Informatie:
Fout:
ID
37660
Beschrijving
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 Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis
Trefwoorden
Versies (5)
- 15-04-19 15-04-19 -
- 17-04-19 17-04-19 -
- 23-04-19 23-04-19 -
- 14-08-19 14-08-19 -
- 14-08-19 14-08-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
14 augustus 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543
Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data
Similar models
Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject initials
Item
Subject initials
integer
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
Item
If subject is female, record childbearing potential
integer
C3831118 (UMLS CUI [1])
Code List
If subject is female, record childbearing potential
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
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])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
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)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
integer
C1305855 (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])
Subject identification
Item
Subject identification
integer
C2348585 (UMLS CUI [1])
Item Group
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
date
C0018941 (UMLS CUI [1])
C0005834 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0005834 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item
Haematology sample not done
integer
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Haematology sample not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1])
C0200345 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0200345 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item
Clinical Chemistry sample not done
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Clinical Chemistry sample not done (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinanalysis sample not done
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Urinanalysis sample not done (1)
Geen commentaren