ID

18745

Description

Phase I study of imatinib and LBH589 in imatinib- and sunitinib-refractory gastrointestinal stromal tumors

Mots-clés

  1. 18/11/2016 18/11/2016 -
  2. 23/11/2016 23/11/2016 -
Téléchargé le

18 novembre 2016

DOI

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Licence

Creative Commons BY-NC-ND 3.0

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

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

Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Screening Date
Description

Screening Date

Type de données

date

Unités de mesure
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0220908
YYYY-MM-DD
Date of birth
Description

Patient date of birth

Type de données

date

Unités de mesure
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0421451
YYYY-MM-DD
Gender
Description

Gender

Type de données

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Type de données

integer

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

Ethnicity Specification

Type de données

text

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

Height

Type de données

integer

Unités de mesure
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Description

Body temperature

Type de données

float

Unités de mesure
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Screening: physical examination, - concomitant therapies, concomitant diseases
Description

Screening: physical examination, - concomitant therapies, concomitant diseases

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

Physical examination

Type de données

integer

Adverse events
Description

Adverse event

Type de données

boolean

Alias
UMLS CUI [1]
C0877248
Systolic blood pressure
Description

Systolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Description

Pulse

Type de données

integer

Unités de mesure
  • Beats/Min
Alias
UMLS CUI [1]
C0232117
Beats/Min
ECOG Status
Description

ECOG Status

Type de données

integer

Alias
UMLS CUI [1]
C1520224
Hematology
Description

Hematology

Type de données

integer

Alias
UMLS CUI [1]
C0474523
Urinanalysis
Description

Urinanalysis

Type de données

integer

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

Tumor biopsy

Type de données

boolean

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

Paraffin Embedded Tissue

Type de données

boolean

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

RECIST

Type de données

boolean

Alias
UMLS CUI [1]
C1709926
ECG
Description

ECG

Type de données

integer

Alias
UMLS CUI [1]
C1623258
Tumor characteristics
Description

Tumor characteristics

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

Date of first diagnosis

Type de données

date

Unités de mesure
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C2316983
YYYY-MM-DD
Location of primary tumor
Description

Location of primary tumor

Type de données

text

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

Size of primary tumor

Type de données

text

Alias
UMLS CUI [1]
C1302656
Number of mitoses
Description

Number of mitoses

Type de données

integer

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

Metastases

Type de données

integer

Alias
UMLS CUI [1]
C0027627

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
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
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])
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])
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])
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])
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])
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])
Code List
Metastases
CL Item
localized (0)
CL Item
metastatic (1)

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