ID
27797
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 16 Form
Stichworte
Versionen (2)
- 29.11.17 29.11.17 -
- 20.09.21 20.09.21 -
Rechteinhaber
Gruppo Italiano Malattie EMatologiche dell'Adulto
Hochgeladen am
29. November 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Visit 16 GIMEMA CML0408 NCT00769327
Visit 16
- StudyEvent: ODM
Beschreibung
Complete Blood Count
Alias
- UMLS CUI-1
- C0009555
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Complete Blood Count Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005771
- UMLS CUI [1,2]
- C0011008
Beschreibung
Hemoglobin
Datentyp
integer
Maßeinheiten
- g/L
Alias
- UMLS CUI [1]
- C0019046
Beschreibung
Leukocytes
Datentyp
integer
Maßeinheiten
- x103/mL
Alias
- UMLS CUI [1]
- C0023516
Beschreibung
Platelets
Datentyp
integer
Maßeinheiten
- x109/L
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
polymorphonuclear
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C1168338
Beschreibung
Lymphocytes
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0024264
Beschreibung
Monocytes
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0026473
Beschreibung
Eosinophils
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0014467
Beschreibung
basophils
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0004827
Beschreibung
metamyelocytes
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0229635
Beschreibung
myelocytes
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0369715
Beschreibung
promyelocytes
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0033416
Beschreibung
blasts
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0368761
Beschreibung
Answer hematology
Datentyp
text
Alias
- UMLS CUI [1]
- C0474523
Beschreibung
Biochemistry
Alias
- UMLS CUI-1
- C1655775
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Date biochemistry examination
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0005477
Beschreibung
Creatinine
Datentyp
integer
Maßeinheiten
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
Glucose
Datentyp
integer
Maßeinheiten
- mg/dL
Alias
- UMLS CUI [1]
- C0202042
Beschreibung
LDH
Datentyp
integer
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0202113
Beschreibung
GOT
Datentyp
integer
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
GPT
Datentyp
integer
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
y-GT
Datentyp
integer
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0202035
Beschreibung
Alkaline phosphatase
Datentyp
integer
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201850
Beschreibung
Total Bilirubin
Datentyp
integer
Maßeinheiten
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Beschreibung
Amylase
Datentyp
integer
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201883
Beschreibung
Lipase
Datentyp
integer
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0373670
Beschreibung
calcium
Datentyp
integer
Maßeinheiten
- mg/dL
Alias
- UMLS CUI [1]
- C0201925
Beschreibung
Phosphorus
Datentyp
integer
Maßeinheiten
- mg/dL
Alias
- UMLS CUI [1]
- C0523826
Beschreibung
Potassium
Datentyp
integer
Maßeinheiten
- mEq/L
Alias
- UMLS CUI [1]
- C0202194
Beschreibung
Magnesium
Datentyp
integer
Maßeinheiten
- mEq/L
Alias
- UMLS CUI [1]
- C0373675
Beschreibung
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Date electrocardiogram
Datentyp
date
Alias
- UMLS CUI [1]
- C2826846
Beschreibung
Electrocardiographic anomalies
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1832603
Beschreibung
Main electrocardiographic anomaly
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C1542147
Beschreibung
Echocardiogram
Alias
- UMLS CUI-1
- C2243117
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Date echocardiogram
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0011008
Beschreibung
Echocardiographic abnormalities
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C1704258
Beschreibung
Main echocardiographic anomaly
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C1542147
Beschreibung
Biopsie
Alias
- UMLS CUI-1
- C0005558
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Bone biopsy performed
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005954
Beschreibung
Date of bone marrow biopsy
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Beschreibung
Reason biopsy not done
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0332307
- UMLS CUI [1,2]
- C0005558
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [1,4]
- C0678257
Beschreibung
Preservation of cellular samples
Alias
- UMLS CUI-1
- C0005822
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Stored cell sample
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
Beschreibung
If not, indicate reasons
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C2919806
Beschreibung
Date taken
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0680532
- UMLS CUI [1,2]
- C0011008
Beschreibung
Laboratory
Datentyp
text
Alias
- UMLS CUI [1]
- C0681902
Beschreibung
Sample identifier
Datentyp
integer
Alias
- UMLS CUI [1]
- C4071975
Beschreibung
Cytogenetics
Alias
- UMLS CUI-1
- C0010802
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Cytogenetics performed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0010802
- UMLS CUI [1,2]
- C0884358
Beschreibung
Reason cytogenetics not performed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0445106
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0010802
Beschreibung
Date taken
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0010802
Beschreibung
Laboratory
Datentyp
text
Alias
- UMLS CUI [1]
- C0022877
Beschreibung
Number of metaphases examined
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0260877
Beschreibung
Ph Phase metaphase number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0457343
Beschreibung
Percent metaphase Ph-
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C0936012
- UMLS CUI [1,2]
- C0025564
- UMLS CUI [1,3]
- C0439165
Beschreibung
Additional abnormalities
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010802
Beschreibung
Number of metaphases with additional anomalies
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1704258
Beschreibung
Description of Abnormalities
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1704258
Beschreibung
FISH (from bone marrow blood)
Alias
- UMLS CUI-1
- C0005953
- UMLS CUI-2
- C0162789
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
FISH performed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Beschreibung
Reason FISH not performed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Beschreibung
Date FISH
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Beschreibung
Laboratory
Datentyp
text
Alias
- UMLS CUI [1]
- C0022877
Beschreibung
Sample
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Number of cells analyzed
Datentyp
integer
Alias
- UMLS CUI [1]
- C2963401
Beschreibung
Number of bcr / abl + cells
Datentyp
integer
Alias
- UMLS CUI [1]
- C1835417
Beschreibung
Probe used
Datentyp
text
Alias
- UMLS CUI [1]
- C0016321
Beschreibung
Classic rearrangement
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Beschreibung
der (9) deletions
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0495650
Beschreibung
Amplification bcr / abl
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Beschreibung
Variation shift
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205419
Beschreibung
Other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Beschreibung
Result description
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0162789
Beschreibung
Molecular Biology (peripheral blood)
Alias
- UMLS CUI-1
- C0026376
- UMLS CUI-2
- C0229664
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Test performed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0884358
Beschreibung
Reason test not performed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
Beschreibung
Date taken
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Laboratory
Datentyp
text
Alias
- UMLS CUI [1]
- C0022877
Beschreibung
RT-PCR Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0599161
- UMLS CUI [1,2]
- C2346633
Beschreibung
CT BCR/ABL
Datentyp
integer
Alias
- UMLS CUI [1]
- C1835417
Beschreibung
CT ABL
Datentyp
integer
Alias
- UMLS CUI [1]
- C1835417
Beschreibung
Ratio BCR/ABLx100/ABL
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0456603
- UMLS CUI [1,2]
- C2733507
- UMLS CUI [1,3]
- C0439165
Beschreibung
Nested PCR performed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0242574
- UMLS CUI [1,2]
- C0599161
Beschreibung
If yes, write down results
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0242574
- UMLS CUI [1,3]
- C0599161
Beschreibung
FISH (peripheral blood)
Alias
- UMLS CUI-1
- C0229664
- UMLS CUI-2
- C0162789
Beschreibung
Acronym
Datentyp
integer
Alias
- UMLS CUI [1]
- C2986333
Beschreibung
Visit
Datentyp
integer
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
FISH performed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Beschreibung
Reason not performed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Beschreibung
Date FISH
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Beschreibung
Laboratory
Datentyp
text
Alias
- UMLS CUI [1]
- C0022877
Beschreibung
Sample
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Number of cells analyzed
Datentyp
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
Beschreibung
Number of bcr / abl + cells
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1835417
- UMLS CUI [1,2]
- C0007584
- UMLS CUI [1,3]
- C0237753
Beschreibung
Probe used
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0182400
- UMLS CUI [1,2]
- C4071975
Beschreibung
Classic rearrangement
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Beschreibung
der (9) deletions
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0495650
Beschreibung
Amplification bcr / abl
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Beschreibung
Variation shift
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205419
Beschreibung
Other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Beschreibung
Result description
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0162789
Ähnliche Modelle
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])