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ID
19061
Beschrijving
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).
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- 02/12/2016 02/12/2016 -
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2 décembre 2016
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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
Similar models
WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
C2732579 (UMLS CUI [1,2])
CL Item
patient (1)
CL Item
doctor (2)
Item Group
Premature end of study
C1279919 (UMLS CUI-1)
C2732579 (UMLS CUI-2)
C2732579 (UMLS CUI-2)
Premature end of study
Item
Premature end of study
boolean
C1279919 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
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])
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])
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])
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])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator's signature
Item
Investigator's signature
boolean
C2346576 (UMLS CUI [1])
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