ID
44082
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 1 Form
Keywords
Versions (3)
- 11/28/17 11/28/17 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
- 9/20/21 9/20/21 -
Copyright Holder
Gruppo Italiano Malattie EMatologiche dell'Adulto
Uploaded on
September 20, 2021
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Visit 1 GIMEMA CML0408 NCT00769327
Visit 1
- StudyEvent: ODM
Description
Comorbidities
Alias
- UMLS CUI-1
- C0009488
Description
Symptoms
Alias
- UMLS CUI-1
- C1457887
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
text
Alias
- UMLS CUI [1]
- C0545082
Description
Visit Date
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
secondary symptoms
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0332138
Description
Asthenia
Data type
boolean
Alias
- UMLS CUI [1]
- C0004093
Description
Fever
Data type
boolean
Alias
- UMLS CUI [1]
- C0015967
Description
Headache
Data type
boolean
Alias
- UMLS CUI [1]
- C0018681
Description
Sweating
Data type
boolean
Alias
- UMLS CUI [1]
- C0038990
Description
Arthralgia
Data type
boolean
Alias
- UMLS CUI [1]
- C0003862
Description
Nausea
Data type
boolean
Alias
- UMLS CUI [1]
- C0027497
Description
Vomiting
Data type
boolean
Alias
- UMLS CUI [1]
- C0042963
Description
Diarrhea
Data type
boolean
Alias
- UMLS CUI [1]
- C0011991
Description
Weight loss
Data type
boolean
Alias
- UMLS CUI [1]
- C1262477
Description
Abdominal Pain
Data type
boolean
Alias
- UMLS CUI [1]
- C0000737
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
text
Alias
- UMLS CUI [1]
- C0545082
Description
Date Physical Exam
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Splenomegaly
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0038002
Description
Hepatomegaly
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0019209
Description
Weight
Data type
integer
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Complete Blood Count
Alias
- UMLS CUI-1
- C0009555
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Complete Blood Count Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0005771
- UMLS CUI [1,2]
- C0011008
Description
Hemoglobin
Data type
integer
Measurement units
- g/L
Alias
- UMLS CUI [1]
- C0019046
Description
Leukocytes
Data type
integer
Measurement units
- x103/mL
Alias
- UMLS CUI [1]
- C0023516
Description
Platelets
Data type
integer
Measurement units
- x109/L
Alias
- UMLS CUI [1]
- C0005821
Description
polymorphonuclear
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C1168338
Description
Lymphocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0024264
Description
Monocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0026473
Description
Eosinophils
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0014467
Description
basophils
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0004827
Description
metamyelocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0229635
Description
myelocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0369715
Description
promyelocytes
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0033416
Description
blasts
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0368761
Description
Answer hematology
Data type
text
Alias
- UMLS CUI [1]
- C0474523
Description
Biochemistry
Alias
- UMLS CUI-1
- C1655775
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date biochemistry examination
Data type
date
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0005477
Description
Creatinine
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Description
Glucose
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0202042
Description
LDH
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0202113
Description
GOT
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
GPT
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
y-GT
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0202035
Description
Alkaline phosphatase
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
Total Bilirubin
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Description
Amylase
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201883
Description
Lipase
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0373670
Description
calcium
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201925
Description
Phosphorus
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0523826
Description
Potassium
Data type
integer
Measurement units
- mEq/L
Alias
- UMLS CUI [1]
- C0202194
Description
Magnesium
Data type
integer
Measurement units
- mEq/L
Alias
- UMLS CUI [1]
- C0373675
Description
Serum Proteins
Alias
- UMLS CUI-1
- C0555903
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date Biochemical Examination
Data type
date
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0005477
Description
Total Protein
Data type
integer
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0555903
Description
Albumin
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0201838
Description
a1 protein
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0860678
Description
a2 protein
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0301684
Description
beta protein
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0005157
Description
gamma protein
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0017007
Description
IgM
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0202084
Description
IgA
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0202083
Description
IgG
Data type
integer
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0202087
Description
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date electrocardiogram
Data type
date
Alias
- UMLS CUI [1]
- C2826846
Description
Electrocardiographic anomalies
Data type
boolean
Alias
- UMLS CUI [1]
- C0522055
Description
Main electrocardiographic anomaly
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C1542147
Description
Echocardiogram
Alias
- UMLS CUI-1
- C2243117
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date echocardiogram
Data type
date
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0011008
Description
Echocardiographic abnormalities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C1704258
Description
Main echocardiographic anomaly
Data type
text
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1542147
Description
Biopsie
Alias
- UMLS CUI-1
- C0005558
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Bone biopsy performed
Data type
boolean
Alias
- UMLS CUI [1]
- C0005954
Description
Date of bone marrow biopsy
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Description
Reason biopsy not done
Data type
text
Alias
- UMLS CUI [1,1]
- C0332307
- UMLS CUI [1,2]
- C0005558
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [1,4]
- C0678257
Description
Preservation of cellular samples
Alias
- UMLS CUI-1
- C0005822
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Stored cell sample
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
Description
If not, indicate reasons
Data type
text
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C2919806
Description
Date taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0680532
- UMLS CUI [1,2]
- C0011008
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0681902
Description
Sample identifier
Data type
integer
Alias
- UMLS CUI [1]
- C4071975
Description
Cytogenetics
Alias
- UMLS CUI-1
- C0010802
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Cytogenetics performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0010802
- UMLS CUI [1,2]
- C0884358
Description
Reason cytogenetics not performed
Data type
text
Alias
- UMLS CUI [1,1]
- C0445106
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0010802
Description
Date taken
Data type
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0010802
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
Number of metaphases examined
Data type
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0260877
Description
Ph Phase metaphase number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0457343
Description
Percent metaphase Ph-
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0936012
- UMLS CUI [1,2]
- C0025564
- UMLS CUI [1,3]
- C0439165
Description
Additional abnormalities
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010802
Description
Number of metaphases with additional anomalies
Data type
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1704258
Description
Description of Abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1704258
Description
FISH (from bone marrow blood)
Alias
- UMLS CUI-1
- C0005953
- UMLS CUI-2
- C0162789
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
FISH performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Description
Reason FISH not performed
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Description
Date FISH
Data type
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
Sample
Data type
integer
Alias
- UMLS CUI [1]
- C0005834
Description
Number of cells analyzed
Data type
integer
Alias
- UMLS CUI [1]
- C2963401
Description
Number of bcr / abl + cells
Data type
integer
Alias
- UMLS CUI [1]
- C1835417
Description
Probe used
Data type
text
Alias
- UMLS CUI [1]
- C0016321
Description
Classic rearrangement
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Description
der (9) deletions
Data type
boolean
Alias
- UMLS CUI [1]
- C0495650
Description
Amplification bcr / abl
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Description
Variation shift
Data type
boolean
Alias
- UMLS CUI [1]
- C0205419
Description
Other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Description
Result description
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0162789
Description
Molecular Biology (peripheral blood)
Alias
- UMLS CUI-1
- C0026376
- UMLS CUI-2
- C0229664
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Test performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0884358
Description
Reason test not performed
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
Description
Date taken
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
RT-PCR Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0599161
- UMLS CUI [1,2]
- C2346633
Description
CT BCR/ABL
Data type
integer
Alias
- UMLS CUI [1]
- C1835417
Description
CT ABL
Data type
integer
Alias
- UMLS CUI [1]
- C1835417
Description
Ratio BCR/ABLx100/ABL
Data type
integer
Alias
- UMLS CUI [1,1]
- C0456603
- UMLS CUI [1,2]
- C2733507
- UMLS CUI [1,3]
- C0439165
Description
Nested PCR performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0242574
- UMLS CUI [1,2]
- C0599161
Description
If yes, write down results
Data type
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0242574
- UMLS CUI [1,3]
- C0599161
Description
FISH (peripheral blood)
Alias
- UMLS CUI-1
- C0229664
- UMLS CUI-2
- C0162789
Description
Acronym
Data type
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
FISH performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Description
Reason not performed
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Description
Date FISH
Data type
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Description
Laboratory
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
Sample
Data type
integer
Alias
- UMLS CUI [1]
- C0005834
Description
Number of cells analyzed
Data type
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0936012
- UMLS CUI [1,3]
- C1274040
- UMLS CUI [1,4]
- C0007634
- UMLS CUI [1,5]
- C0439810
- UMLS CUI [1,6]
- C0750480
Description
Number of bcr / abl + cells
Data type
integer
Alias
- UMLS CUI [1,1]
- C1835417
- UMLS CUI [1,2]
- C0007584
- UMLS CUI [1,3]
- C0237753
Description
Probe used
Data type
text
Alias
- UMLS CUI [1,1]
- C0182400
- UMLS CUI [1,2]
- C4071975
Description
Classic rearrangement
Data type
text
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Description
der (9) deletions
Data type
boolean
Alias
- UMLS CUI [1]
- C0495650
Description
Amplification bcr / abl
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Description
Variation shift
Data type
boolean
Alias
- UMLS CUI [1]
- C0205419
Description
Other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Description
Result description
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0162789
Similar models
Visit 1
- StudyEvent: ODM
C0013216 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0242656 (UMLS CUI [1,2])
C0332138 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C0005954 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
C1698986 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,2])
C2919806 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,3])
C0010802 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0260877 (UMLS CUI [1,3])
C0457343 (UMLS CUI [1,2])
C0025564 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0010802 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0162789 (UMLS CUI-2)
C0884358 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C3250978 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])
C0229664 (UMLS CUI-2)
C0884358 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C2346633 (UMLS CUI [1,2])
C2733507 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0599161 (UMLS CUI [1,2])
C0242574 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
C0162789 (UMLS CUI-2)
C0884358 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0936012 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0007634 (UMLS CUI [1,4])
C0439810 (UMLS CUI [1,5])
C0750480 (UMLS CUI [1,6])
C0007584 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C4071975 (UMLS CUI [1,2])
C3250978 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])