ID

27798

Description

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 5 Form

Keywords

  1. 11/29/17 11/29/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

Gruppo Italiano Malattie EMatologiche dell'Adulto

Uploaded on

November 29, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Visit 5 GIMEMA CML0408 NCT00769327

Visit 5

  1. StudyEvent: ODM
    1. Visit 5
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Acronym
Description

Acronym

Data type

integer

Alias
UMLS CUI [1]
C2986333
Visit
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Date Physical Exam
Description

Date Physical Exam

Data type

date

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

Splenomegaly

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0038002
cm
Hepatomegaly (from the costal bow)
Description

Hepatomegaly

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0019209
cm
Weight
Description

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Complete Blood Count
Description

Complete Blood Count

Alias
UMLS CUI-1
C0009555
Acronym
Description

Acronym

Data type

integer

Alias
UMLS CUI [1]
C2986333
Visit
Description

Visit

Data type

integer

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

Complete Blood Count Date

Data type

date

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

Hemoglobin

Data type

integer

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0019046
g/L
Leukocytes
Description

Leukocytes

Data type

integer

Measurement units
  • x103/mL
Alias
UMLS CUI [1]
C0023516
x103/mL
Platelets
Description

Platelets

Data type

integer

Measurement units
  • x109/L
Alias
UMLS CUI [1]
C0005821
x109/L
polymorphonuclear
Description

polymorphonuclear

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C1168338
%
Lymphocytes
Description

Lymphocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Description

Monocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Description

Eosinophils

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0014467
%
basophils
Description

basophils

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0004827
%
metamyelocytes
Description

metamyelocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0229635
%
myelocytes
Description

myelocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0369715
%
promyelocytes
Description

promyelocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0033416
%
blasts
Description

blasts

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0368761
%
Answer hematology
Description

Answer hematology

Data type

text

Alias
UMLS CUI [1]
C0474523
Biochemistry
Description

Biochemistry

Alias
UMLS CUI-1
C1655775
Acronym
Description

Acronym

Data type

integer

Alias
UMLS CUI [1]
C2986333
Visit
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Date biochemistry examination
Description

Date biochemistry examination

Data type

date

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

Creatinine

Data type

integer

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Glucose
Description

Glucose

Data type

integer

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0202042
mg/dL
LDH
Description

LDH

Data type

integer

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0202113
U/L
GOT
Description

GOT

Data type

integer

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
GPT
Description

GPT

Data type

integer

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
y-GT
Description

y-GT

Data type

integer

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0202035
U/L
Alkaline phosphatase
Description

Alkaline phosphatase

Data type

integer

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Total Bilirubin
Description

Total Bilirubin

Data type

integer

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Amylase
Description

Amylase

Data type

integer

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201883
U/L
Lipase
Description

Lipase

Data type

integer

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0373670
U/L
Calcium
Description

calcium

Data type

integer

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201925
mg/dL
Phosphorus
Description

Phosphorus

Data type

integer

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0523826
mg/dL
Potassium
Description

Potassium

Data type

integer

Measurement units
  • mEq/L
Alias
UMLS CUI [1]
C0202194
mEq/L
Magnesium
Description

Magnesium

Data type

integer

Measurement units
  • mEq/L
Alias
UMLS CUI [1]
C0373675
mEq/L
Electrocardiogram
Description

Electrocardiogram

Alias
UMLS CUI-1
C1623258
Acronym
Description

Acronym

Data type

integer

Alias
UMLS CUI [1]
C2986333
Visit
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Date electrocardiogram
Description

Date electrocardiogram

Data type

date

Alias
UMLS CUI [1]
C2826846
Electrocardiographic anomalies
Description

Electrocardiographic anomalies

Data type

boolean

Alias
UMLS CUI [1]
C1832603
Main electrocardiographic anomaly
Description

Main electrocardiographic anomaly

Data type

text

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C1542147

Similar models

Visit 5

  1. StudyEvent: ODM
    1. Visit 5
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

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