ID

5350

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 Severe complications till day +100 DRKS00003789

Severe complications till day +100

Show identification of patient
Description

Show identification of patient

Dummy
Description

Dummy

Data type

text

Severe infection occurred
Description

Severe infection occurred

Infection occurred
Description

Infection occurred

Data type

integer

Severe pulmonary complications
Description

Severe pulmonary complications

Radiologic changes and/or oxygen support
Description

Radiologic changes and/or oxygen support

Data type

integer

Mechanical ventilation
Description

Mechanical ventilation

Data type

integer

Severe cardio-vascular complications
Description

Severe cardio-vascular complications

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 renal complications
Description

Severe renal complications

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

Severe hepatic complications
Description

Severe hepatic complications

Relevant bilirubine elevation > CTCAE grade 2
Description

Relevant bilirubine elevation

Data type

integer

VOD
Description

VOD

VOD
Description

VOD

Data type

integer

Severe neurological complications
Description

Severe neurological complications

Leukencephalopathy
Description

Leukencephalopathy

Data type

integer

CNS hemorrhage
Description

CNS hemorrhage

Data type

integer

Seizures
Description

Seizures

Data type

integer

Severe gastrointestinal complications
Description

Severe gastrointestinal complications

Ileus
Description

Ileus

Data type

integer

Gastrointestinal hemorrhage
Description

Gastrointestinal hemorrhage

Data type

integer

Other severe complications
Description

Other severe complications

Other severe complication(s)
Description

Other severe complication(s)

Data type

integer

Other severe complication(s) specified
Description

Other severe complication(s) specified

Data type

text

Similar models

Severe complications till day +100

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Dummy
Item
Dummy
text
Item
Infection occurred
integer
Code List
Infection occurred
CL Item
No (1)
CL Item
Yes (2)
Item
Radiologic changes and/or oxygen support
integer
Code List
Radiologic changes and/or oxygen support
CL Item
No (1)
CL Item
Yes (2)
Item
Mechanical ventilation
integer
Code List
Mechanical ventilation
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
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
Relevant bilirubine elevation > CTCAE grade 2
integer
Code List
Relevant bilirubine elevation > CTCAE grade 2
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Item Group
Item
VOD
integer
Code List
VOD
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
Ileus
integer
Code List
Ileus
CL Item
No (1)
CL Item
Yes (2)
Item
Gastrointestinal hemorrhage
integer
Code List
Gastrointestinal hemorrhage
CL Item
No (1)
CL Item
Yes (2)
Item
Other severe complication(s)
integer
Code List
Other severe complication(s)
CL Item
No (1)
CL Item
Yes (2)
Other severe complication(s) specified
Item
Other severe complication(s) specified
text

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