ID

19060

Description

Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

Mots-clés

  1. 02/12/2016 02/12/2016 -
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2 décembre 2016

DOI

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Licence

Creative Commons BY-NC-ND 3.0

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WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24 DRKS00000657

WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24

Final medical examination
Description

Final medical examination

Alias
UMLS CUI-1
C0582103
Date
Description

Examination Date

Type de données

date

Unités de mesure
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C2826643
YYYY-MM-DD
Physical Examination
Description

Physical Examination

Type de données

integer

Alias
UMLS CUI [1]
C0031809
Adverse Event
Description

Adverse Event

Type de données

boolean

Alias
UMLS CUI [1]
C0877248
DLT
Description

Dose-limiting toxicity

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512043
UMLS CUI [1,2]
C0013221
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

Alias
UMLS CUI [1]
C0428883
Pulse
Description

Heart rate

Type de données

integer

Unités de mesure
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
Weight
Description

Body 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
ECOG Status
Description

ECOG Status

Type de données

integer

Alias
UMLS CUI [1]
C1520224
Haematology
Description

Haematology

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]
C0677862
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

Similar models

WTZ-GIST-09-01 (Imatinib + LBH589) Final Medical Examination 2009-011417-24

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Final medical examination
C0582103 (UMLS CUI-1)
Examination Date
Item
Date
date
C2826643 (UMLS CUI [1])
Item
Physical Examination
integer
C0031809 (UMLS CUI [1])
Code List
Physical Examination
CL Item
not pathologic (0)
CL Item
pathologic (1)
Adverse Event
Item
Adverse Event
boolean
C0877248 (UMLS CUI [1])
Dose-limiting toxicity
Item
DLT
boolean
C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Pulse
integer
C0018810 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body temperature
Item
Temperature
float
C0005903 (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
Haematology
integer
C0474523 (UMLS CUI [1])
Code List
Haematology
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])
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
pathol. (1)

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