ID

31497

Descripción

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram

Palabras clave

  1. 28/8/18 28/8/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

28 de agosto de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

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Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384

Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

Local Laboratory
Descripción

Local Laboratory

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C0205276
Date and time sample taken
Descripción

Specimen Collection; Date in time; Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Has the subject fasted?
Descripción

Fasting

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
Laboratory Test
Descripción

Laboratory Procedures

Tipo de datos

integer

Alias
UMLS CUI [1]
C0022885
If Laboratory Test was Clinical Chemistry, please specify.
Descripción

Chemistry, Clinical; Specification

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2348235
If Laboratory Test was Hematology, please specify.
Descripción

Hematology (discipline); Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0018943
UMLS CUI [1,2]
C2348235
Laboratory Test Result
Descripción

Laboratory test finding

Tipo de datos

text

Alias
UMLS CUI [1]
C0587081
Numeric Test result
Descripción

Numeric Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C2347373
Character Test result
Descripción

Laboratory test finding; Data Type -Character

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C2350015
Local Urinalysis
Descripción

Local Urinalysis

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0205276
Date and time sample taken
Descripción

Date in time; Time; Specimen Collection

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Result of dipstick
Descripción

Urine dipstick test; Laboratory test finding

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0587081
If result of dipstick was positive, was sedimentary microscopy performed?
Descripción

If yes, provide details of repeated tests in the add entry section below.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C1446409
UMLS CUI [2,1]
C0430397
UMLS CUI [2,2]
C2700128
Laboratory Test
Descripción

Laboratory Procedures

Tipo de datos

integer

Alias
UMLS CUI [1]
C0022885
If Laboratory Test was Urine dipstick, please specify.
Descripción

Urine dipstick test; Specification

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C2348235
If Laboratory Test was microscopy, please specify.
Descripción

Microscopic urinalysis; Specification

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2348235
Laboratory Test Result
Descripción

Laboratory test finding

Tipo de datos

text

Alias
UMLS CUI [1]
C0587081
Numeric Test result
Descripción

Numeric Test Result

Tipo de datos

text

Alias
UMLS CUI [1]
C2347373
Character Test result
Descripción

Laboratory test finding; Data Type -Character

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C2350015
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/ time
Descripción

Date in time; Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
Blood pressure
Descripción

Blood Pressure

Tipo de datos

text

Alias
UMLS CUI [1]
C0005823
Blood pressure finding (systolic/ diastolic)
Descripción

Blood pressure finding

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C1271104
mmHg
Heart rate
Descripción

heart rate

Tipo de datos

text

Alias
UMLS CUI [1]
C0018810
Heart rate finding
Descripción

Finding of heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0577802
beats/min
Respiration rate
Descripción

Respiratory rate

Tipo de datos

text

Alias
UMLS CUI [1]
C0231832
Respiration rate finding
Descripción

Finding of rate of respiration

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0577970
breaths/min
12- Lead ECG
Descripción

12- Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Descripción

Electrocardiogram Collection Date Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Descripción

heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Descripción

Electrocardiogram: P-R interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Descripción

QRS complex duration (observable entity)

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Descripción

QT interval - finding

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc Interval
Descripción

qtc interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Descripción

qtc interval; Measurement method

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C1299991
Result of ECG
Descripción

EKG finding

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
ECG Abnormalities
Descripción

ECG Abnormalities

Alias
UMLS CUI-1
C0522055
Date and Time of ECG
Descripción

Electrocardiogram Collection Date Time

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826846
Record clinically significant abnormalities (check all that apply) Rhythm
Descripción

ECG abnormality; Clinically Significant Indicator | Cardiac rhythm type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2985739
UMLS CUI [2]
C0232187
If other abnormal rhythm, enter comment
Descripción

heart; rhythm abnormal (symptom); Other; Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1533266
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
Record clinically significant abnormalities (check all that apply) Morphology
Descripción

ECG abnormality; Clinically Significant Indicator | Morphology

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2985739
UMLS CUI [2]
C0332437
If other morphology, enter comment.
Descripción

Morphology; Other; Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
Record clinically significant abnormalities (check all that apply) Conduction
Descripción

Abnormal cardiac conduction; Clinically Significant Indicator

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C2985739
If other conduction, enter comment.
Descripción

Abnormal cardiac conduction; Other; Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
Record clinically significant abnormalities (check all that apply) Myocardial infarction
Descripción

ECG abnormality; Clinically Significant Indicator | Myocardial Infarction

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2985739
UMLS CUI [2]
C0027051
If other myocardial infarction, enter comment.
Descripción

Myocardial Infarction; Other; Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
Record clinically significant abnormalities (check all that apply) Depolarisation/ Repolarisation
Descripción

Electrocardiogram repolarisation abnormality; Clinically Significant Indicator

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C2985739
If other depolarisation/ repolarisation, enter comment.
Descripción

Electrocardiogram repolarisation abnormality; Other; Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
Other abnormalities
Descripción

Electrocardiogram abnormal; C0205394 Other

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
If other abnormalities, enter comment
Descripción

Electrocardiogram abnormal; Other; Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
Pharmacokinetics Blood
Descripción

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Actual date/ time
Descripción

Date in time; Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
Summary Holter- 12- Lead
Descripción

Summary Holter- 12- Lead

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0013801
UMLS CUI-3
C0242482
Start Date and Time of Holter
Descripción

Holter Electrocardiography; Start Date and Time of Procedure

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3897500
Stop Date and Time of Holter
Descripción

Holter Electrocardiography; End Date and Time of Procedure

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3899266
Interpretation of Holter
Descripción

Holter Electrocardiography; EKG finding

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0438154
Summary Holter Abnormalities
Descripción

Summary Holter Abnormalities

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0522055
UMLS CUI-3
C0242482
Start Date and Time of Holter
Descripción

Holter Electrocardiography; Start Date and Time of Procedure

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3897500
Stop Date and Time of Holter
Descripción

Holter Electrocardiography; End Date and Time of Procedure

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3899266
Record clinically significant abnormalities below. Check all that apply.
Descripción

Holter Electrocardiography; Electrocardiogram abnormal; Clinically Significant Indicator

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0522055
UMLS CUI [1,3]
C2985739
If other abnormal heart rhythm, please specify.
Descripción

heart; rhythm abnormal (symptom); Other; Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1533266
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
If other ECG morphology, please specify.
Descripción

Electrocardiography; Morphology; Other; Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0332437
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
If other cardiac conduction, please specify.
Descripción

Abnormal cardiac conduction; Other; Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
If other myocardial infarction, please specify.
Descripción

Myocardial Infarction; Other; Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
If other cardiac depolarisation/ repolarisation, please specify.
Descripción

Electrocardiogram repolarisation abnormality; Other; Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0948857
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
If other ECG abnormality, please specify / Cardiologist comments
Descripción

ECG abnormality; Other; Specification | Cardiologists; Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
UMLS CUI [2,1]
C0175906
UMLS CUI [2,2]
C0947611

Similar models

Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Local Laboratory
C0022877 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Specimen Collection; Date in time; Time
Item
Date and time sample taken
datetime
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Laboratory Test
integer
C0022885 (UMLS CUI [1])
Code List
Laboratory Test
CL Item
Clinical Chemistry (98)
CL Item
Haematology (99)
Item
If Laboratory Test was Clinical Chemistry, please specify.
integer
C0008000 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If Laboratory Test was Clinical Chemistry, please specify.
CL Item
Albumin (1)
CL Item
Alkaline Phosphatase (2)
CL Item
ALT (3)
CL Item
AST (4)
CL Item
Chloride (5)
CL Item
Creatinine (6)
CL Item
GGT (7)
CL Item
Glucose, fasting (8)
CL Item
Potassium (9)
CL Item
Sodium (10)
CL Item
Total Bilirubin (11)
CL Item
Direct Bilirubin (12)
CL Item
Total Protein (13)
CL Item
Uric Acid (14)
CL Item
BUN (15)
CL Item
Calcium (16)
CL Item
Total CO2 (17)
CL Item
Creatine Phosphokinase (18)
Item
If Laboratory Test was Hematology, please specify.
text
C0018943 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If Laboratory Test was Hematology, please specify.
CL Item
Basophils (1)
CL Item
Eosinophils (2)
CL Item
Haemoglobin (3)
CL Item
Lymphocytes (4)
CL Item
Monocytes (5)
CL Item
Neutrophils (6)
CL Item
Platelets (7)
CL Item
RBC (8)
CL Item
WBC (9)
CL Item
MCH (10)
CL Item
MCHC (11)
CL Item
MCV (12)
CL Item
Reticulocyte (13)
Item
Laboratory Test Result
text
C0587081 (UMLS CUI [1])
Code List
Laboratory Test Result
CL Item
Numeric result (97)
CL Item
Character result (98)
CL Item
No result (99)
Numeric Test Result
Item
Numeric Test result
text
C2347373 (UMLS CUI [1])
Laboratory test finding; Data Type -Character
Item
Character Test result
text
C0587081 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item Group
Local Urinalysis
C0042014 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Date in time; Time; Specimen Collection
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
CL Item
No result (NR)
CL Item
Negative (NEG)
CL Item
Positive (POS)
Urine dipstick test; Positive | Microscopic urinalysis; Urine Sediment Analysis Measurement
Item
If result of dipstick was positive, was sedimentary microscopy performed?
boolean
C0430370 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0430397 (UMLS CUI [2,1])
C2700128 (UMLS CUI [2,2])
Item
Laboratory Test
integer
C0022885 (UMLS CUI [1])
Code List
Laboratory Test
CL Item
Urine dipstick (98)
CL Item
Urine microscopy (99)
Item
If Laboratory Test was Urine dipstick, please specify.
integer
C0430370 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If Laboratory Test was Urine dipstick, please specify.
CL Item
Protein (1)
CL Item
Glucose (2)
CL Item
Ketones (3)
CL Item
Blood (4)
CL Item
pH (5)
CL Item
Specific Gravity (6)
Item
If Laboratory Test was microscopy, please specify.
integer
C0430397 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If Laboratory Test was microscopy, please specify.
CL Item
White blood cells (1)
CL Item
Red blood cells (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Item
Laboratory Test Result
text
C0587081 (UMLS CUI [1])
Code List
Laboratory Test Result
CL Item
Numeric result (97)
CL Item
Character result  (98)
CL Item
No result (99)
Numeric Test Result
Item
Numeric Test result
text
C2347373 (UMLS CUI [1])
Laboratory test finding; Data Type -Character
Item
Character Test result
text
C0587081 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date in time; Time
Item
Actual date/ time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Blood pressure
text
C0005823 (UMLS CUI [1])
Code List
Blood pressure
CL Item
Not done (ND)
CL Item
Done (Y)
Blood pressure finding
Item
Blood pressure finding (systolic/ diastolic)
text
C1271104 (UMLS CUI [1])
Item
Heart rate
text
C0018810 (UMLS CUI [1])
Code List
Heart rate
CL Item
Not done (ND)
CL Item
Done (Y)
Finding of heart rate
Item
Heart rate finding
integer
C0577802 (UMLS CUI [1])
Item
Respiration rate
text
C0231832 (UMLS CUI [1])
Code List
Respiration rate
CL Item
Not done (ND)
CL Item
Done (Y)
Finding of rate of respiration
Item
Respiration rate finding
integer
C0577970 (UMLS CUI [1])
Item Group
12- Lead ECG
C0430456 (UMLS CUI-1)
Electrocardiogram Collection Date Time
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
qtc interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0489625 (UMLS CUI [1,1])
C1299991 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionaly complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
ECG Abnormalities
C0522055 (UMLS CUI-1)
Electrocardiogram Collection Date Time
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Item
Record clinically significant abnormalities (check all that apply) Rhythm
integer
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0232187 (UMLS CUI [2])
Code List
Record clinically significant abnormalities (check all that apply) Rhythm
CL Item
Sinus bradyycardia (1)
CL Item
Sinus bradycadia (heart rate 40- 50 beats/min) (21)
CL Item
Sinus bradycadia (heart rate 30- 39 beats/min) (22)
CL Item
Sinus bradycadia (heart rate <30 beats/min) (23)
CL Item
Sinus pause (3)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (2)
CL Item
Ectopic supraventricular beats (4)
CL Item
Ectopic supraventricular rhythm (20)
CL Item
Wandering atrial pacemaker (17)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (26)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (6)
CL Item
Atrial flutter (7)
CL Item
Atrial fibrillation (8)
CL Item
Junctional rhythm (heart rate <= 100 beats/min) (9)
CL Item
Junctional rhythm (25)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (24)
CL Item
Ectopic ventricular beats (9)
CL Item
Ventricular cpouplets (12)
CL Item
Bigeminy (13)
CL Item
Tigeminy (28)
CL Item
Electral alterans (14)
CL Item
R on T phenomenon (29)
CL Item
Ventricular fibrillation (18)
CL Item
Idioventricular rhythm (19)
CL Item
Sustained ventricular tachycardia (10)
CL Item
Non- sustained ventricular tachycardia (11)
CL Item
Wide QRS tachycardia (diagnosis unknown) (32)
CL Item
Ventricular tachycardia (27)
CL Item
Monomorphic ventricular tachycardia (30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (15)
CL Item
Polymorphic (sustained and non- sustained) ventricular tachycardia (31)
CL Item
Artificial Pacemaker (16)
CL Item
Other abnormal rhythm, enter comment (99)
heart; rhythm abnormal (symptom); Other; Comment
Item
If other abnormal rhythm, enter comment
text
C1533266 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities (check all that apply) Morphology
integer
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0332437 (UMLS CUI [2])
Code List
Record clinically significant abnormalities (check all that apply) Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (14)
CL Item
Other morphology, enter comment (99)
Morphology; Other; Comment
Item
If other morphology, enter comment.
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities (check all that apply) Conduction
integer
C0232219 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Code List
Record clinically significant abnormalities (check all that apply) Conduction
CL Item
First degree AV block (PR interval >200msec) (1)
CL Item
Short PR interval (20)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (16)
CL Item
Thrid degree AV block (4)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (5)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (6)
CL Item
Incomplete right bundle branch block (7)
CL Item
Incomplete left bundle branch block (13)
CL Item
Right bundle branch block (8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (15)
CL Item
Left bundle branch block (9)
CL Item
Bifascicular block (17)
CL Item
Non- specific intraventricular conduction delay (QRS>= 120msec) (10)
CL Item
Accessory pathway (Wollf- Parkinson Wite, Lown- Ganong- Levine) (11)
CL Item
Prolonged QT interval (19)
CL Item
QT/ QTc prolongation >= 500msec (12)
CL Item
AV dissociation (18)
CL Item
Other conduction, enter comment (99)
Abnormal cardiac conduction; Other; Comment
Item
If other conduction, enter comment.
text
C0232219 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities (check all that apply) Myocardial infarction
integer
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Code List
Record clinically significant abnormalities (check all that apply) Myocardial infarction
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non Q-wave (20)
CL Item
Other myocardial infarction, enter comment (99)
Myocardial Infarction; Other; Comment
Item
If other myocardial infarction, enter comment.
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities (check all that apply) Depolarisation/ Repolarisation
integer
C0948857 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Code List
Record clinically significant abnormalities (check all that apply) Depolarisation/ Repolarisation
CL Item
Non-specific ST-T changes (7)
CL Item
J point elevation (19)
CL Item
ST elevation (8)
CL Item
ST- elevation- pericarditis (21)
CL Item
ST depression (9)
CL Item
U waves abnormal (10)
CL Item
T wave inversion (11)
CL Item
T wave peaked (12)
CL Item
T waves flat (15)
CL Item
T waves biphasic (16)
CL Item
Notched T- waves (18)
CL Item
Low QRS voltage (13)
CL Item
T- wave flattering/ inversion (17)
CL Item
Other depolarisation/ repolarisation, enter comment (99)
Electrocardiogram repolarisation abnormality; Other; Comment
Item
If other depolarisation/ repolarisation, enter comment.
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Other abnormalities
integer
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Code List
Other abnormalities
CL Item
Yes (99)
Electrocardiogram abnormal; Other; Comment
Item
If other abnormalities, enter comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Pharmacokinetics Blood
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Date in time; Time
Item
Actual date/ time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Summary Holter- 12- Lead
C0430456 (UMLS CUI-1)
C0013801 (UMLS CUI-2)
C0242482 (UMLS CUI-3)
Holter Electrocardiography; Start Date and Time of Procedure
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Holter Electrocardiography; End Date and Time of Procedure
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item Group
Summary Holter Abnormalities
C0013801 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0242482 (UMLS CUI-3)
Holter Electrocardiography; Start Date and Time of Procedure
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3897500 (UMLS CUI [1,2])
Holter Electrocardiography; End Date and Time of Procedure
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C3899266 (UMLS CUI [1,2])
Item
Record clinically significant abnormalities below. Check all that apply.
integer
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Code List
Record clinically significant abnormalities below. Check all that apply.
CL Item
No abnormalities (0)
CL Item
Sinus bradycardia (50- 59 beats/min) (1)
CL Item
Sinus bradycardia (40- 49 beats/min) (2)
CL Item
Sinus bradycardia (30- 39 beats/min) (3)
CL Item
Sinus bradycardia (<30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (>100 beats/min) (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
Wandering atrial pacemaker (9)
CL Item
Multifocal atrial tachycaria (wandering atrial pacemaker w/rate >100 beats/min) (10)
CL Item
Non- sustained supraventricular tachycardia (>100beats/min, >30 beats) (11)
CL Item
Sustained supraventricular tachycardia (>100beats/min, >30 beats) (12)
CL Item
Atrial flutter (13)
CL Item
Atrial fibrillation (14)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (15)
CL Item
Junctional tachycardia (>100 beats/min) (16)
CL Item
Ventricular premature depolarisation (17)
CL Item
Ventricular couplets (18)
CL Item
Bigeminy (19)
CL Item
Trigeminy (20)
CL Item
Electrical alterrans (21)
CL Item
R on T phenomenon (22)
CL Item
Ventricular fibrillation (23)
CL Item
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (24)
CL Item
Non- sustained ventricular tachycardia (>100 beats/min, 3- 30 beats) (25)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (26)
CL Item
Wide QRS tachycardia (diagnosis unknown) (27)
CL Item
Monomorphic non- sustained ventricular tachycardia (>100 beats/min, 3- 30 beats) (28)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (29)
CL Item
Polymorphic non- sustained ventricular tachycardia (>100 beats/min, 3- 30 beats) (30)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (31)
CL Item
Torsade de Pointes (TdP) (32)
CL Item
Pacemaker (33)
CL Item
First degree AV block (PR Interval >200msec) (34)
CL Item
Short PR Interval (35)
CL Item
Second degree AV block (Mobitz type 1) (36)
CL Item
Second degree AV block (Mobitz type 2) (37)
CL Item
2:1 AV blovk (38)
CL Item
Third degree AV block (39)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (40)
CL Item
Right axis deviation (QRS axis mor positive than +110 degreees) (41)
CL Item
Incomplete right bundle branch block (42)
CL Item
Incomplete left bundle branch block (43)
CL Item
Right bundle branc block (44)
CL Item
Left anterior hemiblock (45)
CL Item
Left posterior hemiblock (46)
CL Item
Left bundle branch block (47)
CL Item
Bifascicular block (48)
CL Item
Non- specific intraventircular conduction delay (QRS >= 120msec) (49)
CL Item
Accessory pahway (Wollf- Parkinson- White, Lown- Ganong- Levine) (50)
CL Item
QTc prolongation >= 500 msec (51)
CL Item
AV dissociation (52)
CL Item
Myocardial infarction, old (53)
CL Item
Myocardial infarction, non- Q- wave (54)
CL Item
Non- specific ST-T changes (55)
CL Item
J point elevation (56)
CL Item
ST elevation (57)
CL Item
ST depression (58)
CL Item
ST segment abnormality (59)
CL Item
U waves (60)
CL Item
T wave inversion (61)
CL Item
T wave peaked (62)
CL Item
T waves biphasic (63)
CL Item
T waves flat (64)
CL Item
Notched T- waves (65)
CL Item
Low QRS voltage (66)
CL Item
T wave abnormality (67)
CL Item
Other abnormal rhythm (94)
CL Item
Other morphology (95)
CL Item
Other conduction (96)
CL Item
Other myocardial infarction (97)
CL Item
Other depolarisation/ repolarisation (98)
CL Item
Other abnormality/ Cardiologist comments (99)
heart; rhythm abnormal (symptom); Other; Specification
Item
If other abnormal heart rhythm, please specify.
text
C1533266 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Electrocardiography; Morphology; Other; Specification
Item
If other ECG morphology, please specify.
text
C1623258 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Abnormal cardiac conduction; Other; Specification
Item
If other cardiac conduction, please specify.
text
C0232219 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Myocardial Infarction; Other; Specification
Item
If other myocardial infarction, please specify.
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Electrocardiogram repolarisation abnormality; Other; Specification
Item
If other cardiac depolarisation/ repolarisation, please specify.
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
ECG abnormality; Other; Specification | Cardiologists; Comment
Item
If other ECG abnormality, please specify / Cardiologist comments
text
C1832603 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])

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