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. 2018-03-07 2018-03-07 -
  2. 2021-09-17 2021-09-17 -
Rättsinnehavare

Technische Universität Dresden,Dr. Röllig

Uppladdad den

17 september 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

26496_Daunorubicin Acute Myeloid Leukemia NCT02140242

Engelsk

Visit Registration/Randomization I

12 Formulär  
Randomization I
Beskrivning

Randomization I

Alias
UMLS CUI-1
C0034656
Patient inclusion number
Beskrivning

inclusion number

Datatyp

integer

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

treatment arm

Datatyp

integer

Alias
UMLS CUI [1]
C1522541
Randomization number
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1]
C2986235
Registration
Beskrivning

Registration

Alias
UMLS CUI-1
C1514821
Local trial center number
Beskrivning

local trial center number

Datatyp

integer

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

Registration date

Datatyp

date

Alias
UMLS CUI [1]
C2985881
Registration date confirmed
Beskrivning

confirm registration date

Datatyp

boolean

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

Demographics

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

Age

Datatyp

integer

Alias
UMLS CUI [1]
C0001779
Sex
Beskrivning

Gender

Datatyp

integer

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

Inclusion/Exclusion Criteria

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

Eligibility criteria

Datatyp

boolean

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

Informed consent date

Datatyp

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.
Beskrivning

Study subject participation status confirmed

Datatyp

boolean

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

inclusion number

Datatyp

integer

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

Randomization

Datatyp

boolean

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

Randomization result

Datatyp

integer

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

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

Datatyp

integer

Alias
UMLS CUI [1]
C2986235
SAL Registry
Beskrivning

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.
Beskrivning

Informed consent registries

Datatyp

integer

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

Registry Numbers

Datatyp

integer

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

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

Datatyp

text

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

D T L - (xxx) - (xxx)

Datatyp

text

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0034975
UMLS CUI [1,3]
C1549709
Tillbaka till toppen

Similar models

Visit Registration/Randomization I

12 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Randomization I
C0034656 (UMLS CUI-1)
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial