Information:
Fel:
ID
5332
Beskrivning
Prospective non–randomized multicenter 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/
Länk
http://clinicaltrials.gov/ct2/show/NCT00662090
Nyckelord
Versioner (1)
- 2014-08-05 2014-08-05 - Martin Dugas
Uppladdad den
5 augusti 2014
DOI
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Licens
Creative Commons BY 4.0
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EWOG MDS 2006 IST FUP {0} DRKS00003789
Similar models
IST FUP {0}
- StudyEvent: SE
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Dummy
Item
Dummy
text
CL Item
Day 31-60 (2)
CL Item
Day 61-90 (3)
CL Item
Day 91-120 (4)
CL Item
Day 121-180 (5)
CL Item
Day 181-240 (6)
CL Item
Day 241-270 (7)
CL Item
Day 271-360 (8)
CL Item
Semi annual after year 1 (9)
Semi annual (months)
Item
Semi annual (number of months)
integer
CL Item
No (1)
CL Item
Yes (2)
Reason for steroids
Item
Reason for steroids
text
Date of last dose
Item
Date of last dose
date
CL Item
No (1)
CL Item
Yes (2)
CL Item
CR (1)
CL Item
NR (2)
CL Item
Toxicity (3)
CL Item
Other reason (99)
Other reason
Item
Other reason
text
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
Date of first tapering
Item
Date of first tapering
date
CL Item
No (1)
CL Item
Yes (2)
Date of last dose
Item
Date of last dose
date
CL Item
CR (1)
CL Item
NR (2)
CL Item
Toxicity (3)
CL Item
Other reason (99)
Other reason
Item
Other reason
text
CL Item
No (1)
CL Item
Yes (2)
Date of restart
Item
Date of restart
date
Reason for restarting CSA
Item
Reason for restarting CSA
text
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
Date of first tapering
Item
Date of first tapering
date
Date of last dose
Item
Date of last dose
date
Total dose since day 31
Item
Total dose since day 31
integer
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Bacterial organism
Item
Bacterial organism
text
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Fungal organism
Item
Fungal organism
text
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Parasitic organism
Item
Parasitic organism
text
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Virus
Item
Virus
text
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
CL Item
No (1)
CL Item
Yes (2)
EBV PCR date
Item
EBV PCR date
date
EBV PCR value
Item
EBV PCR value
integer
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
Other site
Item
Other site
text
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
Other type of treatment
Item
Other type of treatment
text
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
Yes (2)
CL Item
No (1)
CL Item
CTCAE grade 3 (3)
CL Item
CTCAE grade 4 (4)
Type
Item
Type
text
CL Item
No (1)
CL Item
Yes (2)
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
CL Item
Complete response (1)
CL Item
Partial response (3)
CL Item
Non response (4)
CL Item
Clonal evolution (5)
CL Item
Relapse (6)
CL Item
PNH disease (7)
Date
Item
Date
date
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)