ID
40328
Beschreibung
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
Stichworte
Versionen (1)
- 08.04.20 08.04.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
8. April 2020
DOI
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Lizenz
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
Beschreibung
Vitals
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Vitals - Collect Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Beschreibung
Vitals - Collect Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Beschreibung
Vitals - Day
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439228
Beschreibung
Vitals - Hour
Datentyp
integer
Maßeinheiten
- h
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439227
Beschreibung
Vials - Min
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439232
Beschreibung
Vitals - Position
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1262869
Beschreibung
Vitals - Use in Report
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0684224
Beschreibung
Vitals - Unscheduled
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C3854240
Beschreibung
Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Pulse
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
Temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature Source
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449416
Beschreibung
Respiratory Rate
Datentyp
integer
Maßeinheiten
- r/min
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
SPCO2 %
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0007012
Beschreibung
Vitals - Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
Beschreibung
Vitals - Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Beschreibung
Vitals - BP required
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0005823
- UMLS CUI [3]
- C1514873
Beschreibung
Vitals - HR required
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0018810
- UMLS CUI [3]
- C1514873
Beschreibung
Vitals - Temp. required
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0005903
- UMLS CUI [3]
- C1514873
Beschreibung
Vitals - Resp. required
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0231832
- UMLS CUI [3]
- C1514873
Beschreibung
Vitals - SPCO2 required
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0007012
- UMLS CUI [3]
- C1514873
Beschreibung
Vitals - Collection Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0947611
Beschreibung
PK
Alias
- UMLS CUI-1
- C0031327
Beschreibung
PK - Collect Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C1317250
Beschreibung
PK - Collect Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0040223
Beschreibung
PK - Day
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0439228
Beschreibung
PK - Hour
Datentyp
integer
Maßeinheiten
- h
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0439227
Beschreibung
PK - Min
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0439232
Beschreibung
PK - Collection Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0947611
Beschreibung
Dosing
Alias
- UMLS CUI-1
- C0178602
Beschreibung
Dosing - Day
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439228
Beschreibung
Dosing - Hour
Datentyp
integer
Maßeinheiten
- h
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439227
Beschreibung
Dosing - Min
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439232
Beschreibung
Dosing - Date Dose Administered
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Beschreibung
Dosing - Time Dose Administered
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beschreibung
Dosing - Drug
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0013227
Beschreibung
UserID of user who confirms dose is correct.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0750484
Beschreibung
Medications - Drug
Alias
- UMLS CUI-1
- C0013227
Beschreibung
Prior Medication - Collection Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C1317250
Beschreibung
Prior Medication - Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0040223
Beschreibung
There were no prior medications for this subject
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826257
Beschreibung
Prior Medication - Drug Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C2360065
Beschreibung
Prior Medication - Drug Dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0678766
Beschreibung
Prior Medication - Route
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0013153
Beschreibung
Prior Medication - Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C3146298
Beschreibung
Prior Medication - Duration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0449238
Beschreibung
Prior Medication - Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0806020
Beschreibung
Prior Medication - Stop Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C1522314
Beschreibung
Prior Medication - Continuing During Study
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826257
- UMLS CUI [1,2]
- C0549178
Beschreibung
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Concomitant Medication - Collection Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1317250
Beschreibung
Concomitant Medication - Collect Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0552379
Beschreibung
There were no concomitant medications for this subject
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Concomitant Medication - Drug Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beschreibung
Concomitant Medication - Dose/Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C2826646
Beschreibung
Concomitant Medication - Freq/Day
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826654
Beschreibung
Concomitant Medication - Route
Datentyp
text
Alias
- UMLS CUI [1]
- C2826730
Beschreibung
Concomitant Medication - Indication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Concomitant Medication - Taken to treat AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2981656
Beschreibung
Concomitant Medication - Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Concomitant Medication - Start Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Beschreibung
Concomitant Medication - Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Concomitant Medication - Stop Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1522314
Beschreibung
Concomitant Medication - Continuing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Ähnliche Modelle
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])