ID

13013

Beschrijving

Pilot Clinical Trial of Pazopanib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible (PAZOPANIB-AML) https://clinicaltrials.gov/ct2/show/NCT01361334 Principal Investigator: PD Dr. Torsten Kessler, University Hospital Muenster, Germany

Link

https://clinicaltrials.gov/ct2/show/NCT01361334

Trefwoorden

  1. 14-08-15 14-08-15 - Martin Dugas
  2. 11-01-16 11-01-16 -
  3. 11-02-16 11-02-16 -
Geüploaded op

11 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Adverse Event AML Pazopanib NCT01361334

Adverse Event AML Pazopanib NCT01361334

Adverse Event
Beschrijving

Adverse Event

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

Patientennummer (derived)

Datatype

text

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

AE: Sheet number

Datatype

integer

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

AE: Signature date

Datatype

date

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

AE: Signature date Status

Datatype

text

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

AE: Signature Investigator

Datatype

text

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

AE: Neue eForm

Datatype

text

Comment adverse event
Beschrijving

Kommentar Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0947611
AERQG
Beschrijving

AERQG

AE: Nummer
Beschrijving

Adverse Event Number

Datatype

integer

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

Adverse Event Term

Datatype

text

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

Adverse Event Start Date

Datatype

date

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

AE: Start date Status

Datatype

text

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

SAE

Datatype

boolean

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

CTCAE grade

Datatype

text

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

AE: Relationship to study treatment XXX

Datatype

text

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

AE: Action taken with study treatment XXX

Datatype

text

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

AE: AE that caused study discontinuation

Datatype

text

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

AE End date

Datatype

date

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

AE: End date Status

Datatype

text

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

AE: Ongoing

Datatype

text

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

AE: Outcome XXX

Datatype

text

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

AE: Toxicity (CTCAE) Grade

Datatype

text

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

AE: Relationship to study treatment

Datatype

text

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

AE: Action taken with study treatment

Datatype

text

Alias
UMLS CUI [1]
C1299575
AE: Outcome
Beschrijving

AE: Outcome

Datatype

text

Alias
UMLS CUI [1]
C1705586

Similar models

Adverse Event AML Pazopanib NCT01361334

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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])
Code List
AE: Signature Investigator
CL Item
ja (1)
CL Item
nein (0)
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])
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])
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])
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])
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])
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])
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])
Code List
AE: Ongoing
CL Item
ja (1)
Item
AE: Outcome XXX
text
C1705586 (UMLS CUI [1])
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])
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])
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])
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])
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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