ID

36146

Beskrivning

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

Nyckelord

  1. 2019-04-17 2019-04-17 -
  2. 2019-04-17 2019-04-17 -
  3. 2019-04-23 2019-04-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 april 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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
Beskrivning

Randomisation Number

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

Was the subject able to be randomised?

Datatyp

boolean

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

Randomisation Number

Datatyp

integer

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

Date of Randomisation

Datatyp

date

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

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
Beskrivning

Dosing Date and Time

Datatyp

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
Beskrivning

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
Beskrivning

Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Beskrivning

RR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
IntervalC0489636
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc (b) Interval
Beskrivning

QTc (b) Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

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

Result of the ECG

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart
Beskrivning

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
Beskrivning

Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Beskrivning

RR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc (b) Interval
Beskrivning

QTc (b) Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

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

Result of the ECG

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart
Beskrivning

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
Beskrivning

Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Beskrivning

RR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc (b) Interval
Beskrivning

QTc (b) Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

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

Result of the ECG

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - 30 mins
Beskrivning

12-Lead ECG - 30 mins

Alias
UMLS CUI-1
C0430456
Time of ECG
Beskrivning

Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Beskrivning

RR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc (b) Interval
Beskrivning

QTc (b) Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

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

Result of the ECG

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - 1 hr
Beskrivning

12-Lead ECG - 1 hr

Alias
UMLS CUI-1
C0430456
Time of ECG
Beskrivning

Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Beskrivning

RR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc (b) Interval
Beskrivning

QTc (b) Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

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

Result of the ECG

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - 24 hr
Beskrivning

12-Lead ECG - 24 hr

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

Date and Time of ECG

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Beskrivning

RR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489636
msec
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc (b) Interval
Beskrivning

QTc (b) Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

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

Result of the ECG

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Dosing date/ time
Beskrivning

Dosing date/ time

Datatyp

datetime

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

Vital Signs - Pre dose

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

Actual time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beskrivning

Respiration rate

Datatyp

integer

Måttenheter
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Vital Signs - 30 mins
Beskrivning

Vital Signs - 30 mins

Alias
UMLS CUI-1
C0518766
Actual time
Beskrivning

Actual time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs - 24 hrs
Beskrivning

Vital Signs - 24 hrs

Alias
UMLS CUI-1
C0518766
Actual date/time
Beskrivning

Actual date/time

Datatyp

datetime

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

Systolic Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Pharmacokinetics Blood - GW856553
Beskrivning

Pharmacokinetics Blood - GW856553

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

Dosing date/time

Datatyp

datetime

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

Pre dose - Actual time

Datatyp

time

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

30 mins - Actual time

Datatyp

time

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

1 hr - Actual time

Datatyp

time

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

2 hrs - Actual time

Datatyp

time

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

3 hrs - Actual time

Datatyp

time

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

4 hrs - Actual time

Datatyp

time

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

6 hrs - Actual time

Datatyp

time

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

8 hrs - Actual time

Datatyp

time

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

10 hrs - Actual time

Datatyp

time

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

12 hrs - Actual date/time

Datatyp

datetime

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

18 hrs- Actual date/time

Datatyp

datetime

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

24 hrs (Day2) - Actual date/time

Datatyp

time

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

36 hrs (Day 2) - Actual date/time

Datatyp

datetime

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

48 hrs (Day 3) - Actual date/time

Datatyp

datetime

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

72 hrs (Day4) - Actual date/time

Datatyp

datetime

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

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
Beskrivning

Haematology Date and time sample taken

Datatyp

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
Beskrivning

Haematology sampling not done

Datatyp

integer

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

Clinical Chemistry Date and time sample taken

Datatyp

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
Beskrivning

Clinical Chemistry sampling not done

Datatyp

integer

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

Urinalysis Date and time sample taken

Datatyp

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
Beskrivning

Urinalysis sampling not done

Datatyp

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)
Beskrivning

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
Beskrivning

Haematology Date and time sample taken

Datatyp

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
Beskrivning

Haematology sampling not done

Datatyp

integer

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

Clinical Chemistry Date and time sample taken

Datatyp

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
Beskrivning

Clinical Chemistry sampling not done

Datatyp

integer

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

Urinalysis Date and time sample taken

Datatyp

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
Beskrivning

Urinalysis sampling not done

Datatyp

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)
Beskrivning

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
Beskrivning

AST/ ALT Date and time sample taken

Datatyp

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
Beskrivning

AST/ ALT sampling not done

Datatyp

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
Beskrivning

Investigational Product

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

Date/ time of dose

Datatyp

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?
Beskrivning

Did the subject receive the correct treatment during this dosing interval?

Datatyp

boolean

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

If subject did not receive correct treatment, record reasons

Datatyp

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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial