ID

36226

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

April 23, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Daunorubicin Acute Myeloid Leukemia NCT02140242

English

Visit 9/10/11/12 (Day 2, 3, 4, 5 Induction II)

12 forms  
Induction Visits
Description

Induction Visits

Alias
UMLS CUI-1
C3179010
UMLS CUI-2
C0545082
Randomization number
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0034656
Clinical Chemistry
Description

Clinical Chemistry

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

Clinical Chemistry

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0022885
Date of Sampling
Description

Date of Sampling

Data type

date

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

xx . xxxx

Data type

float

Alias
UMLS CUI [1]
C1278039
Units for Bilirubin
Description

Units used

Data type

integer

Alias
UMLS CUI [1]
C1519795
Value is
Description

Significance

Data type

integer

Alias
UMLS CUI [1]
C2826293
Creatinine value
Description

xx . xxxx

Data type

float

Alias
UMLS CUI [1]
C0201976
Units for Creatinine
Description

Units used

Data type

integer

Alias
UMLS CUI [1]
C1519795
Value is
Description

Significance

Data type

integer

Alias
UMLS CUI [1]
C2826293
Cardiac Enzymes
Description

Cardiac Enzymes

Alias
UMLS CUI-1
C0443763
Cardiac Enzymes
Description

Cardiac Enzymes measurement

Data type

integer

Alias
UMLS CUI [1]
C0201934
Date of sampling
Description

Date of sampling

Data type

date

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

xxx , x

Data type

float

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

Unit used

Data type

integer

Alias
UMLS CUI [1]
C1519795
Value is
Description

Significance

Data type

integer

Alias
UMLS CUI [1]
C2826293
Troponin T value
Description

xxx , x

Data type

float

Alias
UMLS CUI [1]
C0523953
Unit for TnT
Description

Unit used

Data type

integer

Alias
UMLS CUI [1]
C1519795
Value is
Description

Significance

Data type

integer

Alias
UMLS CUI [1]
C2826293
Troponin I value
Description

xxx , x

Data type

float

Alias
UMLS CUI [1]
C0920210
Unit for TnI
Description

Unit used

Data type

integer

Alias
UMLS CUI [1]
C1519795
Value is
Description

Significance

Data type

integer

Alias
UMLS CUI [1]
C2826293
Drug Administration
Description

Drug Administration

Alias
UMLS CUI-1
C3469597
Cytarabine Administration date
Description

Cytarabine Administration date

Data type

date

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

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

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0010711
mg
further entry?
Description

further entry?

Data type

boolean

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

Daunorubicin Administration Date

Data type

date

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

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

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0010711
mg
further entry?
Description

further entry?

Data type

boolean

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

Treatment Modification

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

dose modifications

Data type

boolean

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

delay or suspension of administration

Data type

boolean

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

dose modifications

Data type

boolean

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

delay or suspension of administration

Data type

boolean

Alias
UMLS CUI [1]
C1299700
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Similar models

Visit 9/10/11/12 (Day 2, 3, 4, 5 Induction II)

12 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
μg/l (1)
CL Item
pg/ml (2)
CL Item
ng/ml (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
μg/l (1)
CL Item
pg/ml (2)
CL Item
ng/ml (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])
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