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ID
19054
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).
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- 12/1/16 12/1/16 -
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December 1, 2016
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Creative Commons BY-NC-ND 3.0
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WTZ-GIST-09-01 (Imatinib + LBH589) Adverse Event 2009-011417-24 DRKS00000657
WTZ-GIST-09-01 (Imatinib + LBH589) Adverse Event 2009-011417-24
- StudyEvent: ODM
Similar models
WTZ-GIST-09-01 (Imatinib + LBH589) Adverse Event 2009-011417-24
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Adverse Event
Item
No adverse event within the whole study?
boolean
C0877248 (UMLS CUI [1])
Adverse Event Number
Item
Adverse Event Number
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Adverse Event Description
Item
Adverse Event Description
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Adverse Event Onset Date
Item
Adverse Event Onset
date
C2985916 (UMLS CUI [1])
Adverse Event Ongoing
Item
Adverse Event Ongoing?
boolean
C2826663 (UMLS CUI [1])
Adverse Event End Date
Item
Stop Date
date
C2697886 (UMLS CUI [1])
CTC grade
Item
CTC grade
text
C2985911 (UMLS CUI [1])
Adverse Event Severity
Item
Adverse Event Severity
text
C1710066 (UMLS CUI [1])
Relationship
Item
Relationship
text
C0015608 (UMLS CUI [1])
Imatinib
Item
Action Imatinib
text
C0935989 (UMLS CUI [1])
LBH
Item
Action LBH
text
C1566164 (UMLS CUI [1])
Action
Item
Further action
text
C0441472 (UMLS CUI [1])
Adverse Event Outcome
Item
Outcome?
text
C1705586 (UMLS CUI [1])
Seriousness of Adverse Event
Item
Serious
boolean
C1710056 (UMLS CUI [1])