ID

36146

Descripción

Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Palabras clave

  1. 17/4/19 17/4/19 -
  2. 17/4/19 17/4/19 -
  3. 23/4/19 23/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

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The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543

Period 1 - Randomisation Number; 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

Randomisation Number
Descripción

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Descripción

Was the subject able to be randomised?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0085732
Randomisation Number
Descripción

Randomisation Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of Randomisation
Descripción

Date of Randomisation

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
12 Lead ECG - Dosing Date and Time
Descripción

12 Lead ECG - Dosing Date and Time

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing Date and Time
Descripción

Dosing Date and Time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart
Descripción

12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3812758
Time of ECG
Descripción

Time of ECG

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0430456
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
RR Interval
Descripción

RR Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
IntervalC0489636
msec
QRS Duration
Descripción

QRS Duration

Tipo de datos

integer

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

PR Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
Uncorrected QT Interval
Descripción

Uncorrected QT Interval

Tipo de datos

integer

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

QTc (b) Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
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
12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart
Descripción

12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3812758
Time of ECG
Descripción

Time of ECG

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0430456
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
RR Interval
Descripción

RR Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Descripción

PR Interval

Tipo de datos

integer

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

QRS Duration

Tipo de datos

integer

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

Uncorrected QT Interval

Tipo de datos

integer

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

QTc (b) Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
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
12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart
Descripción

12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3812758
Time of ECG
Descripción

Time of ECG

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0430456
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
RR Interval
Descripción

RR Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Descripción

PR Interval

Tipo de datos

integer

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

QRS Duration

Tipo de datos

integer

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

Uncorrected QT Interval

Tipo de datos

integer

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

QTc (b) Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
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
12-Lead ECG - 30 mins
Descripción

12-Lead ECG - 30 mins

Alias
UMLS CUI-1
C0430456
Time of ECG
Descripción

Time of ECG

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0430456
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
RR Interval
Descripción

RR Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Descripción

PR Interval

Tipo de datos

integer

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

QRS Duration

Tipo de datos

integer

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

Uncorrected QT Interval

Tipo de datos

integer

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

QTc (b) Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
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
12-Lead ECG - 1 hr
Descripción

12-Lead ECG - 1 hr

Alias
UMLS CUI-1
C0430456
Time of ECG
Descripción

Time of ECG

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0430456
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
RR Interval
Descripción

RR Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Descripción

PR Interval

Tipo de datos

integer

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

QRS Duration

Tipo de datos

integer

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

Uncorrected QT Interval

Tipo de datos

integer

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

QTc (b) Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
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
12-Lead ECG - 24 hr
Descripción

12-Lead ECG - 24 hr

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

Date and Time of ECG

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0430456
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
RR Interval
Descripción

RR Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Descripción

PR Interval

Tipo de datos

integer

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

QRS Duration

Tipo de datos

integer

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

Uncorrected QT Interval

Tipo de datos

integer

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

QTc (b) Interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0489625
msec
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
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Dosing date/ time
Descripción

Dosing date/ time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Vital Signs - Pre dose
Descripción

Vital Signs - Pre dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Actual time
Descripción

Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Descripción

Respiration rate

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Vital Signs - 30 mins
Descripción

Vital Signs - 30 mins

Alias
UMLS CUI-1
C0518766
Actual time
Descripción

Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Descripción

Systolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs - 24 hrs
Descripción

Vital Signs - 24 hrs

Alias
UMLS CUI-1
C0518766
Actual date/time
Descripción

Actual date/time

Tipo de datos

datetime

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

Systolic Blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Descripción

Diastolic Blood Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Pharmacokinetics Blood - GW856553
Descripción

Pharmacokinetics Blood - GW856553

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

Dosing date/time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Pre dose - Actual time
Descripción

Pre dose - Actual time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0040223
30 mins - Actual time
Descripción

30 mins - Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
1 hr - Actual time
Descripción

1 hr - Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
2 hrs - Actual time
Descripción

2 hrs - Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
3 hrs - Actual time
Descripción

3 hrs - Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
4 hrs - Actual time
Descripción

4 hrs - Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
6 hrs - Actual time
Descripción

6 hrs - Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
8 hrs - Actual time
Descripción

8 hrs - Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
10 hrs - Actual time
Descripción

10 hrs - Actual time

Tipo de datos

time

Alias
UMLS CUI [1]
C0040223
12 hrs - Actual date/time
Descripción

12 hrs - Actual date/time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
18 hrs- Actual date/time
Descripción

18 hrs- Actual date/time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
24 hrs (Day2) - Actual date/time
Descripción

24 hrs (Day2) - Actual date/time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
36 hrs (Day 2) - Actual date/time
Descripción

36 hrs (Day 2) - Actual date/time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
48 hrs (Day 3) - Actual date/time
Descripción

48 hrs (Day 3) - Actual date/time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
72 hrs (Day4) - Actual date/time
Descripción

72 hrs (Day4) - Actual date/time

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
Electronically Transferred Lab Data - Pre dose
Descripción

Electronically Transferred Lab Data - Pre dose

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
UMLS CUI-4
C0439565
Haematology Date and time sample taken
Descripción

Haematology Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sampling not done
Descripción

Haematology sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Descripción

Clinical Chemistry Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sampling not done
Descripción

Clinical Chemistry sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Descripción

Urinalysis Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Urinalysis sampling not done
Descripción

Urinalysis sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data - 24 hrs (Day 2)
Descripción

Electronically Transferred Lab Data - 24 hrs (Day 2)

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Haematology Date and time sample taken
Descripción

Haematology Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sampling not done
Descripción

Haematology sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Descripción

Clinical Chemistry Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sampling not done
Descripción

Clinical Chemistry sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Descripción

Urinalysis Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Urinalysis sampling not done
Descripción

Urinalysis sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data - 72 hrs (Day 4)
Descripción

Electronically Transferred Lab Data - 72 hrs (Day 4)

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
AST/ ALT Date and time sample taken
Descripción

AST/ ALT Date and time sample taken

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0200345
UMLS CUI [3]
C0201836
AST/ ALT sampling not done
Descripción

AST/ ALT sampling not done

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C1272696
UMLS CUI [2,1]
C0201899
UMLS CUI [2,2]
C0022885
UMLS CUI [2,3]
C0870078
UMLS CUI [2,4]
C1272696
Investigational Product
Descripción

Investigational Product

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]
C0040223
UMLS CUI [1,4]
C0011008
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 during this dosing interval?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If subject did not receive correct treatment, record reasons.
Descripción

If subject did not receive correct treatment, record reasons

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0392360

Similar models

Period 1 - Randomisation Number; 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of Randomisation
Item
Date of Randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
12 Lead ECG - Dosing Date and Time
C0430456 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing Date and Time
Item
Dosing Date and Time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart
C0430456 (UMLS CUI-1)
C3812758 (UMLS CUI-2)
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
IntervalC0489636 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (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
12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart
C0430456 (UMLS CUI-1)
C3812758 (UMLS CUI-2)
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (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 (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (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
12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart
C0430456 (UMLS CUI-1)
C3812758 (UMLS CUI-2)
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (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 (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (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
12-Lead ECG - 30 mins
C0430456 (UMLS CUI-1)
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (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 (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (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
12-Lead ECG - 1 hr
C0430456 (UMLS CUI-1)
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (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 (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (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
12-Lead ECG - 24 hr
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (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 (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine  (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (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
C0518766 (UMLS CUI-1)
Dosing date/ time
Item
Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Vital Signs - Pre dose
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
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])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Vital Signs - 30 mins
C0518766 (UMLS CUI-1)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
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
Vital Signs - 24 hrs
C0518766 (UMLS CUI-1)
Actual date/time
Item
Actual date/time
datetime
C0011008 (UMLS CUI [1,1])
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 - GW856553
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Dosing date/time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pre dose - Actual time
Item
Pre dose - Actual time
time
C0439565 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
30 mins - Actual time
Item
30 mins - Actual time
time
C0040223 (UMLS CUI [1])
1 hr - Actual time
Item
1 hr - Actual time
time
C0040223 (UMLS CUI [1])
2 hrs - Actual time
Item
2 hrs - Actual time
time
C0040223 (UMLS CUI [1])
3 hrs - Actual time
Item
3 hrs - Actual time
time
C0040223 (UMLS CUI [1])
4 hrs - Actual time
Item
4 hrs - Actual time
time
C0040223 (UMLS CUI [1])
6 hrs - Actual time
Item
6 hrs - Actual time
time
C0040223 (UMLS CUI [1])
8 hrs - Actual time
Item
8 hrs - Actual time
time
C0040223 (UMLS CUI [1])
10 hrs - Actual time
Item
10 hrs - Actual time
time
C0040223 (UMLS CUI [1])
12 hrs - Actual date/time
Item
12 hrs - Actual date/time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
18 hrs- Actual date/time
Item
18 hrs- Actual date/time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
24 hrs (Day2) - Actual date/time
Item
24 hrs (Day2) - Actual date/time
time
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
36 hrs (Day 2) - Actual date/time
Item
36 hrs (Day 2) - Actual date/time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
48 hrs (Day 3) - Actual date/time
Item
48 hrs (Day 3) - Actual date/time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
72 hrs (Day4) - Actual date/time
Item
72 hrs (Day4) - Actual date/time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically Transferred Lab Data - Pre dose
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0439565 (UMLS CUI-4)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sampling not done
integer
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Haematology sampling not done
CL Item
Haematology sampling not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sampling not done
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Clinical Chemistry sampling not done
CL Item
Clinical Chemistry sampling not done (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Urinalysis sampling not done
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Urinalysis sampling not done
CL Item
Urinalysis sampling not done (1)
Item Group
Electronically Transferred Lab Data - 24 hrs (Day 2)
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sampling not done
integer
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Haematology sampling not done
CL Item
Haematology sampling not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sampling not done
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Clinical Chemistry sampling not done
CL Item
Clinical Chemistry sampling not done (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Urinalysis sampling not done
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Urinalysis sampling not done
CL Item
Urinalysis sampling not done (1)
Item Group
Electronically Transferred Lab Data - 72 hrs (Day 4)
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
AST/ ALT Date and time sample taken
Item
AST/ ALT Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Item
AST/ ALT sampling not done
integer
C0201899 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C0201899 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C0870078 (UMLS CUI [2,3])
C1272696 (UMLS CUI [2,4])
Code List
AST/ ALT sampling not done
CL Item
AST/ ALT sampling not done (1)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date/ time of dose
Item
Date/ time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Did the subject receive the correct treatment 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 receive correct treatment, record reasons
Item
If subject did not receive correct treatment, record reasons.
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])

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