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Adverse Event AML Pazopanib NCT01361334

1 forms  
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Patient number (derived)
Description

Patientennummer (derived)

Data type

text

Alias
UMLS CUI [1]
C2348585
AE: Sheet number
Description

AE: Sheet number

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750480
AE: Signature date
Description

AE: Signature date

Data type

date

Alias
UMLS CUI [1]
C0807937
AE: Signature date Status
Description

AE: Signature date Status

Data type

text

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C2985875
AE: Signature Investigator
Description

AE: Signature Investigator

Data type

text

Alias
UMLS CUI [1]
C2346576
AE: Neue eForm
Description

AE: Neue eForm

Data type

text

Comment adverse event
Description

Kommentar Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0947611
AERQG
Description

AERQG

AE: Nummer
Description

Adverse Event Number

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750480
AE: Term
Description

Adverse Event Term

Data type

text

Alias
UMLS CUI [1]
C2826934
AE: Start Datum
Description

Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1]
C2697888
AE: Start date Status
Description

AE: Start date Status

Data type

text

Alias
UMLS CUI [1,1]
C2697888
UMLS CUI [1,2]
C0449438
Serious adverse event
Description

SAE

Data type

boolean

Alias
UMLS CUI [1]
C1519255
AE: Toxizität (CTCAE) Grad
Description

CTCAE grade

Data type

text

Alias
UMLS CUI [1]
C2985911
AE: Relationship to study treatment XXX
Description

AE: Relationship to study treatment XXX

Data type

text

Alias
UMLS CUI [1]
C3828190
AE: Action taken with study treatment XXX
Description

AE: Action taken with study treatment XXX

Data type

text

Alias
UMLS CUI [1]
C1299575
AE: AE that caused study discontinuation
Description

AE: AE that caused study discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1518546
AE: Endedatum
Description

AE End date

Data type

date

Alias
UMLS CUI [1]
C2697886
AE: End date Status
Description

AE: End date Status

Data type

text

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C0449438
AE: Ongoing
Description

AE: Ongoing

Data type

text

Alias
UMLS CUI [1]
C2826663
AE: Outcome XXX
Description

AE: Outcome XXX

Data type

text

Alias
UMLS CUI [1]
C1705586
AE: Toxicity (CTCAE) Grade
Description

AE: Toxicity (CTCAE) Grade

Data type

text

Alias
UMLS CUI [1]
C1516728
AE: Relationship to study treatment
Description

AE: Relationship to study treatment

Data type

text

Alias
UMLS CUI [1]
C3828190
AE: Action taken with study treatment
Description

AE: Action taken with study treatment

Data type

text

Alias
UMLS CUI [1]
C1299575
AE: Outcome
Description

AE: Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
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Similar models

Adverse Event AML Pazopanib NCT01361334

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Patientennummer (derived)
Item
Patient number (derived)
text
C2348585 (UMLS CUI [1])
AE: Sheet number
Item
AE: Sheet number
integer
C0877248 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
AE: Signature date
Item
AE: Signature date
date
C0807937 (UMLS CUI [1])
Item
AE: Signature date Status
text
C2346576 (UMLS CUI [1,1])
C2985875 (UMLS CUI [1,2])
AE: Signature date Status
Code List
AE: Signature date Status
CL Item
T (1)
CL Item
TM (2)
CL Item
M (3)
Item
AE: Signature Investigator
text
C2346576 (UMLS CUI [1])
AE: Signature Investigator
Code List
AE: Signature Investigator
CL Item
ja (1)
CL Item
nein (0)
AE: Neue eForm
Code List
AE: Neue eForm
CL Item
 (1)
Kommentar Adverse Event
Item
Comment adverse event
text
C0947611 (UMLS CUI [1])
Item Group
Adverse Event Number
Item
AE: Nummer
integer
C0877248 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Adverse Event Term
Item
AE: Term
text
C2826934 (UMLS CUI [1])
Adverse Event Start Date
Item
AE: Start Datum
date
C2697888 (UMLS CUI [1])
Item
AE: Start date Status
text
C2697888 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
AE: Start date Status
Code List
AE: Start date Status
CL Item
T (1)
CL Item
TM (2)
CL Item
M (3)
SAE
Item
Serious adverse event
boolean
C1519255 (UMLS CUI [1])
Item
AE: Toxizität (CTCAE) Grad
text
C2985911 (UMLS CUI [1])
AE: Toxicity (CTCAE) Grade XXX
Code List
AE: Toxizität (CTCAE) Grad
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
0 (0)
Item
AE: Relationship to study treatment XXX
text
C3828190 (UMLS CUI [1])
AE: Relationship to study treatment XXX
Code List
AE: Relationship to study treatment XXX
CL Item
0 (0)
CL Item
1 (1)
Item
AE: Action taken with study treatment XXX
text
C1299575 (UMLS CUI [1])
AE: Action taken with study treatment XXX
Code List
AE: Action taken with study treatment XXX
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
AE: AE that caused study discontinuation
text
C0877248 (UMLS CUI [1,1])
C1518546 (UMLS CUI [1,2])
AE: AE that caused study discontinuation
Code List
AE: AE that caused study discontinuation
CL Item
ja (1)
CL Item
nein (0)
AE End date
Item
AE: Endedatum
date
C2697886 (UMLS CUI [1])
Item
AE: End date Status
text
C2697886 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
AE: End date Status
Code List
AE: End date Status
CL Item
T (1)
CL Item
TM (2)
CL Item
M (3)
Item
AE: Ongoing
text
C2826663 (UMLS CUI [1])
AE: Ongoing
Code List
AE: Ongoing
CL Item
ja (1)
Item
AE: Outcome XXX
text
C1705586 (UMLS CUI [1])
AE: Outcome XXX
Code List
AE: Outcome XXX
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
AE: Toxicity (CTCAE) Grade
text
C1516728 (UMLS CUI [1])
AE: Toxicity (CTCAE) Grade
Code List
AE: Toxicity (CTCAE) Grade
CL Item
mild  (1)
C2945599 (UMLS CUI-1)
CL Item
moderate (2)
C0205081 (UMLS CUI-1)
CL Item
severe (3)
C0205082 (UMLS CUI-1)
CL Item
life threatening (4)
C1517874 (UMLS CUI-1)
CL Item
death (5)
C0011065 (UMLS CUI-1)
CL Item
none (0)
C0549184 (UMLS CUI-1)
Item
AE: Relationship to study treatment
text
C3828190 (UMLS CUI [1])
AE: Relationship to study treatment
Code List
AE: Relationship to study treatment
CL Item
no rational possibility of a relation (0)
CL Item
rational possibility of a relation (1)
Item
AE: Action taken with study treatment
text
C1299575 (UMLS CUI [1])
AE: Action taken with study treatment
Code List
AE: Action taken with study treatment
CL Item
none (0)
CL Item
change of dose (1)
CL Item
Medication discharged temporarily (2)
CL Item
Medication discharged (3)
Item
AE: Outcome
text
C1705586 (UMLS CUI [1])
AE: Outcome
Code List
AE: Outcome
CL Item
Revovery (0)
CL Item
improved (1)
CL Item
not yet improved (2)
CL Item
Recovery with permanent disability (3)
CL Item
death (4)
C0011065 (UMLS CUI-1)
CL Item
unknown (5)
C0439673 (UMLS CUI-1)
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