ID
36234
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
Versioner (1)
- 2019-04-23 2019-04-23 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 april 2019
DOI
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Licens
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
Follow-up - Electronically Transferred Lab Data; 12-Lead ECG; Vital Signs; Study Conclusion; Pregnancy Information
Beskrivning
Electronically Transferred Lab Data - Pre dose
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
- UMLS CUI-4
- C0439565
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
Beskrivning
Haematology sampling not done
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C1272696
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
Beskrivning
Clinical Chemistry sampling not done
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
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
Beskrivning
Urinalysis sampling not done
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Beskrivning
Electronically Transferred Lab Data - 24 hrs (Day 2)
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
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
Beskrivning
Haematology sampling not done
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C1272696
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
Beskrivning
Clinical Chemistry sampling not done
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
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
Beskrivning
Urinalysis sampling not done
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1272696
Beskrivning
Electronically Transferred Lab Data - 72 hrs (Day 4)
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
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
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
Beskrivning
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0013798
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C0040223
Beskrivning
Heart Rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
RR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0489636
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
Uncorrected QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTc (b) Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
Method of QTc Calculation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beskrivning
Result of the ECG
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Actual date/ time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Respiration rate
Datatyp
integer
Måttenheter
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beskrivning
Temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beskrivning
Date of subject completion or date and time of subject withdrawal
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2983670
- UMLS CUI [2,1]
- C0422727
- UMLS CUI [2,2]
- C0011008
Beskrivning
Was the subject withdrawn from the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
If subject was withdrawn from study, specify primary reason for withdrawal
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Beskrivning
If other reason for withdrawal, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
Beskrivning
Data owner should check the box when data cleaning is complete
Datatyp
text
Alias
- UMLS CUI [1]
- C1519316
Beskrivning
Office Use 1
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0442603
Beskrivning
Office Use 2
Datatyp
text
Alias
- UMLS CUI [1]
- C0442603
Beskrivning
Pregnancy Information (F)
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
Pregnancy Information (M)
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Similar models
Follow-up - Electronically Transferred Lab Data; 12-Lead ECG; Vital Signs; Study Conclusion; Pregnancy Information
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0439565 (UMLS CUI-4)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
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])
C0013798 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C2911685 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1533716 (UMLS CUI-2)
C1533716 (UMLS CUI-2)