ID

5289

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
Uploaded on

August 4, 2014

DOI

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License

Creative Commons BY 4.0

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Ewing Study Toxicity DRKS00003588

Toxicity

  1. StudyEvent: SE
    1. Toxicity
Show identification of patient
Description

Show identification of patient

Patient
Description

Dummy item in ItemGroup 'Display patient'

Data type

text

General condition ctc scale
Description

General condition ctc scale

Allgemeinzustand
Description

General condition

Data type

integer

Toxicity hematology
Description

Toxicity hematology

Hämoglobin
Description

Grade Hemoglobin

Data type

integer

Leukozyten
Description

Grade leukocytes

Data type

integer

Granulozyten
Description

Grade granulocytes

Data type

integer

Thrombozyten
Description

Grade platelets

Data type

integer

Toxicity infection
Description

Toxicity infection

Infektion
Description

Grade infection

Data type

integer

Fieber
Description

Grade fever

Data type

integer

Toxicity gut
Description

Toxicity gut

Stomatitis
Description

Grade stomatitis

Data type

integer

Erbrechen
Description

Grade vomiting

Data type

integer

Diarrhoe
Description

Grade diarrhea

Data type

integer

Parenterale Analgesie erforderlich
Description

Parenteral analgesia required

Data type

integer

Dauer der parenteralen Analgesie
Description

Duration of parenteral analgesia

Data type

integer

Measurement units
  • Tage
Tage
Parenterale Ernährung erforderlich
Description

Parenteral nutrition required

Data type

integer

Dauer der parenteralen Ernährung
Description

Duration of parenteral nutrition

Data type

integer

Measurement units
  • Tage
Tage
Parenterale Antibiose erforderlich
Description

Parenteral antibiotic therapy required

Data type

integer

Dauer der parenterale Antibiose
Description

Duration of parenteral antibiotic therapy

Data type

integer

Measurement units
  • Tage
Tage
Toxicity skin
Description

Toxicity skin

Hautveränderungen
Description

Grade changes in the skin

Data type

integer

Toxicity renal
Description

Toxicity renal

Kreatinin
Description

Grade creatinine

Data type

integer

Proteinurie
Description

Grade proteinuria

Data type

integer

Hämaturie
Description

Grade hematuria

Data type

integer

Glomeruläre Filtrationsrate (GFR)
Description

Grade glomerular filtration rate

Data type

integer

Tubuläre Phosphatreabsorption
Description

Grade tubular phosphate reabsorption

Data type

integer

Toxicity liver
Description

Toxicity liver

Bilirubin
Description

Grade bilirubin

Data type

integer

S-GOT/S-GPT
Description

Grade S-GOT/S-GPT

Data type

integer

VOD-Prävention durchgeführt
Description

VOD prevention done

Data type

integer

VOD-Prävention mit Ursodiol
Description

VOD prevention with Ursodiol

Data type

integer

VOD-Prävention mit Heparin
Description

VOD prevention with Heparin

Data type

integer

VOD aufgetreten
Description

VOD occurred

Data type

integer

Leberfunktionsstörung nach Bearman
Description

Leberfunktionsstörung nach Bearman

Data type

integer

Toxicity lungs
Description

Toxicity lungs

Pulmonale Toxizität aufgetreten
Description

Pulmonary toxicity occurred

Data type

integer

Pneumonitis
Description

Pneumonitis

Data type

integer

Andere pulmonale Toxizität
Description

Other pulmonary toxicity

Data type

integer

Beschreibung andere pulmonale Toxizität
Description

Other pulmonary toxicity specified

Data type

text

Toxicity cardiac
Description

Toxicity cardiac

Herzfunktion
Description

Grade cardiac function

Data type

integer

ECHO: LV-SF
Description

Grade echo: LV-SF

Data type

integer

Toxicity neurological
Description

Toxicity neurological

Zentrale Neurotoxizität
Description

Grade central neurotoxicity

Data type

integer

Krampfanfälle
Description

Grade peripheral neurotoxicity

Data type

integer

Periphere Neurotoxizität
Description

Grade peripheral neurotoxicity

Data type

integer

Toxicity other
Description

Toxicity other

Andere Toxizität aufgetreten
Description

Other toxicity occurred

Data type

integer

Toxicity other
Description

Toxicity other

Beschreibung andere Toxizität
Description

Other toxicity text

Data type

text

Similar models

Toxicity

  1. StudyEvent: SE
    1. Toxicity
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Dummy item in ItemGroup 'Display patient'
Item
Patient
text
Item
Allgemeinzustand
integer
Code List
Allgemeinzustand
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Hämoglobin
integer
Code List
Hämoglobin
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Leukozyten
integer
Code List
Leukozyten
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Granulozyten
integer
Code List
Granulozyten
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Thrombozyten
integer
Code List
Thrombozyten
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Infektion
integer
Code List
Infektion
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Fieber
integer
Code List
Fieber
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item Group
Item
Stomatitis
integer
Code List
Stomatitis
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Erbrechen
integer
Code List
Erbrechen
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Diarrhoe
integer
Code List
Diarrhoe
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Parenterale Analgesie erforderlich
integer
Code List
Parenterale Analgesie erforderlich
CL Item
Nein (0)
CL Item
Ja (1)
Duration of parenteral analgesia
Item
Dauer der parenteralen Analgesie
integer
Item
Parenterale Ernährung erforderlich
integer
Code List
Parenterale Ernährung erforderlich
CL Item
Nein (0)
CL Item
Ja (1)
Duration of parenteral nutrition
Item
Dauer der parenteralen Ernährung
integer
Item
Parenterale Antibiose erforderlich
integer
Code List
Parenterale Antibiose erforderlich
CL Item
Nein (0)
CL Item
Ja (1)
Duration of parenteral antibiotic therapy
Item
Dauer der parenterale Antibiose
integer
Item Group
Item
Hautveränderungen
integer
Code List
Hautveränderungen
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item Group
Item
Kreatinin
integer
Code List
Kreatinin
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Proteinurie
integer
Code List
Proteinurie
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Hämaturie
integer
Code List
Hämaturie
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Glomeruläre Filtrationsrate (GFR)
integer
Code List
Glomeruläre Filtrationsrate (GFR)
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Tubuläre Phosphatreabsorption
integer
Code List
Tubuläre Phosphatreabsorption
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item Group
Item
Bilirubin
integer
Code List
Bilirubin
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
S-GOT/S-GPT
integer
Code List
S-GOT/S-GPT
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
VOD-Prävention durchgeführt
integer
Code List
VOD-Prävention durchgeführt
CL Item
Nein (0)
CL Item
Ja (1)
Item
VOD-Prävention mit Ursodiol
integer
Code List
VOD-Prävention mit Ursodiol
CL Item
Nein (0)
CL Item
Ja (1)
Item
VOD-Prävention mit Heparin
integer
Code List
VOD-Prävention mit Heparin
CL Item
Nein (0)
CL Item
Ja (1)
Item
VOD aufgetreten
integer
Code List
VOD aufgetreten
CL Item
Nein (0)
CL Item
Ja (1)
Item
Leberfunktionsstörung nach Bearman
integer
Code List
Leberfunktionsstörung nach Bearman
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
Item Group
Item
Pulmonale Toxizität aufgetreten
integer
Code List
Pulmonale Toxizität aufgetreten
CL Item
Nein (0)
CL Item
Ja (1)
Item
Pneumonitis
integer
Code List
Pneumonitis
CL Item
Nein (0)
CL Item
Radiologisch Veränderungen, keine Steroide erforderlich (1)
CL Item
Steroide erforderlich (2)
CL Item
Sauerstoffgabe erforderlich (3)
CL Item
Beatmung erforderlich (4)
Item
Andere pulmonale Toxizität
integer
Code List
Andere pulmonale Toxizität
CL Item
Nein (0)
CL Item
Ja (1)
Other pulmonary toxicity specified
Item
Beschreibung andere pulmonale Toxizität
text
Item
Herzfunktion
integer
Code List
Herzfunktion
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
ECHO: LV-SF
integer
Code List
ECHO: LV-SF
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Zentrale Neurotoxizität
integer
Code List
Zentrale Neurotoxizität
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Krampfanfälle
integer
Code List
Krampfanfälle
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item
Periphere Neurotoxizität
integer
Code List
Periphere Neurotoxizität
CL Item
Grad 0 (0)
CL Item
Grad 1 (1)
CL Item
Grad 2 (2)
CL Item
Grad 3 (3)
CL Item
Grad 4 (4)
Item Group
Item
Andere Toxizität aufgetreten
integer
Code List
Andere Toxizität aufgetreten
CL Item
Nein (0)
CL Item
Ja (1)
Item Group
Other toxicity text
Item
Beschreibung andere Toxizität
text

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