Information:
Error:
ID
44149
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 16 Form
Keywords
Versions (2)
- 11/29/17 11/29/17 -
- 9/20/21 9/20/21 -
Copyright Holder
Gruppo Italiano Malattie EMatologiche dell'Adulto
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Visit 16 GIMEMA CML0408 NCT00769327
Similar models
Visit 16
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
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])
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])
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
C0522055 (UMLS CUI [1])
Main electrocardiographic anomaly
Item
Main electrocardiographic anomaly
text
C0522055 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,2])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date echocardiogram
Item
Date echocardiogram
date
C0013516 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Echocardiographic abnormalities
Item
Echocardiographic abnormalities
boolean
C0013516 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Main echocardiographic anomaly
Item
Main echocardiographic anomaly
text
C0013516 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Bone biopsy performed
Item
Bone biopsy performed
boolean
C0005954 (UMLS CUI [1])
Date of bone marrow biopsy
Item
Date of bone marrow biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,2])
Reason biopsy not done
Item
Reason biopsy not done
text
C0332307 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
C0005558 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Stored cell sample
Item
Stored cell sample
boolean
C0370003 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,2])
If not, indicate reasons
Item
If not, indicate reasons
text
C0370003 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C2919806 (UMLS CUI [1,3])
C1698986 (UMLS CUI [1,2])
C2919806 (UMLS CUI [1,3])
Date taken
Item
Date taken
date
C0680532 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Laboratory
Item
Laboratory
text
C0681902 (UMLS CUI [1])
Sample identifier
Item
Sample identifier
integer
C4071975 (UMLS CUI [1])
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Cytogenetics performed
Item
Cytogenetics performed
boolean
C0010802 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Reason cytogenetics not performed
Item
Reason cytogenetics not performed
text
C0445106 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,3])
Date taken
Item
Date taken
date
C1302413 (UMLS CUI [1,1])
C0010802 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,2])
Laboratory
Item
Laboratory
text
C0022877 (UMLS CUI [1])
Number of metaphases examined
Item
Number of metaphases examined
integer
C1621812 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0260877 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0260877 (UMLS CUI [1,3])
Ph Phase metaphase number
Item
Ph Phase metaphase number
integer
C0237753 (UMLS CUI [1,1])
C0457343 (UMLS CUI [1,2])
C0457343 (UMLS CUI [1,2])
Percent metaphase Ph-
Item
Percent metaphase Ph-
integer
C0936012 (UMLS CUI [1,1])
C0025564 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0025564 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Additional abnormalities
Item
Additional abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0010802 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,2])
Number of metaphases with additional anomalies
Item
Number of metaphases with additional anomalies
integer
C1621812 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Description of Abnormalities
Item
Description of Abnormalities
text
C0678257 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Item Group
FISH (from bone marrow blood)
C0005953 (UMLS CUI-1)
C0162789 (UMLS CUI-2)
C0162789 (UMLS CUI-2)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
FISH performed
Item
FISH performed
boolean
C0162789 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Reason FISH not performed
Item
Reason not performed
text
C0392360 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
Date FISH
Item
Date FISH
date
C0162789 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Laboratory
Item
Laboratory
text
C0022877 (UMLS CUI [1])
CL Item
Sangue Midollare (1)
CL Item
Sangue Periferico (2)
Number of cells analyzed
Item
Number of cells analyzed
integer
C2963401 (UMLS CUI [1])
Number of bcr / abl + cells
Item
Number of bcr / abl + cells
integer
C1835417 (UMLS CUI [1])
Probe used
Item
Probe used
text
C0016321 (UMLS CUI [1])
Classic rearrangement
Item
Classic rearrangement
boolean
C2366845 (UMLS CUI [1,1])
C3250978 (UMLS CUI [1,2])
C3250978 (UMLS CUI [1,2])
der (9) deletions
Item
der (9) deletions
boolean
C0495650 (UMLS CUI [1])
Amplification bcr / abl
Item
Amplification bcr / abl
boolean
C3888919 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,2])
Variation shift
Item
Variation shift
boolean
C0205419 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Result description
Item
Result description
text
C0678257 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])
Item Group
Molecular Biology (peripheral blood)
C0026376 (UMLS CUI-1)
C0229664 (UMLS CUI-2)
C0229664 (UMLS CUI-2)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Test performed
Item
Test performed
boolean
C0005834 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Reason test not performed
Item
Reason not performed
text
C0392360 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
Date taken
Item
Date taken
date
C1302413 (UMLS CUI [1])
Laboratory
Item
Laboratory
text
C0022877 (UMLS CUI [1])
RT-PCR Result
Item
RT-PCR Result
text
C0599161 (UMLS CUI [1,1])
C2346633 (UMLS CUI [1,2])
C2346633 (UMLS CUI [1,2])
CT BCR/ABL
Item
CT BCR/ABL
integer
C1835417 (UMLS CUI [1])
CT ABL
Item
CT ABL
integer
C1835417 (UMLS CUI [1])
Ratio BCR/ABLx100/ABL
Item
Ratio BCR/ABLx100/ABL
integer
C0456603 (UMLS CUI [1,1])
C2733507 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C2733507 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Nested PCR performed
Item
Nested PCR performed
boolean
C0242574 (UMLS CUI [1,1])
C0599161 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,2])
If yes, write down results
Item
If yes, write down results
text
C1274040 (UMLS CUI [1,1])
C0242574 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
C0242574 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
Item Group
FISH (peripheral blood)
C0229664 (UMLS CUI-1)
C0162789 (UMLS CUI-2)
C0162789 (UMLS CUI-2)
Acronym
Item
Acronym
integer
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
FISH performed
Item
FISH performed
boolean
C0162789 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Reason not performed
Item
Reason not performed
text
C0392360 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C3841220 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
Date FISH
Item
Date FISH
date
C0162789 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Laboratory
Item
Laboratory
text
C0022877 (UMLS CUI [1])
CL Item
Sangue Midollare (1)
CL Item
Sangue Periferico (2)
Number of cells analyzed
Item
Number of cells analyzed
integer
C0022885 (UMLS CUI [1,1])
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])
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])
Number of bcr / abl + cells
Item
Number of bcr / abl + cells
integer
C1835417 (UMLS CUI [1,1])
C0007584 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0007584 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Probe used
Item
Probe used
text
C0182400 (UMLS CUI [1,1])
C4071975 (UMLS CUI [1,2])
C4071975 (UMLS CUI [1,2])
Classic rearrangement
Item
Classic rearrangement
text
C2366845 (UMLS CUI [1,1])
C3250978 (UMLS CUI [1,2])
C3250978 (UMLS CUI [1,2])
der (9) deletions
Item
der (9) deletions
boolean
C0495650 (UMLS CUI [1])
Amplification bcr / abl
Item
Amplification bcr / abl
boolean
C3888919 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0243148 (UMLS CUI [1,2])
Variation shift
Item
Variation shift
boolean
C0205419 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Result description
Item
Result description
text
C0678257 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])