 (UMLS CUI [1,1])
C0034975 (UMLS CUI [1,2])
C1549709 (UMLS CUI [1,3])
Registry Number AML Registry
Item
Number in CZECH CELL-AML Registry
text
C0023467 (UMLS CUI [1,1])
C0034975 (UMLS CUI [1,2])
C1549709 (UMLS CUI [1,3])
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