ID
40313
Beskrivning
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
Nyckelord
Versioner (2)
- 2020-04-06 2020-04-06 -
- 2020-04-06 2020-04-06 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
6 april 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883
Adverse Events; Demography; Height Weight; ECG
- StudyEvent: ODM
Beskrivning
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beskrivning
User ID of reviewing physician populated by system.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0035173
- UMLS CUI [1,2]
- C3166277
Beskrivning
Verbatim AE
Datatyp
text
Alias
- UMLS CUI [1]
- C2699044
Beskrivning
Term sent for MedDRA coding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1140263
Beskrivning
AE - MedDRA Code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3898442
Beskrivning
Serious AE
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
SAE
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
AE - Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
AE - Start time
Datatyp
time
Alias
- UMLS CUI [1]
- C2697889
Beskrivning
AE - Continuing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826663
Beskrivning
AE - Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0877248
Beskrivning
AE - Stop time
Datatyp
time
Alias
- UMLS CUI [1]
- C2826658
Beskrivning
AE - Number of episodes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beskrivning
AE - Intensity
Datatyp
text
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
AE - Action
Datatyp
text
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
AE - Therapy
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
AE - Outcome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
AE - Experience Course
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
AE - Intensity (maximum)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0806909
Beskrivning
AE - Action with respect to Investigational Drug
Datatyp
text
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
AE - Total Number episodes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
- UMLS CUI [1,3]
- C0439810
Beskrivning
AE - Is there a reasonable possibility that the AE may have been caused by the Investigational Product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
AE - Corrective Therapy
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
Was patient withdrawn due to this AE?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0877248
Beskrivning
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beskrivning
SAE - Collected
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1516698
Beskrivning
Enter all that apply
Datatyp
integer
Alias
- UMLS CUI [1]
- C3828190
Beskrivning
2. Did the SAE abate
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beskrivning
3. If study medication was interrupted, stopped, or dose reduced: Was study medication reintroduced
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0420247
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0376495
Beskrivning
3. If study medication was reintroduced, did SAE recur?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0376495
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beskrivning
4. If Relationship to Investigational drug was NOT RELATED or UNLIKELY choose an assessment. The SAE is probably associated with
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
5. Please provide details supporting the selection made in item 4
Datatyp
text
Alias
- UMLS CUI [1]
- C1522508
Beskrivning
Please provide a brief narrative description of the SAE
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Was the randomization code broken at the investigational site
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0805701
Beskrivning
Randomization/study medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0304229
Beskrivning
Form activated if SAE_Reason = Fatal
Datatyp
date
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Form activated if SAE_Reason = Fatal
Datatyp
text
Alias
- UMLS CUI [1]
- C0007465
Beskrivning
Form activated if SAE_Reason = Fatal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004398
Beskrivning
Dorm activated if SAE_Reason = Fatal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0011900
Beskrivning
SAE Report signed by:
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0684224
- UMLS CUI [1,3]
- C1519316
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Demography - Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C2985720
Beskrivning
Demography - Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0040223
Beskrivning
Demography - Day
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0439228
Beskrivning
Demography - Hour
Datatyp
integer
Måttenheter
- h
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0439227
Beskrivning
Demography - Min
Datatyp
integer
Måttenheter
- min
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0439232
Beskrivning
Date of Birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Race Other
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
Beskrivning
Subject Type
Datatyp
text
Alias
- UMLS CUI [1]
- C2348569
Beskrivning
Group of Patient when SUBTYPE = Patient (Normal entered where SUBTYPE = volunteer)
Datatyp
text
Alias
- UMLS CUI [1]
- C1522242
Beskrivning
Height Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-2
- C0005910
Beskrivning
Height Weight - Physical Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C2826643
Beskrivning
Height Weight - Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0040223
Beskrivning
Height Weight - Day
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0439228
Beskrivning
Height Weight - Hour
Datatyp
integer
Måttenheter
- h
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0439227
Beskrivning
Height Weight - Min
Datatyp
integer
Måttenheter
- min
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0439232
Beskrivning
Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
ECG
Alias
- UMLS CUI-1
- C1623258
Beskrivning
ECG Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
ECG Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beskrivning
ECG Day
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0439228
Beskrivning
ECG Hour
Datatyp
integer
Måttenheter
- h
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0439227
Beskrivning
ECG Min
Datatyp
integer
Måttenheter
- min
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0439232
Beskrivning
ECG Normal
Datatyp
text
Alias
- UMLS CUI [1]
- C0522054
Beskrivning
Ventricular Rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C2189285
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0520880
Beskrivning
QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTc Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
ECG Interpretation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Beskrivning
ECG Interpretation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Beskrivning
ECG Holter
Alias
- UMLS CUI-1
- C0013801
Beskrivning
ECG Holter Day
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0439228
Beskrivning
ECG Holter Hour
Datatyp
integer
Måttenheter
- h
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0439227
Beskrivning
ECG Holter Min
Datatyp
integer
Måttenheter
- min
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0439232
Beskrivning
ECG Recording Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
Beskrivning
ECG Holter Start time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1301880
Beskrivning
ECG Recording Stop Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
Beskrivning
ECG Holter Stop Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1522314
Beskrivning
ECG Holter - Type of Monitoring
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0332307
Beskrivning
ECG Holter Normal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0522054
Beskrivning
ECG Holter - Analysis Details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0936012
- UMLS CUI [1,3]
- C1522508
Similar models
Adverse Events; Demography; Height Weight; ECG
- StudyEvent: ODM
C2603343 (UMLS CUI [1,2])
C3166277 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C4086638 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C3853704 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0376495 (UMLS CUI [2])
C0376495 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0684224 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
C2985720 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,2])
C2826643 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
C0005910 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
C0013798 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1283169 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0936012 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])