ID

44055

Descripción

Study documentation part: Pre-Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3.

Palabras clave

Versiones (4)
  1. 6/7/15 6/7/15 -
  2. 6/8/15 6/8/15 -
  3. 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
  4. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Pre-Treatment

Inglés

Pre- Treatment events

8 formularios  
PRE-TREATMENT EVENTS
Descripción

PRE-TREATMENT EVENTS

CTC CODE:
Descripción

CTC CODE:

Tipo de datos

text

Alias
UMLS CUI-1
C0805701
UMLS CUI-2
C1516728
UMLS CUI-3
C1705313
Onset date:
Descripción

ONSET DATE

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
CTC grade:
Descripción

CTC grade

Tipo de datos

text

Alias
UMLS CUI-1
C2985911
Treatment required:
Descripción

Treatment required

Tipo de datos

boolean

Alias
UMLS CUI-1
C0332307
UMLS CUI-2
C0877248
UMLS CUI-3
C0087111
UMLS CUI-4
C1521801
BONE MARROW BIOPSY I ASPIRATE
Descripción

BONE MARROW BIOPSY I ASPIRATE

Alias
UMLS CUI-1
C0005954
Date of procedure:
Descripción

DATE OF PROCEDURE

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Indicate procedure:
Descripción

INDICATE PROCEDURE

Tipo de datos

text

Was cytogenetic analysis performed?
Descripción

WAS CYTOGENETIC ANALYSIS PERFORMED ?

Tipo de datos

boolean

Alias
UMLS CUI-1
C0752095
UMLS CUI-2
C0162789
UMLS CUI-3
C0022526
UMLS CUI-4
C0884358
UMLS CUI-5
C0011008
Number of metaphases examined:
Descripción

NUMBER OF METAPHASES EXAMINED

Tipo de datos

integer

Alias
UMLS CUI-1
C1621812
Number of metaphases positive for philadelphia chromosome:
Descripción

NUMBER OF ME T APHASES POSITIVE FOR PHILADELPHIA CHROMOSOME

Tipo de datos

integer

Alias
UMLS CUI-1
C0856536
Was the specimen adequate for light microscopic analysis?
Descripción

WAS THE SPECIMEN ADEQUATE FOR LIGHT MICROSCOPIC ANALYSIS ?

Tipo de datos

boolean

Number of blasts:
Descripción

Number of blasts

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C1982687
%
Number of promyelocytes:
Descripción

Number of promyelocytes

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0455279
%
Number of basophils:
Descripción

Number of basophils

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0200641
%
Cellularity form:
Descripción

Cellularity form

Tipo de datos

text

Cellularity results:
Descripción

Cellularity results

Tipo de datos

text

Is the subject eligible based on clonal evolution?
Descripción

IS THE SUBJECT ELIGIBLE BASED ON CLONAL EVOLUTION?

Tipo de datos

boolean

If yes, specify additional clones
Descripción

Additional clones

Tipo de datos

text

EQ-5D
Descripción

EQ-5D

Alias
UMLS CUI-1
C2733251
Evaluation of EQ-5D:
Descripción

Evaluation of EQ-5D

Tipo de datos

text

Alias
UMLS CUI [1]
C2733251
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Similar models

Pre- Treatment events

8 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
PRE-TREATMENT EVENTS
CTC CODE
Item
CTC CODE:
text
C0805701 (UMLS CUI-1)
C1516728 (UMLS CUI-2)
C1705313 (UMLS CUI-3)
DATE
Item
Onset date:
date
C0011008 (UMLS CUI-1)
CTC grade
Item
CTC grade:
text
C2985911 (UMLS CUI-1)
Treatment required
Item
Treatment required:
boolean
C0332307 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C1521801 (UMLS CUI-4)
Item Group
BONE MARROW BIOPSY I ASPIRATE
C0005954 (UMLS CUI-1)
DATE
Item
Date of procedure:
date
C0011008 (UMLS CUI-1)
Item
Indicate procedure:
text
INDICATE PROCEDURE
Code List
Indicate procedure:
CL Item
Aspirate (1)
CL Item
Biopsy (2)
CL Item
Both (Aspirate and biopsy) (3)
CYTOGENETIC ANALYSIS
Item
Was cytogenetic analysis performed?
boolean
C0752095 (UMLS CUI-1)
C0162789 (UMLS CUI-2)
C0022526 (UMLS CUI-3)
C0884358 (UMLS CUI-4)
C0011008 (UMLS CUI-5)
NUMBER OF METAPHASES
Item
Number of metaphases examined:
integer
C1621812 (UMLS CUI-1)
PHILADELPHIA CHROMOSOME POSITIVE
Item
Number of metaphases positive for philadelphia chromosome:
integer
C0856536 (UMLS CUI-1)
MICROSCOPIC ANALYSIS
Item
Was the specimen adequate for light microscopic analysis?
boolean
BLASTS
Item
Number of blasts:
float
C1982687 (UMLS CUI [1])
PROMYELOCYTES
Item
Number of promyelocytes:
float
C0455279 (UMLS CUI [1])
BASOPHILS
Item
Number of basophils:
float
C0200641 (UMLS CUI [1])
Item
Cellularity form:
text
CELLULARITY FORM
Code List
Cellularity form:
CL Item
Clot (1)
CL Item
Biopsy (2)
Item
Cellularity results:
text
CELLULARITY RESULTS
Code List
Cellularity results:
CL Item
Absent (1)
CL Item
Hypocellular (Less than 20%) (2)
CL Item
Normal (20-40%) (3)
CL Item
Hypercellular (41-100%) (4)
CL Item
Not done (5)
CLONAL EVOLUTION
Item
Is the subject eligible based on clonal evolution?
boolean
Additional clones
Item
If yes, specify additional clones
text
Item Group
EQ-5D
C2733251 (UMLS CUI-1)
EQ-5D
Item
Evaluation of EQ-5D:
text
C2733251 (UMLS CUI [1])
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