ID

44775

Descripción

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

Palabras clave

Versiones (3)
  1. 2/8/15 2/8/15 -
  2. 6/8/15 6/8/15 -
  3. 18/11/21 18/11/21 -
Titular de derechos de autor

Bristol-Myers Squibb

Subido en

18 de noviembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

On-Treatment 1

9 formularios  
VITAL SIGNS (DAY 1)
Descripción

VITAL SIGNS (DAY 1)

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

Were vital signs taken?

Tipo de datos

boolean

Alias
UMLS CUI-1
C0518766
Date:
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Position:
Descripción

Position

Tipo de datos

text

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

Blood pressure systolic

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic (in mm Hg):
Descripción

Blood pressure diastolic

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (in bpm):
Descripción

Heart rate:

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PHYSICAL MEASUREMENTS (DAY 1)
Descripción

PHYSICAL MEASUREMENTS (DAY 1)

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

Were any physical measurements taken?

Tipo de datos

boolean

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

Date of measurement

Tipo de datos

date

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

Weight

Tipo de datos

float

Unidades de medida
  • Kg
Alias
UMLS CUI [1]
C0005910
Kg
Performance status (ECOG):
Descripción

Performance status (ECOG)

Tipo de datos

integer

Alias
UMLS CUI-1
C1520224
EXTRAMEDULLARY INVOLVEMENT (DAY 1)
Descripción

EXTRAMEDULLARY INVOLVEMENT (DAY 1)

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

Date of assessment

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Is extramedullary disease presen?
Descripción

Is extramedullary disease presen?

Tipo de datos

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
Descripción

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

Tipo de datos

text

Alias
UMLS CUI-1
C0805701
UMLS CUI-2
C1517060
UMLS CUI-3
C0012634
VITAL SIGNS (END OF MONTH 1)
Descripción

VITAL SIGNS (END OF MONTH 1)

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

Were vital signs taken?

Tipo de datos

boolean

Alias
UMLS CUI-1
C0518766
Date:
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Position:
Descripción

Position

Tipo de datos

text

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

Blood pressure systolic

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic (in mm Hg):
Descripción

Blood pressure diastolic

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (in bpm):
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PHYSICAL MEASUREMENTS (END OF MONTH 1)
Descripción

PHYSICAL MEASUREMENTS (END OF MONTH 1)

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

Were any physical measurements taken?

Tipo de datos

boolean

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

Date of measurement

Tipo de datos

date

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

Weight

Tipo de datos

float

Unidades de medida
  • Kg
Alias
UMLS CUI [1]
C0005910
Kg
Performance status (ECOG):
Descripción

Performance status (ECOG)

Tipo de datos

integer

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

EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 1)

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

Date of assessment

Tipo de datos

date

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

Is extramedullary disease present?

Tipo de datos

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
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C1517060
UMLS CUI [1,3]
C0012634
CHEST X-RAY
Descripción

CHEST X-RAY

Alias
UMLS CUI-1
C0039985
Was a chest X-ray performed?
Descripción

Was a chest X-ray performed?

Tipo de datos

boolean

Alias
UMLS CUI-1
C0039985
Date of chest X-ray:
Descripción

Date of chest X-ray:

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Interpretation of X-ray report:
Descripción

Interpretation of X-ray report:

Tipo de datos

text

Alias
UMLS CUI-1
C0043299
UMLS CUI-2
C0684224
If Abnormal, please specify clinically relevant abnormalities:
Descripción

If Abnormal, please specify clinically relevant abnormalities:

Tipo de datos

text

Alias
UMLS CUI-1
C0436503
TRANSFUSION
Descripción

TRANSFUSION

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

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

Tipo de datos

boolean

Alias
UMLS CUI-1
C1879316
Date of transfusion:
Descripción

Date of transfusion

Tipo de datos

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
Descripción

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

Tipo de datos

text

Alias
UMLS CUI-1
C0011008
UMLS CUI-2
C0332307
EXTERNAL DATA TRACKING
Descripción

EXTERNAL DATA TRACKING

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

Were any of the following protocol specified activities performed?

Tipo de datos

boolean

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

If yes, provide date and time

Tipo de datos

datetime

Alias
UMLS CUI-1
C0011008
ELECTROCARDIOGRAM
Descripción

ELECTROCARDIOGRAM

Alias
UMLS CUI-1
C1623258
Was an Electrocardiogram done?
Descripción

Was an Electrocardiogram done?

Tipo de datos

boolean

Alias
UMLS CUI-1
C1623258
Date and time:
Descripción

Date and time:

Tipo de datos

datetime

Alias
UMLS CUI-1
C0011008
Heart rate (in bpm):
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR Interval (in sec):
Descripción

PR Interval

Tipo de datos

float

Unidades de medida
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS Width (in sec):
Descripción

QRS Width

Tipo de datos

float

Unidades de medida
  • sec
Alias
UMLS CUI [1]
C0520880
sec
QT Interval (in sec):
Descripción

QT Interval

Tipo de datos

float

Alias
UMLS CUI-1
C0429028
Bazett's QTc (in msec):
Descripción

Bazett's QTc (in msec):

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Fridericia's QTc (in msec):
Descripción

Fridericia's QTc

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Electrocardiogram interpretation:
Descripción

Electrocardiogram interpretation

Tipo de datos

text

Alias
UMLS CUI-1
C2826714
If abnormal, ECG corresponds to Hypertrophy? Provide from the following: 1= Left atrial hypertrophy, 2= Right atrial hypertrophy, 3= Left ventricular hypertrophy, 4= Right ventricular hypertrophy
Descripción

If abnormal, ECG corresponds to Hypertrophy?

Tipo de datos

text

Alias
UMLS CUI-1
C1383860
If abnormal, ECG corresponds to infarction? Provide from the following: 5= Acute infarction, 6= Subacute infarction (Recent), 7= Old infarction
Descripción

If abnormal, ECG corresponds to infarction? Select from the following: 5= Acute infarction, 6= Subacute infarction (Recent), 7= Old infarction

Tipo de datos

text

Alias
UMLS CUI-1
C0027051
If abnormal, ECG corresponds to ST/T Morphology? Provide from the following: 8= Myocardial ischemia, 9= Digitalis effect, 10= Symmetrical T- Wave inversions, 12= Other non-specific ST/T
Descripción

If abnormal, ECG corresponds to ST/T Morphology? Provide from the following: 8= Myocardial ischemia, 9= Digitalis effect, 10= Symmetrical T- Wave inversions, 12= Other non-specific ST/T

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0489650
UMLS CUI [1,2]
C1623258
UMLS CUI [1,3]
C0332437
If abnormal, ECG corresponds to disorders of Rhythm? Provide from the following: 13= Sinus tachycardia, 14= Sinus bradycardia, 15= Supraventricular premature beat, 17= Supraventricular tachycardia, 19= Atrial fibrillation, 20= Atrial flutter, 16= Ventricular premature beat, 18= Ventricular tachycardia, 73= Ventricular fibrillation, 55=Torsade de pointes, 21= Other rhythm abnormalities, 22= Pacemaker rhythm
Descripción

If abnormal, ECG corresponds to disorders of Rhythm? Provide from the following: 13= Sinus tachycardia, 14= Sinus bradycardia, 15= Supraventricular premature beat, 17= Supraventricular tachycardia, 19= Atrial fibrillation, 20= Atrial flutter, 16= Ventricular premature beat, 18= Ventricular tachycardia, 73= Ventricular fibrillation, 55=Torsade de pointes, 21= Other rhythm abnormalities, 22= Pacemaker rhythm

Tipo de datos

text

Alias
UMLS CUI-1
C0199571
If abnormal, ECG corresponds to disorders of conduction? Provide from the following: 23= 1° A-V Block, 24= 2° A-V Block, 25= 3° A-V Block, 26= LBB Block, 27= RBB Block, 29= Other intraventricular conduction defect, 28= Pre-excitation syndrom
Descripción

If abnormal, ECG corresponds to disorders of conduction? Provide from the following: 23= 1° A-V Block, 24= 2° A-V Block, 25= 3° A-V Block, 26= LBB Block, 27= RBB Block, 29= Other intraventricular conduction defect, 28= Pre-excitation syndrom

Tipo de datos

text

Alias
UMLS CUI-1
C0264886
Other abnormalities? 30= Left axis deviation, 98= Other (in this case specify please)
Descripción

Other abnormalities? 30= Left axis deviation, 98= Other (in this case specify please)

Tipo de datos

text

Alias
UMLS CUI-1
C0522055
BONE MARROW BIOPSY/ ASPIRATE
Descripción

BONE MARROW BIOPSY/ ASPIRATE

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

Was a bone marrow procedure performed?

Tipo de datos

boolean

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

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

Number of metaphases positive for philadelphia chromosome

Tipo de datos

integer

Alias
UMLS CUI-1
C0031526
Was the specimen adequate for light microscopic analysis?
Descripción

Was the specimen adequate for light microscopic analysis?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0430389
Number of blasts:
Descripción

Number of blasts

Tipo de datos

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0368761
%
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

Alias
UMLS CUI [1,1]
C1561532
UMLS CUI [1,2]
C0449438
Cellularity results:
Descripción

Cellularity results

Tipo de datos

text

Alias
UMLS CUI [1]
C1561532
If "Not done", please specify:
Descripción

If "Not done", please specify:

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0005954
UMLS CUI [1,2]
C1272696
DRUG DISPENSATION
Descripción

DRUG DISPENSATION

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1880359
Was drug dispensed?
Descripción

Was drug dispensed?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1880359
Date of dispensation:
Descripción

Date of dispensation

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1880359
Container number:
Descripción

Container number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
BMS-354825 DOSING
Descripción

BMS-354825 DOSING

Alias
UMLS CUI-1
C1455147
UMLS CUI-2
C0178602
Start date:
Descripción

Start date

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Stop date:
Descripción

Stop date

Tipo de datos

date

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

Actual dose taken per day (in mg)

Tipo de datos

float

Alias
UMLS CUI-1
C0450442
UMLS CUI-2
C0677800
UMLS CUI-3
C1521941
UMLS CUI-4
C1521801
UMLS CUI-5
C0178602
Reason for dose modification:
Descripción

Reason for dose modification

Tipo de datos

text

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

For the reasons asking for specification, please explain the cause

Tipo de datos

text

Alias
UMLS CUI-1
C2348235
CONCOMITANT MEDICATIONS
Descripción

CONCOMITANT MEDICATIONS

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

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

Tipo de datos

boolean

Alias
UMLS CUI-1
C2347852
Medication name:
Descripción

Medication name

Tipo de datos

text

Alias
UMLS CUI-1
C2360065
Date started:
Descripción

Date started:

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Date stopped:
Descripción

Date stopped

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Reason:
Descripción

Reason

Tipo de datos

text

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

NON-SERIOUS ADVERSE EVENTS

Alias
UMLS CUI [1]
C1518404
Did the subject experience any new or changed non- serious adverse events since the last collection?
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518404
CTC code:
Descripción

CTC code

Tipo de datos

text

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

CTC grade

Tipo de datos

integer

Alias
UMLS CUI-1
C2985911
Onset date:
Descripción

Onset date

Tipo de datos

date

Alias
UMLS CUI-1
C0011008
Resolution date:
Descripción

Resolution date

Tipo de datos

date

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

Relationship to study drug:

Tipo de datos

text

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

Action taken regarding study drug

Tipo de datos

text

Alias
UMLS CUI-1
C0013227
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
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Similar models

On-Treatment 1

9 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
VITAL SIGNS (DAY 1)
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 (DAY 1)
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):
integer
C1520224 (UMLS CUI-1)
Item Group
EXTRAMEDULLARY INVOLVEMENT (DAY 1)
C1517060 (UMLS CUI-1)
C1314939 (UMLS CUI-2)
DATE
Item
Date of assessment:
date
C0011008 (UMLS CUI-1)
Extramedullary disease
Item
Is extramedullary disease presen?
boolean
C1517060 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Extramedullary disease 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
C0805701 (UMLS CUI-1)
C1517060 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Item Group
VITAL SIGNS (END OF MONTH 1)
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 1)
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):
integer
C1520224 (UMLS CUI-1)
Item Group
EXTRAMEDULLARY INVOLVEMENT (END OF MONTH 1)
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)
Extramedullary disease 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
C0805701 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Item Group
CHEST X-RAY
C0039985 (UMLS CUI-1)
CHEST X-RAY
Item
Was a chest X-ray performed?
boolean
C0039985 (UMLS CUI-1)
Date
Item
Date of chest X-ray:
date
C0011008 (UMLS CUI-1)
Item
Interpretation of X-ray report:
text
C0043299 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
x-ray report
Code List
Interpretation of X-ray report:
CL Item
Normal  (1)
CL Item
Abnormal (2)
X-ray report interpretation
Item
If Abnormal, please specify clinically relevant abnormalities:
text
C0436503 (UMLS CUI-1)
Item Group
TRANSFUSION
C1879316 (UMLS CUI-1)
Transfusion
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)
transfusion type
Item
Type of transfusion(s), provide all that apply from below: 1= Paked cells, 3= Plasma, 5=Platelets, 98= Other
text
C0011008 (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
ELECTROCARDIOGRAM
C1623258 (UMLS CUI-1)
Electrocardiogram
Item
Was an Electrocardiogram done?
boolean
C1623258 (UMLS CUI-1)
DATE AND TIME
Item
Date and time:
datetime
C0011008 (UMLS CUI-1)
HEART RATE
Item
Heart rate (in bpm):
integer
C0018810 (UMLS CUI [1])
PR INTERVAL
Item
PR Interval (in sec):
float
C0429087 (UMLS CUI [1])
QRS WIDTH
Item
QRS Width (in sec):
float
C0520880 (UMLS CUI [1])
QT INTERVAL
Item
QT Interval (in sec):
float
C0429028 (UMLS CUI-1)
Bazett's QTc
Item
Bazett's QTc (in msec):
float
C0489625 (UMLS CUI [1])
QTc
Item
Fridericia's QTc (in msec):
float
C0489625 (UMLS CUI [1])
Item
Electrocardiogram interpretation:
text
C2826714 (UMLS CUI-1)
Electrocardiogram interpretation
Code List
Electrocardiogram interpretation:
CL Item
Normal (1)
CL Item
Abnormal (2)
Cardiac hypertrophy
Item
If abnormal, ECG corresponds to Hypertrophy? Provide from the following: 1= Left atrial hypertrophy, 2= Right atrial hypertrophy, 3= Left ventricular hypertrophy, 4= Right ventricular hypertrophy
text
C1383860 (UMLS CUI-1)
Cardiac infarction
Item
If abnormal, ECG corresponds to infarction? Provide from the following: 5= Acute infarction, 6= Subacute infarction (Recent), 7= Old infarction
text
C0027051 (UMLS CUI-1)
ST/T MORPHOLOGY
Item
If abnormal, ECG corresponds to ST/T Morphology? Provide from the following: 8= Myocardial ischemia, 9= Digitalis effect, 10= Symmetrical T- Wave inversions, 12= Other non-specific ST/T
text
C0489650 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,3])
RHYTHM
Item
If abnormal, ECG corresponds to disorders of Rhythm? Provide from the following: 13= Sinus tachycardia, 14= Sinus bradycardia, 15= Supraventricular premature beat, 17= Supraventricular tachycardia, 19= Atrial fibrillation, 20= Atrial flutter, 16= Ventricular premature beat, 18= Ventricular tachycardia, 73= Ventricular fibrillation, 55=Torsade de pointes, 21= Other rhythm abnormalities, 22= Pacemaker rhythm
text
C0199571 (UMLS CUI-1)
CONDUCTION
Item
If abnormal, ECG corresponds to disorders of conduction? Provide from the following: 23= 1° A-V Block, 24= 2° A-V Block, 25= 3° A-V Block, 26= LBB Block, 27= RBB Block, 29= Other intraventricular conduction defect, 28= Pre-excitation syndrom
text
C0264886 (UMLS CUI-1)
Electrocardiogram abnormalities
Item
Other abnormalities? 30= Left axis deviation, 98= Other (in this case specify please)
text
C0522055 (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)
specimen adequate for light microscopic analysis
Item
Was the specimen adequate for light microscopic analysis?
boolean
C0370003 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0430389 (UMLS CUI [1,3])
BLASTS
Item
Number of blasts:
float
C0368761 (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
C1561532 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
CELLULARITY FORM
Code List
Cellularity form:
CL Item
Clot (1)
CL Item
Biopsy (2)
Item
Cellularity results:
text
C1561532 (UMLS CUI [1])
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)
Bone marrow biopsy not done
Item
If "Not done", please specify:
text
C0005954 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
DRUG DISPENSATION
C0013227 (UMLS CUI [1,1])
C1880359 (UMLS CUI [1,2])
drug dispensation
Item
Was drug dispensed?
boolean
C0013227 (UMLS CUI [1,1])
C1880359 (UMLS CUI [1,2])
DATE of dispensation
Item
Date of dispensation:
date
C0011008 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1880359 (UMLS CUI [1,3])
Container number
Item
Container number:
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
BMS-354825 DOSING
C1455147 (UMLS CUI-1)
C0178602 (UMLS CUI-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
C0450442 (UMLS CUI-1)
C0677800 (UMLS CUI-2)
C1521941 (UMLS CUI-3)
C1521801 (UMLS CUI-4)
C0178602 (UMLS CUI-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
C1518404 (UMLS CUI [1])
NON-SERIOUS ADVERSE EVENTS
Item
Did the subject experience any new or changed non- serious adverse events since the last collection?
boolean
C1518404 (UMLS CUI [1])
CTC CODE
Item
CTC code:
text
C0805701 (UMLS CUI-1)
C1516728 (UMLS CUI-2)
C1705313 (UMLS CUI-3)
CTC grade
Item
CTC grade:
integer
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)
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