ID

10882

Description

CWS-2007-HR: A randomised phase-III trial of the Cooperative Soft-Tissue-Study-Group for localised high-risk rhabdomyosarcoma and localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in children, adolescents, and young adults http://clinicaltrials.gov/show/NCT00876031 http://www.cws.olgahospital-stuttgart.de CWS-2007-HR B4 - Block 1 O-TI

Link

http://clinicaltrials.gov/show/NCT00876031

Keywords

Versions (2)
  1. 8/6/14 8/6/14 - Martin Dugas
  2. 6/11/15 6/11/15 - Martin Dugas
Uploaded on

June 11, 2015

DOI

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License

Creative Commons BY 4.0
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Rhabdomyosarcoma treatment CWS-2007-HR DRKS00003774 NCT00876031

German English

Treatment B4 - Block 1 O-TI Rhabdomyosarcoma NCT00876031

1 forms  
Datum 1. Block
Description

Datum 1. Block

Date 1st block
Description

Datum des 1. Block

Data type

date

O-TIE body dimensions
Description

O-TIE 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
  • m²
Alias
UMLS CUI-1
C0005902
m²
Block O-TI
Description

Block O-TI

Start date
Description

Datum Beginn

Data type

date

Trofosfamide cumulative dose/course
Description

Trofosfamide kumulativ/Block

Data type

float

Measurement units
  • mg
mg
Idarubicine cumulative dose/course
Description

Idarubicin kumulativ/Block

Data type

float

Measurement units
  • mg
mg
Trofosfamide target value (BSA based)
Description

Sollwert Trofosfamid

Data type

float

Measurement units
  • mg
mg
Idarubicin target value (BSA based)
Description

Sollwert Idarubicin nach KOF

Data type

float

Measurement units
  • mg
mg
Difference prepreceding block [days]
Description

Abstand Blöcke in Tagen

Data type

integer

Toxicity common
Description

Toxicity common

Karnofsky/Lansky index
Description

Karnofsky/Lansky Index

Data type

integer

Toxicity hematology
Description

Toxicity hematology

Hemoglobin
Description

Hemoglobin toxicity

Data type

integer

Alias
UMLS CUI-1
C0019046
UMLS CUI-2
C0040539
Leukocytes (10E9/l)
Description

Leukozyten (10E9/l)

Data type

integer

Neutrophils Granulocytes
Description

Neutrophile Granulozyten

Data type

integer

Platelets (G/l)
Description

Thrombozyten (G/l)

Data type

integer

Toxicity infection
Description

Toxicity infection

Infection
Description

Infektion

Data type

integer

Fever (degree C)
Description

Fieber ( Grad C)

Data type

integer

Toxicity gastrointestinal
Description

Toxicity gastrointestinal

Nausea
Description

Übelkeit

Data type

integer

Vomiting [episodes/24h]
Description

Erbrechen [Episoden/24 Std]

Data type

integer

Mucositis/stomatitis (clinical examination)
Description

Mucositis (klinisch)

Data type

integer

Diarrhea
Description

Diarrhoe

Data type

integer

Toxicity kidney
Description

Toxicity kidney

Creatinine
Description

Kreatinin

Data type

integer

Proterinuria (g/24 hrs)
Description

Proteinurie (g/24 Std.)

Data type

integer

Hematuria/Hemoglobinuria
Description

Hämaturie/Hämoglobinurie

Data type

integer

Toxicity neurology
Description

Toxicity neurology

Confusion
Description

Verwirrtheit

Data type

integer

Neuropathy sensory
Description

Neuropathie sensorisch

Data type

integer

Neuropathy motor
Description

Neuropathie motorisch

Data type

integer

Toxicity liver
Description

Toxicity liver

Bilirubin
Description

Bilirubin

Data type

integer

S-GOT/S-GPT
Description

S-GOT/S-GPT

Data type

integer

Toxicity Herz
Description

Toxicity Herz

Arrhytmia
Description

Arrhytmie

Data type

integer

Left ventricular systolic dysfunction
Description

Linksventrikuläre Herzfunktion

Data type

integer

Toxicity other
Description

Toxicity other

Other toxicity specified
Description

Bezeichnung andere Toxizität

Data type

text

Toxicity grade
Description

Toxizität Grad

Data type

integer

Toxicity comment
Description

Toxicity comment

Comments about toxicity
Description

Bemerkungen zur Toxizität

Data type

text

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Similar models

Treatment B4 - Block 1 O-TI Rhabdomyosarcoma NCT00876031

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Datum des 1. Block
Item
Date 1st block
date
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)
Item Group
Datum Beginn
Item
Start date
date
Trofosfamide kumulativ/Block
Item
Trofosfamide cumulative dose/course
float
Idarubicin kumulativ/Block
Item
Idarubicine cumulative dose/course
float
Sollwert Trofosfamid
Item
Trofosfamide target value (BSA based)
float
Sollwert Idarubicin nach KOF
Item
Idarubicin target value (BSA based)
float
Abstand Blöcke in Tagen
Item
Difference prepreceding block [days]
integer
Item
Karnofsky/Lansky index
integer
Karnofsky- Lansky Index in 5 Stufen
Code List
Karnofsky/Lansky index
CL Item
100% (100)
CL Item
90% (90)
CL Item
80% (80)
CL Item
70% (70)
CL Item
60% (60)
CL Item
50% (50)
CL Item
40% (40)
CL Item
30% (30)
CL Item
20% (20)
CL Item
10% (10)
CL Item
Death (0)
Item
Hemoglobin
integer
C0019046 (UMLS CUI-1)
C0040539 (UMLS CUI-2)
Toxicity grade
Code List
Hemoglobin
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Leukocytes (10E9/l)
integer
Toxicity grade
Code List
Leukocytes (10E9/l)
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Neutrophils Granulocytes
integer
Toxicity grade
Code List
Neutrophils Granulocytes
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Platelets (G/l)
integer
Toxicity grade
Code List
Platelets (G/l)
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Infection
integer
Toxicity grade
Code List
Infection
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Fever (degree C)
integer
Toxicity grade
Code List
Fever (degree C)
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Nausea
integer
Toxicity grade
Code List
Nausea
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Vomiting [episodes/24h]
integer
Toxicity grade
Code List
Vomiting [episodes/24h]
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Mucositis/stomatitis (clinical examination)
integer
Toxicity grade
Code List
Mucositis/stomatitis (clinical examination)
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Diarrhea
integer
Toxicity grade
Code List
Diarrhea
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Creatinine
integer
Toxicity grade
Code List
Creatinine
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Proterinuria (g/24 hrs)
integer
Toxicity grade
Code List
Proterinuria (g/24 hrs)
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Hematuria/Hemoglobinuria
integer
Toxicity grade
Code List
Hematuria/Hemoglobinuria
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Confusion
integer
Toxicity grade
Code List
Confusion
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Neuropathy sensory
integer
Toxicity grade
Code List
Neuropathy sensory
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Neuropathy motor
integer
Toxicity grade
Code List
Neuropathy motor
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item Group
Item
Bilirubin
integer
Toxicity grade
Code List
Bilirubin
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
S-GOT/S-GPT
integer
Toxicity grade
Code List
S-GOT/S-GPT
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item Group
Item
Arrhytmia
integer
Toxicity grade
Code List
Arrhytmia
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Left ventricular systolic dysfunction
integer
Toxicity grade
Code List
Left ventricular systolic dysfunction
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item Group
Bezeichnung andere Toxizität
Item
Other toxicity specified
text
Item
Toxicity grade
integer
Toxicity grade
Code List
Toxicity grade
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Bemerkungen zur Toxizität
Item
Comments about toxicity
text
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