ID

27800

Beschreibung

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 13 Form

Stichworte

  1. 29.11.17 29.11.17 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

Gruppo Italiano Malattie EMatologiche dell'Adulto

Hochgeladen am

29. November 2017

DOI

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Visit 13 GIMEMA CML0408 NCT00769327

  1. StudyEvent: ODM
    1. Visit 13
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Acronym
Beschreibung

Acronym

Datentyp

integer

Alias
UMLS CUI [1]
C2986333
Visit
Beschreibung

Visit

Datentyp

text

Alias
UMLS CUI [1]
C0545082
Date Physical Exam
Beschreibung

Date Physical Exam

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Splenomegaly (from the costal bow)
Beschreibung

Splenomegaly

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0038002
cm
Hepatomegaly (from the costal bow)
Beschreibung

Hepatomegaly

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0019209
cm
Weight
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Complete Blood Count
Beschreibung

Complete Blood Count

Alias
UMLS CUI-1
C0009555
Acronym
Beschreibung

Acronym

Datentyp

integer

Alias
UMLS CUI [1]
C2986333
Visit
Beschreibung

Visit

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Complete Blood Count Date
Beschreibung

Complete Blood Count Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0011008
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

integer

Maßeinheiten
  • g/L
Alias
UMLS CUI [1]
C0019046
g/L
Leukocytes
Beschreibung

Leukocytes

Datentyp

integer

Maßeinheiten
  • x103/mL
Alias
UMLS CUI [1]
C0023516
x103/mL
Platelets
Beschreibung

Platelets

Datentyp

integer

Maßeinheiten
  • x109/L
Alias
UMLS CUI [1]
C0005821
x109/L
polymorphonuclear
Beschreibung

polymorphonuclear

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C1168338
%
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Beschreibung

Monocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Beschreibung

Eosinophils

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0014467
%
basophils
Beschreibung

basophils

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0004827
%
metamyelocytes
Beschreibung

metamyelocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0229635
%
myelocytes
Beschreibung

myelocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0369715
%
promyelocytes
Beschreibung

promyelocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0033416
%
blasts
Beschreibung

blasts

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0368761
%
Answer hematology
Beschreibung

Answer hematology

Datentyp

text

Alias
UMLS CUI [1]
C0474523
Biochemistry
Beschreibung

Biochemistry

Alias
UMLS CUI-1
C1655775
Acronym
Beschreibung

Acronym

Datentyp

integer

Alias
UMLS CUI [1]
C2986333
Visit
Beschreibung

Visit

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Date biochemistry examination
Beschreibung

Date biochemistry examination

Datentyp

date

Alias
UMLS CUI [1,1]
C2826641
UMLS CUI [1,2]
C0005477
Creatinine
Beschreibung

Creatinine

Datentyp

integer

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Glucose
Beschreibung

Glucose

Datentyp

integer

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0202042
mg/dL
LDH
Beschreibung

LDH

Datentyp

integer

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0202113
U/L
GOT
Beschreibung

GOT

Datentyp

integer

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
GPT
Beschreibung

GPT

Datentyp

integer

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
y-GT
Beschreibung

y-GT

Datentyp

integer

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0202035
U/L
Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

integer

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Total Bilirubin
Beschreibung

Total Bilirubin

Datentyp

integer

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Amylase
Beschreibung

Amylase

Datentyp

integer

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201883
U/L
Lipase
Beschreibung

Lipase

Datentyp

integer

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0373670
U/L
Calcium
Beschreibung

calcium

Datentyp

integer

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0201925
mg/dL
Phosphorus
Beschreibung

Phosphorus

Datentyp

integer

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0523826
mg/dL
Potassium
Beschreibung

Potassium

Datentyp

integer

Maßeinheiten
  • mEq/L
Alias
UMLS CUI [1]
C0202194
mEq/L
Magnesium
Beschreibung

Magnesium

Datentyp

integer

Maßeinheiten
  • mEq/L
Alias
UMLS CUI [1]
C0373675
mEq/L
Electrocardiogram
Beschreibung

Electrocardiogram

Alias
UMLS CUI-1
C1623258
Acronym
Beschreibung

Acronym

Datentyp

integer

Alias
UMLS CUI [1]
C2986333
Visit
Beschreibung

Visit

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Date electrocardiogram
Beschreibung

Date electrocardiogram

Datentyp

date

Alias
UMLS CUI [1]
C2826846
Electrocardiographic anomalies
Beschreibung

Electrocardiographic anomalies

Datentyp

boolean

Alias
UMLS CUI [1]
C1832603
Main electrocardiographic anomaly
Beschreibung

Main electrocardiographic anomaly

Datentyp

text

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C1542147
Molecular Biology (peripheral blood)
Beschreibung

Molecular Biology (peripheral blood)

Alias
UMLS CUI-1
C0026376
UMLS CUI-2
C0229664
Acronym
Beschreibung

Acronym

Datentyp

integer

Alias
UMLS CUI [1]
C2986333
Visit
Beschreibung

Visit

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Test performed
Beschreibung

Test performed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0884358
Reason not performed
Beschreibung

Reason test not performed

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C3841220
Date taken
Beschreibung

Date taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Laboratory
Beschreibung

Laboratory

Datentyp

text

Alias
UMLS CUI [1]
C0022877
RT-PCR Result
Beschreibung

RT-PCR Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0599161
UMLS CUI [1,2]
C2346633
CT BCR/ABL
Beschreibung

CT BCR/ABL

Datentyp

integer

Alias
UMLS CUI [1]
C1835417
CT ABL
Beschreibung

CT ABL

Datentyp

integer

Alias
UMLS CUI [1]
C1835417
Ratio BCR/ABLx100/ABL
Beschreibung

Ratio BCR/ABLx100/ABL

Datentyp

integer

Alias
UMLS CUI [1,1]
C0456603
UMLS CUI [1,2]
C2733507
UMLS CUI [1,3]
C0439165
Nested PCR performed
Beschreibung

Nested PCR performed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242574
UMLS CUI [1,2]
C0599161
If yes, write down results
Beschreibung

If yes, write down results

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0242574
UMLS CUI [1,3]
C0599161

Ähnliche Modelle

Visit 13

  1. StudyEvent: ODM
    1. Visit 13
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Date Physical Exam
Item
Date Physical Exam
date
C2826643 (UMLS CUI [1])
Splenomegaly
Item
Splenomegaly (from the costal bow)
integer
C0038002 (UMLS CUI [1])
Hepatomegaly
Item
Hepatomegaly (from the costal bow)
integer
C0019209 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item Group
Complete Blood Count
C0009555 (UMLS CUI-1)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Complete Blood Count Date
Item
Complete Blood Count Date
date
C0005771 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin
integer
C0019046 (UMLS CUI [1])
Leukocytes
Item
Leukocytes
integer
C0023516 (UMLS CUI [1])
Platelets
Item
Platelets
integer
C0005821 (UMLS CUI [1])
polymorphonuclear
Item
polymorphonuclear
integer
C1168338 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
integer
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes
integer
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
integer
C0014467 (UMLS CUI [1])
basophils
Item
basophils
integer
C0004827 (UMLS CUI [1])
metamyelocytes
Item
metamyelocytes
integer
C0229635 (UMLS CUI [1])
myelocytes
Item
myelocytes
integer
C0369715 (UMLS CUI [1])
promyelocytes
Item
promyelocytes
integer
C0033416 (UMLS CUI [1])
blasts
Item
blasts
integer
C0368761 (UMLS CUI [1])
Answer hematology
Item
Answer hematology
text
C0474523 (UMLS CUI [1])
Item Group
Biochemistry
C1655775 (UMLS CUI-1)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date biochemistry examination
Item
Date biochemistry examination
date
C2826641 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
integer
C0201976 (UMLS CUI [1])
Glucose
Item
Glucose
integer
C0202042 (UMLS CUI [1])
LDH
Item
LDH
integer
C0202113 (UMLS CUI [1])
GOT
Item
GOT
integer
C0201899 (UMLS CUI [1])
GPT
Item
GPT
integer
C0201836 (UMLS CUI [1])
y-GT
Item
y-GT
integer
C0202035 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
integer
C0201850 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
integer
C0201913 (UMLS CUI [1])
Amylase
Item
Amylase
integer
C0201883 (UMLS CUI [1])
Lipase
Item
Lipase
integer
C0373670 (UMLS CUI [1])
calcium
Item
Calcium
integer
C0201925 (UMLS CUI [1])
Phosphorus
Item
Phosphorus
integer
C0523826 (UMLS CUI [1])
Potassium
Item
Potassium
integer
C0202194 (UMLS CUI [1])
Magnesium
Item
Magnesium
integer
C0373675 (UMLS CUI [1])
Item Group
Electrocardiogram
C1623258 (UMLS CUI-1)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date electrocardiogram
Item
Date electrocardiogram
date
C2826846 (UMLS CUI [1])
Electrocardiographic anomalies
Item
Electrocardiographic anomalies
boolean
C1832603 (UMLS CUI [1])
Main electrocardiographic anomaly
Item
Main electrocardiographic anomaly
text
C1832603 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Item Group
Molecular Biology (peripheral blood)
C0026376 (UMLS CUI-1)
C0229664 (UMLS CUI-2)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Test performed
Item
Test performed
boolean
C0005834 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Reason test not performed
Item
Reason not performed
text
C0392360 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
Date taken
Item
Date taken
date
C1302413 (UMLS CUI [1])
Laboratory
Item
Laboratory
text
C0022877 (UMLS CUI [1])
RT-PCR Result
Item
RT-PCR Result
text
C0599161 (UMLS CUI [1,1])
C2346633 (UMLS CUI [1,2])
CT BCR/ABL
Item
CT BCR/ABL
integer
C1835417 (UMLS CUI [1])
CT ABL
Item
CT ABL
integer
C1835417 (UMLS CUI [1])
Ratio BCR/ABLx100/ABL
Item
Ratio BCR/ABLx100/ABL
integer
C0456603 (UMLS CUI [1,1])
C2733507 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Nested PCR performed
Item
Nested PCR performed
boolean
C0242574 (UMLS CUI [1,1])
C0599161 (UMLS CUI [1,2])
If yes, write down results
Item
If yes, write down results
text
C1274040 (UMLS CUI [1,1])
C0242574 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])

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