ID

44111

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 0 form.

Keywords

Versions (2)
  1. 11/28/17 11/28/17 -
  2. 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 0 GIMEMA CML0408 NCT00769327

English Italian

Visit 0

1 forms  
  1. StudyEvent: ODM
    1. Visit 0
Enrollment
Description

Enrollment

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

Acronym

Data type

text

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

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Place of Birth
Description

Place of Birth

Data type

text

Alias
UMLS CUI [1]
C0032040
Country of Birth
Description

Country of Birth

Data type

text

Alias
UMLS CUI [1]
C1300001
City of residence
Description

City of residence

Data type

text

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

Country of Residence

Data type

text

Alias
UMLS CUI [1]
C3258975
Residence address
Description

Residence address

Data type

text

Alias
UMLS CUI [1]
C0421449
Cap
Description

Cap

Data type

text

Date of Diagnosis
Description

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

Data type

date

Alias
UMLS CUI [1]
C2316983
Informed Consent signed
Description

Informed Consent signed

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Informed Consent Date
Description

Informed Consent Date

Data type

date

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

Inclusion Criteria confirmed

Data type

boolean

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

Inclusion Criteria

Data type

text

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

Exclusion Criteria verified

Data type

boolean

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

Exclusion Criteria

Data type

text

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

Pregnancy Test negative

Data type

integer

Alias
UMLS CUI [1]
C0032976
Symptoms
Description

Symptoms

Alias
UMLS CUI-1
C1457887
Acronym
Description

Acronym

Data type

text

Alias
UMLS CUI [1]
C2986333
Visit
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Visit Date
Description

Visit Date

Data type

date

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

Secondary Symptoms to LMC

Data type

boolean

Alias
UMLS CUI [1]
C0037088
Fatigue
Description

Fatigue

Data type

boolean

Alias
UMLS CUI [1]
C0015672
Fever
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Headache
Description

Headache

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Sweating
Description

Sweating

Data type

boolean

Alias
UMLS CUI [1]
C0038990
Artralgia
Description

Artralgia

Data type

boolean

Alias
UMLS CUI [1]
C0003862
Nausea
Description

Nausea

Data type

boolean

Alias
UMLS CUI [1]
C0027497
Vomiting
Description

Vomiting

Data type

boolean

Alias
UMLS CUI [1]
C0042963
Diarrhea
Description

Diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0011991
Weight loss
Description

Weight loss

Data type

boolean

Alias
UMLS CUI [1]
C1262477
Abdominal Pain
Description

Abdominal Pain

Data type

boolean

Alias
UMLS CUI [1]
C0000737
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Acronym
Description

Acronym

Data type

text

Alias
UMLS CUI [1]
C2986333
Visit
Description

Visit

Data type

integer

Alias
UMLS CUI [1]
C0545082
Physical Examination Date
Description

Physical Examination Date

Data type

date

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

splenomegaly

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0038002
cm
hepatomegaly (cm from the costal bow) - optinal
Description

hepatomegaly

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0019209
cm
Weight
Description

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Complete Blood Count
Description

Complete Blood Count

Alias
UMLS CUI-1
C0009555
Acronym
Description

Acronym

Data type

text

Alias
UMLS CUI [1]
C2986333
Visit
Description

Visit

Data type

integer

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

Date complete blood count

Data type

date

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

Hemoglobin

Data type

integer

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0019046
g/L
Leukocytes
Description

Leukocytes

Data type

integer

Measurement units
  • x103/mL
Alias
UMLS CUI [1]
C0023516
x103/mL
Platelets
Description

Platelets

Data type

integer

Measurement units
  • x109/L
Alias
UMLS CUI [1]
C0005821
x109/L
polymorphonuclear
Description

polymorphonuclear

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C1168338
%
Lymphocytes
Description

Lymphocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0024264
%
Monocytes
Description

Monocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophils
Description

Eosinophils

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0200638
%
Basophils
Description

Basophils

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0200641
%
Metamyelocytes
Description

Metamyelocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0229635
%
Myelocytes
Description

Myelocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0369715
%
Promyelocytes
Description

Promyelocytes

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0455279
%
Blasts
Description

Blasts

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0368761
%
Answer hematology
Description

Answer hematology

Data type

text

Alias
UMLS CUI [1]
C0474523
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Similar models

Visit 0

1 forms
  1. StudyEvent: ODM
    1. Visit 0
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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