ID

41696

Descripción

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

Palabras clave

Versiones (2)
  1. 22/12/20 22/12/20 -
  2. 22/12/20 22/12/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de diciembre de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

Inglés

Part 1, Period 1 - 3: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics

1 formularios  
Date of Visit
Descripción

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Local Laboratory - Haematology (Period 1 - 3)
Descripción

Local Laboratory - Haematology (Period 1 - 3)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date and time sample taken (Haematology)
Descripción

Date and time sample taken (Haematology)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0018941
Has the subject fasted? (Haematology)
Descripción

Has the subject fasted? (Haematology)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0018941
Local Laboratory - Haematology (Period 1 - 3)
Descripción

Local Laboratory - Haematology (Period 1 - 3)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematologic test
Descripción

Haematologic test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018941
Numeric result (Haemoatology)
Descripción

Numeric result (Haemoatology)

Tipo de datos

float

Alias
UMLS CUI [1]
C2347373
UMLS CUI [2]
C0474523
Character result (Haematology)
Descripción

Character result (Haematology)

Tipo de datos

text

Alias
UMLS CUI [1]
C2350015
UMLS CUI [2]
C0474523
No result (Haematology)
Descripción

No result (Haematology)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0474523
Local Laboratory - Clinical Chemistry (Period 1 - 3)
Descripción

Local Laboratory - Clinical Chemistry (Period 1 - 3)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date and time sample taken (Clinical Chemistry)
Descripción

Date and time sample taken (Clinical Chemistry)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0008000
Has the subject fasted? (Clinical Chemistry)
Descripción

Has the subject fasted? (Clinical Chemistry)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0008000
Local Laboratory - Clinical Chemistry (Period 1 - 3)
Descripción

Local Laboratory - Clinical Chemistry (Period 1 - 3)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Clinical Chemistry Test
Descripción

Clinical Chemistry Test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0525044
Numeric result (Clinical Chemistry)
Descripción

Numeric result (Clinical Chemistry)

Tipo de datos

float

Alias
UMLS CUI [1]
C2347373
UMLS CUI [2]
C0008000
Character result (Clinical Chemistry)
Descripción

Character result (Clinical Chemistry)

Tipo de datos

text

Alias
UMLS CUI [1]
C2350015
UMLS CUI [2]
C0008000
No result (Clinical Chemistry)
Descripción

No result (Clinical Chemistry)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C0008000
Investigational Product (Dose) (Period 1 - 3)
Descripción

Investigational Product (Dose) (Period 1 - 3)

Alias
UMLS CUI-1
C0304229
Date/time of dose
Descripción

Date/time of dose

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Number of Inhalations
Descripción

Number of Inhalations

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0354922
UMLS CUI [1,2]
C0237753
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Descripción

Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If subject did not recieve the correct treatment, record reason
Descripción

If subject did not recieve the correct treatment, record reason

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [2]
C0392360
ECG (Period 1 - 3)
Descripción

ECG (Period 1 - 3)

Alias
UMLS CUI-1
C0013798
Dosing date/time
Descripción

Dosing date/time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
Timepoint
Descripción

Timepoint

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348792
Time of ECG
Descripción

Time of ECG

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Heart rate
Descripción

Heart rate

Tipo de datos

integer

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

PR Interval

Tipo de datos

integer

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

QRS Duration

Tipo de datos

integer

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

Uncorrected QT Interval

Tipo de datos

integer

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

QTc Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QTc (b) Interval
Descripción

QTc (b) Interval

Tipo de datos

integer

Unidades de medida
  • ms
Alias
UMLS CUI [1]
C1882512
ms
Method of QTc Calculation
Descripción

Method of QTc Calculation

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Descripción

Result of the ECG

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs (Period 1 - 3)
Descripción

Vital Signs (Period 1 - 3)

Alias
UMLS CUI-1
C0518766
Dosing date/time (Vital Signs)
Descripción

Dosing date/time (Vital Signs)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Vital Signs Timepoint
Descripción

Vital Signs Timepoint

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Vital Signs - Actual time
Descripción

Vital Signs - Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Vital Signs - Diastolic Blood Pressure
Descripción

Vital Signs - Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0428883
mm[Hg]
Vital Signs - Systolic Blood Pressure
Descripción

Vital Signs - Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0871470
mm[Hg]
Vital Signs - Heart rate
Descripción

Vital Signs - Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Pulmonary Function Tests (Period 1 - 3)
Descripción

Pulmonary Function Tests (Period 1 - 3)

Alias
UMLS CUI-1
C0024119
Dosing date/time (Pulmonary Function Tests)
Descripción

Dosing date/time (Pulmonary Function Tests)

Tipo de datos

datetime

Alias
UMLS CUI [1]
C0178602
UMLS CUI [2,1]
C0024119
UMLS CUI [2,2]
C1264639
Pulmonary Function Tests Timepoint
Descripción

Pulmonary Function Tests Timepoint

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C2348792
Date/time of test
Descripción

Date/time of test

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1264639
FEV1 (3 readings) - 1
Descripción

FEV1 (3 readings) - 1

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 2
Descripción

FEV1 (3 readings) - 2

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
FEV1 (3 readings) - 3
Descripción

FEV1 (3 readings) - 3

Tipo de datos

integer

Unidades de medida
  • L
Alias
UMLS CUI [1]
C0748133
L
Local Laboratory - Haematology (24Hr Lab) (Period 1 - 3)
Descripción

Local Laboratory - Haematology (24Hr Lab) (Period 1 - 3)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date and time sample taken (Haematology, 24 Hr Lab)
Descripción

Date and time sample taken (Haematology, 24 Hr Lab)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0018941
Has the subject fasted? (Haematology, 24 Hr Lab)
Descripción

Has the subject fasted? (Haematology, 24 Hr Lab)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0018941
Local Laboratory - Haematology (24 Hr Lab) (Period 1 - 3)
Descripción

Local Laboratory - Haematology (24 Hr Lab) (Period 1 - 3)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Haematologic test (24 Hr Lab)
Descripción

Haematologic test (24 Hr Lab)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018941
Numeric result (Haemoatology, 24 Hr Lab)
Descripción

Numeric result (Haemoatology, 24 Hr Lab)

Tipo de datos

float

Alias
UMLS CUI [1]
C2347373
UMLS CUI [2]
C0474523
Character result (Haematology, 24 Hr Lab)
Descripción

Character result (Haematology, 24 Hr Lab)

Tipo de datos

text

Alias
UMLS CUI [1]
C2350015
UMLS CUI [2]
C0474523
No result (Haematology, 24 Hr Lab)
Descripción

No result (Haematology, 24 Hr Lab)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0474523
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3)
Descripción

Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
Descripción

Date and time sample taken (Clinical Chemistry, 24 Hr Lab)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
UMLS CUI [2]
C0008000
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
Descripción

Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C0008000
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3)
Descripción

Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Clinical Chemistry Test (24 Hr Lab)
Descripción

Clinical Chemistry Test (24 Hr Lab)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0525044
Numeric result (Clinical Chemistry, 24 Hr Lab)
Descripción

Numeric result (Clinical Chemistry, 24 Hr Lab)

Tipo de datos

float

Alias
UMLS CUI [1]
C2347373
UMLS CUI [2]
C0008000
Character result (Clinical Chemistry, 24 Hr Lab)
Descripción

Character result (Clinical Chemistry, 24 Hr Lab)

Tipo de datos

text

Alias
UMLS CUI [1]
C2350015
UMLS CUI [2]
C0008000
No result (Clinical Chemistry, 24 Hr Lab)
Descripción

No result (Clinical Chemistry, 24 Hr Lab)

Tipo de datos

integer

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C0008000
Pharmacokinetics Blood (Period 1 - 3)
Descripción

Pharmacokinetics Blood (Period 1 - 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Dosing date/time (Pharmacokinetics Blood)
Descripción

Dosing date/time (Pharmacokinetics Blood)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0005767
Pharmacokinetics Blood (Period 1 - 3)
Descripción

Pharmacokinetics Blood (Period 1 - 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Pharmacokinetics Blood Timepoint
Descripción

Pharmacokinetics Blood Timepoint

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [2]
C2348792
Actual date/time (Pharmacokinetics Blood)
Descripción

Actual date/time (Pharmacokinetics Blood)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [2]
C1264639
Pharmacokinetics Urine (Period 1 - 3)
Descripción

Pharmacokinetics Urine (Period 1 - 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
Dosing date/time (Pharmacokinetics Urine)
Descripción

Dosing date/time (Pharmacokinetics Urine)

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0042036
Pharmacokinetics Urine (Period 1 - 3)
Descripción

Pharmacokinetics Urine (Period 1 - 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
Pharmacokinetics Urine Timepoint
Descripción

Pharmacokinetics Urine Timepoint

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C2348792
Was all of the sample collected for this interval? (Pharmacokinetics Urine)
Descripción

Was all of the sample collected for this interval? (Pharmacokinetics Urine)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0042036
Start date and Actual start time (Pharmacokinetics Urine)
Descripción

Start date and Actual start time (Pharmacokinetics Urine)

Tipo de datos

datetime

Alias
UMLS CUI [1]
C3897500
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0042036
Stop date and Actual stop time (Pharmacokinetics Urine)
Descripción

Stop date and Actual stop time (Pharmacokinetics Urine)

Tipo de datos

datetime

Alias
UMLS CUI [1]
C3899266
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0042036
Total sample volume (Pharmacokinetics Urine)
Descripción

Total sample volume (Pharmacokinetics Urine)

Tipo de datos

integer

Unidades de medida
  • mL
Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0042036
UMLS CUI [2]
C1278293
mL
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Similar models

Part 1, Period 1 - 3: Local Laboratory; Investigational Product; ECG, Vital Signs; Pharmacokinetics

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
Has the subject fasted? (Haematology)
Item
Has the subject fasted? (Haematology)
boolean
C0015663 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematologic test
integer
C0018941 (UMLS CUI [1])
Haematologic test
Code List
Haematologic test
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)
Item
Numeric result (Haemoatology)
float
C2347373 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Character result (Haematology)
Item
Character result (Haematology)
text
C2350015 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Item
No result (Haematology)
integer
C0474523 (UMLS CUI [1])
No result (Haematology)
Code List
No result (Haematology)
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry)
Item
Date and time sample taken (Clinical Chemistry)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
Has the subject fasted? (Clinical Chemistry)
Item
Has the subject fasted? (Clinical Chemistry)
boolean
C0015663 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item Group
Local Laboratory - Clinical Chemistry (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test
integer
C0525044 (UMLS CUI [1])
Clinical Chemistry Test
Code List
Clinical Chemistry Test
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)
Item
Numeric result (Clinical Chemistry)
float
C2347373 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Character result (Clinical Chemistry)
Item
Character result (Clinical Chemistry)
text
C2350015 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item
No result (Clinical Chemistry)
integer
C0587081 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
No result (Clinical Chemistry)
Code List
No result (Clinical Chemistry)
CL Item
No result (1)
Item Group
Investigational Product (Dose) (Period 1 - 3)
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])
Number of Inhalations
Item
Number of Inhalations
integer
C0354922 (UMLS CUI [1,1])
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])
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])
Item Group
ECG (Period 1 - 3)
C0013798 (UMLS CUI-1)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
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)
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (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])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machcine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
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 (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)
Item Group
Vital Signs (Period 1 - 3)
C0518766 (UMLS CUI-1)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Vital Signs Timepoint
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Vital Signs Timepoint
Code List
Vital Signs Timepoint
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
36 hours Post-Dose (11)
CL Item
48 hours Post-Dose (12)
Vital Signs - Actual time
Item
Vital Signs - Actual time
time
C2826762 (UMLS CUI [1])
Vital Signs - Diastolic Blood Pressure
Item
Vital Signs - Diastolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Vital Signs - Systolic Blood Pressure
Item
Vital Signs - Systolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Vital Signs - Heart rate
Item
Vital Signs - Heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Pulmonary Function Tests (Period 1 - 3)
C0024119 (UMLS CUI-1)
Dosing date/time (Pulmonary Function Tests)
Item
Dosing date/time (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1])
C0024119 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
Item
Pulmonary Function Tests Timepoint
integer
C0024119 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Pulmonary Function Tests Timepoint
Code List
Pulmonary Function Tests Timepoint
CL Item
Pre-Dose (1)
CL Item
2 hours Post-Dose (2)
Date/time of test
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
FEV1 (3 readings) - 1
Item
FEV1 (3 readings) - 1
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2
Item
FEV1 (3 readings) - 2
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3
Item
FEV1 (3 readings) - 3
integer
C0748133 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology (24Hr Lab) (Period 1 - 3)
C0022885 (UMLS CUI-1)
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])
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])
Item Group
Local Laboratory - Haematology (24 Hr Lab) (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Item
Haematologic test (24 Hr Lab)
integer
C0018941 (UMLS CUI [1])
Haematologic test
Code List
Haematologic test (24 Hr Lab)
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])
Character result (Haematology, 24 Hr Lab)
Item
Character result (Haematology, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
Item
No result (Haematology, 24 Hr Lab)
integer
C0474523 (UMLS CUI [1])
No result (Haematology, 24 Hr Lab)
Code List
No result (Haematology, 24 Hr Lab)
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3)
C0022885 (UMLS CUI-1)
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])
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])
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Period 1 - 3)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test (24 Hr Lab)
integer
C0525044 (UMLS CUI [1])
Clinical Chemistry Test (24 Hr Lab)
Code List
Clinical Chemistry Test (24 Hr Lab)
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])
Character result (Clinical Chemistry, 24 Hr Lab)
Item
Character result (Clinical Chemistry, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item
No result (Clinical Chemistry, 24 Hr Lab)
integer
C0587081 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
No result (Clinical Chemistry, 24 Hr Lab)
Code List
No result (Clinical Chemistry, 24 Hr Lab)
CL Item
No result (1)
Item Group
Pharmacokinetics Blood (Period 1 - 3)
C0031328 (UMLS CUI-1)
C0005767 (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])
C0005767 (UMLS CUI [2,2])
Item Group
Pharmacokinetics Blood (Period 1 - 3)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Pharmacokinetics Blood Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C2348792 (UMLS CUI [2])
Pharmacokinetics Blood - Timepoint
Code List
Pharmacokinetics Blood Timepoint
CL Item
Pre-dose (1)
CL Item
5 mins Post-Dose (2)
CL Item
15 minsPost-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 2) (12)
CL Item
48 hours Post-Dose (Day 3) (13)
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])
Item Group
Pharmacokinetics Urine (Period 1 - 3)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
Dosing date/time (Pharmacokinetics Urine)
Item
Dosing date/time (Pharmacokinetics Urine)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Item Group
Pharmacokinetics Urine (Period 1 - 3)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
Item
Pharmacokinetics Urine Timepoint
integer
C0031328 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C2348792 (UMLS CUI [2])
Pharmacokinetics Urine Timepoint
Code List
Pharmacokinetics Urine Timepoint
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? (Pharmacokinetics Urine)
Item
Was all of the sample collected for this interval? (Pharmacokinetics Urine)
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Start date and Actual start time (Pharmacokinetics Urine)
Item
Start date and Actual start time (Pharmacokinetics Urine)
datetime
C3897500 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Stop date and Actual stop time (Pharmacokinetics Urine)
Item
Stop date and Actual stop time (Pharmacokinetics Urine)
datetime
C3899266 (UMLS CUI [1])
C0031328 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
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])
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