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

Infektion
Description

Infection

Data type

integer

Bakteriell > CTCAE Grad 2
Description

Bacterial > CTCAE grade 2

Data type

integer

Bakterieller Organismus
Description

Bacterial organism

Data type

text

Fungal > CTCAE Grad 2
Description

Fungal > CTCAE grade 2

Data type

integer

Fungaler Organismus
Description

Fungal organism

Data type

text

Parasitär > CTCAE Grad 2
Description

Parasitic > CTCAE grade 2

Data type

integer

Parasitärer Organismus
Description

Parasitic organism

Data type

text

Viral > CTCAE Grad 2
Description

Viral > CTCAE grade 2

Data type

integer

Virus
Description

Virus

Data type

text

Unbekannt > CTCAE Grad 2
Description

Unknown > CTCAE grade 2

Data type

integer

Organismus der unbekannten Infektion
Description

Organism of unknown infection

Data type

text

Complications - EBV PCR
Description

Complications - EBV PCR

EBV PCR durchgeführt
Description

EBV PCR performed

Data type

integer

EBV PCR Datum
Description

EBV PCR date

Data type

date

EBV PCR Wert
Description

EBV PCR value

Data type

integer

Measurement units
  • Kopien/ml PB
Kopien/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

Fieber
Description

Fever

Data type

integer

Malaise
Description

Malaise

Data type

integer

Gewichtsverlust
Description

Weight loss

Data type

integer

Complications - EBV LPD site
Description

Complications - EBV LPD site

Mediastinale Lymphknoten
Description

Mediastinal lymphnodes

Data type

integer

Abdominale Lymphknoten
Description

Abdominal lymphnodes

Data type

integer

Inguinale Lymphknoten
Description

Inguinal lymphnodes

Data type

integer

Axiläre Lymphknoten
Description

Axillary lymphnodes

Data type

integer

Zervikale Lymphknoten
Description

Cervical lymphnodes

Data type

integer

Darm
Description

Gut

Data type

integer

Lunge
Description

Lung

Data type

integer

Tonsillen
Description

Tonsils

Data type

integer

Andere
Description

Other

Data type

integer

Andere Lokalisation
Description

Other site

Data type

text

Complications - EBV LPD treatment
Description

Complications - EBV LPD treatment

Anti CD20 Antikörper
Description

Anti CD20 antibodies

Data type

integer

Virustatische Therapie
Description

Virustatic therapy

Data type

integer

Chemotherapie
Description

Chemo therapy

Data type

integer

Steroide
Description

Steroids

Data type

integer

Reduktion der IST
Description

Reduction of IST

Data type

integer

Ende der IST
Description

Stop of IST

Data type

integer

Andere
Description

Other

Data type

integer

Andere Art der Behandlung
Description

Other type of treatment

Data type

text

Complications - Hemorrhage
Description

Complications - Hemorrhage

Blutung > CTCAE Grad 2
Description

Hemorrhage

Data type

integer

Complications - Renal/Metabolic Lab., Creatinine
Description

Complications - Renal/Metabolic Lab., Creatinine

Niere/Stoffwechsel, Kreatinin > CTCAE Grad 2
Description

Renal/Metabolic Lab., Creatinine

Data type

integer

Hämodialyse oder Hämofiltration
Description

Hemodialysis or hemofiltration

Data type

integer

Fanconi-Syndrom
Description

Fanconi syndrome

Data type

integer

Nephrotisches Syndrom
Description

Nephrotic syndrome

Data type

integer

Complications - Other type of complication
Description

Complications - Other type of complication

Andere Komplikation > CTCAE Grad 2
Description

Other type of complication

Data type

integer

Art
Description

Type

Data type

text

Transfusions
Description

Transfusions

Weiterhin regelmäßige Thrombozytentransfusionen notwendig
Description

Still PLT transfusion dependent

Data type

integer

Weiterhin regelmäßige Erythrozytentransfusionen notwendig
Description

Still RBC transfusion dependent

Data type

integer

Transfusion PLT
Description

Transfusion PLT

Datum der letzten Transfusion
Description

Date of last transfusion

Data type

date

Transfusion RBC
Description

Transfusion RBC

Datum der letzten Transfusion
Description

Date of last transfusion

Data type

date

Complete blood count
Description

Complete blood count

Abnahmedatum des peripheren Bluts
Description

Date of specimen collection

Data type

date

Erythrozyten
Description

Erythrocytes

Data type

float

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

MCV

Data type

integer

Measurement units
  • fL
fL
Hb Wert
Description

Hb value

Data type

float

Measurement units
  • g/dl
g/dl
Retikulozyten
Description

Reticulocytes

Data type

float

Measurement units
Leukozyten
Description

WBC

Data type

float

Measurement units
  • x 10E9/l
x 10E9/l
Absolute Neutrophilenanzahl (in /mm³)
Description

ANC absolute

Data type

integer

Thrombozyten
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
Infektion
integer
Code List
Infektion
CL Item
Nein (1)
CL Item
Ja (2)
Item
Bakteriell > CTCAE Grad 2
integer
Code List
Bakteriell > CTCAE Grad 2
CL Item
Nein (1)
CL Item
CTCAE Grad 3 (3)
CL Item
CTCAE Grad 4 (4)
Bacterial organism
Item
Bakterieller Organismus
text
Item
Fungal > CTCAE Grad 2
integer
Code List
Fungal > CTCAE Grad 2
CL Item
Nein (1)
CL Item
CTCAE Grad 3 (3)
CL Item
CTCAE Grad 4 (4)
Fungal organism
Item
Fungaler Organismus
text
Item
Parasitär > CTCAE Grad 2
integer
Code List
Parasitär > CTCAE Grad 2
CL Item
Nein (1)
CL Item
CTCAE Grad 3 (3)
CL Item
CTCAE Grad 4 (4)
Parasitic organism
Item
Parasitärer Organismus
text
Item
Viral > CTCAE Grad 2
integer
Code List
Viral > CTCAE Grad 2
CL Item
Nein (1)
CL Item
CTCAE Grad 3 (3)
CL Item
CTCAE Grad 4 (4)
Virus
Item
Virus
text
Item
Unbekannt > CTCAE Grad 2
integer
Code List
Unbekannt > CTCAE Grad 2
CL Item
Nein (1)
CL Item
CTCAE Grad 3 (3)
CL Item
CTCAE Grad 4 (4)
Organism of unknown infection
Item
Organismus der unbekannten Infektion
text
Item
EBV PCR durchgeführt
integer
Code List
EBV PCR durchgeführt
CL Item
Nein (1)
CL Item
Ja (2)
EBV PCR date
Item
EBV PCR Datum
date
EBV PCR value
Item
EBV PCR Wert
integer
Item
EBV LPD
integer
Code List
EBV LPD
CL Item
Nein (1)
CL Item
Ja (2)
Item
Fieber
integer
Code List
Fieber
CL Item
Nein (1)
CL Item
Ja (2)
Item
Malaise
integer
Code List
Malaise
CL Item
Nein (1)
CL Item
Ja (2)
Item
Gewichtsverlust
integer
Code List
Gewichtsverlust
CL Item
Nein (1)
CL Item
Ja (2)
Item
Mediastinale Lymphknoten
integer
Code List
Mediastinale Lymphknoten
CL Item
Nein (1)
CL Item
Ja (2)
Item
Abdominale Lymphknoten
integer
Code List
Abdominale Lymphknoten
CL Item
Nein (1)
CL Item
Ja (2)
Item
Inguinale Lymphknoten
integer
Code List
Inguinale Lymphknoten
CL Item
Nein (1)
CL Item
Ja (2)
Item
Axiläre Lymphknoten
integer
Code List
Axiläre Lymphknoten
CL Item
Nein (1)
CL Item
Ja (2)
Item
Zervikale Lymphknoten
integer
Code List
Zervikale Lymphknoten
CL Item
Nein (1)
CL Item
Ja (2)
Item
Darm
integer
Code List
Darm
CL Item
Nein (1)
CL Item
Ja (2)
Item
Lunge
integer
Code List
Lunge
CL Item
Nein (1)
CL Item
Ja (2)
Item
Tonsillen
integer
Code List
Tonsillen
CL Item
Nein (1)
CL Item
Ja (2)
Item
Andere
integer
Code List
Andere
CL Item
Nein (1)
CL Item
Ja (2)
Other site
Item
Andere Lokalisation
text
Item
Anti CD20 Antikörper
integer
Code List
Anti CD20 Antikörper
CL Item
Nein (1)
CL Item
Ja (2)
Item
Virustatische Therapie
integer
Code List
Virustatische Therapie
CL Item
Nein (1)
CL Item
Ja (2)
Item
Chemotherapie
integer
Code List
Chemotherapie
CL Item
Nein (1)
CL Item
Ja (2)
Item
Steroide
integer
Code List
Steroide
CL Item
Nein (1)
CL Item
Ja (2)
Item
Reduktion der IST
integer
Code List
Reduktion der IST
CL Item
Nein (1)
CL Item
Ja (2)
Item
Ende der IST
integer
Code List
Ende der IST
CL Item
Nein (1)
CL Item
Ja (2)
Item
Andere
integer
Code List
Andere
CL Item
Nein (1)
CL Item
Ja (2)
Other type of treatment
Item
Andere Art der Behandlung
text
Item
Blutung > CTCAE Grad 2
integer
Code List
Blutung > CTCAE Grad 2
CL Item
Nein (1)
CL Item
CTCAE Grad 3 (3)
CL Item
CTCAE Grad 4 (4)
Item
Niere/Stoffwechsel, Kreatinin > CTCAE Grad 2
integer
Code List
Niere/Stoffwechsel, Kreatinin > CTCAE Grad 2
CL Item
Nein (1)
CL Item
CTCAE Grad 3 (3)
CL Item
CTCAE Grad 4 (4)
Item
Hämodialyse oder Hämofiltration
integer
Code List
Hämodialyse oder Hämofiltration
CL Item
Nein (1)
CL Item
Ja (2)
Item
Fanconi-Syndrom
integer
Code List
Fanconi-Syndrom
CL Item
Nein (1)
CL Item
Ja (2)
Item
Nephrotisches Syndrom
integer
Code List
Nephrotisches Syndrom
CL Item
Nein (1)
CL Item
Ja (2)
Item
Andere Komplikation > CTCAE Grad 2
integer
Code List
Andere Komplikation > CTCAE Grad 2
CL Item
Nein (1)
CL Item
CTCAE Grad 3 (3)
CL Item
CTCAE Grad 4 (4)
Type
Item
Art
text
Item Group
Item
Weiterhin regelmäßige Thrombozytentransfusionen notwendig
integer
Code List
Weiterhin regelmäßige Thrombozytentransfusionen notwendig
CL Item
Nein (1)
CL Item
Ja (2)
Item
Weiterhin regelmäßige Erythrozytentransfusionen notwendig
integer
Code List
Weiterhin regelmäßige Erythrozytentransfusionen notwendig
CL Item
Nein (1)
CL Item
Ja (2)
Date of last transfusion
Item
Datum der letzten Transfusion
date
Date of last transfusion
Item
Datum der letzten Transfusion
date
Date of specimen collection
Item
Abnahmedatum des peripheren Bluts
date
Erythrocytes
Item
Erythrozyten
float
MCV
Item
MCV
integer
Hb value
Item
Hb Wert
float
Reticulocytes
Item
Retikulozyten
float
WBC
Item
Leukozyten
float
ANC absolute
Item
Absolute Neutrophilenanzahl (in /mm³)
integer
Platelets
Item
Thrombozyten
integer
Item
CSC
integer
Code List
CSC
CL Item
Komplette Remission Def.A (1)
CL Item
Komplette Remission Def.B (2)
CL Item
Gute Teilremission (3)
CL Item
Schlechte Teilremission (4)
CL Item
keine Remission (5)
CL Item
Clonal evolution (6)
CL Item
Rezidiv (7)
CL Item
PNH Erkrankung (8)

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