ID

13979

Description

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.

Mots-clés

  1. 20/03/2016 20/03/2016 -
Téléchargé le

20 mars 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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Adverse Events Ponderosa CML ZKSJ0083

Adverse Events

  1. StudyEvent: ODM
    1. Adverse Events
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Did Adverse Events occur?
Description

Adverse Event

Type de données

boolean

Alias
UMLS CUI [1]
C0877248
Adverse Event:
Description

Adverse Event

Type de données

text

Alias
UMLS CUI [1]
C0877248
Adverse Event Start Date Time
Description

Adverse Event Start Date Time

Type de données

datetime

Alias
UMLS CUI [1]
C2826806
Adverse Event End Date Time
Description

Adverse Event End Date Time

Type de données

datetime

Alias
UMLS CUI [1]
C2826793
Serious adverse event, SAE
Description

Serious adverse event

Type de données

text

Alias
UMLS CUI [1]
C1519255
Connection with intervention
Description

Intervention

Type de données

text

Alias
UMLS CUI [1]
C0184661
Degree of severity
Description

severity of adverse events

Type de données

text

Alias
UMLS CUI [1]
C1710066
Measures taken regarding adverse event
Description

Medication dose changed; adjunctive therapy

Type de données

text

Alias
UMLS CUI [1]
C1608430
UMLS CUI [2]
C0677850
Adverse Event outcome
Description

Adverse Event outcome

Type de données

text

Alias
UMLS CUI [1]
C1705586

Similar models

Adverse Events

  1. StudyEvent: ODM
    1. Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
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])
Item
Connection with intervention
text
C0184661 (UMLS CUI [1])
Code List
Connection with intervention
CL Item
no connection (1)
CL Item
connection exists (2)
CL Item
unknown (3)
Item
Degree of severity
text
C1710066 (UMLS CUI [1])
Code List
Degree of severity
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])
Code List
Measures taken regarding adverse event
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 )
Item
Adverse Event outcome
text
C1705586 (UMLS CUI [1])
Code List
Adverse Event outcome
CL Item
recovered (1 )
CL Item
recovered with consequential damages (2 )
CL Item
unchanged (3 )
CL Item
fatal (4 )
CL Item
unknown (9 )

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