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ID
44111
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 0 form.
Trefwoorden
Versies (2)
- 28-11-17 28-11-17 -
- 20-09-21 20-09-21 -
Houder van rechten
Gruppo Italiano Malattie EMatologiche dell'Adulto
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20 september 2021
DOI
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Licentie
Creative Commons BY-NC 3.0
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Visit 0 GIMEMA CML0408 NCT00769327
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Visit 0
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Acronym
Item
Acronym
text
C2986333 (UMLS CUI [1])
Patient
Item
Patient (surname/name)
text
C1299487 (UMLS CUI [1])
CL Item
male (M)
CL Item
female (F)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Place of Birth
Item
Place of Birth
text
C0032040 (UMLS CUI [1])
Country of Birth
Item
Country of Birth
text
C1300001 (UMLS CUI [1])
City of residence
Item
City of residence
text
C2316883 (UMLS CUI [1,1])
C0421449 (UMLS CUI [1,2])
C0421449 (UMLS CUI [1,2])
Country of Residence
Item
Country of Residence
text
C3258975 (UMLS CUI [1])
Residence address
Item
Residence address
text
C0421449 (UMLS CUI [1])
Cap
Item
Cap
text
Date of Diagnosis
Item
Date of Diagnosis
date
C2316983 (UMLS CUI [1])
Informed Consent signed
Item
Informed Consent signed
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C0009797 (UMLS CUI [1,2])
Inclusion Criteria confirmed
Item
Inclusion Criteria confirmed
boolean
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
Inclusion Criteria
Item
Inclusion Criteria
text
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
Exclusion Criteria verified
Item
Exclusion Criteria verified
boolean
C0680251 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
Exclusion Criteria
Item
Exclusion Criteria
text
C0680251 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Acronym
Item
Acronym
text
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Secondary Symptoms to LMC
Item
Secondary Symptoms to LMC? If yes, indicate which symptoms:
boolean
C0037088 (UMLS CUI [1])
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Sweating
Item
Sweating
boolean
C0038990 (UMLS CUI [1])
Artralgia
Item
Artralgia
boolean
C0003862 (UMLS CUI [1])
Nausea
Item
Nausea
boolean
C0027497 (UMLS CUI [1])
Vomiting
Item
Vomiting
boolean
C0042963 (UMLS CUI [1])
Diarrhea
Item
Diarrhea
boolean
C0011991 (UMLS CUI [1])
Weight loss
Item
Weight loss
boolean
C1262477 (UMLS CUI [1])
Abdominal Pain
Item
Abdominal Pain
boolean
C0000737 (UMLS CUI [1])
Acronym
Item
Acronym
text
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Physical Examination Date
Item
Physical Examination Date
date
C2826643 (UMLS CUI [1])
splenomegaly
Item
splenomegaly (cm from the costal bow)
integer
C0038002 (UMLS CUI [1])
hepatomegaly
Item
hepatomegaly (cm from the costal bow) - optinal
integer
C0019209 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Acronym
Item
Acronym
text
C2986333 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date complete blood count
Item
Date complete blood count
date
C0009555 (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
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
integer
C0200641 (UMLS CUI [1])
Metamyelocytes
Item
Metamyelocytes
integer
C0229635 (UMLS CUI [1])
Myelocytes
Item
Myelocytes
integer
C0369715 (UMLS CUI [1])
Promyelocytes
Item
Promyelocytes
integer
C0455279 (UMLS CUI [1])
Blasts
Item
Blasts
integer
C0368761 (UMLS CUI [1])
Answer hematology
Item
Answer hematology
text
C0474523 (UMLS CUI [1])