Information:
Fel:
ID
13979
Beskrivning
Study part: Adverse Events.Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose. Principal Investigator Prof. Dr. A. Hochhaus.
Nyckelord
Versioner (1)
- 2016-03-20 2016-03-20 -
Uppladdad den
20 mars 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Adverse Events Ponderosa CML ZKSJ0083
Similar models
Adverse Events
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Adverse Event
Item
Did Adverse Events occur?
boolean
C0877248 (UMLS CUI [1])
Adverse Event
Item
Adverse Event:
text
C0877248 (UMLS CUI [1])
Adverse Event Start Date Time
Item
Adverse Event Start Date Time
datetime
C2826806 (UMLS CUI [1])
Adverse Event End Date Time
Item
Adverse Event End Date Time
datetime
C2826793 (UMLS CUI [1])
Serious adverse event
Item
Serious adverse event, SAE
text
C1519255 (UMLS CUI [1])
CL Item
no connection (1)
CL Item
connection exists (2)
CL Item
unknown (3)
CL Item
mild (1 )
CL Item
moderate (2 )
CL Item
severe (3 )
CL Item
life-threatening (4 )
CL Item
fatal (death) (5 )
Item
Measures taken regarding adverse event
text
C1608430 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C0677850 (UMLS CUI [2])
CL Item
no (1 )
CL Item
dose reduction (2 )
CL Item
dose increase (3 )
CL Item
drug interrupted (4 )
CL Item
drug discontinued (5 )
CL Item
adjunctive therapy (6 )
CL Item
unknown (9 )
CL Item
recovered (1 )
CL Item
recovered with consequential damages (2 )
CL Item
unchanged (3 )
CL Item
fatal (4 )
CL Item
unknown (9 )