ID

44111

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 0 form.

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Versionen (2)
  1. 28.11.17 28.11.17 -
  2. 20.09.21 20.09.21 -
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Gruppo Italiano Malattie EMatologiche dell'Adulto

Hochgeladen am

20. September 2021

DOI

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Visit 0 GIMEMA CML0408 NCT00769327

Englisch Italienisch

Visit 0

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 0
Enrollment
Beschreibung

Enrollment

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C1516879
Acronym
Beschreibung

Acronym

Datentyp

text

Alias
UMLS CUI [1]
C2986333
Patient (surname/name)
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Place of Birth
Beschreibung

Place of Birth

Datentyp

text

Alias
UMLS CUI [1]
C0032040
Country of Birth
Beschreibung

Country of Birth

Datentyp

text

Alias
UMLS CUI [1]
C1300001
City of residence
Beschreibung

City of residence

Datentyp

text

Alias
UMLS CUI [1,1]
C2316883
UMLS CUI [1,2]
C0421449
Country of Residence
Beschreibung

Country of Residence

Datentyp

text

Alias
UMLS CUI [1]
C3258975
Residence address
Beschreibung

Residence address

Datentyp

text

Alias
UMLS CUI [1]
C0421449
Cap
Beschreibung

Cap

Datentyp

text

Date of Diagnosis
Beschreibung

Date of the first documented leukemia, performed before any cytotoxic therapy

Datentyp

date

Alias
UMLS CUI [1]
C2316983
Informed Consent signed
Beschreibung

Informed Consent signed

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Informed Consent Date
Beschreibung

Informed Consent Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
Inclusion Criteria confirmed
Beschreibung

Inclusion Criteria confirmed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1516637
Inclusion Criteria
Beschreibung

Inclusion Criteria

Datentyp

text

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1516637
Exclusion Criteria verified
Beschreibung

Exclusion Criteria verified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1516637
Exclusion Criteria
Beschreibung

Exclusion Criteria

Datentyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1516637
Pregnancy Test negative
Beschreibung

Pregnancy Test negative

Datentyp

integer

Alias
UMLS CUI [1]
C0032976
Symptoms
Beschreibung

Symptoms

Alias
UMLS CUI-1
C1457887
Acronym
Beschreibung

Acronym

Datentyp

text

Alias
UMLS CUI [1]
C2986333
Visit
Beschreibung

Visit

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Secondary Symptoms to LMC? If yes, indicate which symptoms:
Beschreibung

Secondary Symptoms to LMC

Datentyp

boolean

Alias
UMLS CUI [1]
C0037088
Fatigue
Beschreibung

Fatigue

Datentyp

boolean

Alias
UMLS CUI [1]
C0015672
Fever
Beschreibung

Fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
Headache
Beschreibung

Headache

Datentyp

boolean

Alias
UMLS CUI [1]
C0018681
Sweating
Beschreibung

Sweating

Datentyp

boolean

Alias
UMLS CUI [1]
C0038990
Artralgia
Beschreibung

Artralgia

Datentyp

boolean

Alias
UMLS CUI [1]
C0003862
Nausea
Beschreibung

Nausea

Datentyp

boolean

Alias
UMLS CUI [1]
C0027497
Vomiting
Beschreibung

Vomiting

Datentyp

boolean

Alias
UMLS CUI [1]
C0042963
Diarrhea
Beschreibung

Diarrhea

Datentyp

boolean

Alias
UMLS CUI [1]
C0011991
Weight loss
Beschreibung

Weight loss

Datentyp

boolean

Alias
UMLS CUI [1]
C1262477
Abdominal Pain
Beschreibung

Abdominal Pain

Datentyp

boolean

Alias
UMLS CUI [1]
C0000737
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Acronym
Beschreibung

Acronym

Datentyp

text

Alias
UMLS CUI [1]
C2986333
Visit
Beschreibung

Visit

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Physical Examination Date
Beschreibung

Physical Examination Date

Datentyp

date

Alias
UMLS CUI [1]
C2826643
splenomegaly (cm from the costal bow)
Beschreibung

splenomegaly

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0038002
cm
hepatomegaly (cm from the costal bow) - optinal
Beschreibung

hepatomegaly

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0019209
cm
Weight
Beschreibung

Weight

Datentyp

integer

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Complete Blood Count
Beschreibung

Complete Blood Count

Alias
UMLS CUI-1
C0009555
Acronym
Beschreibung

Acronym

Datentyp

text

Alias
UMLS CUI [1]
C2986333
Visit
Beschreibung

Visit

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Date complete blood count
Beschreibung

Date complete blood count

Datentyp

date

Alias
UMLS CUI [1,1]
C0009555
UMLS CUI [1,2]
C0011008
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

integer

Maßeinheiten
  • g/L
Alias
UMLS CUI [1]
C0019046
g/L
Leukocytes
Beschreibung

Leukocytes

Datentyp

integer

Maßeinheiten
  • x103/mL
Alias
UMLS CUI [1]
C0023516
x103/mL
Platelets
Beschreibung

Platelets

Datentyp

integer

Maßeinheiten
  • x109/L
Alias
UMLS CUI [1]
C0005821
x109/L
polymorphonuclear
Beschreibung

polymorphonuclear

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C1168338
%
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Beschreibung

Monocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Beschreibung

Eosinophils

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0200638
%
Basophils
Beschreibung

Basophils

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0200641
%
Metamyelocytes
Beschreibung

Metamyelocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0229635
%
Myelocytes
Beschreibung

Myelocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0369715
%
Promyelocytes
Beschreibung

Promyelocytes

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0455279
%
Blasts
Beschreibung

Blasts

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0368761
%
Answer hematology
Beschreibung

Answer hematology

Datentyp

text

Alias
UMLS CUI [1]
C0474523
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Visit 0

1 Formulare
  1. StudyEvent: ODM
    1. Visit 0
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Enrollment
C2348568 (UMLS CUI-1)
C1516879 (UMLS CUI-2)
Acronym
Item
Acronym
text
C2986333 (UMLS CUI [1])
Patient
Item
Patient (surname/name)
text
C1299487 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
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])
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])
Inclusion Criteria confirmed
Item
Inclusion Criteria confirmed
boolean
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Inclusion Criteria
Item
Inclusion Criteria
text
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Exclusion Criteria verified
Item
Exclusion Criteria verified
boolean
C0680251 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Exclusion Criteria
Item
Exclusion Criteria
text
C0680251 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Item
Pregnancy Test negative
integer
C0032976 (UMLS CUI [1])
Pregnancy Test negative
Code List
Pregnancy Test negative
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
Not Applicable (3)
Item Group
Symptoms
C1457887 (UMLS CUI-1)
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])
Item Group
Physical Examination
C0031809 (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])
Item Group
Complete Blood Count
C0009555 (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])
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])
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