ID
40328
Beschrijving
Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity
Trefwoorden
Versies (1)
- 08-04-20 08-04-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 april 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883
Vitals; PK; Dosing; Medications; Concomitant Medication
- StudyEvent: ODM
Beschrijving
Vitals
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Vitals - Collect Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Beschrijving
Vitals - Collect Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Beschrijving
Vitals - Day
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439228
Beschrijving
Vitals - Hour
Datatype
integer
Maateenheden
- h
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439227
Beschrijving
Vials - Min
Datatype
integer
Maateenheden
- min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439232
Beschrijving
Vitals - Position
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1262869
Beschrijving
Vitals - Use in Report
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0684224
Beschrijving
Vitals - Unscheduled
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C3854240
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Pulse
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Temperature Source
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449416
Beschrijving
Respiratory Rate
Datatype
integer
Maateenheden
- r/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
SPCO2 %
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0007012
Beschrijving
Vitals - Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Beschrijving
Vitals - Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Beschrijving
Vitals - BP required
Datatype
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0005823
- UMLS CUI [3]
- C1514873
Beschrijving
Vitals - HR required
Datatype
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0018810
- UMLS CUI [3]
- C1514873
Beschrijving
Vitals - Temp. required
Datatype
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0005903
- UMLS CUI [3]
- C1514873
Beschrijving
Vitals - Resp. required
Datatype
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0231832
- UMLS CUI [3]
- C1514873
Beschrijving
Vitals - SPCO2 required
Datatype
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0007012
- UMLS CUI [3]
- C1514873
Beschrijving
Vitals - Collection Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0947611
Beschrijving
PK
Alias
- UMLS CUI-1
- C0031327
Beschrijving
PK - Collect Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C1317250
Beschrijving
PK - Collect Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0040223
Beschrijving
PK - Day
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0439228
Beschrijving
PK - Hour
Datatype
integer
Maateenheden
- h
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0439227
Beschrijving
PK - Min
Datatype
integer
Maateenheden
- min
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0439232
Beschrijving
PK - Collection Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0947611
Beschrijving
Dosing
Alias
- UMLS CUI-1
- C0178602
Beschrijving
Dosing - Day
Datatype
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439228
Beschrijving
Dosing - Hour
Datatype
integer
Maateenheden
- h
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439227
Beschrijving
Dosing - Min
Datatype
integer
Maateenheden
- min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439232
Beschrijving
Dosing - Date Dose Administered
Datatype
date
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Beschrijving
Dosing - Time Dose Administered
Datatype
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beschrijving
Dosing - Drug
Datatype
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0013227
Beschrijving
UserID of user who confirms dose is correct.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0750484
Beschrijving
Medications - Drug
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Prior Medication - Collection Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C1317250
Beschrijving
Prior Medication - Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0040223
Beschrijving
There were no prior medications for this subject
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826257
Beschrijving
Prior Medication - Drug Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2360065
Beschrijving
Prior Medication - Drug Dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0678766
Beschrijving
Prior Medication - Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0013153
Beschrijving
Prior Medication - Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C3146298
Beschrijving
Prior Medication - Duration
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0449238
Beschrijving
Prior Medication - Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0806020
Beschrijving
Prior Medication - Stop Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C1522314
Beschrijving
Prior Medication - Continuing During Study
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0549178
Beschrijving
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant Medication - Collection Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1317250
Beschrijving
Concomitant Medication - Collect Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0552379
Beschrijving
There were no concomitant medications for this subject
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Concomitant Medication - Drug Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschrijving
Concomitant Medication - Dose/Unit
Datatype
text
Alias
- UMLS CUI [1]
- C2826646
Beschrijving
Concomitant Medication - Freq/Day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826654
Beschrijving
Concomitant Medication - Route
Datatype
text
Alias
- UMLS CUI [1]
- C2826730
Beschrijving
Concomitant Medication - Indication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
Concomitant Medication - Taken to treat AE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2981656
Beschrijving
Concomitant Medication - Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant Medication - Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant Medication - Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Concomitant Medication - Stop Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522314
Beschrijving
Concomitant Medication - Continuing
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Similar models
Vitals; PK; Dosing; Medications; Concomitant Medication
- StudyEvent: ODM
C2603343 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,2])
C0449416 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
C0018810 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
C0005903 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
C0231832 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
C0007012 (UMLS CUI [2])
C1514873 (UMLS CUI [3])
C0947611 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1317250 (UMLS CUI [1,2])
C0552379 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C2981656 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])