ID

19061

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

  1. 12/2/16 12/2/16 -
Uploaded on

December 2, 2016

DOI

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License

Creative Commons BY-NC-ND 3.0

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WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24 DRKS00000657

WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24

End of study report
Description

End of study report

Alias
UMLS CUI-1
C2732579
Date of end of study
Description

Study End Date

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C2983670
YYYY-MM-DD
Who ended the study?
Description

End of study: Physician

Data type

integer

Alias
UMLS CUI [1,1]
C2826892
UMLS CUI [1,2]
C2732579
Premature end of study
Description

Premature end of study

Alias
UMLS CUI-1
C1279919
UMLS CUI-2
C2732579
Premature end of study
Description

Premature end of study

Data type

boolean

Alias
UMLS CUI [1,1]
C1279919
UMLS CUI [1,2]
C2732579
If Yes: reasons for discontinuation of the study (multiple reasons are possible)
Description

Reason for discontinuation

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
Other:
Description

Reason for discontination: Specification

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C2348235
Other remarks or events
Description

Remarks or events

Data type

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2]
C0441471
Investigator's name
Description

Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator's stamp
Description

Investigator's stamp

Data type

boolean

Alias
UMLS CUI [1]
C3825804
Date
Description

Date

Alias
UMLS CUI-1
C0011008
Date
Description

Date

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0011008
YYYY-MM-DD
Investigator's signature
Description

Investigator's signature

Data type

boolean

Alias
UMLS CUI [1]
C2346576

Similar models

WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
End of study report
C2732579 (UMLS CUI-1)
Study End Date
Item
Date of end of study
date
C2983670 (UMLS CUI [1])
Item
Who ended the study?
integer
C2826892 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
Code List
Who ended the study?
CL Item
patient (1)
CL Item
doctor (2)
Item Group
Premature end of study
C1279919 (UMLS CUI-1)
C2732579 (UMLS CUI-2)
Premature end of study
Item
Premature end of study
boolean
C1279919 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
Item
If Yes: reasons for discontinuation of the study (multiple reasons are possible)
integer
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Code List
If Yes: reasons for discontinuation of the study (multiple reasons are possible)
CL Item
lost to follow up (1)
CL Item
Patient died (2)
CL Item
Withdrawal of consent (3)
CL Item
non-compliance of the patient (4)
CL Item
forbidden concomitant therapy (5)
CL Item
disease progression (6)
CL Item
adverse events (7)
CL Item
other (8)
Reason for discontination: Specification
Item
Other:
text
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Remarks or events
Item
Other remarks or events
text
C0947611 (UMLS CUI [1])
C0441471 (UMLS CUI [2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Investigator's stamp
Item
Investigator's stamp
boolean
C3825804 (UMLS CUI [1])
Item Group
Date
C0011008 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator's signature
Item
Investigator's signature
boolean
C2346576 (UMLS CUI [1])

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