ID
40328
Description
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
Mots-clés
Versions (1)
- 08/04/2020 08/04/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
8 avril 2020
DOI
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Licence
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
Description
Vitals
Alias
- UMLS CUI-1
- C0518766
Description
Vitals - Collect Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Description
Vitals - Collect Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Description
Vitals - Day
Type de données
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439228
Description
Vitals - Hour
Type de données
integer
Unités de mesure
- h
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439227
Description
Vials - Min
Type de données
integer
Unités de mesure
- min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439232
Description
Vitals - Position
Type de données
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1262869
Description
Vitals - Use in Report
Type de données
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0684224
Description
Vitals - Unscheduled
Type de données
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C3854240
Description
Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Pulse
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
Temperature
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature Source
Type de données
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449416
Description
Respiratory Rate
Type de données
integer
Unités de mesure
- r/min
Alias
- UMLS CUI [1]
- C0231832
Description
SPCO2 %
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0007012
Description
Vitals - Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Description
Vitals - Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Description
Vitals - BP required
Type de données
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0005823
- UMLS CUI [3]
- C1514873
Description
Vitals - HR required
Type de données
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0018810
- UMLS CUI [3]
- C1514873
Description
Vitals - Temp. required
Type de données
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0005903
- UMLS CUI [3]
- C1514873
Description
Vitals - Resp. required
Type de données
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0231832
- UMLS CUI [3]
- C1514873
Description
Vitals - SPCO2 required
Type de données
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0007012
- UMLS CUI [3]
- C1514873
Description
Vitals - Collection Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0947611
Description
PK
Alias
- UMLS CUI-1
- C0031327
Description
PK - Collect Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C1317250
Description
PK - Collect Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0040223
Description
PK - Day
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0439228
Description
PK - Hour
Type de données
integer
Unités de mesure
- h
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0439227
Description
PK - Min
Type de données
integer
Unités de mesure
- min
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0439232
Description
PK - Collection Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0947611
Description
Dosing
Alias
- UMLS CUI-1
- C0178602
Description
Dosing - Day
Type de données
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439228
Description
Dosing - Hour
Type de données
integer
Unités de mesure
- h
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439227
Description
Dosing - Min
Type de données
integer
Unités de mesure
- min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439232
Description
Dosing - Date Dose Administered
Type de données
date
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Description
Dosing - Time Dose Administered
Type de données
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Dosing - Drug
Type de données
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0013227
Description
UserID of user who confirms dose is correct.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0750484
Description
Medications - Drug
Alias
- UMLS CUI-1
- C0013227
Description
Prior Medication - Collection Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C1317250
Description
Prior Medication - Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0040223
Description
There were no prior medications for this subject
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826257
Description
Prior Medication - Drug Name
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2360065
Description
Prior Medication - Drug Dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0678766
Description
Prior Medication - Route
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0013153
Description
Prior Medication - Indication
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C3146298
Description
Prior Medication - Duration
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0449238
Description
Prior Medication - Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0806020
Description
Prior Medication - Stop Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C1522314
Description
Prior Medication - Continuing During Study
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0549178
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant Medication - Collection Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1317250
Description
Concomitant Medication - Collect Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0552379
Description
There were no concomitant medications for this subject
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Concomitant Medication - Drug Name
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Description
Concomitant Medication - Dose/Unit
Type de données
text
Alias
- UMLS CUI [1]
- C2826646
Description
Concomitant Medication - Freq/Day
Type de données
integer
Alias
- UMLS CUI [1]
- C2826654
Description
Concomitant Medication - Route
Type de données
text
Alias
- UMLS CUI [1]
- C2826730
Description
Concomitant Medication - Indication
Type de données
text
Alias
- UMLS CUI [1]
- C2826696
Description
Concomitant Medication - Taken to treat AE?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2981656
Description
Concomitant Medication - Start Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication - Start Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Medication - Stop Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826744
Description
Concomitant Medication - Stop Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522314
Description
Concomitant Medication - Continuing
Type de données
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])