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WTZ-GIST-09-01 (Imatinib + LBH589) Demographics and Medical History 2009-011417-24

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Demographics
Beschrijving

Demographics

Alias
UMLS CUI-1
C1704791
Screening Date
Beschrijving

Screening Date

Datatype

date

Maateenheden
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0220908
YYYY-MM-DD
Date of birth
Beschrijving

Patient date of birth

Datatype

date

Maateenheden
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0421451
YYYY-MM-DD
Gender
Beschrijving

Gender

Datatype

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschrijving

Ethnicity

Datatype

integer

Alias
UMLS CUI [1]
C0015031
Ethnicity - when other:
Beschrijving

Ethnicity Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C2348235
Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Beschrijving

Body temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Screening: physical examination, - concomitant therapies, concomitant diseases
Beschrijving

Screening: physical examination, - concomitant therapies, concomitant diseases

Alias
UMLS CUI-1
C0031809
UMLS CUI-3
C1707479
UMLS CUI-5
C0243087
Physical examination
Beschrijving

Physical examination

Datatype

integer

Adverse events
Beschrijving

Adverse event

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Systolic blood pressure
Beschrijving

Systolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • Beats/Min
Alias
UMLS CUI [1]
C0232117
Beats/Min
ECOG Status
Beschrijving

ECOG Status

Datatype

integer

Alias
UMLS CUI [1]
C1520224
Hematology
Beschrijving

Hematology

Datatype

integer

Alias
UMLS CUI [1]
C0474523
Urinanalysis
Beschrijving

Urinanalysis

Datatype

integer

Alias
UMLS CUI [1]
C0042014
Tumor biopsies (optional)
Beschrijving

Tumor biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677862
UMLS CUI [1,2]
C0027651
Collection of paraffin blocks/ slides
Beschrijving

Paraffin Embedded Tissue

Datatype

boolean

Alias
UMLS CUI [1]
C1519524
CT/MRI tumor evaluation (RECIST)
Beschrijving

RECIST

Datatype

boolean

Alias
UMLS CUI [1]
C1709926
ECG
Beschrijving

ECG

Datatype

integer

Alias
UMLS CUI [1]
C1623258
Tumor characteristics
Beschrijving

Tumor characteristics

Alias
UMLS CUI-1
C0027651
UMLS CUI-2
C1521970
Date of first diagnosis
Beschrijving

Date of first diagnosis

Datatype

date

Maateenheden
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C2316983
YYYY-MM-DD
Location of primary tumor
Beschrijving

Location of primary tumor

Datatype

text

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1515974
Size of primary tumor
Beschrijving

Size of primary tumor

Datatype

text

Alias
UMLS CUI [1]
C1302656
Number of mitoses
Beschrijving

Number of mitoses

Datatype

integer

Alias
UMLS CUI [1,1]
C0026255
UMLS CUI [1,2]
C0750480
Metastases
Beschrijving

Metastases

Datatype

integer

Alias
UMLS CUI [1]
C0027627
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WTZ-GIST-09-01 (Imatinib + LBH589) Demographics and Medical History 2009-011417-24

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Demographics
C1704791 (UMLS CUI-1)
Screening Date
Item
Screening Date
date
C0011008 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Caucasien (1)
CL Item
Black (2)
CL Item
other (3)
Ethnicity Specification
Item
Ethnicity - when other:
text
C0015031 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Screening: physical examination, - concomitant therapies, concomitant diseases
C0031809 (UMLS CUI-1)
C1707479 (UMLS CUI-3)
C0243087 (UMLS CUI-5)
Item
Physical examination
integer
Physical examination
Code List
Physical examination
CL Item
not pathologic (0)
CL Item
pathologic (1)
Adverse event
Item
Adverse events
boolean
C0877248 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item
ECOG Status
integer
C1520224 (UMLS CUI [1])
ECOG Status
Code List
ECOG Status
CL Item
Fully active (0)
CL Item
80-90% (1)
CL Item
60-70% (2)
CL Item
40-50% (3)
CL Item
10-30% (4)
CL Item
Dead (5)
Item
Hematology
integer
C0474523 (UMLS CUI [1])
Hematology
Code List
Hematology
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Item
Urinanalysis
integer
C0042014 (UMLS CUI [1])
Urinanalysis
Code List
Urinanalysis
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Tumor biopsy
Item
Tumor biopsies (optional)
boolean
C0677862 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Paraffin Embedded Tissue
Item
Collection of paraffin blocks/ slides
boolean
C1519524 (UMLS CUI [1])
RECIST
Item
CT/MRI tumor evaluation (RECIST)
boolean
C1709926 (UMLS CUI [1])
Item
ECG
integer
C1623258 (UMLS CUI [1])
ECG
Code List
ECG
CL Item
normal (0)
CL Item
out of range NCS (1)
CL Item
out of range (2)
Item Group
Tumor characteristics
C0027651 (UMLS CUI-1)
C1521970 (UMLS CUI-2)
Date of first diagnosis
Item
Date of first diagnosis
date
C2316983 (UMLS CUI [1])
Location of primary tumor
Item
Location of primary tumor
text
C0677930 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Size of primary tumor
Item
Size of primary tumor
text
C1302656 (UMLS CUI [1])
Item
Number of mitoses
integer
C0026255 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Number of mitoses
Code List
Number of mitoses
CL Item
low (<=5 hpf) (0)
CL Item
high (> 5-50 hpf) (1)
Item
Metastases
integer
C0027627 (UMLS CUI [1])
Metastases
Code List
Metastases
CL Item
localized (0)
CL Item
metastatic (1)
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