ID

5450

Description

Genetische und immunologische Charakterisierung der schweren aplastischen Anaemie (SAA) bei Kindern und Jugendlichen (EWOG-SAA) http://ewog-mds.org/

Link

http://ewog-mds.org/

Keywords

  1. 8/6/14 8/6/14 - Martin Dugas
Uploaded on

August 6, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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EWOG SAA Status at HSCT

Status at HSCT

  1. StudyEvent: SE
    1. Status at HSCT
Show identification of patient
Description

Show identification of patient

Dummy
Description

Dummy

Data type

text

Body measurements
Description

Body measurements

Body height
Description

Body height

Data type

integer

Measurement units
  • cm
cm
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
kg
Body surface area (BSA)
Description

Body surface area (BSA)

Data type

float

Measurement units
BSA calculated
Description

BSA calculated

Data type

float

Measurement units
Performance status (Karnofsky/Lansky)
Description

Performance status (Karnofsky/Lansky)

Date of assessment
Description

Date of assessment

Data type

date

Score Karnofsky/Lansky
Description

Score Karnofsky/Lansky

Data type

integer

Therapy (SAA specific)
Description

Therapy (SAA specific)

Cyclosporin A
Description

Cyclosporin A

Data type

integer

Date of last dose
Description

Date of last dose

Data type

date

Other immunosuppressive therapy
Description

Other immunosuppressive therapy

Data type

integer

Type of other therapy
Description

Type of other therapy

Data type

text

Clinical data at HSCT (SAA specific)
Description

Clinical data at HSCT (SAA specific)

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

Clinical data at HSCT (SAA specific) - Organ dysfunction
Description

Clinical data at HSCT (SAA specific) - Organ dysfunction

Severe cardio-vascular complications
Description

Cardiac / circulatory

Data type

integer

Shortening fraction < 25 %
Description

Shortening fraction < 25 %

Data type

integer

Inotropic support with catecholamines
Description

Inotropic support with catecholamines

Data type

integer

Anti-arrhythmic therapy
Description

Anti-arrhythmic therapy

Data type

integer

Severe hepatic complications
Description

Severe hepatic complications

Data type

integer

Type
Description

Type

Data type

text

CTCAE grade
Description

CTCAE grade

Data type

integer

Relevant Bilirubine elevation > CTCAE grade 2
Description

Relevant Bilirubine elevation > CTCAE grade 2

Data type

integer

S-GOT/S-GPT elevation
Description

S-GOT/S-GPT elevation

Data type

integer

Leukencephalopathy
Description

Leukencephalopathy

Data type

integer

CNS hemorrhage
Description

CNS hemorrhage

Data type

integer

Seizures
Description

Seizures

Data type

integer

Relevant creatinine elevation > CTCAE grade 2
Description

Relevant creatinine elevation

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

Other type of dysfunction
Description

Other type of dysfunction

Data type

integer

Type
Description

Type

Data type

text

CTCAE grade
Description

CTCAE grade

Data type

integer

Hematology (SAA specific)
Description

Hematology (SAA specific)

Regular RBC transfusions neccessary
Description

Transfusion RBC

Data type

integer

Regular PLT transfusions neccessary
Description

Transfusion PLT

Data type

integer

Granulocyte transfusion
Description

Granulocyte transfusion

Data type

integer

Date of specimen collection
Description

Date of specimen collection

Data type

date

Hb value
Description

Hb value

Data type

float

Measurement units
  • g/dl
g/dl
MCV
Description

MCV

Data type

integer

Measurement units
  • fL
fL
Platelets
Description

Platelets

Data type

integer

Measurement units
  • x 10E9/l
x 10E9/l
WBC
Description

WBC

Data type

float

Measurement units
  • x 10E9/l
x 10E9/l
Neutrophils
Description

ANC in %

Data type

integer

Measurement units
  • %
%
Erythrocytes
Description

Erythrocytes

Data type

float

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

Reticulocytes

Data type

float

Measurement units
Lowest ANC before HSCT (for primary HSCT only)
Description

Lowest ANC before HSCT (for primary HSCT only)

Data type

integer

Measurement units
  • /mm³
/mm³
Disease status at HSCT
Description

Disease status at HSCT

Disease status at HSCT
Description

Disease status at HSCT

Data type

integer

Chronolog. no. of this CR
Description

Chronolog. no. of this CR

Data type

integer

Chronolog. no. of this PR
Description

Chronolog. no. of this PR

Data type

integer

Secondary malignancy
Description

Secondary malignancy

Data type

integer

Similar models

Status at HSCT

  1. StudyEvent: SE
    1. Status at HSCT
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Dummy
Item
Dummy
text
Body height
Item
Body height
integer
Body weight
Item
Body weight
float
Body surface area (BSA)
Item
Body surface area (BSA)
float
BSA calculated
Item
BSA calculated
float
Date of assessment
Item
Date of assessment
date
Item
Score Karnofsky/Lansky
integer
Code List
Score Karnofsky/Lansky
CL Item
100% (100)
CL Item
90% (90)
CL Item
80% (80)
CL Item
70% (70)
CL Item
60% (60)
CL Item
50% (50)
CL Item
40% (40)
CL Item
30% (30)
CL Item
20% (20)
CL Item
10% (10)
Item
Cyclosporin A
integer
Code List
Cyclosporin A
CL Item
Not given (1)
CL Item
Ongoing (2)
CL Item
Stopped (3)
Date of last dose
Item
Date of last dose
date
Item
Other immunosuppressive therapy
integer
Code List
Other immunosuppressive therapy
CL Item
No (1)
CL Item
Yes (2)
Type of other therapy
Item
Type of other therapy
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
Severe cardio-vascular complications
integer
Code List
Severe cardio-vascular complications
CL Item
No (1)
CL Item
Yes (2)
Item
Shortening fraction < 25 %
integer
Code List
Shortening fraction < 25 %
CL Item
No (1)
CL Item
Yes (2)
Item
Inotropic support with catecholamines
integer
Code List
Inotropic support with catecholamines
CL Item
No (1)
CL Item
Yes (2)
Item
Anti-arrhythmic therapy
integer
Code List
Anti-arrhythmic therapy
CL Item
No (1)
CL Item
Yes (2)
Item
Severe hepatic complications
integer
Code List
Severe hepatic complications
CL Item
No (1)
CL Item
Yes (2)
Type
Item
Type
text
Item
CTCAE grade
integer
Code List
CTCAE grade
CL Item
CTCAE grade 1 (1)
CL Item
CTCAE grade 2 (2)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Item
Relevant Bilirubine elevation > CTCAE grade 2
integer
Code List
Relevant Bilirubine elevation > CTCAE grade 2
CL Item
No (1)
CL Item
Yes (2)
Item
S-GOT/S-GPT elevation
integer
Code List
S-GOT/S-GPT elevation
CL Item
No (1)
CL Item
Yes (2)
Item
Leukencephalopathy
integer
Code List
Leukencephalopathy
CL Item
No (1)
CL Item
Yes (2)
Item
CNS hemorrhage
integer
Code List
CNS hemorrhage
CL Item
No (1)
CL Item
Yes (2)
Item
Seizures
integer
Code List
Seizures
CL Item
No (1)
CL Item
Yes (2)
Item
Relevant creatinine elevation > CTCAE grade 2
integer
Code List
Relevant creatinine elevation > 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 dysfunction
integer
Code List
Other type of dysfunction
CL Item
No (1)
CL Item
Yes (2)
Type
Item
Type
text
Item
CTCAE grade
integer
Code List
CTCAE grade
CL Item
CTCAE grade 1 (1)
CL Item
CTCAE grade 2 (2)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Item
Regular RBC transfusions neccessary
integer
Code List
Regular RBC transfusions neccessary
CL Item
No (1)
CL Item
Yes (2)
Item
Regular PLT transfusions neccessary
integer
Code List
Regular PLT transfusions neccessary
CL Item
No (1)
CL Item
Yes (2)
Item
Granulocyte transfusion
integer
Code List
Granulocyte transfusion
CL Item
No (1)
CL Item
Yes (2)
Date of specimen collection
Item
Date of specimen collection
date
Hb value
Item
Hb value
float
MCV
Item
MCV
integer
Platelets
Item
Platelets
integer
WBC
Item
WBC
float
ANC in %
Item
Neutrophils
integer
Erythrocytes
Item
Erythrocytes
float
Reticulocytes
Item
Reticulocytes
float
Lowest ANC before HSCT (for primary HSCT only)
Item
Lowest ANC before HSCT (for primary HSCT only)
integer
Item
Disease status at HSCT
integer
Code List
Disease status at HSCT
CL Item
Complete remission (CR) (1)
CL Item
Partial remission (PR) (2)
CL Item
Refractory disease / Primary induction failure / never in remission (3)
CL Item
Relapse/Progression (4)
CL Item
Untreated (Upfront) (5)
Chronolog. no. of this CR
Item
Chronolog. no. of this CR
integer
Chronolog. no. of this PR
Item
Chronolog. no. of this PR
integer
Item
Secondary malignancy
integer
Code List
Secondary malignancy
CL Item
No (1)
CL Item
Yes (2)

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