ID

42024

Beskrivning

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.

Nyckelord

  1. 2015-07-06 2015-07-06 -
  2. 2015-08-06 2015-08-06 -
  3. 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
  4. 2021-09-20 2021-09-20 -
Uppladdad den

15 mars 2021

DOI

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Creative Commons BY-NC 3.0 Legacy

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Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – Pre-Treatment

Medical tests and examinations

VITAL SIGNS
Beskrivning

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Date:
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI-1
C0011008
Position:
Beskrivning

Position

Datatyp

text

Alias
UMLS CUI-1
C0733755
Systolic blood pressure (in mm Hg):
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure (in mm Hg):
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (bpm):
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PHYSICAL MEASUREMENTS
Beskrivning

PHYSICAL MEASUREMENTS

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

Date of measurement

Datatyp

date

Alias
UMLS CUI-1
C0011008
Height:
Beskrivning

Height

Datatyp

float

Alias
UMLS CUI-1
C0005890
Weight:
Beskrivning

Weight

Datatyp

float

Alias
UMLS CUI-1
C0005910
Performance status (ECOG):
Beskrivning

PERFORMANCE STATUS (ECOG)

Datatyp

text

PREGNANCY TEST
Beskrivning

PREGNANCY TEST

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

WAs A PREGNANCY TEST PERFORMED ?

Datatyp

boolean

Alias
UMLS CUI-1
C0032976
If "No", specify reason:
Beskrivning

IF NO, SPECIFY REASON

Datatyp

text

Alias
UMLS CUI-1
C0392360
If "Yes", specify test:
Beskrivning

If "Yes", specify test

Datatyp

text

Alias
UMLS CUI-1
C0032976
Test result:
Beskrivning

Test result

Datatyp

text

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0884358
UMLS CUI-3
C0032961
UMLS CUI-4
C0332281
UMLS CUI-5
C0449438
Date of test:
Beskrivning

DATE OF TEST

Datatyp

date

Alias
UMLS CUI-1
C0011008
PHYSICAL EXAMINATION
Beskrivning

PHYSICAL EXAMINATION

Alias
UMLS CUI-1
C0031809
Date of examination:
Beskrivning

Date of examination

Datatyp

date

Alias
UMLS CUI-1
C0011008
General appearance:
Beskrivning

General appearance

Datatyp

text

Alias
UMLS CUI-1
C1148438
Head, eyes, ears, nose, throat:
Beskrivning

HEAD, EYES, EARS, NOSE, THROA T

Datatyp

text

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C0031809
UMLS CUI-3
C0449438
Neck:
Beskrivning

NECK

Datatyp

text

Alias
UMLS CUI-1
C0027530
Cardiovascular:
Beskrivning

Cardiovascular

Datatyp

text

Alias
UMLS CUI-1
C0007226
Lungs:
Beskrivning

LUNGS

Datatyp

text

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C0031809
UMLS CUI-3
C0024109
UMLS CUI-4
C0449438
Abdomen:
Beskrivning

ABDOMEN

Datatyp

text

Alias
UMLS CUI-1
C0000726
Lymph nodes:
Beskrivning

LYMPH NODES

Datatyp

text

Alias
UMLS CUI-1
C0024204
Genitourinary:
Beskrivning

GENITOURINARY

Datatyp

text

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C0031809
UMLS CUI-3
C2709259
UMLS CUI-4
C0449438
Extremities:
Beskrivning

EXTREMITIES

Datatyp

text

Alias
UMLS CUI-1
C0015385
Neurological:
Beskrivning

NEUROLOGICAL

Datatyp

text

Alias
UMLS CUI-1
C0027763
Skin:
Beskrivning

SKIN

Datatyp

text

Alias
UMLS CUI-1
C1123023
Musculoskeletal:
Beskrivning

Musculoskeletal

Datatyp

text

Alias
UMLS CUI-1
C0026860
Others:
Beskrivning

OTHER

Datatyp

text

Alias
UMLS CUI-1
C0205394
For systems with "Abnormal" as result, please specify:
Beskrivning

For systems with "Abnormal" as result, please specify

Datatyp

text

Alias
UMLS CUI-1
C2348235
ELECTROCARDIOGRAM
Beskrivning

ELECTROCARDIOGRAM

Alias
UMLS CUI-1
C1623258
Date and time of ECG:
Beskrivning

DATE OF ECG

Datatyp

datetime

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

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
QRS width (sec):
Beskrivning

QRS WIDTH

Datatyp

float

Måttenheter
  • sec
Alias
UMLS CUI [1]
C0520880
sec
Bazett's QTc (msec):
Beskrivning

QTc

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
PR interval (sec):
Beskrivning

PR INTERVAL

Datatyp

float

Måttenheter
  • sec
Alias
UMLS CUI [1]
C0429087
sec
Fridericia's QTc (msec):
Beskrivning

FRIDERICIA'S QTc

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
QT Interval (sec):
Beskrivning

QT INTERVAL

Datatyp

float

Måttenheter
  • sec
Alias
UMLS CUI [1]
C0429028
sec
Interpretation of ECG tracing:
Beskrivning

INTERPRETATION OF ECG TRACING

Datatyp

text

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0459471
Any Hypertrophy, when ECG interpretation abnormal?
Beskrivning

HYPERTROPHY

Datatyp

text

Alias
UMLS CUI-1
C1383860
If ECG interpretation abnormal, any infarction?
Beskrivning

INFARCTION

Datatyp

text

If ECG interpretation abnormal, any ST/ T Morphology?
Beskrivning

ST/T MORPHOLOGY

Datatyp

text

If ECG interpretation abnormal, any rhythm abnormalities?
Beskrivning

RHYTHM

Datatyp

text

If ECG interpretation abnormal, any conduction abnormalities?
Beskrivning

CONDUCTION

Datatyp

text

Other abnormalities:
Beskrivning

OTHER ABNORMALITIES

Datatyp

text

Alias
UMLS CUI-1
C0205394

Similar models

Medical tests and examinations

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
DATE
Item
Date:
date
C0011008 (UMLS CUI-1)
Item
Position:
text
C0733755 (UMLS CUI-1)
Code List
Position:
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
BLOOD PRESSURE SYSTOLIC
Item
Systolic blood pressure (in mm Hg):
integer
C0871470 (UMLS CUI [1])
BLOOD PRESSURE DIASTOLIC
Item
Diastolic blood pressure (in mm Hg):
integer
C0428883 (UMLS CUI [1])
HEART RATE
Item
Heart rate (bpm):
integer
C0018810 (UMLS CUI [1])
Item Group
PHYSICAL MEASUREMENTS
C0205485 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
DATE
Item
Date of measurement:
date
C0011008 (UMLS CUI-1)
Height
Item
Height:
float
C0005890 (UMLS CUI-1)
Weight
Item
Weight:
float
C0005910 (UMLS CUI-1)
PERFORMANCE STATUS (ECOG)
Item
Performance status (ECOG):
text
Item Group
PREGNANCY TEST
C0032976 (UMLS CUI-1)
PREGNANCY TEST
Item
Was a pregnancy test performed?
boolean
C0032976 (UMLS CUI-1)
Item
If "No", specify reason:
text
C0392360 (UMLS CUI-1)
Code List
If "No", specify reason:
CL Item
Post- Menopausal (1)
CL Item
Surgically sterile (2)
CL Item
Male (3)
CL Item
Pre- Menarche (4)
Item
If "Yes", specify test:
text
C0032976 (UMLS CUI-1)
Code List
If "Yes", specify test:
CL Item
Urine HCG (1)
CL Item
Serum HCG (2)
Item
Test result:
text
C0087111 (UMLS CUI-1)
C0884358 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
C0449438 (UMLS CUI-5)
Code List
Test result:
CL Item
Positive (1)
CL Item
Negative (2)
DATE
Item
Date of test:
date
C0011008 (UMLS CUI-1)
Item Group
PHYSICAL EXAMINATION
C0031809 (UMLS CUI-1)
DATE
Item
Date of examination:
date
C0011008 (UMLS CUI-1)
Item
General appearance:
text
C1148438 (UMLS CUI-1)
Code List
General appearance:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Head, eyes, ears, nose, throat:
text
C0030705 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
Code List
Head, eyes, ears, nose, throat:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Neck:
text
C0027530 (UMLS CUI-1)
Code List
Neck:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Cardiovascular:
text
C0007226 (UMLS CUI-1)
Code List
Cardiovascular:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Lungs:
text
C0030705 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0024109 (UMLS CUI-3)
C0449438 (UMLS CUI-4)
Code List
Lungs:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Abdomen:
text
C0000726 (UMLS CUI-1)
Code List
Abdomen:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Lymph nodes:
text
C0024204 (UMLS CUI-1)
Code List
Lymph nodes:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Genitourinary:
text
C0030705 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C2709259 (UMLS CUI-3)
C0449438 (UMLS CUI-4)
Code List
Genitourinary:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Extremities:
text
C0015385 (UMLS CUI-1)
Code List
Extremities:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Neurological:
text
C0027763 (UMLS CUI-1)
Code List
Neurological:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Skin:
text
C1123023 (UMLS CUI-1)
Code List
Skin:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Musculoskeletal:
text
C0026860 (UMLS CUI-1)
Code List
Musculoskeletal:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Item
Others:
text
C0205394 (UMLS CUI-1)
Code List
Others:
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Specification
Item
For systems with "Abnormal" as result, please specify:
text
C2348235 (UMLS CUI-1)
Item Group
ELECTROCARDIOGRAM
C1623258 (UMLS CUI-1)
DATE AND TIME
Item
Date and time of ECG:
datetime
C0011008 (UMLS CUI-1)
HEART RATE
Item
Heart rate (bpm):
integer
C0018810 (UMLS CUI [1])
QRS WIDTH
Item
QRS width (sec):
float
C0520880 (UMLS CUI [1])
QTc
Item
Bazett's QTc (msec):
float
C0489625 (UMLS CUI [1])
PR INTERVAL
Item
PR interval (sec):
float
C0429087 (UMLS CUI [1])
QTc
Item
Fridericia's QTc (msec):
float
C0489625 (UMLS CUI [1])
QT INTERVAL
Item
QT Interval (sec):
float
C0429028 (UMLS CUI [1])
Item
Interpretation of ECG tracing:
text
C1623258 (UMLS CUI-1)
C0459471 (UMLS CUI-2)
Code List
Interpretation of ECG tracing:
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Any Hypertrophy, when ECG interpretation abnormal?
text
C1383860 (UMLS CUI-1)
Code List
Any Hypertrophy, when ECG interpretation abnormal?
CL Item
Left atrial hypertrophy (1)
CL Item
Right atrial hypertrophy (2)
CL Item
Left ventricular hypertrophy (3)
CL Item
Right ventricular hypertrophy (4)
Item
If ECG interpretation abnormal, any infarction?
text
Code List
If ECG interpretation abnormal, any infarction?
CL Item
Acute (1)
CL Item
Subacute (recent) (2)
CL Item
Old (3)
Item
If ECG interpretation abnormal, any ST/ T Morphology?
text
Code List
If ECG interpretation abnormal, any ST/ T Morphology?
CL Item
Myocardial ischemia (1)
CL Item
Digitalis effect (2)
CL Item
Symmetrical T-wave inversions (3)
CL Item
Other non-specific ST/ T (4)
Item
If ECG interpretation abnormal, any rhythm abnormalities?
text
Code List
If ECG interpretation abnormal, any rhythm abnormalities?
CL Item
Sinus tachycardia (1)
CL Item
Sinus bradycardia (2)
CL Item
Supraventricular premature beat (3)
CL Item
Supraventricular tachycardia (4)
CL Item
Atrial fibrillation (5)
CL Item
Atrial flutter (6)
CL Item
Ventricular premature beat (7)
CL Item
Ventricular tachycardia (8)
CL Item
Ventricular fibrillation (9)
CL Item
Torsade de pointes (10)
CL Item
Other rhythm abnormalities (11)
CL Item
Pacemaker rhythm (12)
Item
If ECG interpretation abnormal, any conduction abnormalities?
text
Code List
If ECG interpretation abnormal, any conduction abnormalities?
CL Item
1° A-V Block (1)
CL Item
2° A-V Block (2)
CL Item
3° A-V Block (3)
CL Item
LBB Block (4)
CL Item
RBB Block (5)
CL Item
Other intraventricular conduction defect (6)
CL Item
Pre-excitation syndrom (7)
Item
Other abnormalities:
text
C0205394 (UMLS CUI-1)
Code List
Other abnormalities:
CL Item
Left axis deviation (1)
CL Item
Other (2)

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