ID
40313
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 (2)
- 06.04.20 06.04.20 -
- 06.04.20 06.04.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
6. 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
Adverse Events; Demography; Height Weight; ECG
- StudyEvent: ODM
Beschreibung
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschreibung
User ID of reviewing physician populated by system.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0035173
- UMLS CUI [1,2]
- C3166277
Beschreibung
Verbatim AE
Datentyp
text
Alias
- UMLS CUI [1]
- C2699044
Beschreibung
Term sent for MedDRA coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1140263
Beschreibung
AE - MedDRA Code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3898442
Beschreibung
Serious AE
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
SAE
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
AE - Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2697888
Beschreibung
AE - Start time
Datentyp
time
Alias
- UMLS CUI [1]
- C2697889
Beschreibung
AE - Continuing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826663
Beschreibung
AE - Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0877248
Beschreibung
AE - Stop time
Datentyp
time
Alias
- UMLS CUI [1]
- C2826658
Beschreibung
AE - Number of episodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beschreibung
AE - Intensity
Datentyp
text
Alias
- UMLS CUI [1]
- C1710066
Beschreibung
AE - Action
Datentyp
text
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
AE - Therapy
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschreibung
AE - Outcome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
AE - Experience Course
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
AE - Intensity (maximum)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0806909
Beschreibung
AE - Action with respect to Investigational Drug
Datentyp
text
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
AE - Total Number episodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
- UMLS CUI [1,3]
- C0439810
Beschreibung
AE - Is there a reasonable possibility that the AE may have been caused by the Investigational Product?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
AE - Corrective Therapy
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschreibung
Was patient withdrawn due to this AE?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0877248
Beschreibung
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beschreibung
SAE - Collected
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1516698
Beschreibung
Enter all that apply
Datentyp
integer
Alias
- UMLS CUI [1]
- C3828190
Beschreibung
2. Did the SAE abate
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beschreibung
3. If study medication was interrupted, stopped, or dose reduced: Was study medication reintroduced
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0420247
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C0376495
Beschreibung
3. If study medication was reintroduced, did SAE recur?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0376495
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beschreibung
4. If Relationship to Investigational drug was NOT RELATED or UNLIKELY choose an assessment. The SAE is probably associated with
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
5. Please provide details supporting the selection made in item 4
Datentyp
text
Alias
- UMLS CUI [1]
- C1522508
Beschreibung
Please provide a brief narrative description of the SAE
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Was the randomization code broken at the investigational site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0805701
Beschreibung
Randomization/study medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0304229
Beschreibung
Form activated if SAE_Reason = Fatal
Datentyp
date
Alias
- UMLS CUI [1]
- C1148348
Beschreibung
Form activated if SAE_Reason = Fatal
Datentyp
text
Alias
- UMLS CUI [1]
- C0007465
Beschreibung
Form activated if SAE_Reason = Fatal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschreibung
Dorm activated if SAE_Reason = Fatal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0011900
Beschreibung
SAE Report signed by:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0684224
- UMLS CUI [1,3]
- C1519316
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Demography - Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C2985720
Beschreibung
Demography - Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0040223
Beschreibung
Demography - Day
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0439228
Beschreibung
Demography - Hour
Datentyp
integer
Maßeinheiten
- h
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0439227
Beschreibung
Demography - Min
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C0011298
- UMLS CUI [1,2]
- C0439232
Beschreibung
Date of Birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Race Other
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
Beschreibung
Subject Type
Datentyp
text
Alias
- UMLS CUI [1]
- C2348569
Beschreibung
Group of Patient when SUBTYPE = Patient (Normal entered where SUBTYPE = volunteer)
Datentyp
text
Alias
- UMLS CUI [1]
- C1522242
Beschreibung
Height Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-2
- C0005910
Beschreibung
Height Weight - Physical Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C2826643
Beschreibung
Height Weight - Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0040223
Beschreibung
Height Weight - Day
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0439228
Beschreibung
Height Weight - Hour
Datentyp
integer
Maßeinheiten
- h
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0439227
Beschreibung
Height Weight - Min
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0005910
- UMLS CUI [1,3]
- C0439232
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
ECG
Alias
- UMLS CUI-1
- C1623258
Beschreibung
ECG Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826640
Beschreibung
ECG Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschreibung
ECG Day
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0439228
Beschreibung
ECG Hour
Datentyp
integer
Maßeinheiten
- h
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0439227
Beschreibung
ECG Min
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0439232
Beschreibung
ECG Normal
Datentyp
text
Alias
- UMLS CUI [1]
- C0522054
Beschreibung
Ventricular Rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C2189285
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0520880
Beschreibung
QT Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschreibung
QTc Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
ECG Interpretation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Beschreibung
ECG Interpretation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Beschreibung
ECG Holter
Alias
- UMLS CUI-1
- C0013801
Beschreibung
ECG Holter Day
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0439228
Beschreibung
ECG Holter Hour
Datentyp
integer
Maßeinheiten
- h
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0439227
Beschreibung
ECG Holter Min
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0439232
Beschreibung
ECG Recording Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
Beschreibung
ECG Holter Start time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1301880
Beschreibung
ECG Recording Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
Beschreibung
ECG Holter Stop Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1522314
Beschreibung
ECG Holter - Type of Monitoring
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1283169
- UMLS CUI [1,3]
- C0332307
Beschreibung
ECG Holter Normal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0522054
Beschreibung
ECG Holter - Analysis Details
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0936012
- UMLS CUI [1,3]
- C1522508
Ähnliche Modelle
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])