ID

44055

Description

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.

Keywords

Versions (4)
  1. 7/6/15 7/6/15 -
  2. 8/6/15 8/6/15 -
  3. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

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

English

Pre- Treatment events

8 forms  
PRE-TREATMENT EVENTS
Description

PRE-TREATMENT EVENTS

CTC CODE:
Description

CTC CODE:

Data type

text

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

ONSET DATE

Data type

date

Alias
UMLS CUI-1
C0011008
CTC grade:
Description

CTC grade

Data type

text

Alias
UMLS CUI-1
C2985911
Treatment required:
Description

Treatment required

Data type

boolean

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

BONE MARROW BIOPSY I ASPIRATE

Alias
UMLS CUI-1
C0005954
Date of procedure:
Description

DATE OF PROCEDURE

Data type

date

Alias
UMLS CUI-1
C0011008
Indicate procedure:
Description

INDICATE PROCEDURE

Data type

text

Was cytogenetic analysis performed?
Description

WAS CYTOGENETIC ANALYSIS PERFORMED ?

Data type

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:
Description

NUMBER OF METAPHASES EXAMINED

Data type

integer

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

NUMBER OF ME T APHASES POSITIVE FOR PHILADELPHIA CHROMOSOME

Data type

integer

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

WAS THE SPECIMEN ADEQUATE FOR LIGHT MICROSCOPIC ANALYSIS ?

Data type

boolean

Number of blasts:
Description

Number of blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C1982687
%
Number of promyelocytes:
Description

Number of promyelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455279
%
Number of basophils:
Description

Number of basophils

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200641
%
Cellularity form:
Description

Cellularity form

Data type

text

Cellularity results:
Description

Cellularity results

Data type

text

Is the subject eligible based on clonal evolution?
Description

IS THE SUBJECT ELIGIBLE BASED ON CLONAL EVOLUTION?

Data type

boolean

If yes, specify additional clones
Description

Additional clones

Data type

text

EQ-5D
Description

EQ-5D

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

Evaluation of EQ-5D

Data type

text

Alias
UMLS CUI [1]
C2733251
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Similar models

Pre- Treatment events

8 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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