ID

5289

Beschreibung

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

Link

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

Stichworte

  1. 04.08.14 04.08.14 - Martin Dugas
Hochgeladen am

4. August 2014

DOI

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Lizenz

Creative Commons BY 4.0

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Ewing Study Toxicity DRKS00003588

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

Show identification of patient

Patient
Beschreibung

Dummy item in ItemGroup 'Display patient'

Datentyp

text

General condition ctc scale
Beschreibung

General condition ctc scale

General condition
Beschreibung

General condition

Datentyp

integer

Toxicity hematology
Beschreibung

Toxicity hematology

Hemoglobin
Beschreibung

Grade Hemoglobin

Datentyp

integer

Leukocytes
Beschreibung

Grade leukocytes

Datentyp

integer

Granulocytes
Beschreibung

Grade granulocytes

Datentyp

integer

Platelets
Beschreibung

Grade platelets

Datentyp

integer

Toxicity infection
Beschreibung

Toxicity infection

Infection
Beschreibung

Grade infection

Datentyp

integer

Fever
Beschreibung

Grade fever

Datentyp

integer

Toxicity gut
Beschreibung

Toxicity gut

Stomatitis
Beschreibung

Grade stomatitis

Datentyp

integer

Vomiting
Beschreibung

Grade vomiting

Datentyp

integer

Diarrhea
Beschreibung

Grade diarrhea

Datentyp

integer

Parenteral analgesia required
Beschreibung

Parenteral analgesia required

Datentyp

integer

Duration of parenteral analgesia
Beschreibung

Duration of parenteral analgesia

Datentyp

integer

Maßeinheiten
  • Days
Days
Parenteral nutrition required
Beschreibung

Parenteral nutrition required

Datentyp

integer

Duration of parenteral nutrition
Beschreibung

Duration of parenteral nutrition

Datentyp

integer

Maßeinheiten
  • Days
Days
Parenteral antibiotic therapy required
Beschreibung

Parenteral antibiotic therapy required

Datentyp

integer

Duration of parenteral antibiotic therapy
Beschreibung

Duration of parenteral antibiotic therapy

Datentyp

integer

Maßeinheiten
  • Days
Days
Toxicity skin
Beschreibung

Toxicity skin

Changes in the skin
Beschreibung

Grade changes in the skin

Datentyp

integer

Toxicity renal
Beschreibung

Toxicity renal

Creatinine
Beschreibung

Grade creatinine

Datentyp

integer

Proteinuria
Beschreibung

Grade proteinuria

Datentyp

integer

Hematuria
Beschreibung

Grade hematuria

Datentyp

integer

Glomerular filtration rate (GFR)
Beschreibung

Grade glomerular filtration rate

Datentyp

integer

Tubular phosphate reabsorption
Beschreibung

Grade tubular phosphate reabsorption

Datentyp

integer

Toxicity liver
Beschreibung

Toxicity liver

Bilirubin
Beschreibung

Grade bilirubin

Datentyp

integer

S-GOT/S-GPT
Beschreibung

Grade S-GOT/S-GPT

Datentyp

integer

VOD prevention done
Beschreibung

VOD prevention done

Datentyp

integer

VOD prevention with Ursodiol
Beschreibung

VOD prevention with Ursodiol

Datentyp

integer

VOD prevention with Heparin
Beschreibung

VOD prevention with Heparin

Datentyp

integer

VOD occurred
Beschreibung

VOD occurred

Datentyp

integer

Hepatic dysfunction (Bearman)
Beschreibung

Leberfunktionsstörung nach Bearman

Datentyp

integer

Toxicity lungs
Beschreibung

Toxicity lungs

Pulmonary toxicity occurred
Beschreibung

Pulmonary toxicity occurred

Datentyp

integer

Pneumonitis
Beschreibung

Pneumonitis

Datentyp

integer

Other pulmonary toxicity
Beschreibung

Other pulmonary toxicity

Datentyp

integer

Other pulmonary toxicity specified
Beschreibung

Other pulmonary toxicity specified

Datentyp

text

Toxicity cardiac
Beschreibung

Toxicity cardiac

Cardiac function
Beschreibung

Grade cardiac function

Datentyp

integer

ECHO: LV-SF
Beschreibung

Grade echo: LV-SF

Datentyp

integer

Toxicity neurological
Beschreibung

Toxicity neurological

Central neurotoxicity
Beschreibung

Grade central neurotoxicity

Datentyp

integer

Seizures
Beschreibung

Grade peripheral neurotoxicity

Datentyp

integer

Peripheral neurotoxicity
Beschreibung

Grade peripheral neurotoxicity

Datentyp

integer

Toxicity other
Beschreibung

Toxicity other

Other toxicity occurred
Beschreibung

Other toxicity occurred

Datentyp

integer

Toxicity other
Beschreibung

Toxicity other

Other toxicity specified
Beschreibung

Other toxicity text

Datentyp

text

Ähnliche Modelle

Toxicity

  1. StudyEvent: SE
    1. Toxicity
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Dummy item in ItemGroup 'Display patient'
Item
Patient
text
Item
General condition
integer
Code List
General condition
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)
Item
Hemoglobin
integer
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)
Item
Leukocytes
integer
Code List
Leukocytes
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)
Item
Granulocytes
integer
Code List
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)
Item
Platelets
integer
Code List
Platelets
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)
Item
Infection
integer
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)
Item
Fever
integer
Code List
Fever
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)
Item Group
Item
Stomatitis
integer
Code List
Stomatitis
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)
Item
Vomiting
integer
Code List
Vomiting
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)
Item
Diarrhea
integer
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)
Item
Parenteral analgesia required
integer
Code List
Parenteral analgesia required
CL Item
No (0)
CL Item
Yes (1)
Duration of parenteral analgesia
Item
Duration of parenteral analgesia
integer
Item
Parenteral nutrition required
integer
Code List
Parenteral nutrition required
CL Item
No (0)
CL Item
Yes (1)
Duration of parenteral nutrition
Item
Duration of parenteral nutrition
integer
Item
Parenteral antibiotic therapy required
integer
Code List
Parenteral antibiotic therapy required
CL Item
No (0)
CL Item
Yes (1)
Duration of parenteral antibiotic therapy
Item
Duration of parenteral antibiotic therapy
integer
Item Group
Item
Changes in the skin
integer
Code List
Changes in the skin
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)
Item Group
Item
Creatinine
integer
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)
Item
Proteinuria
integer
Code List
Proteinuria
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)
Item
Hematuria
integer
Code List
Hematuria
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)
Item
Glomerular filtration rate (GFR)
integer
Code List
Glomerular filtration rate (GFR)
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)
Item
Tubular phosphate reabsorption
integer
Code List
Tubular phosphate reabsorption
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)
Item Group
Item
Bilirubin
integer
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)
Item
S-GOT/S-GPT
integer
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)
Item
VOD prevention done
integer
Code List
VOD prevention done
CL Item
No (0)
CL Item
Yes (1)
Item
VOD prevention with Ursodiol
integer
Code List
VOD prevention with Ursodiol
CL Item
No (0)
CL Item
Yes (1)
Item
VOD prevention with Heparin
integer
Code List
VOD prevention with Heparin
CL Item
No (0)
CL Item
Yes (1)
Item
VOD occurred
integer
Code List
VOD occurred
CL Item
No (0)
CL Item
Yes (1)
Item
Hepatic dysfunction (Bearman)
integer
Code List
Hepatic dysfunction (Bearman)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
Item Group
Item
Pulmonary toxicity occurred
integer
Code List
Pulmonary toxicity occurred
CL Item
No (0)
CL Item
Yes (1)
Item
Pneumonitis
integer
Code List
Pneumonitis
CL Item
None (0)
CL Item
Radiographic changes, symptoms do not require steroids (1)
CL Item
Steroids required (2)
CL Item
Oxygen required (3)
CL Item
Assisted ventilation required (4)
Item
Other pulmonary toxicity
integer
Code List
Other pulmonary toxicity
CL Item
No (0)
CL Item
Yes (1)
Other pulmonary toxicity specified
Item
Other pulmonary toxicity specified
text
Item
Cardiac function
integer
Code List
Cardiac function
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)
Item
ECHO: LV-SF
integer
Code List
ECHO: LV-SF
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)
Item
Central neurotoxicity
integer
Code List
Central neurotoxicity
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)
Item
Seizures
integer
Code List
Seizures
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)
Item
Peripheral neurotoxicity
integer
Code List
Peripheral neurotoxicity
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)
Item Group
Item
Other toxicity occurred
integer
Code List
Other toxicity occurred
CL Item
No (0)
CL Item
Yes (1)
Item Group
Other toxicity text
Item
Other toxicity specified
text

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