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

General condition
Description

General condition

Data type

integer

Toxicity hematology
Description

Toxicity hematology

Hemoglobin
Description

Grade Hemoglobin

Data type

integer

Leukocytes
Description

Grade leukocytes

Data type

integer

Granulocytes
Description

Grade granulocytes

Data type

integer

Platelets
Description

Grade platelets

Data type

integer

Toxicity infection
Description

Toxicity infection

Infection
Description

Grade infection

Data type

integer

Fever
Description

Grade fever

Data type

integer

Toxicity gut
Description

Toxicity gut

Stomatitis
Description

Grade stomatitis

Data type

integer

Vomiting
Description

Grade vomiting

Data type

integer

Diarrhea
Description

Grade diarrhea

Data type

integer

Parenteral analgesia required
Description

Parenteral analgesia required

Data type

integer

Duration of parenteral analgesia
Description

Duration of parenteral analgesia

Data type

integer

Measurement units
  • Days
Days
Parenteral nutrition required
Description

Parenteral nutrition required

Data type

integer

Duration of parenteral nutrition
Description

Duration of parenteral nutrition

Data type

integer

Measurement units
  • Days
Days
Parenteral antibiotic therapy required
Description

Parenteral antibiotic therapy required

Data type

integer

Duration of parenteral antibiotic therapy
Description

Duration of parenteral antibiotic therapy

Data type

integer

Measurement units
  • Days
Days
Toxicity skin
Description

Toxicity skin

Changes in the skin
Description

Grade changes in the skin

Data type

integer

Toxicity renal
Description

Toxicity renal

Creatinine
Description

Grade creatinine

Data type

integer

Proteinuria
Description

Grade proteinuria

Data type

integer

Hematuria
Description

Grade hematuria

Data type

integer

Glomerular filtration rate (GFR)
Description

Grade glomerular filtration rate

Data type

integer

Tubular phosphate reabsorption
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 prevention done
Description

VOD prevention done

Data type

integer

VOD prevention with Ursodiol
Description

VOD prevention with Ursodiol

Data type

integer

VOD prevention with Heparin
Description

VOD prevention with Heparin

Data type

integer

VOD occurred
Description

VOD occurred

Data type

integer

Hepatic dysfunction (Bearman)
Description

Leberfunktionsstörung nach Bearman

Data type

integer

Toxicity lungs
Description

Toxicity lungs

Pulmonary toxicity occurred
Description

Pulmonary toxicity occurred

Data type

integer

Pneumonitis
Description

Pneumonitis

Data type

integer

Other pulmonary toxicity
Description

Other pulmonary toxicity

Data type

integer

Other pulmonary toxicity specified
Description

Other pulmonary toxicity specified

Data type

text

Toxicity cardiac
Description

Toxicity cardiac

Cardiac function
Description

Grade cardiac function

Data type

integer

ECHO: LV-SF
Description

Grade echo: LV-SF

Data type

integer

Toxicity neurological
Description

Toxicity neurological

Central neurotoxicity
Description

Grade central neurotoxicity

Data type

integer

Seizures
Description

Grade peripheral neurotoxicity

Data type

integer

Peripheral neurotoxicity
Description

Grade peripheral neurotoxicity

Data type

integer

Toxicity other
Description

Toxicity other

Other toxicity occurred
Description

Other toxicity occurred

Data type

integer

Toxicity other
Description

Toxicity other

Other toxicity specified
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
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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