ID

19259

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).

Keywords

Versions (1)
  1. 12/15/16 12/15/16 -
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December 15, 2016

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Creative Commons BY-NC-ND 3.0
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WTZ-GIST-09-01 (Imatinib + LBH589) Dosage administration record 2009-011417-24 DRKS00000657

English

WTZ-GIST-09-01 (Imatinib + LBH589) Dosage administration record 2009-011417-24

1 forms  
Dosage administration - (V1+2)
Description

Dosage administration - (V1+2)

Alias
UMLS CUI-1
C0001555
Start Date
Description

Start Date

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0808070
YYYY-MM-DD
OR Continuing
Description

Continuing therapy

Data type

boolean

Alias
UMLS CUI [1]
C1553904
OR stop date
Description

Stop Date

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0806020
YYYY-MM-DD
Time of administration
Description

Time of administration

Data type

time

Measurement units
  • HH:NN
Alias
UMLS CUI [1]
C1317775
HH:NN
Imatinib
Description

Imatinib high dosage

Data type

integer

Measurement units
  • tabs à 400mg for daily intake
Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C0444956
tabs à 400mg for daily intake
Imatinib
Description

Imatinib low dosage

Data type

integer

Measurement units
  • tabs à 100mg for daily intake
Alias
UMLS CUI [1,1]
C0935989
UMLS CUI [1,2]
C0445550
tabs à 100mg for daily intake
Dose reduction to
Description

Dose reduction

Data type

integer

Measurement units
  • mg daily
Alias
UMLS CUI [1]
C1707814
mg daily
due to:
Description

Dose reduction cause

Data type

text

Alias
UMLS CUI [1,1]
C0678226
UMLS CUI [1,2]
C1707814
Not taken due to:
Description

Compliance

Data type

text

Alias
UMLS CUI [1]
C1321605
Contribution of study medication
Description

Contribution of study medication

Alias
UMLS CUI-1
C1880177
UMLS CUI-2
C0304229
Monday: date
Description

Monday: date

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0585024
YYYY-MM-DD
Wednesday: date
Description

Wednesday: date

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0585027
YYYY-MM-DD
Friday: date
Description

Friday: date

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0585029
YYYY-MM-DD
Monday: cohort
Description

Monday: cohort

Data type

integer

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0585024
Wednesday: cohort
Description

Wednesday: cohort

Data type

integer

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0585027
Friday: cohort
Description

Friday: cohort

Data type

integer

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0585029
No. tabs 20 mg
Description

Number high dose

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0444956
No. tabs 5 mg
Description

Number low dose

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0445550
Dose reduction to:
Description

Contribution: Dose reduction

Data type

integer

Measurement units
  • mg daily
Alias
UMLS CUI [1,1]
C1707814
UMLS CUI [1,2]
C1880177
mg daily
due to:
Description

Contribution: Dose reduction cause

Data type

text

Alias
UMLS CUI [1,1]
C1707814
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1880177
Not taken due to:
Description

Contribution: compliance

Data type

text

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1880177
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Similar models

WTZ-GIST-09-01 (Imatinib + LBH589) Dosage administration record 2009-011417-24

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Dosage administration - (V1+2)
C0001555 (UMLS CUI-1)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Continuing therapy
Item
OR Continuing
boolean
C1553904 (UMLS CUI [1])
Stop Date
Item
OR stop date
date
C0806020 (UMLS CUI [1])
Time of administration
Item
Time of administration
time
C1317775 (UMLS CUI [1])
Imatinib high dosage
Item
Imatinib
integer
C0935989 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
Imatinib low dosage
Item
Imatinib
integer
C0935989 (UMLS CUI [1,1])
C0445550 (UMLS CUI [1,2])
Dose reduction
Item
Dose reduction to
integer
C1707814 (UMLS CUI [1])
Dose reduction cause
Item
due to:
text
C0678226 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Compliance
Item
Not taken due to:
text
C1321605 (UMLS CUI [1])
Item Group
Contribution of study medication
C1880177 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Monday: date
Item
Monday: date
date
C0011008 (UMLS CUI [1,1])
C0585024 (UMLS CUI [1,2])
Wednesday: date
Item
Wednesday: date
date
C0011008 (UMLS CUI [1,1])
C0585027 (UMLS CUI [1,2])
Friday: date
Item
Friday: date
date
C0011008 (UMLS CUI [1,1])
C0585029 (UMLS CUI [1,2])
Item
Monday: cohort
integer
C0599755 (UMLS CUI [1,1])
C0585024 (UMLS CUI [1,2])
Monday: cohort
Code List
Monday: cohort
CL Item
10 mg LBH589 (-1)
CL Item
20 mg LBH589 (0)
CL Item
30 mg LBH589 (1)
CL Item
40 mg LBH589 (2)
Item
Wednesday: cohort
integer
C0599755 (UMLS CUI [1,1])
C0585027 (UMLS CUI [1,2])
Wednesday: cohort
Code List
Wednesday: cohort
CL Item
10 mg LBH589 (-1)
CL Item
20 mg LBH589 (0)
CL Item
30 mg LBH589 (1)
CL Item
40 mg LBH589 (2)
Item
Friday: cohort
integer
C0599755 (UMLS CUI [1,1])
C0585029 (UMLS CUI [1,2])
Friday: cohort
Code List
Friday: cohort
CL Item
10 mg LBH589 (-1)
CL Item
20 mg LBH589 (0)
CL Item
30 mg LBH589 (1)
CL Item
40 mg LBH589 (2)
Number high dose
Item
No. tabs 20 mg
integer
C0449788 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
Number low dose
Item
No. tabs 5 mg
integer
C0449788 (UMLS CUI [1,1])
C0445550 (UMLS CUI [1,2])
Contribution: Dose reduction
Item
Dose reduction to:
integer
C1707814 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Contribution: Dose reduction cause
Item
due to:
text
C1707814 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1880177 (UMLS CUI [1,3])
Contribution: compliance
Item
Not taken due to:
text
C1321605 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
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