ID

26890

Beschreibung

Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome Documentation part: Unscheduled

Stichworte

Versionen (1)
  1. 27.10.17 27.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

27. Oktober 2017

DOI

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Pharmacokinetics of a new unmarketed formulation of ropinirole Unscheduled 101468/199

Englisch

Unscheduled

1 Formulare  
  1. StudyEvent: ODM
    1. Unscheduled
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0244821
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product
Beschreibung

Investigational Product

Datentyp

integer

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0304229
Date of Dose of Ropinirole
Beschreibung

Date of Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose of Ropinirole
Beschreibung

Time of Dose

Datentyp

time

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Dose of Ropinirole
Beschreibung

Dose

Datentyp

float

Maßeinheiten
  • mg/day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0244821
mg/day
Units of Ropinirole
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0244821
Route of Administration of Ropinirole
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0244821
12-lead ECG
Beschreibung

12-lead ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1623258
UMLS CUI-3
C0031809
Start Date of ECG
Beschreibung

Start Date of ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time ECG
Beschreibung

Planned Relative Time ECG

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Time of ECG
Beschreibung

Start Time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Beschreibung

Ventricular Rate

Datentyp

integer

Maßeinheiten
  • Beats/min
Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc Interval
Beschreibung

QTc Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
ECG Abnormalities
Beschreibung

ECG Abnormalities

Alias
UMLS CUI-1
C0522055
UMLS CUI-2
C0430456
Start Date of ECG
Beschreibung

Start Date of ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Beschreibung

Start Time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Rhythm Abnormalities
Beschreibung

Record clinically significant abnormalities below. Check all that apply:

Datentyp

integer

Alias
UMLS CUI [1,1]
C0199556
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0430456
Rhythm Abnormalities, if Other please specify
Beschreibung

Rhythm Abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0199556
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0430456
P-Wave and QRS Morphology Abnormalities
Beschreibung

Record clinically significant abnormalities below. Check all that apply:

Datentyp

integer

Alias
UMLS CUI [1]
C2216025
UMLS CUI [2]
C0429098
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0430456
P-Wave and QRS Morphology Abnormalities, if Other please specify
Beschreibung

P-Wave and QRS Morphology Abnormalities

Datentyp

text

Alias
UMLS CUI [1]
C2216025
UMLS CUI [2]
C0429098
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0430456
Conduction Abnormalities
Beschreibung

Conduction Abnormalities

Datentyp

integer

Alias
UMLS CUI [1]
C0232219
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0430456
Conduction Abnormalities, if Other please specify
Beschreibung

Conduction Abnormalities

Datentyp

text

Alias
UMLS CUI [1]
C0232219
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0430456
Myocardial Infarction
Beschreibung

Myocardial Infarction

Datentyp

integer

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0430456
Myocardial Infarction, if Other please specify
Beschreibung

Myocardial Infarction

Datentyp

text

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0430456
Depolarisation/Repolarisation (QRS-T) Abnormalities
Beschreibung

Repolarisation Abnormalities

Datentyp

integer

Alias
UMLS CUI [1]
C0948857
Depolarisation/Repolarisation (QRS-T) Abnormalities, if Other please specify
Beschreibung

Repolarisation Abnormalities

Datentyp

text

Alias
UMLS CUI [1]
C0948857
Other ECG Abnormalities
Beschreibung

Other ECG Abnormalities

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0430456
Other ECG Abnormalities, please specify
Beschreibung

Other ECG Abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0430456
Laboratory Result Data Haematology
Beschreibung

Laboratory Result Data Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Time sample taken
Beschreibung

Time sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Has the subject fasted?
Beschreibung

fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
haemoglobin
Beschreibung

haemoglobin

Datentyp

float

Maßeinheiten
  • g/L
Alias
UMLS CUI [1]
C0518015
g/L
haematocrit
Beschreibung

haematocrit

Datentyp

float

Alias
UMLS CUI [1]
C0018935
red blood cell count
Beschreibung

red blood cell

Datentyp

float

Maßeinheiten
  • 10*6/uL
Alias
UMLS CUI [1]
C0014772
10*6/uL
WBC (White Blood Cell count)
Beschreibung

WBC

Datentyp

float

Alias
UMLS CUI [1]
C0023508
platelet count
Beschreibung

platelet count

Datentyp

float

Maßeinheiten
  • 10*3/uL
Alias
UMLS CUI [1]
C0005821
10*3/uL
Differential WBC count
Beschreibung

Differential WBC count

Datentyp

float

Alias
UMLS CUI [1]
C0162401
Mean cell haemoglobin (MCH)
Beschreibung

Mean cell haemoglobin (MCH)

Datentyp

float

Alias
UMLS CUI [1]
C0369183
Mean cell haemoglobin concentration (MCHC)
Beschreibung

Mean cell haemoglobin concentration (MCHC)

Datentyp

float

Alias
UMLS CUI [1]
C0474535
Laboratory Result Data Clinical Chemistry
Beschreibung

Laboratory Result Data Clinical Chemistry

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
UMLS CUI-3
C0587081
Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Time sample taken
Beschreibung

Time sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Has the subject fasted?
Beschreibung

fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
Sodium
Beschreibung

Sodium

Datentyp

float

Alias
UMLS CUI [1]
C0337443
Potassium
Beschreibung

Potassium

Datentyp

float

Alias
UMLS CUI [1]
C0202194
Urea
Beschreibung

Urea

Datentyp

float

Alias
UMLS CUI [1]
C0523961
Creatinine
Beschreibung

Creatinine

Datentyp

float

Alias
UMLS CUI [1]
C0201976
Total Protein
Beschreibung

Total Protein

Datentyp

float

Alias
UMLS CUI [1]
C0555903
Albumin
Beschreibung

Albumin

Datentyp

float

Alias
UMLS CUI [1]
C0201838
Albumin/globulin ratio
Beschreibung

Albumin/globulin ratio

Datentyp

float

Alias
UMLS CUI [1]
C0201837
Total bilirubin
Beschreibung

Total bilirubin

Datentyp

float

Alias
UMLS CUI [1]
C0201913
AST (SGOT)
Beschreibung

AST (SGOT)

Datentyp

float

Alias
UMLS CUI [1]
C0201899
ALT (SGPT)
Beschreibung

ALT (SGPT)

Datentyp

float

Alias
UMLS CUI [1]
C0201836
Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

float

Alias
UMLS CUI [1]
C0201850
Alkaline phosphatase (AP)
Beschreibung

Alkaline phosphatase (AP)

Datentyp

float

Alias
UMLS CUI [1]
C0201850
Gamma glutamyl transferase (GGT)
Beschreibung

Gamma glutamyl transferase (GGT)

Datentyp

float

Alias
UMLS CUI [1]
C0202035
Calcium
Beschreibung

Calcium

Datentyp

float

Alias
UMLS CUI [1]
C0201925
Phosphate
Beschreibung

Phosphate

Datentyp

float

Alias
UMLS CUI [1]
C0523826
Cholesterol
Beschreibung

Cholesterol

Datentyp

float

Alias
UMLS CUI [1]
C1445957
Triglycerides
Beschreibung

Triglycerides

Datentyp

float

Alias
UMLS CUI [1]
C0202236
Glucose
Beschreibung

Glucose

Datentyp

float

Alias
UMLS CUI [1]
C0202042
Creatine phosphokinase
Beschreibung

Creatine phosphokinase

Datentyp

float

Alias
UMLS CUI [1]
C0201973
Iron
Beschreibung

Iron

Datentyp

float

Alias
UMLS CUI [1]
C0337439
Total Iron Binding Capacity
Beschreibung

Total Iron Binding Capacity

Datentyp

float

Alias
UMLS CUI [1]
C1283048
Ferritin
Beschreibung

Ferritin

Datentyp

float

Alias
UMLS CUI [1]
C0015879
Transferrin
Beschreibung

Transferrin

Datentyp

float

Alias
UMLS CUI [1]
C0202105
Chloride
Beschreibung

Chloride

Datentyp

float

Alias
UMLS CUI [1]
C0201952
FSH/LH
Beschreibung

(females only)

Datentyp

float

Alias
UMLS CUI [1,1]
C2122182
UMLS CUI [1,2]
C1254595
Urinalysis, Dipstick Test
Beschreibung

Urinalysis, Dipstick Test

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C0022885
Urine sample date
Beschreibung

Urine sample date

Datentyp

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
Urine sample time
Beschreibung

Urine sample time

Datentyp

time

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0040223
Result of dipstick
Beschreibung

Result of dipstick

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0587081
Urine Dipstick: Proteins
Beschreibung

Urine Dipstick: Proteins

Datentyp

integer

Alias
UMLS CUI [1,1]
C0428541
UMLS CUI [1,2]
C0430370
Urine Dipstick: Glucose
Beschreibung

Urine Dipstick: Glucose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0004076
UMLS CUI [1,2]
C0430370
Urine Dipstick: pH
Beschreibung

Urine Dipstick: pH

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
Urine Dipstick: Bilirubin
Beschreibung

Urine Dipstick: Bilirubin

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430374
UMLS CUI [1,2]
C0430370
Urine Dipstick: Blood
Beschreibung

Urine Dipstick: Blood

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430372
UMLS CUI [1,2]
C0430370
Urine Dipstick: Specific gravity
Beschreibung

Urine Dipstick: Specific gravity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0202517
UMLS CUI [1,2]
C0430370
Was sedimentary microscopy performed?
Beschreibung

sedimentary microscopy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2700128
Urinalysis (Microscopy) Test: Casts
Beschreibung

casts

Datentyp

text

Alias
UMLS CUI [1,1]
C4048266
UMLS CUI [1,2]
C0430397
Urinalysis (Microscopy) Test: Cells
Beschreibung

Cells

Datentyp

text

Alias
UMLS CUI [1,1]
C0919738
UMLS CUI [1,2]
C0430397
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Ähnliche Modelle

Unscheduled

1 Formulare
  1. StudyEvent: ODM
    1. Unscheduled
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
C0244821 (UMLS CUI-2)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Investigational Product
integer
C0244821 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational Product
Code List
Investigational Product
CL Item
Ropinirole (1)
Date of Dose
Item
Date of Dose of Ropinirole
date
C0244821 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose of Ropinirole
time
C0244821 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Dose
Item
Dose of Ropinirole
float
C3174092 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
Units
Item
Units of Ropinirole
text
C1519795 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
Route
Item
Route of Administration of Ropinirole
text
C0013153 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Planned Relative Time ECG
Item
Planned Relative Time ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Item Group
ECG Abnormalities
C0522055 (UMLS CUI-1)
C0430456 (UMLS CUI-2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Rhythm Abnormalities
integer
C0199556 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Rhythm Abnormalities
Code List
Rhythm Abnormalities
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (1)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (2)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (3)
CL Item
Sinus pause (4)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (5)
CL Item
Ectopic supraventricular beats (6)
CL Item
Ectopic supraventricular rhythm (7)
CL Item
Wandering atrial pacemaker (8)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (9)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (10)
CL Item
Atrial flutter (11)
CL Item
Atrial fibrillation (12)
CL Item
unctional rhythm (heart rate ≤100 beats/min) (13)
CL Item
Junctional rhythm (14)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (15)
CL Item
Ectopic ventricular beats (16)
CL Item
Ventricular couplets (17)
CL Item
Bigeminy (18)
CL Item
Trigeminy (19)
CL Item
Electrical alternans (20)
CL Item
R on T phenomenon (21)
CL Item
Ventricular fibrillation (22)
CL Item
Idioventricular rhythm (heart rate < 100 beats/min) (23)
CL Item
Sustained ventricular tachycardia (24)
CL Item
Non-sustained ventricular tachycardia (25)
CL Item
Ventricular tachycardia (26)
CL Item
Monomorphic ventricular tachycardia (27)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (28)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (29)
CL Item
Artificial pacemaker (30)
CL Item
Other abnormal rhythm (31)
Rhythm Abnormalities
Item
Rhythm Abnormalities, if Other please specify
text
C0199556 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
Item
P-Wave and QRS Morphology Abnormalities
integer
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
P-Wave and QRS Morphology Abnormalities
Code List
P-Wave and QRS Morphology Abnormalities
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 (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology (6)
P-Wave and QRS Morphology Abnormalities
Item
P-Wave and QRS Morphology Abnormalities, if Other please specify
text
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0430456 (UMLS CUI [3,2])
Item
Conduction Abnormalities
integer
C0232219 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Conduction Abnormalities
Code List
Conduction Abnormalities
CL Item
First degree AV block (PR interval > 200 msec) (1)
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 (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30°) (6)
CL Item
Right axis deviation (QRS axis more positive than +110°) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch block (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec) (15)
CL Item
QT/QTc prolongation ≥ 500 msec (17)
CL Item
AV dissociation (18)
CL Item
Other conduction (19)
Conduction Abnormalities
Item
Conduction Abnormalities, if Other please specify
text
C0232219 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Item
Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Myocardial Infarction
Code List
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 (7)
CL Item
Other myocardial infarction (8)
Myocardial Infarction
Item
Myocardial Infarction, if Other please specify
text
C0027051 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Item
Depolarisation/Repolarisation (QRS-T) Abnormalities
integer
C0948857 (UMLS CUI [1])
Repolarisation Abnormalities
Code List
Depolarisation/Repolarisation (QRS-T) Abnormalities
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/inversion (13)
CL Item
Other depolarisation/repolarisation (14)
Repolarisation Abnormalities
Item
Depolarisation/Repolarisation (QRS-T) Abnormalities, if Other please specify
text
C0948857 (UMLS CUI [1])
Other ECG Abnormalities
Item
Other ECG Abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Other ECG Abnormalities
Item
Other ECG Abnormalities, please specify
text
C1704258 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item Group
Laboratory Result Data Haematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
haemoglobin
Item
haemoglobin
float
C0518015 (UMLS CUI [1])
haematocrit
Item
haematocrit
float
C0018935 (UMLS CUI [1])
red blood cell
Item
red blood cell count
float
C0014772 (UMLS CUI [1])
WBC
Item
WBC (White Blood Cell count)
float
C0023508 (UMLS CUI [1])
platelet count
Item
platelet count
float
C0005821 (UMLS CUI [1])
Differential WBC count
Item
Differential WBC count
float
C0162401 (UMLS CUI [1])
Mean cell haemoglobin (MCH)
Item
Mean cell haemoglobin (MCH)
float
C0369183 (UMLS CUI [1])
Mean cell haemoglobin concentration (MCHC)
Item
Mean cell haemoglobin concentration (MCHC)
float
C0474535 (UMLS CUI [1])
Item Group
Laboratory Result Data Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C0587081 (UMLS CUI-3)
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Albumin/globulin ratio
Item
Albumin/globulin ratio
float
C0201837 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline phosphatase (AP)
Item
Alkaline phosphatase (AP)
float
C0201850 (UMLS CUI [1])
Gamma glutamyl transferase (GGT)
Item
Gamma glutamyl transferase (GGT)
float
C0202035 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Phosphate
Item
Phosphate
float
C0523826 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
float
C1445957 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
float
C0202236 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Creatine phosphokinase
Item
Creatine phosphokinase
float
C0201973 (UMLS CUI [1])
Iron
Item
Iron
float
C0337439 (UMLS CUI [1])
Total Iron Binding Capacity
Item
Total Iron Binding Capacity
float
C1283048 (UMLS CUI [1])
Ferritin
Item
Ferritin
float
C0015879 (UMLS CUI [1])
Transferrin
Item
Transferrin
float
C0202105 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
FSH/LH
Item
FSH/LH
float
C2122182 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Item Group
Urinalysis, Dipstick Test
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Urine sample date
Item
Urine sample date
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Urine sample time
Item
Urine sample time
time
C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Result of dipstick
integer
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Result of dipstick
Code List
Result of dipstick
CL Item
Negative (1)
CL Item
Positive. If positive, record results of individual tests below. (2)
CL Item
No Result (3)
Item
Urine Dipstick: Proteins
integer
C0428541 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urine Dipstick Proteins
Code List
Urine Dipstick: Proteins
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Glucose
integer
C0004076 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urine Dipstick Proteins
Code List
Urine Dipstick: Glucose
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: pH
integer
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urine Dipstick Proteins
Code List
Urine Dipstick: pH
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Bilirubin
integer
C0430374 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urine Dipstick Proteins
Code List
Urine Dipstick: Bilirubin
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Blood
integer
C0430372 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urine Dipstick Proteins
Code List
Urine Dipstick: Blood
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
Item
Urine Dipstick: Specific gravity
integer
C0202517 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urine Dipstick Proteins
Code List
Urine Dipstick: Specific gravity
CL Item
none or negative (1)
CL Item
trace (2)
CL Item
+ or 1+ (3)
CL Item
++ or 2+ (4)
CL Item
+++ or 3+ (5)
CL Item
++++ or 4+ (6)
CL Item
+++++ or 5+ (7)
sedimentary microscopy
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
casts
Item
Urinalysis (Microscopy) Test: Casts
text
C4048266 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Cells
Item
Urinalysis (Microscopy) Test: Cells
text
C0919738 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
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