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 3/4/5/6 (Day 2, 3, 4, 5 Induction I)

12 Formulär  
Induction Visits
Beskrivning

Induction Visits

Alias
UMLS CUI-1
C3179010
UMLS CUI-2
C0545082
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
Clinical Chemistry
Beskrivning

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Clinical Chemistry
Beskrivning

Clinical Chemistry

Datatyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0022885
Date of sampling
Beskrivning

Date of sampling

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Bilirubin (total) value
Beskrivning

xx . xxxx

Datatyp

float

Alias
UMLS CUI [1]
C1278039
Units for Bilirubin
Beskrivning

Units used

Datatyp

integer

Alias
UMLS CUI [1]
C1519795
Value is
Beskrivning

Significance

Datatyp

integer

Alias
UMLS CUI [1]
C2826293
Creatinine value
Beskrivning

xx . xxxx

Datatyp

float

Alias
UMLS CUI [1]
C0201976
Units for Creatinine
Beskrivning

Units used

Datatyp

integer

Alias
UMLS CUI [1]
C1519795
Value is
Beskrivning

Significance

Datatyp

integer

Alias
UMLS CUI [1]
C2826293
Cardiac Enzymes
Beskrivning

Cardiac Enzymes

Alias
UMLS CUI-1
C0443763
Cardiac Enzymes
Beskrivning

Cardiac Enzymes measurement

Datatyp

integer

Alias
UMLS CUI [1]
C0201934
Date of sampling
Beskrivning

Date of sampling

Datatyp

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
NT-proBNP value
Beskrivning

xxx , x

Datatyp

float

Alias
UMLS CUI [1]
C3272900
Unit for NT-proBNP
Beskrivning

Unit used

Datatyp

integer

Alias
UMLS CUI [1]
C1519795
Value is
Beskrivning

Significance

Datatyp

integer

Alias
UMLS CUI [1]
C2826293
Troponin T value
Beskrivning

xxx , x

Datatyp

float

Alias
UMLS CUI [1]
C0523953
Unit for TNT
Beskrivning

Unit used

Datatyp

integer

Alias
UMLS CUI [1]
C1519795
Value is
Beskrivning

Significance

Datatyp

integer

Alias
UMLS CUI [1]
C2826293
Troponin I value
Beskrivning

xxx , x

Datatyp

float

Alias
UMLS CUI [1]
C0920210
Unit for TnI
Beskrivning

Unit used

Datatyp

integer

Alias
UMLS CUI [1]
C1519795
Value is
Beskrivning

Significance

Datatyp

integer

Alias
UMLS CUI [1]
C2826293
Drug Administration
Beskrivning

Drug Administration

Alias
UMLS CUI-1
C3469597
Cytarabine Administration date
Beskrivning

Cytarabine Administration date

Datatyp

date

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0011008
Total dose administered
Beskrivning

"In case the total dose is a number with one or more positions after decimal point, please round.

Datatyp

integer

Måttenheter
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0010711
mg
further entry?
Beskrivning

further entry?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705654
UMLS CUI [1,2]
C1517331
Daunorubicin Administration Date
Beskrivning

Daunorubicin Administration Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011015
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0011008
Total dose administered
Beskrivning

"In case the total dose is a number with one or more positions after decimal point, please round.

Datatyp

integer

Måttenheter
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0010711
mg
further entry?
Beskrivning

further entry?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705654
UMLS CUI [1,2]
C1517331
Treatment Modification
Beskrivning

Treatment Modification

Alias
UMLS CUI-1
C1299575
One or more dose modifications of Cytarabine?
Beskrivning

dose modifications

Datatyp

boolean

Alias
UMLS CUI [1]
C1707811
Any delay or suspension of administration?
Beskrivning

delay or suspension of administration

Datatyp

boolean

Alias
UMLS CUI [1]
C1299700
One or more dose modifications of Daunorubicin?
Beskrivning

dose modifications

Datatyp

boolean

Alias
UMLS CUI [1]
C1707811
Any delay or suspension of administration?
Beskrivning

delay or suspension of administration

Datatyp

boolean

Alias
UMLS CUI [1]
C1299700
Tillbaka till toppen

Similar models

Visit 3/4/5/6 (Day 2, 3, 4, 5 Induction I)

12 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Induction Visits
C3179010 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Item
Clinical Chemistry
integer
C0008000 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Full blood count
Code List
Clinical Chemistry
CL Item
Not done (1)
CL Item
Failed (2)
Date of sampling
Item
Date of sampling
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Bilirubin
Item
Bilirubin (total) value
float
C1278039 (UMLS CUI [1])
Item
Units for Bilirubin
integer
C1519795 (UMLS CUI [1])
Units used
Code List
Units for Bilirubin
CL Item
mg/dl (1)
CL Item
g/l (2)
CL Item
μmol/l (3)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Significance
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Creatinine
Item
Creatinine value
float
C0201976 (UMLS CUI [1])
Item
Units for Creatinine
integer
C1519795 (UMLS CUI [1])
Units used
Code List
Units for Creatinine
CL Item
mg/dl (1)
CL Item
μmol/l (2)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Significance
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Item Group
Cardiac Enzymes
C0443763 (UMLS CUI-1)
Item
Cardiac Enzymes
integer
C0201934 (UMLS CUI [1])
Full blood count
Code List
Cardiac Enzymes
CL Item
Not done (1)
CL Item
Failed (2)
Date of sampling
Item
Date of sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
NT-proBNP
Item
NT-proBNP value
float
C3272900 (UMLS CUI [1])
Item
Unit for NT-proBNP
integer
C1519795 (UMLS CUI [1])
Unit used
Code List
Unit for NT-proBNP
CL Item
pg/ml (1)
CL Item
pmol/l (2)
CL Item
ng/ml (μg/l) (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Significance
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
TnT
Item
Troponin T value
float
C0523953 (UMLS CUI [1])
Item
Unit for TNT
integer
C1519795 (UMLS CUI [1])
Unit used
Code List
Unit for TNT
CL Item
pg/ml (1)
CL Item
pmol/l (2)
CL Item
ng/ml (μg/l) (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Significance
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
TnI
Item
Troponin I value
float
C0920210 (UMLS CUI [1])
Item
Unit for TnI
integer
C1519795 (UMLS CUI [1])
Unit used
Code List
Unit for TnI
CL Item
pg/ml (1)
CL Item
pmol/l (2)
CL Item
ng/ml (μg/l) (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Significance
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Item Group
Drug Administration
C3469597 (UMLS CUI-1)
Cytarabine Administration date
Item
Cytarabine Administration date
date
C0010711 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Total dose
Item
Total dose administered
integer
C3174092 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
further entry?
Item
further entry?
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
Daunorubicin Administration Date
Item
Daunorubicin Administration Date
date
C0011015 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Total dose
Item
Total dose administered
integer
C3174092 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
further entry?
Item
further entry?
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
Item Group
Treatment Modification
C1299575 (UMLS CUI-1)
dose modifications
Item
One or more dose modifications of Cytarabine?
boolean
C1707811 (UMLS CUI [1])
delay or suspension of administration
Item
Any delay or suspension of administration?
boolean
C1299700 (UMLS CUI [1])
dose modifications
Item
One or more dose modifications of Daunorubicin?
boolean
C1707811 (UMLS CUI [1])
delay or suspension of administration
Item
Any delay or suspension of administration?
boolean
C1299700 (UMLS CUI [1])
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