ID

5331

Description

Prospective non–randomized multi​center study for epidemiology and characterization of Myelodysplastic Syndromes(MDS) and Juvenile Myelomonocytic Leukemia (JMML) in child­hood. PI: Prof. Dr. Charlotte Niemeyer http://clinicaltrials.gov/ct2/show/NCT00662090 http://www.ewog-mds.org/

Link

http://clinicaltrials.gov/ct2/show/NCT00662090

Keywords

  1. 8/5/14 8/5/14 - Martin Dugas
Uploaded on

August 5, 2014

DOI

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License

Creative Commons BY 4.0

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EWOG MDS 2006 Status Day 30 DRKS00003789

Status Day 30

  1. StudyEvent: SE
    1. Status Day 30
Show identification of patient
Description

Show identification of patient

Dummy
Description

Dummy

Data type

text

Complications - Infection
Description

Complications - Infection

Infection
Description

Infection

Data type

integer

Bacterial > CTCAE grade 2
Description

Bacterial > CTCAE grade 2

Data type

integer

Bacterial organism
Description

Bacterial organism

Data type

text

Fungal > CTCAE grade 2
Description

Fungal > CTCAE grade 2

Data type

integer

Fungal organism
Description

Fungal organism

Data type

text

Parasitic > CTCAE grade 2
Description

Parasitic > CTCAE grade 2

Data type

integer

Parasitic organism
Description

Parasitic organism

Data type

text

Viral > CTCAE grade 2
Description

Viral > CTCAE grade 2

Data type

integer

Virus
Description

Virus

Data type

text

Unknown > CTCAE grade 2
Description

Unknown > CTCAE grade 2

Data type

integer

Organism of unknown infection
Description

Organism of unknown infection

Data type

text

Complications - EBV PCR
Description

Complications - EBV PCR

EBV PCR performed
Description

EBV PCR performed

Data type

integer

EBV PCR date
Description

EBV PCR date

Data type

date

EBV PCR value
Description

EBV PCR value

Data type

integer

Measurement units
  • Copies/ml PB
Copies/ml PB
Complications - EBV LPD
Description

Complications - EBV LPD

EBV LPD
Description

EBV LPD

Data type

integer

Complications - EBV LPD symptoms
Description

Complications - EBV LPD symptoms

Fever
Description

Fever

Data type

integer

Malaise
Description

Malaise

Data type

integer

Weight loss
Description

Weight loss

Data type

integer

Complications - EBV LPD site
Description

Complications - EBV LPD site

Mediastinal lymphnodes
Description

Mediastinal lymphnodes

Data type

integer

Abdominal lymphnodes
Description

Abdominal lymphnodes

Data type

integer

Inguinal lymphnodes
Description

Inguinal lymphnodes

Data type

integer

Axillary lymphnodes
Description

Axillary lymphnodes

Data type

integer

Cervical lymphnodes
Description

Cervical lymphnodes

Data type

integer

Gut
Description

Gut

Data type

integer

Lung
Description

Lung

Data type

integer

Tonsils
Description

Tonsils

Data type

integer

Other
Description

Other

Data type

integer

Other site
Description

Other site

Data type

text

Complications - EBV LPD treatment
Description

Complications - EBV LPD treatment

Anti CD20 antibodies
Description

Anti CD20 antibodies

Data type

integer

Virustatic therapy
Description

Virustatic therapy

Data type

integer

Chemo therapy
Description

Chemo therapy

Data type

integer

Steroids
Description

Steroids

Data type

integer

Reduction of IST
Description

Reduction of IST

Data type

integer

Stop of IST
Description

Stop of IST

Data type

integer

Other
Description

Other

Data type

integer

Other type of treatment
Description

Other type of treatment

Data type

text

Complications - Hemorrhage
Description

Complications - Hemorrhage

Hemorrhage > CTCAE grade 2
Description

Hemorrhage

Data type

integer

Complications - Renal/Metabolic Lab., Creatinine
Description

Complications - Renal/Metabolic Lab., Creatinine

Renal/Metabolic Lab., Creatinine > CTCAE grade 2
Description

Renal/Metabolic Lab., Creatinine

Data type

integer

Hemodialysis or hemofiltration
Description

Hemodialysis or hemofiltration

Data type

integer

Fanconi syndrome
Description

Fanconi syndrome

Data type

integer

Nephrotic syndrome
Description

Nephrotic syndrome

Data type

integer

Complications - Other type of complication
Description

Complications - Other type of complication

Other type of complication > CTCAE grade 2
Description

Other type of complication

Data type

integer

Type
Description

Type

Data type

text

Transfusions
Description

Transfusions

Still regular PLT transfusions neccessary
Description

Still PLT transfusion dependent

Data type

integer

Still regular RBC transfusions neccessary
Description

Still RBC transfusion dependent

Data type

integer

Transfusion PLT
Description

Transfusion PLT

Date of last transfusion
Description

Date of last transfusion

Data type

date

Transfusion RBC
Description

Transfusion RBC

Date of last transfusion
Description

Date of last transfusion

Data type

date

Complete blood count
Description

Complete blood count

Date of specimen collection
Description

Date of specimen collection

Data type

date

Erythrocytes
Description

Erythrocytes

Data type

float

Measurement units
  • x 10E6 / µl
x 10E6 / µl
MCV
Description

MCV

Data type

integer

Measurement units
  • fL
fL
Hb value
Description

Hb value

Data type

float

Measurement units
  • g/dl
g/dl
Reticulocytes
Description

Reticulocytes

Data type

float

Measurement units
WBC
Description

WBC

Data type

float

Measurement units
  • x 10E9/l
x 10E9/l
Absolute neutrophil count (ANC) (in /mm³)
Description

ANC absolute

Data type

integer

Platelets
Description

Platelets

Data type

integer

Measurement units
  • x 10E9/l
x 10E9/l
Study centre specific variables
Description

Study centre specific variables

CSC
Description

CSC

Data type

integer

Similar models

Status Day 30

  1. StudyEvent: SE
    1. Status Day 30
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Dummy
Item
Dummy
text
Item
Infection
integer
Code List
Infection
CL Item
No (1)
CL Item
Yes (2)
Item
Bacterial > CTCAE grade 2
integer
Code List
Bacterial > CTCAE grade 2
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Bacterial organism
Item
Bacterial organism
text
Item
Fungal > CTCAE grade 2
integer
Code List
Fungal > CTCAE grade 2
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Fungal organism
Item
Fungal organism
text
Item
Parasitic > CTCAE grade 2
integer
Code List
Parasitic > CTCAE grade 2
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Parasitic organism
Item
Parasitic organism
text
Item
Viral > CTCAE grade 2
integer
Code List
Viral > CTCAE grade 2
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Virus
Item
Virus
text
Item
Unknown > CTCAE grade 2
integer
Code List
Unknown > CTCAE grade 2
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Organism of unknown infection
Item
Organism of unknown infection
text
Item
EBV PCR performed
integer
Code List
EBV PCR performed
CL Item
No (1)
CL Item
Yes (2)
EBV PCR date
Item
EBV PCR date
date
EBV PCR value
Item
EBV PCR value
integer
Item
EBV LPD
integer
Code List
EBV LPD
CL Item
No (1)
CL Item
Yes (2)
Item
Fever
integer
Code List
Fever
CL Item
No (1)
CL Item
Yes (2)
Item
Malaise
integer
Code List
Malaise
CL Item
No (1)
CL Item
Yes (2)
Item
Weight loss
integer
Code List
Weight loss
CL Item
No (1)
CL Item
Yes (2)
Item
Mediastinal lymphnodes
integer
Code List
Mediastinal lymphnodes
CL Item
No (1)
CL Item
Yes (2)
Item
Abdominal lymphnodes
integer
Code List
Abdominal lymphnodes
CL Item
No (1)
CL Item
Yes (2)
Item
Inguinal lymphnodes
integer
Code List
Inguinal lymphnodes
CL Item
No (1)
CL Item
Yes (2)
Item
Axillary lymphnodes
integer
Code List
Axillary lymphnodes
CL Item
No (1)
CL Item
Yes (2)
Item
Cervical lymphnodes
integer
Code List
Cervical lymphnodes
CL Item
No (1)
CL Item
Yes (2)
Item
Gut
integer
Code List
Gut
CL Item
No (1)
CL Item
Yes (2)
Item
Lung
integer
Code List
Lung
CL Item
No (1)
CL Item
Yes (2)
Item
Tonsils
integer
Code List
Tonsils
CL Item
No (1)
CL Item
Yes (2)
Item
Other
integer
Code List
Other
CL Item
No (1)
CL Item
Yes (2)
Other site
Item
Other site
text
Item
Anti CD20 antibodies
integer
Code List
Anti CD20 antibodies
CL Item
No (1)
CL Item
Yes (2)
Item
Virustatic therapy
integer
Code List
Virustatic therapy
CL Item
No (1)
CL Item
Yes (2)
Item
Chemo therapy
integer
Code List
Chemo therapy
CL Item
No (1)
CL Item
Yes (2)
Item
Steroids
integer
Code List
Steroids
CL Item
No (1)
CL Item
Yes (2)
Item
Reduction of IST
integer
Code List
Reduction of IST
CL Item
No (1)
CL Item
Yes (2)
Item
Stop of IST
integer
Code List
Stop of IST
CL Item
No (1)
CL Item
Yes (2)
Item
Other
integer
Code List
Other
CL Item
No (1)
CL Item
Yes (2)
Other type of treatment
Item
Other type of treatment
text
Item
Hemorrhage > CTCAE grade 2
integer
Code List
Hemorrhage > CTCAE grade 2
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Item
Renal/Metabolic Lab., Creatinine > CTCAE grade 2
integer
Code List
Renal/Metabolic Lab., Creatinine > CTCAE grade 2
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Item
Hemodialysis or hemofiltration
integer
Code List
Hemodialysis or hemofiltration
CL Item
No (1)
CL Item
Yes (2)
Item
Fanconi syndrome
integer
Code List
Fanconi syndrome
CL Item
No (1)
CL Item
Yes (2)
Item
Nephrotic syndrome
integer
Code List
Nephrotic syndrome
CL Item
No (1)
CL Item
Yes (2)
Item
Other type of complication > CTCAE grade 2
integer
Code List
Other type of complication > CTCAE grade 2
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Type
Item
Type
text
Item Group
Item
Still regular PLT transfusions neccessary
integer
Code List
Still regular PLT transfusions neccessary
CL Item
No (1)
CL Item
Yes (2)
Item
Still regular RBC transfusions neccessary
integer
Code List
Still regular RBC transfusions neccessary
CL Item
No (1)
CL Item
Yes (2)
Date of last transfusion
Item
Date of last transfusion
date
Date of last transfusion
Item
Date of last transfusion
date
Date of specimen collection
Item
Date of specimen collection
date
Erythrocytes
Item
Erythrocytes
float
MCV
Item
MCV
integer
Hb value
Item
Hb value
float
Reticulocytes
Item
Reticulocytes
float
WBC
Item
WBC
float
ANC absolute
Item
Absolute neutrophil count (ANC) (in /mm³)
integer
Platelets
Item
Platelets
integer
Item
CSC
integer
Code List
CSC
CL Item
CR Def.A (1)
CL Item
CR Def.B (2)
CL Item
GPR (3)
CL Item
PPR (4)
CL Item
NR (5)
CL Item
Clonal evolution (6)
CL Item
Relapse (7)
CL Item
PNH disease (8)

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