ID

13958

Description

Study part: Visit 2 (3 Months).Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose. Principal Investigator Prof. Dr. A. Hochhaus.

Mots-clés

Versions (1)
  1. 20/03/2016 20/03/2016 -
Téléchargé le

20 mars 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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Visit 2 (3 Months) Ponderosa CML ZKSJ0083

Anglais

Visit 2 (3 Months)

1 Formulaires  
  1. StudyEvent: ODM
    1. Visit 2 (3 Months)
Patient status
Description

Patient status

Alias
UMLS CUI-1
C0449437
Date of visit
Description

visit date

Type de données

date

Alias
UMLS CUI [1]
C1320303
Patient died?
Description

Patient died

Type de données

boolean

Alias
UMLS CUI [1]
C1546956
Blood pressure
Description

Blood pressure

Alias
UMLS CUI-1
C0005823
Blood pressure measurement carried out?
Description

Blood pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0005823
Systolic Blood Pressure
Description

systolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

diastolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Laboratory parameters
Description

Laboratory parameters

Alias
UMLS CUI-1
C0587081
Urea
Description

Urea measurement

Type de données

text

Alias
UMLS CUI [1]
C0523961
Creatinine
Description

Creatinine

Type de données

text

Alias
UMLS CUI [1]
C0201976
Uric acid
Description

uric acid

Type de données

text

Alias
UMLS CUI [1]
C0041980
Total Bilirubin
Description

total bilirubin

Type de données

text

Alias
UMLS CUI [1]
C0201913
Bilirubin, direct
Description

Bilirubin direct

Type de données

text

Alias
UMLS CUI [1]
C0201916
Glucose
Description

Glucose

Type de données

text

Alias
UMLS CUI [1]
C0017725
Total protein
Description

Protein total

Type de données

text

Alias
UMLS CUI [1]
C0555903
Albumin
Description

Albumin

Type de données

text

Alias
UMLS CUI [1]
C0201838
ASAT (AST, GOT)
Description

ASAT

Type de données

text

Alias
UMLS CUI [1]
C0201899
ALAT (ALT, GPT)
Description

ALAT

Type de données

text

Alias
UMLS CUI [1]
C0201836
Gamma-GT
Description

Gamma-GT

Type de données

text

Alias
UMLS CUI [1]
C0202035
Alkaline phosphatase
Description

Alkaline phosphatase

Type de données

text

Alias
UMLS CUI [1]
C0201850
Cholesterol
Description

Cholesterol

Type de données

text

Alias
UMLS CUI [1]
C1445957
Triglycerides
Description

triglycerides

Type de données

text

Alias
UMLS CUI [1]
C0202236
Amylase
Description

Amylase

Type de données

text

Alias
UMLS CUI [1]
C0201883
Lipase
Description

Lipase

Type de données

text

Alias
UMLS CUI [1]
C0373670
Leukocytes
Description

leukocytes

Type de données

float

Unités de mesure
  • x10^3 /µl
Alias
UMLS CUI [1]
C1271681
x10^3 /µl
Erythrocytes
Description

erythrocytes

Type de données

float

Unités de mesure
  • x10^6 /µl
Alias
UMLS CUI [1]
C0014772
x10^6 /µl
Hemoglobin
Description

hemoglobin

Type de données

float

Unités de mesure
  • g/dl
Alias
UMLS CUI [1]
C0518015
g/dl
Hematocrit
Description

hematocrit

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C0518014
%
Erythrocyte Mean Corpuscular Volume, MCV
Description

MCV

Type de données

float

Unités de mesure
  • fl
Alias
UMLS CUI [1]
C1948043
fl
Mean Corpuscular Hemoglobin, MCH
Description

MCH Mean Corpuscular Hemoglobin

Type de données

float

Unités de mesure
  • pg
Alias
UMLS CUI [1]
C1261502
pg
Mean corpuscular hemoglobin concentration MCHC
Description

MCHC Mean corpuscular hemoglobin concentration

Type de données

float

Unités de mesure
  • g/dl
Alias
UMLS CUI [1]
C0474535
g/dl
Platelets
Description

platelets

Type de données

float

Unités de mesure
  • x10^3 /µl
Alias
UMLS CUI [1]
C0005821
x10^3 /µl
Ponatinib treatment
Description

Ponatinib treatment

Alias
UMLS CUI-1
C0087111
Was the treatment interrupted or ended?
Description

treatment status

Type de données

text

Alias
UMLS CUI [1]
C0749659
Treatment Begin Date
Description

Treatment Begin Date

Type de données

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date
Description

Treatment End Date

Type de données

date

Alias
UMLS CUI [1]
C1531784
Reason
Description

Reason

Type de données

text

Alias
UMLS CUI [1]
C0392360
Were there any dosage changes?
Description

dosage change

Type de données

boolean

Alias
UMLS CUI [1]
C0420247
Start date of dosage change
Description

start date dosage change

Type de données

date

Alias
UMLS CUI [1,1]
C3173309
UMLS CUI [1,2]
C0420247
Dosage
Description

dosage

Type de données

text

Alias
UMLS CUI [1]
C0178602
Reason of dosage change
Description

Reason dosage change

Type de données

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0420247
Response
Description

Response

Alias
UMLS CUI-1
C0521982
Hematologic findings known?
Description

hematologic findings

Type de données

boolean

Alias
UMLS CUI [1]
C0018941
Date of hematologic test
Description

date hematologic findings

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0018941
Hematologic test
Description

Hematologic test

Type de données

text

Alias
UMLS CUI [1]
C0018941
BCR-ABL Mutation
Description

BCR-ABL Mutation

Type de données

text

Alias
UMLS CUI [1]
C3888919
Please mention if other:
Description

Other

Type de données

text

Alias
UMLS CUI [1]
C0205394
Cytogenetic Analysis carried out?
Description

Cytogenetic Analysis

Type de données

boolean

Alias
UMLS CUI [1]
C0752095
Date of Cytogenetic Analysis
Description

date Cytogenetic Analysis

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0752095
Laboratory of Cytogenetic Analysis
Description

Laboratory

Type de données

text

Alias
UMLS CUI [1]
C0022877
Evaluated mitosis
Description

Mitosis

Type de données

integer

Alias
UMLS CUI [1]
C0026255
Normal karyotype
Description

Normal karyotype

Type de données

integer

Alias
UMLS CUI [1]
C0333684
Philadelphia negative, with additional aberrations
Description

Philadelphia negative

Type de données

integer

Alias
UMLS CUI [1]
C3888511
Philadelphia Chromosome t(9;22)
Description

Philadelphia Chromosome

Type de données

integer

Alias
UMLS CUI [1]
C0031526
Philadelphia Chromosome with additional aberrations
Description

Philadelphia Chromosome with additional aberrations

Type de données

integer

Alias
UMLS CUI [1,1]
C0031526
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0008625
Not evaluable mitoses
Description

Mitosis

Type de données

integer

Alias
UMLS CUI [1]
C0026255
Cytogenetic response
Description

Response Cytogenetic

Type de données

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0010802
Bone marrow biopsy performed?
Description

bone marrow biopsy

Type de données

text

Alias
UMLS CUI [1]
C0005954
Date of bone marrow biopsy
Description

date bone marrow biopsy

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005954
Bone marrow biopsy findings
Description

Biopsy finding bone marrow

Type de données

text

Alias
UMLS CUI [1,1]
C1287401
UMLS CUI [1,2]
C0005953
If other, please mention:
Description

Other

Type de données

text

Alias
UMLS CUI [1]
C0205394
Molecular Analysis known?
Description

Molecular Analysis

Type de données

boolean

Alias
UMLS CUI [1]
C1513380
Date of Molecular Analysis
Description

date Molecular Analysis

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1513380
Laboratory of Molecular Analysis
Description

Laboratory

Type de données

text

Alias
UMLS CUI [1]
C0022877
BCR-ABL International Scale
Description

International Scale BCR-ABL

Type de données

integer

Unités de mesure
  • %
Alias
UMLS CUI [1,1]
C3258465
UMLS CUI [1,2]
C1835417
%
Polymerase Chain Reaction, PCR
Description

Polymerase Chain Reaction

Type de données

text

Alias
UMLS CUI [1]
C0032520
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Similar models

Visit 2 (3 Months)

1 Formulaires
  1. StudyEvent: ODM
    1. Visit 2 (3 Months)
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Patient status
C0449437 (UMLS CUI-1)
visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Patient died
Item
Patient died?
boolean
C1546956 (UMLS CUI [1])
Item Group
Blood pressure
C0005823 (UMLS CUI-1)
Blood pressure
Item
Blood pressure measurement carried out?
boolean
C0005823 (UMLS CUI [1])
systolic blood pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
diastolic blood pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item Group
Laboratory parameters
C0587081 (UMLS CUI-1)
Item
Urea
text
C0523961 (UMLS CUI [1])
Urea measurement
Code List
Urea
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Creatinine
text
C0201976 (UMLS CUI [1])
Creatinine
Code List
Creatinine
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Uric acid
text
C0041980 (UMLS CUI [1])
Urea measurement
Code List
Uric acid
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
Urea measurement
Code List
Total Bilirubin
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Bilirubin, direct
text
C0201916 (UMLS CUI [1])
Urea measurement
Code List
Bilirubin, direct
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Glucose
text
C0017725 (UMLS CUI [1])
Urea measurement
Code List
Glucose
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Total protein
text
C0555903 (UMLS CUI [1])
Urea measurement
Code List
Total protein
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Albumin
text
C0201838 (UMLS CUI [1])
Urea measurement
Code List
Albumin
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
ASAT (AST, GOT)
text
C0201899 (UMLS CUI [1])
Urea measurement
Code List
ASAT (AST, GOT)
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
ALAT (ALT, GPT)
text
C0201836 (UMLS CUI [1])
Urea measurement
Code List
ALAT (ALT, GPT)
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Gamma-GT
text
C0202035 (UMLS CUI [1])
Urea measurement
Code List
Gamma-GT
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Alkaline phosphatase
text
C0201850 (UMLS CUI [1])
Urea measurement
Code List
Alkaline phosphatase
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Cholesterol
text
C1445957 (UMLS CUI [1])
Urea measurement
Code List
Cholesterol
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Triglycerides
text
C0202236 (UMLS CUI [1])
Urea measurement
Code List
Triglycerides
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Amylase
text
C0201883 (UMLS CUI [1])
Urea measurement
Code List
Amylase
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
Item
Lipase
text
C0373670 (UMLS CUI [1])
Urea measurement
Code List
Lipase
CL Item
Normal (1)
CL Item
Grade of deviation 1 according to CTCAE (2)
CL Item
Grade of deviation 2 according to CTCAE (3)
CL Item
Grade of deviation 3 according to CTCAE (4)
CL Item
Grade of deviation 4 according to CTCAE (5)
CL Item
not analyzed (5)
leukocytes
Item
Leukocytes
float
C1271681 (UMLS CUI [1])
erythrocytes
Item
Erythrocytes
float
C0014772 (UMLS CUI [1])
hemoglobin
Item
Hemoglobin
float
C0518015 (UMLS CUI [1])
hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
MCV
Item
Erythrocyte Mean Corpuscular Volume, MCV
float
C1948043 (UMLS CUI [1])
MCH Mean Corpuscular Hemoglobin
Item
Mean Corpuscular Hemoglobin, MCH
float
C1261502 (UMLS CUI [1])
MCHC Mean corpuscular hemoglobin concentration
Item
Mean corpuscular hemoglobin concentration MCHC
float
C0474535 (UMLS CUI [1])
platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Item Group
Ponatinib treatment
C0087111 (UMLS CUI-1)
Item
Was the treatment interrupted or ended?
text
C0749659 (UMLS CUI [1])
treatment status
Code List
Was the treatment interrupted or ended?
CL Item
yes (1)
CL Item
no (2)
CL Item
interrupted (3)
CL Item
ended (4)
Treatment Begin Date
Item
Treatment Begin Date
date
C3173309 (UMLS CUI [1])
Treatment End Date
Item
Treatment End Date
date
C1531784 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
dosage change
Item
Were there any dosage changes?
boolean
C0420247 (UMLS CUI [1])
start date dosage change
Item
Start date of dosage change
date
C3173309 (UMLS CUI [1,1])
C0420247 (UMLS CUI [1,2])
dosage
Item
Dosage
text
C0178602 (UMLS CUI [1])
Reason dosage change
Item
Reason of dosage change
text
C0392360 (UMLS CUI [1,1])
C0420247 (UMLS CUI [1,2])
Item Group
Response
C0521982 (UMLS CUI-1)
hematologic findings
Item
Hematologic findings known?
boolean
C0018941 (UMLS CUI [1])
date hematologic findings
Item
Date of hematologic test
date
C0011008 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Item
Hematologic test
text
C0018941 (UMLS CUI [1])
Hematologic test
Code List
Hematologic test
CL Item
CHR (1)
CL Item
no CHR (2)
Item
BCR-ABL Mutation
text
C3888919 (UMLS CUI [1])
BCR-ABL Mutation
Code List
BCR-ABL Mutation
CL Item
T315I  (1)
CL Item
Other (2)
Other
Item
Please mention if other:
text
C0205394 (UMLS CUI [1])
Cytogenetic Analysis
Item
Cytogenetic Analysis carried out?
boolean
C0752095 (UMLS CUI [1])
date Cytogenetic Analysis
Item
Date of Cytogenetic Analysis
date
C0011008 (UMLS CUI [1,1])
C0752095 (UMLS CUI [1,2])
Laboratory
Item
Laboratory of Cytogenetic Analysis
text
C0022877 (UMLS CUI [1])
Mitosis
Item
Evaluated mitosis
integer
C0026255 (UMLS CUI [1])
Normal karyotype
Item
Normal karyotype
integer
C0333684 (UMLS CUI [1])
Philadelphia negative
Item
Philadelphia negative, with additional aberrations
integer
C3888511 (UMLS CUI [1])
Philadelphia Chromosome
Item
Philadelphia Chromosome t(9;22)
integer
C0031526 (UMLS CUI [1])
Philadelphia Chromosome with additional aberrations
Item
Philadelphia Chromosome with additional aberrations
integer
C0031526 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0008625 (UMLS CUI [1,3])
Mitosis
Item
Not evaluable mitoses
integer
C0026255 (UMLS CUI [1])
Item
Cytogenetic response
text
C0521982 (UMLS CUI [1,1])
C0010802 (UMLS CUI [1,2])
Response Cytogenetic
Code List
Cytogenetic response
CL Item
no response (1)
CL Item
CyR (2)
CL Item
partial (PCyR)  (3)
CL Item
complete (CcyR) (4)
CL Item
complete (CcyR) (4)
CL Item
not determined (5)
Item
Bone marrow biopsy performed?
text
C0005954 (UMLS CUI [1])
bone marrow biopsy
Code List
Bone marrow biopsy performed?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
date bone marrow biopsy
Item
Date of bone marrow biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
Item
Bone marrow biopsy findings
text
C1287401 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Biopsy finding bone marrow
Code List
Bone marrow biopsy findings
CL Item
Chronic phase (1)
C0457343 (UMLS CUI-1)
C1516669 (UMLS CUI-2)
CL Item
Accelerated phase (2)
C0457345 (UMLS CUI-1)
CL Item
Blast crisis (3)
C0005699 (UMLS CUI-1)
CL Item
Other (4)
C0205394 (UMLS CUI-1)
Other
Item
If other, please mention:
text
C0205394 (UMLS CUI [1])
Molecular Analysis
Item
Molecular Analysis known?
boolean
C1513380 (UMLS CUI [1])
date Molecular Analysis
Item
Date of Molecular Analysis
date
C0011008 (UMLS CUI [1,1])
C1513380 (UMLS CUI [1,2])
Laboratory
Item
Laboratory of Molecular Analysis
text
C0022877 (UMLS CUI [1])
International Scale BCR-ABL
Item
BCR-ABL International Scale
integer
C3258465 (UMLS CUI [1,1])
C1835417 (UMLS CUI [1,2])
Item
Polymerase Chain Reaction, PCR
text
C0032520 (UMLS CUI [1])
Polymerase Chain Reaction
Code List
Polymerase Chain Reaction, PCR
CL Item
no MMR (1)
CL Item
MMR (2)
CL Item
MR4 (3)
CL Item
MR4.5 (4)
CL Item
MR5 (5)
CL Item
CMR (6)
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