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ID
41709
Beschreibung
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive
Stichworte
Versionen (1)
- 02.01.21 02.01.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
2. Januar 2021
DOI
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Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673
Part 2, Period 4, Cohort 1 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities
Ähnliche Modelle
Part 2, Period 4, Cohort 1 Days 7, 8: Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Local Laboratory; Pharmacokinetics; Summary Holter; Holter Abnormalities
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Investigational Product (Dose) (Part 2 Period 4)
C0304229 (UMLS CUI-1)
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Number of Inhalations
Item
Number of Inhalations
integer
C0354922 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
If subject did not recieve the correct treatment, record reason
Item
If subject did not recieve the correct treatment, record reason
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Date and time sample taken (Haematology, 24 Hr Lab)
Item
Date and time sample taken (Haematology, 24 Hr Lab)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
Has the subject fasted? (Haematology, 24 Hr Lab)
Item
Has the subject fasted? (Haematology, 24 Hr Lab)
boolean
C0015663 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0018941 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hameoglobin (3)
CL Item
Haematocrit (4)
CL Item
Neutrophils (5)
CL Item
Lymphocytes (6)
CL Item
Monocytes (7)
CL Item
Eosinophils (8)
CL Item
Basophils (9)
CL Item
MCV (10)
CL Item
MCH (11)
CL Item
MCHC (12)
Numeric result (Haemoatology, 24 Hr Lab)
Item
Numeric result (Haemoatology, 24 Hr Lab)
float
C2347373 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
C0474523 (UMLS CUI [2])
Character result (Haematology, 24 Hr Lab)
Item
Character result (Haematology, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
C0474523 (UMLS CUI [2])
Item
No result (Haematology, 24 Hr Lab)
integer
C0474523 (UMLS CUI [1])
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
Item
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
Item
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
boolean
C0015663 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test (24 Hr Lab)
integer
C0525044 (UMLS CUI [1])
CL Item
ALT (1)
CL Item
AST (2)
CL Item
Total Bilrubin (3)
CL Item
Direct Bilirubin (4)
CL Item
Glucose Fasting (5)
CL Item
GGT (6)
CL Item
Total Protein (7)
CL Item
Albumin (8)
CL Item
Potassium (9)
CL Item
Sodium (10)
CL Item
Calcium (11)
CL Item
Urea (12)
CL Item
Creatinine (13)
CL Item
Uric Acid (14)
CL Item
Alkaline Phosphatase (15)
Numeric result (Clinical Chemistry, 24 Hr Lab)
Item
Numeric result (Clinical Chemistry, 24 Hr Lab)
float
C2347373 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
Character result (Clinical Chemistry, 24 Hr Lab)
Item
Character result (Clinical Chemistry, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
Item
No result (Clinical Chemistry, 24 Hr Lab)
integer
C0587081 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
CL Item
No result (1)
Dosing date/time (ECG)
Item
Dosing date/time (ECG)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
CL Item
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
15 mins Post-Dose (4)
CL Item
45 mins Post-Dose (5)
CL Item
90 mins Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
QTc (b) Interval
Item
QTc (b) Interval
integer
C1882512 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
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 additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item
Vital Signs Timepoint
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
CL Item
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
15 mins Post-Dose (4)
CL Item
45 mins Post-Dose (5)
CL Item
90 mins Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
CL Item
24 hours Post-Dose (10)
CL Item
48 hours Post-Dose (11)
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Pharmacokinetics Blood (Part 2 Period 4)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0005767 (UMLS CUI-2)
Dosing date/time (Pharamacokinetics Blood)
Item
Dosing date/time (Pharamacokinetics Blood)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0005767 (UMLS CUI [2,2])
C1264639 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0005767 (UMLS CUI [2,2])
Item Group
Pharmacokinetics Blood (Part 2 Period 4)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0005767 (UMLS CUI-2)
Item
Pharmacokinetics Blood Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C2348792 (UMLS CUI [2])
C0005767 (UMLS CUI [1,2])
C2348792 (UMLS CUI [2])
CL Item
Pre-Dose (1)
CL Item
5 mins Post-Dose (2)
CL Item
15 mins Post-Dose (3)
CL Item
30 mins Post-Dose (4)
CL Item
1 hour Post-Dose (5)
CL Item
2 hours Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
CL Item
16 hours Post-Dose (10)
CL Item
20 hours Post-Dose (11)
CL Item
24 hours Post-Dose (Day 8) (12)
CL Item
36 hours Post-Dose (Day 8) (13)
CL Item
48 hours Post-Dose (Day 9) (14)
CL Item
96-120 Hours (15)
Actual date/time (Pharmacokinetics Blood)
Item
Actual date/time (Pharmacokinetics Blood)
datetime
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
C0005767 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Item Group
Pharmacokinetics Urine (Part 2 Period 4)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
C0042036 (UMLS CUI-2)
Dosing date/time (Pharmacokinetics Blood)
Item
Dosing date/time (Pharmacokinetics Blood)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C1264639 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Item Group
Pharmacokinetics Urine (Part 2 Period 4)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
C0042036 (UMLS CUI-2)
Item
Pharmacokinetics Urine Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C2348792 (UMLS CUI [2])
C0042036 (UMLS CUI [1,2])
C2348792 (UMLS CUI [2])
CL Item
0-4 hours Post-Dose (1)
CL Item
4-8 hours Post-Dose (2)
CL Item
8-12 hours Post-Dose (3)
CL Item
12-24 hours Post-Dose (4)
CL Item
24-48 hours Post-Dose (5)
Was all of the sample collected for this interval?
Item
Was all of the sample collected for this interval?
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
Start date and Actual start time (Pharmacokinetics Urine)
Item
Start date and Actual start time (Pharmacokinetics Urine)
datetime
C3897500 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [2])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [2])
Stop date and Actual stop time (Pharmacokinetics Urine)
Item
Stop date and Actual stop time (Pharmacokinetics Urine)
datetime
C3899266 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [2])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [2])
Total sample volume (Pharmacokinetics Urine)
Item
Total sample volume (Pharmacokinetics Urine)
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C1278293 (UMLS CUI [2])
C0042036 (UMLS CUI [1,2])
C1278293 (UMLS CUI [2])
Item Group
Summary Holter (Part 2 Period 4)
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
C0242482 (UMLS CUI-2)
Dosing date/time (Summary Holter)
Item
Dosing date/time (Summary Holter)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2])
C1264639 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2])
Item Group
Summary Holter (Part 2 Period 4) (Pre-Dose - 24 hours)
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
C0242482 (UMLS CUI-2)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Maximum heart rate
Item
Maximum heart rate
integer
C0018810 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,2])
Minimum heart rate
Item
Minimum heart rate
integer
C0018810 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,2])
Mean heart rate
Item
Mean heart rate
integer
C1881634 (UMLS CUI [1])
Number of ventricular runs
Item
Number of ventricular runs
integer
C2189285 (UMLS CUI [1])
Number of ventricular runs - Not done, specify reason
Item
Number of ventricular runs - Not done, specify reason
text
C2189285 (UMLS CUI [1])
C2826287 (UMLS CUI [2])
C2826287 (UMLS CUI [2])
Item
Number of ventricular runs - Not applicable
text
C2189285 (UMLS CUI [1])
CL Item
Not applicable (X)
Number of supraventricular runs
Item
Number of supraventricular runs
integer
C0039240 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Number of supraventricular runs - Not done, specify reason
Item
Number of supraventricular runs - Not done, specify reason
text
C0039240 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2])
Item
Number of supraventricular runs - Not applicable
text
C0039240 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Code List
Number of supraventricular runs - Not applicable
CL Item
Not applicable (X)
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
C4086187 (UMLS CUI [1,2])
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
Holter Abnormalities (Part 2 Period 4)
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item Group
Holter Abnormalities (Part 2 Period 4)
C0013801 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
CL Item
Electrical alternans (A21)
CL Item
R on T phenomenon (A22)
CL Item
Ventricular fibrillation (A23)
CL Item
Trigeminy (A20)
CL Item
Ventricular premature depolarisation (A17)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (A26)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A25)
CL Item
Idioventricular rhythm (<= beats/min, defined by wide QRS complex) (A24)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (A12)
CL Item
Atrial flutter (A13)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A28)
CL Item
Atrial fibrillation (A14)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A29)
CL Item
Ventricular couplets (A18)
CL Item
Bigeminy (A19)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (A10)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (A11)
CL Item
Torsade de Pointes (TdP) (A32)
CL Item
Pacemaker (A33)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A27)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A30)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (A15)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A31)
CL Item
Junctional tachycardia (>100 beats/min) (A16)
CL Item
Short PR Interval (A35)
CL Item
No abnormalities (A00)
CL Item
Sinus bradycardia (50-59 beats/min) (A01)
CL Item
Sinus bradycardia (40-49 beats/min) (A02)
CL Item
Sinus bradycardia (30-39 beats/min) (A03)
CL Item
Sinus bradycardia (<30 beats/min) (A04)
CL Item
Sinus pause (A05)
CL Item
Sinus tachycardia (>100 beats/min) (A06)
CL Item
Ectopic supraventricular beats (A07)
CL Item
Ectopic supraventricular rhythm (A08)
CL Item
Wandering atrial pacemaker (A09)
CL Item
First degree AV block (PR Interval >200msec) (A34)
CL Item
Second degree AV block (Mobitz type 1) (A36)
CL Item
Second degree AV block (Mobitz type 2) (A37)
CL Item
2:1 AV block (A38)
CL Item
Third degree AV block (A39)
CL Item
Left axis deviation (QRS axis more negative thant -30 degrees) (A40)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (A41)
CL Item
Incomplete right bundle branch block (A42)
CL Item
Incomplete left bundle branch block (A43)
CL Item
Right bundle branch block (A44)
CL Item
Left anterior hemiblock (A45)
CL Item
Left posterior hemiblock (A46)
CL Item
Left bundle branch block (A47)
CL Item
Bifascicular block (A48)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (A49)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-levine) (A50)
CL Item
QTc prolongation >=500 msec (A51)
CL Item
AV dissociation (A52)
CL Item
Myocardial Infarction, old (A53)
CL Item
Myocardial Infarction, non Q-wave (A54)
CL Item
Non-specific ST-T changes (A55)
CL Item
J point elevation (A56)
CL Item
ST elevation (A57)
CL Item
ST depression (A58)
CL Item
St segment abnormality (A59)
CL Item
U waves (A60)
CL Item
T wave Inversion (A61)
CL Item
T wave peaked (A62)
CL Item
T waves biphasic (A63)
CL Item
T waves flat (A64)
CL Item
Notched T-waves (A65)
CL Item
Low QRS voltage (A66)
CL Item
T wave abnormality (A67)
CL Item
Other abnormal rhythm (A94)
CL Item
Other morphology (A95)
CL Item
Other conduction (A96)
CL Item
Other myocardial infarction (A97)
CL Item
Other depolarisation/repolarisation (A98)
CL Item
Other abnormality/Cardiologist comments (A99)
Other abnormal rhythm, specify
Item
Other abnormal rhythm, specify
text
C0199556 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Other morphology, specify
Item
Other morphology, specify
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other conduction, specify
Item
Other conduction, specify
text
C0340494 (UMLS CUI [1])
C2348235 (UMLS CUI [2])
C2348235 (UMLS CUI [2])
Other myocardial infarction, specify
Item
Other myocardial infarction, specify
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other depolarisation/repolrisation, specify
Item
Other depolarisation/repolrisation, specify
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other abnormality/ Cardiologist comments
Item
Other abnormality/ Cardiologist comments
text
C1704258 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
Item
Holter monitoring method
integer
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
C0871511 (UMLS CUI [1,2])
CL Item
12 Lead 1000Hz (1)
CL Item
12 Lead 180Hz (2)
CL Item
3 Lead 180Hz (3)
CL Item
3 Lead 512Hz (4)
Item Group
Pulmonary Function Tests (Part 2 Period 4)
C0024119 (UMLS CUI-1)
Dosing date/time (Pulmonary Function Tests)
Item
Dosing date/time (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0024119 (UMLS CUI [2])
C1264639 (UMLS CUI [1,2])
C0024119 (UMLS CUI [2])
Item Group
Pulmonary Function Tests (Part 2 Period 4)
C0024119 (UMLS CUI-1)
Item
Pulmonary Function Tests Timepoint
integer
C0024119 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
CL Item
Pre-Dose (1)
CL Item
30 mins Post-Dose (2)
CL Item
2 hours Post-Dose (3)
Date/time of test
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
FEV (3 readings) - 1
Item
FEV (3 readings) - 1
integer
C0748133 (UMLS CUI [1])
FEV (3 readings) - 2
Item
FEV (3 readings) - 2
integer
C0748133 (UMLS CUI [1])
FEV (3 readings) - 3
Item
FEV (3 readings) - 3
integer
C0748133 (UMLS CUI [1])
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