ID

36226

Descripción

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

Palabras clave

  1. 24/10/17 24/10/17 - Julian Varghese
  2. 23/4/19 23/4/19 - Sarah Riepenhausen
  3. 20/9/21 20/9/21 -
Titular de derechos de autor

PD Dr. med. Christoph Röllig, MSc

Subido en

23 de abril de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0

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Daunorubicin Acute Myeloid Leukemia NCT02140242

Visit 2 (Day 1 Induction I)

Visit 2
Descripción

Visit 2

Alias
UMLS CUI-1
C0545082
Randomization number
Descripción

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0034656
Date of visit
Descripción

Visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Full Blood Count
Descripción

Full Blood Count

Alias
UMLS CUI-1
C0005771
Full blood count
Descripción

Full blood count

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005771
Date of sampling
Descripción

Date of sampling

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Leukocytes Value
Descripción

Leukocytes

Tipo de datos

integer

Alias
UMLS CUI [1]
C0023508
Unit for leukocytes
Descripción

Unit used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

Significance

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Haemoglobin value
Descripción

Hemoglobin

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518015
Unit for Haemoglobin
Descripción

Unit used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

Significance

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Platelets value
Descripción

Platelets

Tipo de datos

integer

Alias
UMLS CUI [1]
C0032181
Unit for Platelets
Descripción

Unit used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

Significance

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Neutrophiles value
Descripción

Neutrophiles

Tipo de datos

integer

Alias
UMLS CUI [1]
C0200633
Unit for Neutrophiles
Descripción

Unit used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

Significance

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Lymphocytes value
Descripción

Lymphocytes

Tipo de datos

integer

Alias
UMLS CUI [1]
C0200635
Unit for Lymphocytes
Descripción

Unit used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

Significance

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Monocytes value
Descripción

Monocytes

Tipo de datos

integer

Alias
UMLS CUI [1]
C0200637
Unit for Monocytes
Descripción

Unit used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

Significance

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Basophiles value
Descripción

Basophiles

Tipo de datos

integer

Alias
UMLS CUI [1]
C0200641
Unit for Basophiles
Descripción

Unit used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

Significance

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Eosinophiles value
Descripción

Eosinophiles

Tipo de datos

integer

Alias
UMLS CUI [1]
C0750879
Unit for Eosinophiles
Descripción

Unit used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

Significance

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Percentage of blasts in pB
Descripción

Blast percentage

Tipo de datos

integer

Unidades de medida
  • %
Alias
UMLS CUI [1,1]
C0587348
UMLS CUI [1,2]
C0229664
%
Clinical Chemistry
Descripción

Clinical Chemistry

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

Clinical Chemistry

Tipo de datos

integer

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

Date of sampling

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
AST (GOT) value
Descripción

xx . xxxx

Tipo de datos

float

Alias
UMLS CUI [1]
C0201899
Units for AST (GOT)
Descripción

Units used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

If value is „of clinical significance“: „Please check, whether an AE has occured“

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
ALT (GPT) value
Descripción

xx . xxxx

Tipo de datos

float

Alias
UMLS CUI [1]
C0201836
Units for ALT (GPT)
Descripción

Units used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

If value is „of clinical significance“: „Please check, whether an AE has occured“

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Bilirubin (total) value
Descripción

xx . xxxx

Tipo de datos

float

Alias
UMLS CUI [1]
C1278039
Units for Bilirubin
Descripción

Units used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

If value is „of clinical significance“: „Please check, whether an AE has occured“

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Creatinine value
Descripción

xx . xxxx

Tipo de datos

float

Alias
UMLS CUI [1]
C0201976
Units for Creatinine
Descripción

Units used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

If value is „of clinical significance“: „Please check, whether an AE has occured“

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Sodium value
Descripción

xx . xxxx

Tipo de datos

float

Alias
UMLS CUI [1]
C0337443
Units for Sodium
Descripción

Units used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

If value is „of clinical significance“: „Please check, whether an AE has occured“

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Potassium value
Descripción

xx . xxxx

Tipo de datos

float

Alias
UMLS CUI [1]
C0202194
Units for Potassium
Descripción

Units used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

If value is „of clinical significance“: „Please check, whether an AE has occured“

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Coagulation
Descripción

Coagulation

Alias
UMLS CUI-1
C0005790
Coagulation
Descripción

Coagulation

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005790
Date of sampling
Descripción

Date of sampling

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
PTT (partial thromboplastin time) value
Descripción

PTT

Tipo de datos

integer

Unidades de medida
  • sec
Alias
UMLS CUI [1]
C0030605
sec
Value is
Descripción

If value is „of clinical significance“: „Please check, whether an AE has occured“

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
INR Value
Descripción

x . xx

Tipo de datos

float

Alias
UMLS CUI [1]
C0525032
Value is
Descripción

If value is „of clinical significance“: „Please check, whether an AE has occured“

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293
Fibrinogen value
Descripción

xxx . xx

Tipo de datos

float

Alias
UMLS CUI [1]
C0337428
Units for Fibrinogen
Descripción

Units used

Tipo de datos

integer

Alias
UMLS CUI [1]
C1519795
Value is
Descripción

If value is „of clinical significance“: „Please check, whether an AE has occured“

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826293

Similar models

Visit 2 (Day 1 Induction I)

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Visit 2
C0545082 (UMLS CUI-1)
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Full Blood Count
C0005771 (UMLS CUI-1)
Item
Full blood count
integer
C0005771 (UMLS CUI [1])
Code List
Full blood count
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])
Leukocytes
Item
Leukocytes Value
integer
C0023508 (UMLS CUI [1])
Item
Unit for leukocytes
integer
C1519795 (UMLS CUI [1])
Code List
Unit for leukocytes
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Hemoglobin
Item
Haemoglobin value
integer
C0518015 (UMLS CUI [1])
Item
Unit for Haemoglobin
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Haemoglobin
CL Item
mmol/l (1)
CL Item
g/dl (2)
CL Item
g/l (3)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Platelets
Item
Platelets value
integer
C0032181 (UMLS CUI [1])
Item
Unit for Platelets
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Platelets
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Neutrophiles
Item
Neutrophiles value
integer
C0200633 (UMLS CUI [1])
Item
Unit for Neutrophiles
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Neutrophiles
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Lymphocytes
Item
Lymphocytes value
integer
C0200635 (UMLS CUI [1])
Item
Unit for Lymphocytes
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Lymphocytes
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Monocytes
Item
Monocytes value
integer
C0200637 (UMLS CUI [1])
Item
Unit for Monocytes
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Monocytes
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Basophiles
Item
Basophiles value
integer
C0200641 (UMLS CUI [1])
Item
Unit for Basophiles
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Basophiles
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Eosinophiles
Item
Eosinophiles value
integer
C0750879 (UMLS CUI [1])
Item
Unit for Eosinophiles
integer
C1519795 (UMLS CUI [1])
Code List
Unit for Eosinophiles
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Blast percentage
Item
Percentage of blasts in pB
integer
C0587348 (UMLS CUI [1,1])
C0229664 (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])
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])
AST (GOT)
Item
AST (GOT) value
float
C0201899 (UMLS CUI [1])
Item
Units for AST (GOT)
integer
C1519795 (UMLS CUI [1])
Code List
Units for AST (GOT)
CL Item
U/l (1)
CL Item
μmol/s*l (μkat/l) (2)
CL Item
nkat/ (3)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
ALT (GPT)
Item
ALT (GPT) value
float
C0201836 (UMLS CUI [1])
Item
Units for ALT (GPT)
integer
C1519795 (UMLS CUI [1])
Code List
Units for ALT (GPT)
CL Item
U/l (1)
CL Item
μmol/s*l (μkat/l) (2)
CL Item
nkat/ (3)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Bilirubin
Item
Bilirubin (total) value
float
C1278039 (UMLS CUI [1])
Item
Units for Bilirubin
integer
C1519795 (UMLS CUI [1])
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])
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])
Code List
Units for Creatinine
CL Item
mg/dl (1)
CL Item
μmol/l (2)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Sodium
Item
Sodium value
float
C0337443 (UMLS CUI [1])
Item
Units for Sodium
integer
C1519795 (UMLS CUI [1])
Code List
Units for Sodium
CL Item
mmol/l (1)
CL Item
mEq/l (mval/l) (2)
CL Item
mg/dl (3)
CL Item
g/l (4)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Potassium
Item
Potassium value
float
C0202194 (UMLS CUI [1])
Item
Units for Potassium
integer
C1519795 (UMLS CUI [1])
Code List
Units for Potassium
CL Item
mmol/l (1)
CL Item
mEq/l (mval/l) (2)
CL Item
mg/dl (3)
CL Item
mg/l (4)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Item Group
Coagulation
C0005790 (UMLS CUI-1)
Item
Coagulation
integer
C0005790 (UMLS CUI [1])
Code List
Coagulation
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])
PTT
Item
PTT (partial thromboplastin time) value
integer
C0030605 (UMLS CUI [1])
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
INR
Item
INR Value
float
C0525032 (UMLS CUI [1])
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Fibrinogen
Item
Fibrinogen value
float
C0337428 (UMLS CUI [1])
Item
Units for Fibrinogen
integer
C1519795 (UMLS CUI [1])
Code List
Units for Fibrinogen
CL Item
g/l (1)
CL Item
mg/dl (2)
Item
Value is
integer
C2826293 (UMLS CUI [1])
Code List
Value is
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)

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