ID
42061
Beschrijving
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
Trefwoorden
Versies (3)
- 28-11-17 28-11-17 -
- 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
- 20-09-21 20-09-21 -
Houder van rechten
Gruppo Italiano Malattie EMatologiche dell'Adulto
Geüploaded op
15 maart 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Visit 1 GIMEMA CML0408 NCT00769327
Visit 1
- StudyEvent: ODM
Beschrijving
Comorbidities
Alias
- UMLS CUI-1
- C0009488
Beschrijving
Symptoms
Alias
- UMLS CUI-1
- C1457887
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
text
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Visit Date
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
secondary symptoms
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0332138
Beschrijving
Asthenia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004093
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Headache
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018681
Beschrijving
Sweating
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038990
Beschrijving
Arthralgia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0003862
Beschrijving
Nausea
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027497
Beschrijving
Vomiting
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042963
Beschrijving
Diarrhea
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011991
Beschrijving
Weight loss
Datatype
boolean
Alias
- UMLS CUI [1]
- C0043096
Beschrijving
Abdominal Pain
Datatype
boolean
Alias
- UMLS CUI [1]
- C0000737
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
text
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Date Physical Exam
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Splenomegaly
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0038002
Beschrijving
Hepatomegaly
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0019209
Beschrijving
Weight
Datatype
integer
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Complete Blood Count
Alias
- UMLS CUI-1
- C0009555
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Complete Blood Count Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005771
- UMLS CUI [1,2]
- C0011008
Beschrijving
Hemoglobin
Datatype
integer
Maateenheden
- g/L
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
Leukocytes
Datatype
integer
Maateenheden
- x103/mL
Alias
- UMLS CUI [1]
- C0023516
Beschrijving
Platelets
Datatype
integer
Maateenheden
- x109/L
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
polymorphonuclear
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C1168338
Beschrijving
Lymphocytes
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0024264
Beschrijving
Monocytes
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0026473
Beschrijving
Eosinophils
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0014467
Beschrijving
basophils
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0004827
Beschrijving
metamyelocytes
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0229635
Beschrijving
myelocytes
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0369715
Beschrijving
promyelocytes
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0033416
Beschrijving
blasts
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0368761
Beschrijving
Answer hematology
Datatype
text
Alias
- UMLS CUI [1]
- C0474523
Beschrijving
Biochemistry
Alias
- UMLS CUI-1
- C1655775
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Date biochemistry examination
Datatype
date
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0005477
Beschrijving
Creatinine
Datatype
integer
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Glucose
Datatype
integer
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0202042
Beschrijving
LDH
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0202113
Beschrijving
GOT
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
GPT
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
y-GT
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0202035
Beschrijving
Alkaline phosphatase
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Total Bilirubin
Datatype
integer
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Amylase
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201883
Beschrijving
Lipase
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0373670
Beschrijving
calcium
Datatype
integer
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0201925
Beschrijving
Phosphorus
Datatype
integer
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0523826
Beschrijving
Potassium
Datatype
integer
Maateenheden
- mEq/L
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Magnesium
Datatype
integer
Maateenheden
- mEq/L
Alias
- UMLS CUI [1]
- C0373675
Beschrijving
Serum Proteins
Alias
- UMLS CUI-1
- C0555903
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Date Biochemical Examination
Datatype
date
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0005477
Beschrijving
Total Protein
Datatype
integer
Maateenheden
- g/dL
Alias
- UMLS CUI [1]
- C0555903
Beschrijving
Albumin
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
a1 protein
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0860678
Beschrijving
a2 protein
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0301684
Beschrijving
beta protein
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0005157
Beschrijving
gamma protein
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0017007
Beschrijving
IgM
Datatype
integer
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0202084
Beschrijving
IgA
Datatype
integer
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0202083
Beschrijving
IgG
Datatype
integer
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0202087
Beschrijving
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Date electrocardiogram
Datatype
date
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
Electrocardiographic anomalies
Datatype
boolean
Alias
- UMLS CUI [1]
- C1832603
Beschrijving
Main electrocardiographic anomaly
Datatype
text
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C1542147
Beschrijving
Echocardiogram
Alias
- UMLS CUI-1
- C2243117
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Date echocardiogram
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0011008
Beschrijving
Echocardiographic abnormalities
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C1704258
Beschrijving
Main echocardiographic anomaly
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1542147
Beschrijving
Biopsie
Alias
- UMLS CUI-1
- C0005558
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Bone biopsy performed
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005954
Beschrijving
Date of bone marrow biopsy
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Beschrijving
Reason biopsy not done
Datatype
text
Alias
- UMLS CUI [1,1]
- C0332307
- UMLS CUI [1,2]
- C0005558
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [1,4]
- C0678257
Beschrijving
Preservation of cellular samples
Alias
- UMLS CUI-1
- C0005822
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Stored cell sample
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
Beschrijving
If not, indicate reasons
Datatype
text
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C2919806
Beschrijving
Date taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C0680532
- UMLS CUI [1,2]
- C0011008
Beschrijving
Laboratory
Datatype
text
Alias
- UMLS CUI [1]
- C0681902
Beschrijving
Sample identifier
Datatype
integer
Alias
- UMLS CUI [1]
- C4071975
Beschrijving
Cytogenetics
Alias
- UMLS CUI-1
- C0010802
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Cytogenetics performed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0010802
- UMLS CUI [1,2]
- C0884358
Beschrijving
Reason cytogenetics not performed
Datatype
text
Alias
- UMLS CUI [1,1]
- C0445106
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0010802
Beschrijving
Date taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0010802
Beschrijving
Laboratory
Datatype
text
Alias
- UMLS CUI [1]
- C0022877
Beschrijving
Number of metaphases examined
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0260877
Beschrijving
Ph Phase metaphase number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0457343
Beschrijving
Percent metaphase Ph-
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C0936012
- UMLS CUI [1,2]
- C0025564
- UMLS CUI [1,3]
- C0439165
Beschrijving
Additional abnormalities
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010802
Beschrijving
Number of metaphases with additional anomalies
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1704258
Beschrijving
Description of Abnormalities
Datatype
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1704258
Beschrijving
FISH (from bone marrow blood)
Alias
- UMLS CUI-1
- C0005953
- UMLS CUI-2
- C0162789
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
FISH performed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Beschrijving
Reason FISH not performed
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Beschrijving
Date FISH
Datatype
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Beschrijving
Laboratory
Datatype
text
Alias
- UMLS CUI [1]
- C0022877
Beschrijving
Sample
Datatype
integer
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Number of cells analyzed
Datatype
integer
Alias
- UMLS CUI [1]
- C2963401
Beschrijving
Number of bcr / abl + cells
Datatype
integer
Alias
- UMLS CUI [1]
- C1835417
Beschrijving
Probe used
Datatype
text
Alias
- UMLS CUI [1]
- C0016321
Beschrijving
Classic rearrangement
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Beschrijving
der (9) deletions
Datatype
boolean
Alias
- UMLS CUI [1]
- C0495650
Beschrijving
Amplification bcr / abl
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Beschrijving
Variation shift
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205419
Beschrijving
Other
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Beschrijving
Result description
Datatype
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0162789
Beschrijving
Molecular Biology (peripheral blood)
Alias
- UMLS CUI-1
- C0026376
- UMLS CUI-2
- C0229664
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Test performed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0884358
Beschrijving
Reason test not performed
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
Beschrijving
Date taken
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Laboratory
Datatype
text
Alias
- UMLS CUI [1]
- C0022877
Beschrijving
RT-PCR Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0599161
- UMLS CUI [1,2]
- C2346633
Beschrijving
CT BCR/ABL
Datatype
integer
Alias
- UMLS CUI [1]
- C1835417
Beschrijving
CT ABL
Datatype
integer
Alias
- UMLS CUI [1]
- C1835417
Beschrijving
Ratio BCR/ABLx100/ABL
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0456603
- UMLS CUI [1,2]
- C2733507
- UMLS CUI [1,3]
- C0439165
Beschrijving
Nested PCR performed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0242574
- UMLS CUI [1,2]
- C0599161
Beschrijving
If yes, write down results
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0242574
- UMLS CUI [1,3]
- C0599161
Beschrijving
FISH (peripheral blood)
Alias
- UMLS CUI-1
- C0229664
- UMLS CUI-2
- C0162789
Beschrijving
Acronym
Datatype
integer
Alias
- UMLS CUI [1]
- C2986333
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
FISH performed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Beschrijving
Reason not performed
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Beschrijving
Date FISH
Datatype
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Beschrijving
Laboratory
Datatype
text
Alias
- UMLS CUI [1]
- C0022877
Beschrijving
Sample
Datatype
integer
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Number of cells analyzed
Datatype
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
Beschrijving
Number of bcr / abl + cells
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1835417
- UMLS CUI [1,2]
- C0007584
- UMLS CUI [1,3]
- C0237753
Beschrijving
Probe used
Datatype
text
Alias
- UMLS CUI [1,1]
- C0182400
- UMLS CUI [1,2]
- C4071975
Beschrijving
Classic rearrangement
Datatype
text
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Beschrijving
der (9) deletions
Datatype
boolean
Alias
- UMLS CUI [1]
- C0495650
Beschrijving
Amplification bcr / abl
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Beschrijving
Variation shift
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205419
Beschrijving
Other
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Beschrijving
Result description
Datatype
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0162789
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