ID

44775

Description

Study documentation part: On- 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 (3)
  1. 8/2/15 8/2/15 -
  2. 8/6/15 8/6/15 -
  3. 11/18/21 11/18/21 -
Copyright Holder

Bristol-Myers Squibb

Uploaded on

November 18, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

English

On-Treatment 4

9 forms  
VITAL SIGNS (END OF MONTH 6)
Description

VITAL SIGNS (END OF MONTH 6)

Alias
UMLS CUI-1
C0518766
Were vital signs taken?
Description

Were vital signs taken?

Data type

boolean

Alias
UMLS CUI-1
C0518766
Date:
Description

Date

Data type

date

Alias
UMLS CUI-1
C0011008
Position:
Description

Position

Data type

text

Alias
UMLS CUI-1
C0733755
Blood pressure systolic (in mm Hg):
Description

Blood pressure systolic

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic (in mm Hg):
Description

Blood pressure diastolic

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (in bpm):
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PHYSICAL MEASUREMENTS (END OF MONTH 6)
Description

PHYSICAL MEASUREMENTS (END OF MONTH 6)

Alias
UMLS CUI-1
C0205485
UMLS CUI-2
C0242485
Were any physical measurements taken?
Description

Were any physical measurements taken?

Data type

boolean

Alias
UMLS CUI-1
C0205485
UMLS CUI-2
C0242485
Date of measurement:
Description

Date of measurement

Data type

date

Alias
UMLS CUI-1
C0011008
Weight (in Kg):
Description

Weight

Data type

float

Measurement units
  • Kg
Alias
UMLS CUI [1]
C0005910
Kg
Performance status (ECOG):
Description

Performance status (ECOG)

Data type

text

Alias
UMLS CUI-1
C1520224
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 6)
Description

EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 6)

Alias
UMLS CUI-1
C1517060
UMLS CUI-2
C1314939
Date of assessment:
Description

Date of assessment

Data type

date

Alias
UMLS CUI-1
C0011008
Is extramedullary disease present?
Description

Is extramedullary disease present?

Data type

boolean

Alias
UMLS CUI-1
C1517060
UMLS CUI-2
C0012634
If yes, please provide the side code(s) from below: 1=Skin/ Soft tissue, 2=Bone, 3=Visceral (lung), 4=Visceral (liver), 5=Visceral (other), 6=Lymph node, 8=Bone marrow, 9=CNS, 10=Mediastinum, 14=Effusion, 16=Spleen, 18= Intestine, 19= Ascites, 25= Pelvis, 26=Peritoneum, 34= Ovary, 36= Pleura, 37= Gastric, 98= Other
Description

If yes, please provide the side code(s) from below: 1=Skin/ Soft tissue, 2=Bone, 3=Visceral (lung), 4=Visceral (liver), 5=Visceral (other), 6=Lymph node, 8=Bone marrow, 9=CNS, 10=Mediastinum, 14=Effusion, 16=Spleen, 18= Intestine, 19= Ascites, 25= Pelvis, 26=Peritoneum, 34= Ovary, 36= Pleura, 37= Gastric, 98= Other

Data type

text

Alias
UMLS CUI-1
C1515974
UMLS CUI-2
C0221198
UMLS CUI-3
C0220825
UMLS CUI-4
C1513040
TRANSFUSIONS
Description

TRANSFUSIONS

Alias
UMLS CUI-1
C1879316
Did the subject recieve any transfusion(s) since the last data collection?
Description

Did the subject recieve any transfusion(s) since the last data collection?

Data type

boolean

Alias
UMLS CUI-1
C1879316
Date of transfusion:
Description

Date of transfusion

Data type

date

Alias
UMLS CUI-1
C0011008
Type of transfusion(s), provide all that apply from below: 1= Paked cells, 3= Plasma, 5=Platelets, 98= Other
Description

Type of transfusion(s), provide all that apply from below: 1= Paked cells, 3= Plasma, 5=Platelets, 98= Other

Data type

text

Alias
UMLS CUI-1
C1879316
UMLS CUI-2
C0332307
EXTERNAL DATA TRACKING
Description

EXTERNAL DATA TRACKING

Alias
UMLS CUI-1
C1516800
Were any of the following protocol specified activities performed?
Description

Were any of the following protocol specified activities performed?

Data type

boolean

Alias
UMLS CUI-1
C1516800
If yes, provide date and time:
Description

If yes, provide date and time

Data type

datetime

Alias
UMLS CUI-1
C0011008
BONE MARROW BIOPSY/ ASPIRATE
Description

BONE MARROW BIOPSY/ ASPIRATE

Alias
UMLS CUI-1
C0005954
Was a bone marrow procedure performed?
Description

Was a bone marrow procedure performed?

Data type

boolean

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

Alias
UMLS CUI-1
C0184661
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
C1512699
UMLS CUI-2
C0936012
UMLS CUI-3
C0025564
Number of metaphases positive for philadelphia chromosome:
Description

Number of metaphases positive for philadelphia chromosome:

Data type

integer

Alias
UMLS CUI-1
C0031526
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

If "Not done", please specify:
Description

If "Not done", please specify:

Data type

text

Alias
UMLS CUI-1
C2348235
DRUG DISPENSATION
Description

DRUG DISPENSATION

Was drug dispensed?
Description

Was drug dispensed?

Data type

boolean

Date of dispensation:
Description

Date of dispensation

Data type

date

Alias
UMLS CUI-1
C0011008
Container number:
Description

Container number

Data type

text

BMS-354825 DOSING
Description

BMS-354825 DOSING

Alias
UMLS CUI [1,1]
C1455147
UMLS CUI [1,2]
C0178602
Start date:
Description

Start date

Data type

date

Alias
UMLS CUI-1
C0011008
Stop date:
Description

Stop date

Data type

date

Alias
UMLS CUI-1
C0011008
Actual dose taken per day (in mg):
Description

Actual dose taken per day (in mg)

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0205344
UMLS CUI [1,3]
C0439423
UMLS CUI [1,4]
C1533734
UMLS CUI [1,5]
C0205436
mg
Reason for dose modification:
Description

Reason for dose modification

Data type

text

Alias
UMLS CUI-1
C1707811
For the reasons asking for specification, please explain the cause:
Description

For the reasons asking for specification, please explain the cause

Data type

text

Alias
UMLS CUI-1
C2348235
CONCOMITANT MEDICATIONS
Description

CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
Were any additions or changes made to concomitant medications since the last data collection?
Description

Were any additions or changes made to concomitant medications since the last data collection?

Data type

boolean

Alias
UMLS CUI-1
C2347852
Medication name:
Description

Medication name

Data type

text

Alias
UMLS CUI-1
C2360065
Date started:
Description

Date started:

Data type

date

Alias
UMLS CUI-1
C0011008
Date stopped:
Description

Date stopped

Data type

date

Alias
UMLS CUI-1
C0011008
Reason:
Description

Reason

Data type

text

Alias
UMLS CUI-1
C0392360
NON-SERIOUS ADVERSE EVENTS
Description

NON-SERIOUS ADVERSE EVENTS

Did the subject experience any new or changed non- serious adverse events since the last collection?
Description

Did the subject experience any new or changed non- serious adverse events since the last collection?

Data type

boolean

CTC code:
Description

CTC code

Data type

text

Alias
UMLS CUI-1
C0805701
UMLS CUI-2
C1516728
UMLS CUI-3
C1705313
CTC grade:
Description

CTC grade

Data type

text

Alias
UMLS CUI-1
C2985911
Onset date:
Description

Onset date

Data type

date

Alias
UMLS CUI-1
C0011008
Resolution date:
Description

Resolution date

Data type

date

Alias
UMLS CUI-1
C0011008
Relationship to study drug:
Description

Relationship to study drug:

Data type

text

Alias
UMLS CUI-1
C0013227
Action taken regarding study drug:
Description

Action taken regarding study drug

Data type

text

Alias
UMLS CUI-1
C0013227
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
PREGNANCY TEST (END OF MONTH 4)
Description

PREGNANCY TEST (END OF MONTH 4)

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Description

Was a pregnancy test performed?

Data type

boolean

Alias
UMLS CUI-1
C0032976
Date of test:
Description

Date of test

Data type

date

Alias
UMLS CUI-1
C0011008
If no test was performed, specify reason:
Description

If no test was performed, specify reason

Data type

text

Alias
UMLS CUI-1
C0392360
If a test was performed, please specify result:
Description

If a test was performed, please specify result

Data type

text

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0884358
UMLS CUI-3
C0032961
UMLS CUI-4
C0332281
UMLS CUI-5
C0449438
Specify test
Description

Specify test

Data type

text

Alias
UMLS CUI-1
C0032976
PREGNANCY TEST (END OF MONTH 6)
Description

PREGNANCY TEST (END OF MONTH 6)

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Description

Was a pregnancy test performed?

Data type

boolean

Alias
UMLS CUI-1
C0032976
Date of test:
Description

Date of test

Data type

date

Alias
UMLS CUI-1
C0011008
If no test was performed, specify reason:
Description

If no test was performed, specify reason

Data type

text

Alias
UMLS CUI-1
C0392360
If a test was performed, please specify result:
Description

If a test was performed, please specify result

Data type

text

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0884358
UMLS CUI-3
C0032961
UMLS CUI-4
C0332281
UMLS CUI-5
C0449438
Specify test:
Description

Specify test

Data type

text

Alias
UMLS CUI-1
C0032976
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Similar models

On-Treatment 4

9 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
VITAL SIGNS (END OF MONTH 6)
C0518766 (UMLS CUI-1)
Vital signs
Item
Were vital signs taken?
boolean
C0518766 (UMLS CUI-1)
DATE
Item
Date:
date
C0011008 (UMLS CUI-1)
Item
Position:
text
C0733755 (UMLS CUI-1)
POSITION
Code List
Position:
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
BLOOD PRESSURE SYSTOLIC
Item
Blood pressure systolic (in mm Hg):
float
C0871470 (UMLS CUI [1])
BLOOD PRESSURE DIASTOLIC
Item
Blood pressure diastolic (in mm Hg):
float
C0428883 (UMLS CUI [1])
HEART RATE
Item
Heart rate (in bpm):
integer
C0018810 (UMLS CUI [1])
Item Group
PHYSICAL MEASUREMENTS (END OF MONTH 6)
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
Physical measurements
Item
Were any physical measurements taken?
boolean
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
DATE
Item
Date of measurement:
date
C0011008 (UMLS CUI-1)
Weight
Item
Weight (in Kg):
float
C0005910 (UMLS CUI [1])
ECOG
Item
Performance status (ECOG):
text
C1520224 (UMLS CUI-1)
Item Group
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 6)
C1517060 (UMLS CUI-1)
C1314939 (UMLS CUI-2)
DATE
Item
Date of assessment:
date
C0011008 (UMLS CUI-1)
Extramedullary disease
Item
Is extramedullary disease present?
boolean
C1517060 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
SITE CODE
Item
If yes, please provide the side code(s) from below: 1=Skin/ Soft tissue, 2=Bone, 3=Visceral (lung), 4=Visceral (liver), 5=Visceral (other), 6=Lymph node, 8=Bone marrow, 9=CNS, 10=Mediastinum, 14=Effusion, 16=Spleen, 18= Intestine, 19= Ascites, 25= Pelvis, 26=Peritoneum, 34= Ovary, 36= Pleura, 37= Gastric, 98= Other
text
C1515974 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C1513040 (UMLS CUI-4)
Item Group
TRANSFUSIONS
C1879316 (UMLS CUI-1)
TRANSFUSIONS
Item
Did the subject recieve any transfusion(s) since the last data collection?
boolean
C1879316 (UMLS CUI-1)
DATE
Item
Date of transfusion:
date
C0011008 (UMLS CUI-1)
Type of transfusion
Item
Type of transfusion(s), provide all that apply from below: 1= Paked cells, 3= Plasma, 5=Platelets, 98= Other
text
C1879316 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
Item Group
EXTERNAL DATA TRACKING
C1516800 (UMLS CUI-1)
EXTERNAL DATA TRACKING
Item
Were any of the following protocol specified activities performed?
boolean
C1516800 (UMLS CUI-1)
DATE AND TIME
Item
If yes, provide date and time:
datetime
C0011008 (UMLS CUI-1)
Item Group
BONE MARROW BIOPSY/ ASPIRATE
C0005954 (UMLS CUI-1)
Bone marrow biopsy
Item
Was a bone marrow procedure performed?
boolean
C0005954 (UMLS CUI-1)
DATE
Item
Date of procedure:
date
C0011008 (UMLS CUI-1)
Item
Indicate procedure:
text
C0184661 (UMLS CUI-1)
Procedure
Code List
Indicate procedure:
CL Item
31 Aspirate (1)
CL Item
16 Biopsy (2)
CL Item
89 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)
Metaphase
Item
Number of metaphases examined:
integer
C1512699 (UMLS CUI-1)
C0936012 (UMLS CUI-2)
C0025564 (UMLS CUI-3)
Philadelphia chromosome
Item
Number of metaphases positive for philadelphia chromosome:
integer
C0031526 (UMLS CUI-1)
LIGHT 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
1 Absent (1)
CL Item
2 Hypocellular (less than 20%) (2)
CL Item
3 Normal (20-40%) (3)
CL Item
4 Hypercellular (41-100%) (4)
CL Item
95 Not done (5)
Specification
Item
If "Not done", please specify:
text
C2348235 (UMLS CUI-1)
Item Group
DRUG DISPENSATION
drug dispensation
Item
Was drug dispensed?
boolean
DATE
Item
Date of dispensation:
date
C0011008 (UMLS CUI-1)
Container number
Item
Container number:
text
Item Group
BMS-354825 DOSING
C1455147 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
DATE
Item
Start date:
date
C0011008 (UMLS CUI-1)
DATE
Item
Stop date:
date
C0011008 (UMLS CUI-1)
DOSE
Item
Actual dose taken per day (in mg):
float
C0178602 (UMLS CUI [1,1])
C0205344 (UMLS CUI [1,2])
C0439423 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
C0205436 (UMLS CUI [1,5])
Item
Reason for dose modification:
text
C1707811 (UMLS CUI-1)
Dose modification
Code List
Reason for dose modification:
CL Item
3 Hematologic toxicity (specify) (1)
CL Item
4 Non hematologic toxicity (specify) (2)
CL Item
56 Dosing error (3)
CL Item
57 Raising % blasts (4)
CL Item
59 Loss of response (5)
CL Item
66 No CHR, NEL or RTC within 6 weeks (6)
CL Item
67 NoCCyR after 6 months (7)
CL Item
68 No MCyR after 3 months (8)
CL Item
98 Other (specify) (9)
Specification
Item
For the reasons asking for specification, please explain the cause:
text
C2348235 (UMLS CUI-1)
Item Group
CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
CONCOMITANT MEDICATIONS
Item
Were any additions or changes made to concomitant medications since the last data collection?
boolean
C2347852 (UMLS CUI-1)
MEDICATION NAME
Item
Medication name:
text
C2360065 (UMLS CUI-1)
DATE
Item
Date started:
date
C0011008 (UMLS CUI-1)
DATE
Item
Date stopped:
date
C0011008 (UMLS CUI-1)
Item
Reason:
text
C0392360 (UMLS CUI-1)
REASON
Code List
Reason:
CL Item
3 Adverse event (1)
CL Item
98 Other (2)
Item Group
NON-SERIOUS ADVERSE EVENTS
NON-SERIOUS ADVERSE EVENTS
Item
Did the subject experience any new or changed non- serious adverse events since the last collection?
boolean
CTC CODE
Item
CTC code:
text
C0805701 (UMLS CUI-1)
C1516728 (UMLS CUI-2)
C1705313 (UMLS CUI-3)
CTC grade
Item
CTC grade:
text
C2985911 (UMLS CUI-1)
DATE
Item
Onset date:
date
C0011008 (UMLS CUI-1)
DATE
Item
Resolution date:
date
C0011008 (UMLS CUI-1)
Item
Relationship to study drug:
text
C0013227 (UMLS CUI-1)
Drugs
Code List
Relationship to study drug:
CL Item
Certain (1)
CL Item
Probable (2)
CL Item
Possible (3)
CL Item
Not likely (4)
CL Item
Not related (5)
Item
Action taken regarding study drug:
text
C0013227 (UMLS CUI-1)
Drugs
Code List
Action taken regarding study drug:
CL Item
None (1)
CL Item
Reduced (2)
CL Item
Increased (3)
CL Item
Interrupted (4)
CL Item
Discontinued (5)
Treatment required
Item
Treatment required?
boolean
C0332307 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C1521801 (UMLS CUI-4)
Item Group
PREGNANCY TEST (END OF MONTH 4)
C0032976 (UMLS CUI-1)
PREGNANCY TEST
Item
Was a pregnancy test performed?
boolean
C0032976 (UMLS CUI-1)
DATE
Item
Date of test:
date
C0011008 (UMLS CUI-1)
Item
If no test was performed, specify reason:
text
C0392360 (UMLS CUI-1)
REASON
Code List
If no test was performed, specify reason:
CL Item
1 Post-menopausal (Amenorrhea>= 12 months) (1)
CL Item
2 Surgically sterile (2)
CL Item
5 Male (3)
CL Item
6 Pre-menarche (4)
Item
If a test was performed, please specify result:
text
C0087111 (UMLS CUI-1)
C0884358 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
C0449438 (UMLS CUI-5)
REASON
Code List
If a test was performed, please specify result:
CL Item
Positive (1)
CL Item
Negative (2)
Item
Specify test
text
C0032976 (UMLS CUI-1)
PREGNANCY TEST
Code List
Specify test
CL Item
Urine HCG (1)
CL Item
Serum HCG (2)
Item Group
PREGNANCY TEST (END OF MONTH 6)
C0032976 (UMLS CUI-1)
PREGNANCY TEST
Item
Was a pregnancy test performed?
boolean
C0032976 (UMLS CUI-1)
DATE
Item
Date of test:
date
C0011008 (UMLS CUI-1)
Item
If no test was performed, specify reason:
text
C0392360 (UMLS CUI-1)
REASON
Code List
If no test was performed, specify reason:
CL Item
1 Post-menopausal (Amenorrhea>= 12 months) (1)
CL Item
2 Surgically sterile (2)
CL Item
5 Male (3)
CL Item
6 Pre-menarche (4)
Item
If a test was performed, please specify result:
text
C0087111 (UMLS CUI-1)
C0884358 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
C0449438 (UMLS CUI-5)
Reason
Code List
If a test was performed, please specify result:
CL Item
Positive (1)
CL Item
Negative (2)
Item
Specify test:
text
C0032976 (UMLS CUI-1)
PREGNANCY TEST
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Urine HCG (1)
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Serum HCG (2)
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