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Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 Formulare  
Adverse event
Beschreibung

Adverse event

Name adverse event
Beschreibung

Name adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
Date of Onset
Beschreibung

Adverse Event Onset Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985916
dd/mm/yy
Serious Adverse Event
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Did this event start during a MabThera® infusion?
Beschreibung

Adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1314901
Did this event start within 24 hours of finishing a MabThera® infusion?
Beschreibung

Adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
CTCAE grade
Beschreibung

Initial intensity

Datentyp

integer

Alias
UMLS CUI [1]
C1517874
Test drug adjustment
Beschreibung

Test drug adjustment

Datentyp

integer

Alias
UMLS CUI [1]
C0376209
Was treatment given for this event
Beschreibung

Adverse event treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C2981656
Most extreme intensity CTCAE grade
Beschreibung

Most extreme intensity CTCAE grade

Datentyp

integer

Alias
UMLS CUI [1]
C1517874
Adverse event
Beschreibung

Relationship to study drugs

Datentyp

integer

Adverse Event Outcome
Beschreibung

Adverse Event Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Resolved Date
Beschreibung

Resolved Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Adverse Event Comment
Beschreibung

Adverse Event Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Adverse event treatments
Beschreibung

Adverse event treatments

Name of treatment
Beschreibung

Name of treatment

Datentyp

integer

Alias
UMLS CUI [1]
C2826274
Treatment Start Date
Beschreibung

Treatment Start Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C3173309
dd/mm/yy
Treatment End Date
Beschreibung

Treatment End Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C1531784
dd/mm/yy
Treatment Ongoing
Beschreibung

Treatment Ongoing at final contact

Datentyp

boolean

Alias
UMLS CUI [1]
C2091305
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Ähnliche Modelle

Adverse event or intercurrent illness Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Adverse event
Name adverse event
Item
Name adverse event
integer
C0877248 (UMLS CUI [1])
Adverse Event Onset Date
Item
Date of Onset
date
C2985916 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI [1])
Adverse Event
Item
Did this event start during a MabThera® infusion?
boolean
C1314901 (UMLS CUI [1])
Adverse event
Item
Did this event start within 24 hours of finishing a MabThera® infusion?
boolean
C0877248 (UMLS CUI [1])
Item
CTCAE grade
integer
C1517874 (UMLS CUI [1])
Initial intensity
Code List
CTCAE grade
CL Item
CTCAE grade 1 (1)
C1556202 (UMLS CUI-1)
CL Item
CTCAE grade 2 (2)
C1556203 (UMLS CUI-1)
CL Item
CTCAE grade 3 (3)
C1556204 (UMLS CUI-1)
CL Item
CTCAE grade 4 (4)
C1556205 (UMLS CUI-1)
Item
Test drug adjustment
integer
C0376209 (UMLS CUI [1])
Test drug adjustment
Code List
Test drug adjustment
CL Item
none (1)
C0549184 (UMLS CUI-1)
CL Item
dosage modified/interrupted (2)
C0392747 (UMLS CUI-1)
CL Item
discontinued (3)
C1444662 (UMLS CUI-1)
Adverse event treatment
Item
Was treatment given for this event
boolean
C2981656 (UMLS CUI [1])
Item
Most extreme intensity CTCAE grade
integer
C1517874 (UMLS CUI [1])
Initial intensity
Code List
Most extreme intensity CTCAE grade
CL Item
CTCAE grade 1 (1)
C1556202 (UMLS CUI-1)
CL Item
CTCAE grade 2 (2)
C1556203 (UMLS CUI-1)
CL Item
CTCAE grade 3 (3)
C1556204 (UMLS CUI-1)
CL Item
CTCAE grade 4 (4)
C1556205 (UMLS CUI-1)
Item
Adverse event
integer
Adverse event
Code List
Adverse event
CL Item
unrelated (1)
C0445356 (UMLS CUI-1)
CL Item
remote (2)
C0205157 (UMLS CUI-1)
CL Item
possible (3)
C0332149 (UMLS CUI-1)
CL Item
probable (4)
C1709683 (UMLS CUI-1)
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Adverse Event Outcome
CL Item
resolved, no sequelae (1)
CL Item
resolved, with sequelae (2)
CL Item
unresoved (3)
CL Item
death (4)
Resolved Date
Item
Resolved Date
date
C0011008 (UMLS CUI [1])
Adverse Event Comment
Item
Adverse Event Comment
text
C0947611 (UMLS CUI [1])
Item Group
Adverse event treatments
Name of treatment
Item
Name of treatment
integer
C2826274 (UMLS CUI [1])
Treatment Start Date
Item
Treatment Start Date
date
C3173309 (UMLS CUI [1])
Treatment End Date
Item
Treatment End Date
date
C1531784 (UMLS CUI [1])
Treatment Ongoing
Item
Treatment Ongoing
boolean
C2091305 (UMLS CUI [1])
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