ID
42061
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
Mots-clés
Versions (3)
- 28/11/2017 28/11/2017 -
- 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
- 20/09/2021 20/09/2021 -
Détendeur de droits
Gruppo Italiano Malattie EMatologiche dell'Adulto
Téléchargé le
15 mars 2021
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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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
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
text
Alias
- UMLS CUI [1]
- C0545082
Description
Visit Date
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
secondary symptoms
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0332138
Description
Asthenia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004093
Description
Fever
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015967
Description
Headache
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018681
Description
Sweating
Type de données
boolean
Alias
- UMLS CUI [1]
- C0038990
Description
Arthralgia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0003862
Description
Nausea
Type de données
boolean
Alias
- UMLS CUI [1]
- C0027497
Description
Vomiting
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042963
Description
Diarrhea
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011991
Description
Weight loss
Type de données
boolean
Alias
- UMLS CUI [1]
- C0043096
Description
Abdominal Pain
Type de données
boolean
Alias
- UMLS CUI [1]
- C0000737
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Acronym
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
text
Alias
- UMLS CUI [1]
- C0545082
Description
Date Physical Exam
Type de données
date
Alias
- UMLS CUI [1]
- C2826643
Description
Splenomegaly
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0038002
Description
Hepatomegaly
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0019209
Description
Weight
Type de données
integer
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Complete Blood Count
Alias
- UMLS CUI-1
- C0009555
Description
Acronym
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Complete Blood Count Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0005771
- UMLS CUI [1,2]
- C0011008
Description
Hemoglobin
Type de données
integer
Unités de mesure
- g/L
Alias
- UMLS CUI [1]
- C0019046
Description
Leukocytes
Type de données
integer
Unités de mesure
- x103/mL
Alias
- UMLS CUI [1]
- C0023516
Description
Platelets
Type de données
integer
Unités de mesure
- x109/L
Alias
- UMLS CUI [1]
- C0005821
Description
polymorphonuclear
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C1168338
Description
Lymphocytes
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0024264
Description
Monocytes
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0026473
Description
Eosinophils
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0014467
Description
basophils
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0004827
Description
metamyelocytes
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0229635
Description
myelocytes
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0369715
Description
promyelocytes
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0033416
Description
blasts
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0368761
Description
Answer hematology
Type de données
text
Alias
- UMLS CUI [1]
- C0474523
Description
Biochemistry
Alias
- UMLS CUI-1
- C1655775
Description
Acronym
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date biochemistry examination
Type de données
date
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0005477
Description
Creatinine
Type de données
integer
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Description
Glucose
Type de données
integer
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0202042
Description
LDH
Type de données
integer
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0202113
Description
GOT
Type de données
integer
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
GPT
Type de données
integer
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
y-GT
Type de données
integer
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0202035
Description
Alkaline phosphatase
Type de données
integer
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
Total Bilirubin
Type de données
integer
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Description
Amylase
Type de données
integer
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201883
Description
Lipase
Type de données
integer
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0373670
Description
calcium
Type de données
integer
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0201925
Description
Phosphorus
Type de données
integer
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0523826
Description
Potassium
Type de données
integer
Unités de mesure
- mEq/L
Alias
- UMLS CUI [1]
- C0202194
Description
Magnesium
Type de données
integer
Unités de mesure
- mEq/L
Alias
- UMLS CUI [1]
- C0373675
Description
Serum Proteins
Alias
- UMLS CUI-1
- C0555903
Description
Acronym
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date Biochemical Examination
Type de données
date
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0005477
Description
Total Protein
Type de données
integer
Unités de mesure
- g/dL
Alias
- UMLS CUI [1]
- C0555903
Description
Albumin
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0201838
Description
a1 protein
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0860678
Description
a2 protein
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0301684
Description
beta protein
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0005157
Description
gamma protein
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0017007
Description
IgM
Type de données
integer
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0202084
Description
IgA
Type de données
integer
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0202083
Description
IgG
Type de données
integer
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0202087
Description
Electrocardiogram
Alias
- UMLS CUI-1
- C1623258
Description
Acronym
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date electrocardiogram
Type de données
date
Alias
- UMLS CUI [1]
- C2826846
Description
Electrocardiographic anomalies
Type de données
boolean
Alias
- UMLS CUI [1]
- C1832603
Description
Main electrocardiographic anomaly
Type de données
text
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C1542147
Description
Echocardiogram
Alias
- UMLS CUI-1
- C2243117
Description
Acronym
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Date echocardiogram
Type de données
date
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0011008
Description
Echocardiographic abnormalities
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C1704258
Description
Main echocardiographic anomaly
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Bone biopsy performed
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005954
Description
Date of bone marrow biopsy
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Description
Reason biopsy not done
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Stored cell sample
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
Description
If not, indicate reasons
Type de données
text
Alias
- UMLS CUI [1,1]
- C0370003
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C2919806
Description
Date taken
Type de données
date
Alias
- UMLS CUI [1,1]
- C0680532
- UMLS CUI [1,2]
- C0011008
Description
Laboratory
Type de données
text
Alias
- UMLS CUI [1]
- C0681902
Description
Sample identifier
Type de données
integer
Alias
- UMLS CUI [1]
- C4071975
Description
Cytogenetics
Alias
- UMLS CUI-1
- C0010802
Description
Acronym
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Cytogenetics performed
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0010802
- UMLS CUI [1,2]
- C0884358
Description
Reason cytogenetics not performed
Type de données
text
Alias
- UMLS CUI [1,1]
- C0445106
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0010802
Description
Date taken
Type de données
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0010802
Description
Laboratory
Type de données
text
Alias
- UMLS CUI [1]
- C0022877
Description
Number of metaphases examined
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0260877
Description
Ph Phase metaphase number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0457343
Description
Percent metaphase Ph-
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1,1]
- C0936012
- UMLS CUI [1,2]
- C0025564
- UMLS CUI [1,3]
- C0439165
Description
Additional abnormalities
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010802
Description
Number of metaphases with additional anomalies
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1621812
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1704258
Description
Description of Abnormalities
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
FISH performed
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Description
Reason FISH not performed
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Description
Date FISH
Type de données
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Description
Laboratory
Type de données
text
Alias
- UMLS CUI [1]
- C0022877
Description
Sample
Type de données
integer
Alias
- UMLS CUI [1]
- C0005834
Description
Number of cells analyzed
Type de données
integer
Alias
- UMLS CUI [1]
- C2963401
Description
Number of bcr / abl + cells
Type de données
integer
Alias
- UMLS CUI [1]
- C1835417
Description
Probe used
Type de données
text
Alias
- UMLS CUI [1]
- C0016321
Description
Classic rearrangement
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Description
der (9) deletions
Type de données
boolean
Alias
- UMLS CUI [1]
- C0495650
Description
Amplification bcr / abl
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Description
Variation shift
Type de données
boolean
Alias
- UMLS CUI [1]
- C0205419
Description
Other
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Description
Result description
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Test performed
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0884358
Description
Reason test not performed
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
Description
Date taken
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
Laboratory
Type de données
text
Alias
- UMLS CUI [1]
- C0022877
Description
RT-PCR Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0599161
- UMLS CUI [1,2]
- C2346633
Description
CT BCR/ABL
Type de données
integer
Alias
- UMLS CUI [1]
- C1835417
Description
CT ABL
Type de données
integer
Alias
- UMLS CUI [1]
- C1835417
Description
Ratio BCR/ABLx100/ABL
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0456603
- UMLS CUI [1,2]
- C2733507
- UMLS CUI [1,3]
- C0439165
Description
Nested PCR performed
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0242574
- UMLS CUI [1,2]
- C0599161
Description
If yes, write down results
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C2986333
Description
Visit
Type de données
integer
Alias
- UMLS CUI [1]
- C0545082
Description
FISH performed
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0884358
Description
Reason not performed
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0162789
Description
Date FISH
Type de données
date
Alias
- UMLS CUI [1,1]
- C0162789
- UMLS CUI [1,2]
- C0011008
Description
Laboratory
Type de données
text
Alias
- UMLS CUI [1]
- C0022877
Description
Sample
Type de données
integer
Alias
- UMLS CUI [1]
- C0005834
Description
Number of cells analyzed
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1835417
- UMLS CUI [1,2]
- C0007584
- UMLS CUI [1,3]
- C0237753
Description
Probe used
Type de données
text
Alias
- UMLS CUI [1,1]
- C0182400
- UMLS CUI [1,2]
- C4071975
Description
Classic rearrangement
Type de données
text
Alias
- UMLS CUI [1,1]
- C2366845
- UMLS CUI [1,2]
- C3250978
Description
der (9) deletions
Type de données
boolean
Alias
- UMLS CUI [1]
- C0495650
Description
Amplification bcr / abl
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3888919
- UMLS CUI [1,2]
- C0243148
Description
Variation shift
Type de données
boolean
Alias
- UMLS CUI [1]
- C0205419
Description
Other
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1704258
Description
Result description
Type de données
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0162789
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- StudyEvent: ODM
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