ID

5258

Description

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

Link

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

Keywords

Versions (3)
  1. 8/4/14 8/4/14 - Martin Dugas
  2. 6/25/15 6/25/15 - Martin Dugas
  3. 7/25/15 7/25/15 - Martin Dugas
Uploaded on

August 4, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Ewing Study VIDE course

German English

VIDE course

1 forms  
  1. StudyEvent: SE
    1. VIDE course
Show identification of patient
Description

Show identification of patient

Patient
Description

Dummy item in ItemGroup 'Display patient'

Data type

text

Body dimensions
Description

Body dimensions

Body height
Description

Height

Data type

integer

Measurement units
  • cm
cm
Body weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
Body surface area
Description

BSA

Data type

float

Measurement units
  • m²
m²
BSA calculated
Description

BSA calculated

Data type

float

Measurement units
  • m²
m²
Patient < 1 Year or < 10 kg
Description

Patient younger than 1 year or weight under 10 kg

Data type

integer

VIDE course
Description

VIDE course

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 >5 days
Description

Delay of course > 5 days

Data type

integer

Concurrent radiotherapy
Description

Concurrent radiotherapy

Data type

integer

Schedule deviation in this course
Description

Schedule deviation

Data type

integer

Schedule deviation CTC-Code
Description

Schedule deviation CTC-Code

Reason for schedule deviation
Description

Reason for schedule deviation CTC-code

Data type

integer

VIDE adminstration of chemotherapy
Description

VIDE adminstration of chemotherapy

Vincristine (VCR) cumulative dose per course
Description

VCR cumulative dose per course

Data type

float

Measurement units
  • mg
mg
Vincristine (VCR) cumulative dose per course acc. to protocol
Description

VCR cumulative dose per course according to protocol

Data type

float

Measurement units
  • mg
mg
Ifosfamide (IFO) cumulative dose per course
Description

IFO cumulative dose per course

Data type

integer

Measurement units
  • mg
mg
Ifosfamide (IFO) cumulative dose per course acc. to protocol
Description

IFO cumulative dose per course according to protocol

Data type

integer

Measurement units
  • mg
mg
Doxorubicin (DOXO) cumulative dose per course
Description

DOXO cumulative dose per course

Data type

integer

Measurement units
  • mg
mg
Doxorubicin (DOXO) cumulative dose per course acc. to protocol
Description

DOXO cumulative dose per course acc. to protocol

Data type

integer

Measurement units
  • mg
mg
Etoposide (ETO) cumulative dose per course
Description

ETO cumulative dose per course

Data type

integer

Measurement units
  • mg
mg
Etoposide (ETO) cumulative dose per course acc. to protocol
Description

ETO cumulative dose per course acc. to protocol

Data type

integer

Measurement units
  • mg
mg
CYC substituted for IFO
Description

CYC substituted for IFO

Data type

integer

Other drug substitution
Description

Other drug substitution

Data type

integer

VIDE adminstration of CYC
Description

VIDE adminstration of CYC

Cyclophosphamide (CYC) cumulative dose per course
Description

CYC cumulative dose per course

Data type

integer

Measurement units
  • mg
mg
Cyclophosphamide (CYC) cumulative dose per course acc. to protocol
Description

CYC cumulative dose per course acc. to protocol

Data type

integer

Measurement units
  • mg
mg
VIDE Other drug substitution
Description

VIDE Other drug substitution

Generic drug name
Description

Generic Name

Data type

text

Other generic, specifiy
Description

Generic name specified

Data type

text

Cumulative dose per course
Description

Other drug cumulative dose per course

Data type

float

Measurement units
  • mg
mg
Supportive drug treatment
Description

Supportive drug treatment

G-CSF/GM-CSF
Description

G-CSF/GM-CSF verabreicht

Data type

integer

Other cytokine treatment (e.g. EPO)
Description

Other cytokine treatment

Data type

integer

Other cytokine spcified
Description

Other cytokine spcified

Data type

text

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Similar models

VIDE course

1 forms
  1. StudyEvent: SE
    1. VIDE course
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Dummy item in ItemGroup 'Display patient'
Item
Patient
text
Height
Item
Body height
integer
Weight
Item
Body weight
float
BSA
Item
Body surface area
float
BSA calculated
Item
BSA calculated
float
Item
Patient < 1 Year or < 10 kg
integer
NoYes
Code List
Patient < 1 Year or < 10 kg
CL Item
No (0)
CL Item
Yes (1)
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 >5 days
integer
Course delay
Code List
Delay >5 days
CL Item
No (0)
CL Item
Yes, due to toxicity of previous course (1)
CL Item
Yes, due to other reasons (2)
Item
Concurrent radiotherapy
integer
NoYes
Code List
Concurrent radiotherapy
CL Item
No (0)
CL Item
Yes (1)
Item
Schedule deviation in this course
integer
NoYes
Code List
Schedule deviation in this course
CL Item
No (0)
CL Item
Yes (1)
Item
Reason for schedule deviation
integer
CTC code
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)
VCR cumulative dose per course
Item
Vincristine (VCR) cumulative dose per course
float
VCR cumulative dose per course according to protocol
Item
Vincristine (VCR) cumulative dose per course acc. to protocol
float
IFO cumulative dose per course
Item
Ifosfamide (IFO) cumulative dose per course
integer
IFO cumulative dose per course according to protocol
Item
Ifosfamide (IFO) cumulative dose per course acc. to protocol
integer
DOXO cumulative dose per course
Item
Doxorubicin (DOXO) cumulative dose per course
integer
DOXO cumulative dose per course acc. to protocol
Item
Doxorubicin (DOXO) cumulative dose per course acc. to protocol
integer
ETO cumulative dose per course
Item
Etoposide (ETO) cumulative dose per course
integer
ETO cumulative dose per course acc. to protocol
Item
Etoposide (ETO) cumulative dose per course acc. to protocol
integer
Item
CYC substituted for IFO
integer
NoYes
Code List
CYC substituted for IFO
CL Item
No (0)
CL Item
Yes (1)
Item
Other drug substitution
integer
NoYes
Code List
Other drug substitution
CL Item
No (0)
CL Item
Yes (1)
CYC cumulative dose per course
Item
Cyclophosphamide (CYC) cumulative dose per course
integer
CYC cumulative dose per course acc. to protocol
Item
Cyclophosphamide (CYC) cumulative dose per course acc. to protocol
integer
Item
Generic drug name
text
Generic Name
Code List
Generic drug name
CL Item
Aclarubicin (1)
CL Item
Actinomycin D (Dactinomycin) (3)
CL Item
Alemtuzumab (62)
CL Item
Amsacrine (Acridinyl, Anisidide, m-AMSA, AMSA, Amsidyl) (4)
CL Item
Antibody 14G2a (14G2a)
CL Item
Antibody ch14.18 (CH1418)
CL Item
Antithymozyten globuline (ATG)
CL Item
Asparaginase (L-asparaginase, Colaspase, L-ASP, Crasnitin, Elspar) (6)
CL Item
Azacytidine (12)
CL Item
Beclomethasone (BEC)
CL Item
Bleomycin (14)
CL Item
Budesonide (59)
CL Item
Busulfan (Busulphan, Busulfanum, Myelosan, BSF) (15)
CL Item
Carboplatin (CBDCA, JM8, NSC 241240) (16)
CL Item
Carmustine (BCNU, 1,3-bis(2-chloroethyl)-l-nitrosourea) (13)
CL Item
Chlorambucil (Chlorambucilum, NSC-3088, WR-139013, Chlorbutinum) (19)
CL Item
Ciclosporin (Cyclosporin) (21)
CL Item
Cisplatin, (Cis-platinum, cis-diamminedichloroplatinum, CDDP, DDP, CIS, Platinum) (22)
CL Item
Cladribine (CdA, 2-CdA, 2-chloro-2'-deoxyadenosine, NSC-105014-F) (18)
CL Item
Coli Asparaginase (9)
CL Item
Dexamethasone (23)
CL Item
Co-trimoxazol (93)
CL Item
Cyclophosphamide (Cyclo, CPA, CPM, CTX, CYC, CYT) (20)
CL Item
Cytarabine (Cytosine Arabinoside, Ara-C, Arabinosylcytosine) (5)
CL Item
Dacarbazine (DIC, Imidazole carboxamide, dimethyl-triazeno-imidazole-carboxamide) (26)
CL Item
Daunorubicin (daunomycin, DNR, rubidomycin) (24)
CL Item
Daunoxome (56)
CL Item
Doxorubicin (Adriamycin, Hydroxyl daunorubicin, Dox, Adria) (25)
CL Item
Epirubicin (4'-epi-doxorubicin, NSC-256942, IMI28, epi DX) (27)
CL Item
Epoetin alfa (Erythropoetin) (ERYPOa)
CL Item
Epoetin beta (Erythropoetin) (ERYPOb)
CL Item
Erwinia-Asparaginase (NSC-106977, Porton Asparaginase) (10)
CL Item
Etanercept (ETAN)
CL Item
Etoposide (VP-16, VP-16-213, EPEG, EPE, epipodophyllotoxin) (55)
CL Item
Fludarabine (2-F-ara-AMP, FAMP, NSC-312887, Fludarabine phosphate) (28)
CL Item
Fluorouracil (5-Fluorouracil, 5FU) (29)
CL Item
Folinic Acid (LV, calcium leucovorin, calcium folinate, citrovorum factor) (37)
CL Item
G-CSF (30)
CL Item
GM-CSF (31)
CL Item
Hydrocortisone (94)
CL Item
Hydroxyurea (32)
CL Item
Idarubicin (33)
CL Item
Ifosfamide (36)
CL Item
Imatinib (STI571)
CL Item
Immunglobuline (human) (60)
CL Item
Interferon ALPHA (34)
CL Item
Interferon GAMMA (35)
CL Item
Interleukin 1 (IL1)
CL Item
Interleukin 12 (IL12)
CL Item
Interleukin 13 (IL13)
CL Item
Interleukin 2 (IL2)
CL Item
Interleukin 3 (IL3)
CL Item
Interleukin 4 (IL4)
CL Item
Interleukin 6 (IL6)
CL Item
Interleukin 7 (IL7)
CL Item
Interleukin 8 (IL8)
CL Item
Lomustine (17)
CL Item
Mechlorethamine (38)
CL Item
Melphalan (39)
CL Item
Mitomycin (MIT)
CL Item
Monoclonal AB (MonoAB)
CL Item
Muromonab (OKT3)
CL Item
Mycophenolat (MMF)
CL Item
Mesna (40)
CL Item
Mitoxantrone (42)
CL Item
Mercaptopurine (43)
CL Item
Methotrexate (44)
CL Item
Nimustine (2)
CL Item
Paclitaxel (47)
CL Item
PEG-ASP (11)
CL Item
Prednisone (45)
CL Item
Procarbazine (46)
CL Item
Rasburicase (57)
CL Item
Rituximab (58)
CL Item
Tacrolimus (FK506)
CL Item
Teniposid (54)
CL Item
Thiotepa (48)
CL Item
Tioguanine (49)
CL Item
Topotecan (TOPO)
CL Item
Treosulfan (61)
CL Item
Tretinoin (ATRA) (ATRA)
CL Item
Trofosfamide (50)
CL Item
Vinblastine (51)
CL Item
Vincristine (52)
CL Item
Vindesine (53)
CL Item
Other (999)
Generic name specified
Item
Other generic, specifiy
text
Other drug cumulative dose per course
Item
Cumulative dose per course
float
Item
G-CSF/GM-CSF
integer
NoYes
Code List
G-CSF/GM-CSF
CL Item
No (0)
CL Item
Yes (1)
Item
Other cytokine treatment (e.g. EPO)
integer
NoYes
Code List
Other cytokine treatment (e.g. EPO)
CL Item
No (0)
CL Item
Yes (1)
Other cytokine spcified
Item
Other cytokine spcified
text
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