ID
27797
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 16 Form
Trefwoorden
Versies (2)
- 29-11-17 29-11-17 -
- 20-09-21 20-09-21 -
Houder van rechten
Gruppo Italiano Malattie EMatologiche dell'Adulto
Geüploaded op
29 november 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Visit 16 GIMEMA CML0408 NCT00769327
Visit 16
- StudyEvent: ODM
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
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
Similar models
Visit 16
- StudyEvent: ODM
C0011008 (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])