ID

11217

Description

EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Link

http://clinicaltrials.gov/ct2/show/NCT00824083

Keywords

  1. 8/4/14 8/4/14 - Martin Dugas
  2. 6/25/15 6/25/15 - Martin Dugas
Uploaded on

June 25, 2015

DOI

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License

Creative Commons BY 4.0

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Ewing Study DRKS00003588

Add-on R1

  1. StudyEvent: SE
    1. Add-on R1
Body dimensions
Description

Body dimensions

Body height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI-1
C0005890
cm
Body weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI-1
C0005910
kg
Body surface area
Description

BSA

Data type

float

Measurement units
Alias
UMLS CUI-1
C0005902
BSA calculated
Description

BSA calculated

Data type

float

Measurement units
Alias
UMLS CUI-1
C0005902
Patient < 1 Year or < 10 kg
Description

Patient younger than 1 year or weight under 10 kg

Data type

boolean

Add-on Kurs
Description

Add-on Kurs

Day 1 of this course
Description

Day 1 of course

Data type

date

Course no. (please read help text!)
Description

Number of course

Data type

integer

Delay?
Description

Delay

Data type

integer

Alias
UMLS CUI-1
C0205421
Schedule deviation in this course
Description

Schedule deviation

Data type

integer

Zoledron acid
Description

Zoledronic acid

Data type

float

Measurement units
  • mg
Alias
UMLS CUI-1
C0257685
mg
Dose Zoledron acid acc. to protocol
Description

Zoledron acid dose acc. to protocol

Data type

float

Measurement units
  • mg
mg
Concurrent radiotherapy
Description

Concurrent radiotherapy

Data type

boolean

Schedule deviation CTC-Code
Description

Schedule deviation CTC-Code

Reason for schedule deviation
Description

Reason for schedule deviation CTC-code

Data type

integer

Alias
UMLS CUI-1
C1705236
UMLS CUI-2
C0566251

Similar models

Add-on R1

  1. StudyEvent: SE
    1. Add-on R1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Height
Item
Body height
integer
C0005890 (UMLS CUI-1)
Weight
Item
Body weight
float
C0005910 (UMLS CUI-1)
BSA
Item
Body surface area
float
C0005902 (UMLS CUI-1)
BSA calculated
Item
BSA calculated
float
C0005902 (UMLS CUI-1)
Patient younger than 1 year or weight under 10 kg
Item
Patient < 1 Year or < 10 kg
boolean
Item Group
Day 1 of course
Item
Day 1 of this course
date
Number of course
Item
Course no. (please read help text!)
integer
Item
Delay?
integer
C0205421 (UMLS CUI-1)
Code List
Delay?
CL Item
No (0)
CL Item
Yes, due to toxicity of previous course (1)
CL Item
Yes, due to other reasons (2)
Item
Schedule deviation in this course
integer
Code List
Schedule deviation in this course
CL Item
No (0)
CL Item
Yes (1)
Zoledronic acid
Item
Zoledron acid
float
C0257685 (UMLS CUI-1)
Zoledron acid dose acc. to protocol
Item
Dose Zoledron acid acc. to protocol
float
Concurrent radiotherapy
Item
Concurrent radiotherapy
boolean
Item
Reason for schedule deviation
integer
C1705236 (UMLS CUI-1)
C0566251 (UMLS CUI-2)
Code List
Reason for schedule deviation
CL Item
General condition (1)
CL Item
Tox. Haemoglobin (11)
CL Item
Tox. WBC (12)
CL Item
Tox. Granulocytes (13)
CL Item
Tox. Platelets (14)
CL Item
Tox. Infection (21)
CL Item
Tox. Fever (22)
CL Item
Tox. Stomatitis (31)
CL Item
Tox. Vomiting (32)
CL Item
Tox. Diarrhoea (33)
CL Item
Tox. Changes in the skin (40)
CL Item
Tox. Creatinine (51)
CL Item
Tox. Proteinuria (52)
CL Item
Tox. Haematuria (53)
CL Item
Tox. Glomerular filtration rate (GFR) (54)
CL Item
Tox. Tubular phosphate reabsorption (55)
CL Item
Tox. Bilirubin (61)
CL Item
Tox. SGOT/SGPT (62)
CL Item
Tox. Cardiac function (71)
CL Item
Tox. ECHO: LV-SF (72)
CL Item
Tox. Central neurotoxicity (81)
CL Item
Tox. Peripheral neurotoxicity (82)
CL Item
Tox. Other toxicity (90)
CL Item
Techical problems (93)
CL Item
Planning problems (94)
CL Item
Patients'/Parents' refusal (95)
CL Item
To little weight/to young (96)
CL Item
Mistake (97)
CL Item
Mobilisation course (98)
CL Item
Radiotherapy (99)
CL Item
Problem of medication (0)
CL Item
Post transplantation course (102)
CL Item
Physician choice/clinical decision (use only if not related to another “good” reason that has it’s own code) (103)
CL Item
Post amputation (104)

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